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Psychological Support for Patients With an Implantable Cardioverter Defibrillator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00152763
Recruitment Status : Completed
First Posted : September 9, 2005
Results First Posted : January 28, 2011
Last Update Posted : January 28, 2011
Sponsor:
Information provided by:
University Health Network, Toronto

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Anxiety
Depression
Interventions Behavioral: Cognitive Behaviour Therapy (CBT)
Other: Usual Cardiac Care (UCC)
Enrollment 193
Recruitment Details Recruitment commenced in October 2003 at Toronto General Hospital and St. Michael's Hospital in Toronto, Ontario, Canada and concluded in August 2006.
Pre-assignment Details Upon recruitment, participants completed baseline psychological assessment prior to being randomized to the experimental intervention arm (cognitive behaviour therapy) or usual care.
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Period Title: Overall Study
Started 77 19 20 77
Completed 67 14 16 63
Not Completed 10 5 4 14
Reason Not Completed
Death             4             1             2             1
Lost to Follow-up             6             4             2             13
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men Total
Hide Arm/Group Description Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet. Total of all reporting groups
Overall Number of Baseline Participants 77 19 20 77 193
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 19 participants 20 participants 77 participants 193 participants
61.29  (13.17) 54.58  (15.75) 55.35  (18.30) 64.2  (13.35) 61.68  (14.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 19 participants 20 participants 77 participants 193 participants
Female
0
   0.0%
19
 100.0%
20
 100.0%
0
   0.0%
39
  20.2%
Male
77
 100.0%
0
   0.0%
0
   0.0%
77
 100.0%
154
  79.8%
1.Primary Outcome
Title Hospital Anxiety and Depression Scale - Depression Scale at Baseline
Hide Description Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analyses but data on participants who died over follow-up were omitted.
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.70  (3.41) 7.47  (5.02) 5.35  (3.82) 4.12  (4.01)
2.Primary Outcome
Title Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up
Hide Description Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Time Frame Six-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analyses but data on participants who died over follow-up were omitted.
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.21  (3.31) 4.86  (3.25) 5.50  (4.22) 3.82  (3.39)
3.Primary Outcome
Title Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up
Hide Description Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.
Time Frame Twelve-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analyses but data on participants who died over follow-up were omitted.
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.52  (3.29) 4.67  (4.19) 5.87  (3.12) 4.15  (3.36)
4.Primary Outcome
Title Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline
Hide Description Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analyses but data on participants who died over follow-up were omitted.
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.53  (4.26) 9.32  (5.50) 7.70  (3.85) 4.80  (3.93)
5.Primary Outcome
Title Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up
Hide Description Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Time Frame Six-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analyses but data on participants who died over follow-up were omitted.
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.06  (3.84) 7.28  (4.01) 6.83  (4.67) 4.69  (3.92)
6.Primary Outcome
Title Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up
Hide Description Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.
Time Frame Twelve-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analyses but data on participants who died over follow-up were omitted.
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.06  (3.97) 8.00  (3.70) 7.25  (3.57) 4.43  (3.77)
7.Primary Outcome
Title Impact of Events Scale-Revised - Total Score at Baseline
Hide Description Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis although data for participants who died over follow-up were omitted.
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 12 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.81  (0.66) 1.56  (0.99) 1.20  (0.85) 0.63  (0.51)
8.Primary Outcome
Title Impact of Events Scale-Revised - Total Score at 6-months Follow-up
Hide Description Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Time Frame Six-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis although data for participants who died over follow-up were omitted.
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 12 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.70  (0.52) 0.76  (0.83) 0.68  (0.64) 0.54  (0.62)
9.Primary Outcome
Title Impact of Events Scale-Revised - Total Score at 12-months Follow-up
Hide Description Psychometric measure of post traumatic stress disorder symptoms, scores range from 0 to 4. A score threshold of 1.4 has been found to diagnostic of post traumatic stress disorder in war veterans. Higher scores represent greater total post traumatic stress disorder symptoms.
Time Frame Twelve-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis although data for participants who died over follow-up were omitted.
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 12 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.70  (0.64) 0.69  (0.53) 0.82  (0.69) 0.46  (0.47)
10.Primary Outcome
Title Impact of Events Scale-Revised - Intrusiveness Scale at Baseline
Hide Description Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.80  (0.71) 1.53  (0.98) 1.25  (0.95) 0.61  (0.64)
11.Primary Outcome
Title Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up
Hide Description Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Time Frame Six-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.61  (0.52) 0.82  (0.96) 0.73  (0.73) 0.56  (0.73)
12.Primary Outcome
Title Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up
Hide Description Psychometric measure of post traumatic stress disorder intrusiveness symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder intrusiveness symptoms.
Time Frame Twelve-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.62  (0.62) 0.64  (0.60) 0.80  (0.70) 0.42  (0.47)
13.Primary Outcome
Title Impact of Events Scale-Revised - Avoidance Scale at Baseline
Hide Description Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis although data from participants who died were omitted from analysis
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 12 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.84  (0.62) 1.68  (1.10) 1.25  (0.82) 0.64  (0.58)
14.Primary Outcome
Title Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up
Hide Description Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Time Frame Six-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis although data from participants who died were omitted from analysis
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 12 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.86  (0.64) 0.77  (0.87) 0.74  (0.71) 0.55  (0.64)
15.Primary Outcome
Title Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up
Hide Description Psychometric assessment of post traumatic stress disorder avoidance symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder avoidance symptoms.
Time Frame Twelve-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis although data from participants who died were omitted from analysis
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 12 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.82  (0.74) 0.84  (0.65) 0.98  (0.86) 0.57  (0.66)
16.Primary Outcome
Title Impact of Event Scale-Revised Hyperarousal Scale at Baseline
Hide Description Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.78  (0.86) 1.40  (1.11) 1.07  (0.98) 0.64  (0.67)
17.Primary Outcome
Title Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up
Hide Description Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Time Frame Six-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.61  (0.70) 0.64  (0.87) 0.56  (0.61) 0.52  (0.70)
18.Primary Outcome
Title Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up
Hide Description Psychometric measure of post traumatic stress disorder hyper-arousal symptoms, scores range from 0 to 4. Higher scores represent greater post traumatic stress disorder hyperarousal symptoms.
Time Frame Twelve-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.64  (0.73) 0.57  (0.54) 0.67  (0.70) 0.39  (0.43)
19.Primary Outcome
Title Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline
Hide Description Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 12 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.98  (0.39) 1.17  (0.28) 1.23  (0.41) 0.83  (0.33)
20.Primary Outcome
Title Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up
Hide Description Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Time Frame Six-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 12 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.92  (0.40) 1.04  (0.38) 1.07  (0.36) 0.84  (0.35)
21.Primary Outcome
Title Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up
Hide Description Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Time Frame Twelve-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 12 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.98  (0.40) 1.13  (0.35) 1.07  (0.40) 0.93  (0.35)
22.Secondary Outcome
Title SF-36 Mental Component Summary Scale at Baseline
Hide Description Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
45.90  (13.40) 37.44  (13.69) 42.33  (12.43) 49.84  (10.56)
23.Secondary Outcome
Title SF-36 Mental Component Summary Scale at 6-months Follow-up
Hide Description Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Time Frame Six-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
48.73  (10.34) 43.82  (11.64) 45.67  (10.84) 51.32  (10.99)
24.Secondary Outcome
Title SF-36 Mental Component Summary Scale at 12-months Follow-up
Hide Description Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.
Time Frame Twelve-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
49.92  (10.50) 46.26  (14.00) 41.58  (9.02) 51.61  (46.26)
25.Secondary Outcome
Title SF-36 Physical Component Summary Score at Baseline
Hide Description Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
39.19  (10.46) 36.13  (7.06) 37.60  (11.81) 38.85  (10.15)
26.Secondary Outcome
Title SF-36 Physical Component Summary Score at 6-months Follow-up
Hide Description Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Time Frame Six-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
42.54  (10.58) 41.46  (12.43) 41.22  (12.85) 42.69  (10.06)
27.Secondary Outcome
Title SF-36 Physical Component Summary Score at 12-months Follow-up
Hide Description Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.
Time Frame Twelve-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
Overall Number of Participants Analyzed 73 18 16 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
42.65  (10.33) 42.70  (10.44) 42.82  (14.53) 41.54  (11.23)
28.Secondary Outcome
Title Percentage of Participants Who Received ICD Therapies
Hide Description Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.
Time Frame 12-months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Cardiac Care Cognitive Behaviour Therapy
Hide Arm/Group Description:
Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This includes all men and women who received UCC.
Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet. These data are on men and women combined within CBT.
Overall Number of Participants Analyzed 97 96
Measure Type: Number
Unit of Measure: Percentage of participants
30.5 31.9
Time Frame [Not Specified]
Adverse Event Reporting Description Death was the only adverse event collected.
 
Arm/Group Title Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Hide Arm/Group Description Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
All-Cause Mortality
Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/77 (5.19%)   1/19 (5.26%)   2/20 (10.00%)   1/77 (1.30%) 
General disorders         
Deaths  4/77 (5.19%)  1/19 (5.26%)  2/20 (10.00%)  1/77 (1.30%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Cardiac Care - Men Cognitive Behaviour Therapy - Women Usual Cardiac Care - Women Cognitive Therapy Group - Men
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jane Irvine
Organization: University Health Network, Toronto General Hospital
Phone: (416) 736-5115 ext 22444
EMail: jirvine@yorku.ca
Publications:
Irvine, J. Stanley, J., Ong, L., Cribbie, R., Ritvo, P., Katz, J., Dorian, P., O'Donnell, S., Harris, L., Cameron, D., Hill, A., Newman, D., Johnson, S. N., Bilanovic, A. Sears, S F. Acceptability of a Cognitive Behavior Therapy Intervention to Implantable Cardioverter Defibrillator Recipients, Journal of Cognitive Psychotherapy, 2010; 24(4) (November), 243-264.
Layout table for additonal information
Responsible Party: Jane Irvine, University Health Network, Toronto General Hospital
ClinicalTrials.gov Identifier: NCT00152763    
Other Study ID Numbers: NA 5170
Grant number NA 5170
First Submitted: September 7, 2005
First Posted: September 9, 2005
Results First Submitted: October 27, 2010
Results First Posted: January 28, 2011
Last Update Posted: January 28, 2011