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Psychological Support for Patients With an Implantable Cardioverter Defibrillator

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152763
First received: September 7, 2005
Last updated: January 5, 2011
Last verified: January 2011
History of Changes
  Purpose

About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating ICD therapy. The aims of the current study are:

  1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
  2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
  3. to explore if the psychosocial intervention results in less need for appropriate ICD therapies.

Condition Intervention Phase
Anxiety
Depression
 Behavioral: Cognitive Behaviour Therapy (CBT)
Other: Usual Cardiac Care (UCC)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychological Support for Patients With an Implantable Cardioverter Defibrillator

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Hospital Anxiety and Depression Scale - Depression Scale at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.

  • Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up [ Time Frame: Six-months follow-up ] [ Designated as safety issue: No ]
    Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.

  • Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up [ Time Frame: Twelve-months follow-up ] [ Designated as safety issue: No ]
    Psychometric scale measuring symptoms of depression, score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater depressive symptoms.

  • Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.

  • Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up [ Time Frame: Six-months follow-up ] [ Designated as safety issue: No ]
    Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.

  • Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up [ Time Frame: Twelve-months follow-up ] [ Designated as safety issue: No ]
    Psychometric scale measuring symptoms of anxiety,score range is 0 to 24. Scores >= 8 represent clinically elevated scores. Higher scores represent greater anxiety symptoms.

  • Impact of Events Scale-Revised - Total Score at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Impact of Events Scale-Revised - Total Score at 6-months Follow-up [ Time Frame: Six-months follow-up ] [ Designated as safety issue: No ]
    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.

  • Impact of Events Scale-Revised - Total Score at 12-months Follow-up [ Time Frame: Twelve-months follow-up ] [ Designated as safety issue: No ]
    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.

  • Impact of Events Scale-Revised - Intrusiveness Scale at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up [ Time Frame: Six-months follow-up ] [ Designated as safety issue: No ]
    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.

  • Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up [ Time Frame: Twelve-months follow-up ] [ Designated as safety issue: No ]
    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.

  • Impact of Events Scale-Revised - Avoidance Scale at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up [ Time Frame: Six-months follow-up ] [ Designated as safety issue: No ]
    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.

  • Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up [ Time Frame: Twelve-months follow-up ] [ Designated as safety issue: No ]
    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.

  • Impact of Event Scale-Revised Hyperarousal Scale at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up [ Time Frame: Six-months follow-up ] [ Designated as safety issue: No ]
    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.

  • Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up [ Time Frame: Twelve-months follow-up ] [ Designated as safety issue: No ]
    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.

  • Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.

  • Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up [ Time Frame: Six-months follow-up ] [ Designated as safety issue: No ]
    Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.

  • Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up [ Time Frame: Twelve-months follow-up ] [ Designated as safety issue: No ]
    Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.


Secondary Outcome Measures:
  • SF-36 Mental Component Summary Scale at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.

  • SF-36 Mental Component Summary Scale at 6-months Follow-up [ Time Frame: Six-months follow-up ] [ Designated as safety issue: No ]
    Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.

  • SF-36 Mental Component Summary Scale at 12-months Follow-up [ Time Frame: Twelve-months follow-up ] [ Designated as safety issue: No ]
    Quality of life measure - mental health summary, scores range from 0 to 100 with higher scores representing better mental health.

  • SF-36 Physical Component Summary Score at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.

  • SF-36 Physical Component Summary Score at 6-months Follow-up [ Time Frame: Six-months follow-up ] [ Designated as safety issue: No ]
    Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.

  • SF-36 Physical Component Summary Score at 12-months Follow-up [ Time Frame: Twelve-months follow-up ] [ Designated as safety issue: No ]
    Quality of life measure of physical health, scores range from 0 to 100 with higher scores representing better physical health.

  • Percentage of Participants Who Received ICD Therapies [ Time Frame: 12-months follow-up ] [ Designated as safety issue: No ]
    Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.


Enrollment: 193
Study Start Date: October 2003
Study Completion Date: November 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavior Therapy - males
Eight telephone sessions of cognitive behavior therapy tailored to psychological adaptation to an ICD, plus a psycho-educational booklet for participants and a therapist manual. This arm included the males.
 Behavioral: Cognitive Behaviour Therapy (CBT)
Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual.
Experimental: Cognitive Behavior Therapy - females
Eight telephone sessions of cognitive behavior therapy tailored to psychological adaptation to an ICD, plus a psycho-educational booklet for participants and a therapist manual. This arm included the females.
 Behavioral: Cognitive Behaviour Therapy (CBT)
Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual.
Active Comparator: Usual Cardiac Care - Males
The UCC was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received 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. This arm was just for males randomized.
 Other: Usual Cardiac Care (UCC)
Usual cardiac care (UCC) was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received 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.
Active Comparator: Usual Cardiac Care - females
The UCC was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received 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. This arm was for females randomized.
 Other: Usual Cardiac Care (UCC)
Usual cardiac care (UCC) was defined as whatever the respective ICD treatment sites routinely offer their patients. All patients received 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.

Detailed Description:

About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating ICD therapy. The aims of the current study are:

  1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
  2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
  3. to explore if the psychosocial intervention results in less need for appropriate ICD therapies.

This study will randomize 218 ICD patients to receive either usual cardiac care (n=109) OR usual cardiac care plus CBT (n=109). Participants are recruited from two hospitals in Toronto that perform ICD implants (St. Michael's Hospital and the Toronto General Hospital). Counselling follows a CBT manual and involves both face-to-face sessions and telephone sessions. The telephone is employed as a means to deliver therapy as at least half of our ICD subjects reside outside of Toronto and all patients are prohibited from driving an automobile for the first six months following ICD implant. Outcome is assessed 6 and 12-months following the date of randomization and include measures of psychological function and quality of life. Secondary outcome is frequency of ICD therapies over follow-up (i.e., anti-tachycardia pacing terminations and DC shocks).

Inclusion Criteria:

  • Patients from either Toronto General hospital or St. Michael's Hospital who have coronary heart disease,
  • Receiving their first ICD implant for secondary prevention of SCD or primary prevention of SCD if their underlying heart disease was hypertrophic cardiomyopathy.

Exclusion Criteria:

  • Not able to read or understand English;
  • Evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
  • Receiving an ICD for primary prevention of ICD.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients from either Toronto General hospital or St. Michael's Hospital who have coronary heart disease,
  • Receiving their first ICD implant for secondary prevention of SCD or for primary prevention of SCD and their underlying heart disease was hypertrophic cardiomyopathy.

Exclusion Criteria:

  • Not able to read or understand English;
  • Evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;
  • Receiving an ICD for primary prevention of ICD.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152763

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Jane Irvine, D.Phil. University Health Network, Toronto General Hospital
  More Information

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jane Irvine, University Health Network, Toronto General Hospital
ClinicalTrials.gov Identifier: NCT00152763     History of Changes
Other Study ID Numbers: NA 5170, Grant number NA 5170
Study First Received: September 7, 2005
Results First Received: October 27, 2010
Last Updated: January 5, 2011
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
health anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
 Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 16, 2013