Psychological Support for Patients With an Implantable Cardioverter Defibrillator
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Hospital Anxiety and Depression Scale - Depression Scale at Baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Hospital Anxiety and Depression Scale - Depression Scale at Baseline
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Twelve-months follow-up
Psychometric measure of phobic anxiety, scores range from 1 to 3. Higher scores represent greater phobic anxiety symptoms.
次要结局
- SF-36 Mental Component Summary Scale at Baseline(Baseline)
- SF-36 Mental Component Summary Scale at 6-months Follow-up(Six-months follow-up)
- SF-36 Mental Component Summary Scale at 12-months Follow-up(Twelve-months follow-up)
- SF-36 Physical Component Summary Score at Baseline(Baseline)
- SF-36 Physical Component Summary Score at 6-months Follow-up(Six-months follow-up)
- SF-36 Physical Component Summary Score at 12-months Follow-up(Twelve-months follow-up)
- Percentage of Participants Who Received ICD Therapies(12-months follow-up)