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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

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 9, 2005
Results First Submitted Date  ICMJE October 27, 2010
Results First Posted Date  ICMJE January 28, 2011
Last Update Posted Date January 28, 2011
Study Start Date  ICMJE October 2003
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2011)
  • Hospital Anxiety and Depression Scale - Depression Scale at Baseline [ Time Frame: Baseline ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
  • Psychological distress (symptoms of anxiety and depression)
  • Quality of life
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2011)
  • SF-36 Mental Component Summary Scale at Baseline [ Time Frame: Baseline ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Percentage of participants who received ICD shocks or anti-tachycardia therapies, data extracted from participants ICD devices over follow-up.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
ICD therapies
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Official Title  ICMJE Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Brief Summary

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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety
  • Depression
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Cognitive Behaviour Therapy (CBT)
  • 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.
    Intervention: Behavioral: Cognitive Behaviour Therapy (CBT)
  • 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.
    Intervention: Other: Usual Cardiac Care (UCC)
  • 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.
    Intervention: Other: Usual Cardiac Care (UCC)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2011)
193
Original Enrollment  ICMJE
 (submitted: September 7, 2005)
218
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00152763
Other Study ID Numbers  ICMJE NA 5170
Grant number NA 5170
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jane Irvine, University Health Network, Toronto General Hospital
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jane Irvine, D.Phil. University Health Network, Toronto General Hospital
PRS Account University Health Network, Toronto
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP