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Completed

NCT Number: 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:

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behaviour Therapy (CBT)

Behavioral

Cognitive behavior therapy tailored to psychological adaptation to an ICD, included 8 telephone counselling sessions, plus psycho-educational booklet and a therapist manual.

Usual Cardiac Care (UCC)

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 9, 2005
Registry last updated
Jan 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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