- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00152763
Psychological Support for Patients With an Implantable Cardioverter Defibrillator
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:
- to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
- to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
- to explore if the psychosocial intervention results in less need for appropriate ICD therapies.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
- to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
- 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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Six-months follow-up
|
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.
|
Twelve-months follow-up
|
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.
|
Baseline
|
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.
|
Six-months follow-up
|
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.
|
Twelve-months follow-up
|
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.
|
Baseline
|
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.
|
Six-months follow-up
|
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.
|
Twelve-months follow-up
|
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.
|
Baseline
|
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.
|
Six-months follow-up
|
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.
|
Twelve-months follow-up
|
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.
|
Baseline
|
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.
|
Six-months follow-up
|
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.
|
Twelve-months follow-up
|
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.
|
Baseline
|
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.
|
Six-months follow-up
|
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.
|
Twelve-months follow-up
|
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.
|
Baseline
|
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.
|
Six-months follow-up
|
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.
|
Twelve-months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Six-months follow-up
|
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.
|
Twelve-months follow-up
|
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.
|
Baseline
|
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.
|
Six-months follow-up
|
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.
|
Twelve-months follow-up
|
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.
|
12-months follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jane Irvine, D.Phil., University Health Network, Toronto General Hospital
Publications and helpful links
General 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.
- Ford J, Rosman L, Wuensch K, Irvine J, Sears SF. Cognitive-Behavioral Treatment of Posttraumatic Stress in Patients With Implantable Cardioverter Defibrillators: Results From a Randomized Controlled Trial. J Trauma Stress. 2016 Aug;29(4):388-92. doi: 10.1002/jts.22111. Epub 2016 Jul 14.
- Irvine J, Firestone J, Ong L, Cribbie R, Dorian P, Harris L, Ritvo P, Katz J, Newman D, Cameron D, Johnson S, Bilanovic A, Hill A, O'Donnell S, Sears S Jr. A randomized controlled trial of cognitive behavior therapy tailored to psychological adaptation to an implantable cardioverter defibrillator. Psychosom Med. 2011 Apr;73(3):226-33. doi: 10.1097/PSY.0b013e31820afc63. Epub 2011 Feb 14.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA 5170
- Grant number NA 5170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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