Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Psychosocial Outcome Measures: Change in depression and anxiety symptoms
研究概览
简要总结
The psychosocial development of adults with congenital heart disease (CHD) can be challenged by many issues including family overprotection, impaired peer relationships, delayed progression into independent adulthood, and difficulties with career and future planning. One-third of patients have diagnosable mood or anxiety disorders and the prevalence of depression is 3 times that of the general Canadian population. Unfortunately, most adults with CHD and significant depression or anxiety do not receive mental health treatment. Despite an increasing awareness of the unique psychosocial concerns of this patient population by both health care providers and patients, there have been no interventions targeting psychosocial outcomes in the adult CHD population. Our quantitative and qualitative research suggests that patients themselves are very interested in psychological services that target their distinctive life experiences, are provided in a group setting, and emphasize coping and resilience. The overarching aim of this proposal is to assess the feasibility of a full-scale randomized controlled trial of a group intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Documented congenital heart disease (CHD), as confirmed by echocardiogram, cardiac catheterization, or previous surgery
- •Age greater than or equal to 18 years
- •English-language proficiency sufficient to read and complete the consent form and questionnaires and participate in an English-language group
- •No planned surgery during patient's participation in the study
- •Clinically-elevated score (i.e >=8) on the Hospital Anxiety and Depression Scale depression (HADS-D) or anxiety (HADS-A) subscale
排除标准
- •Current psychotherapy or pharmacotherapy
- •Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart
- •Report of suicidal intent during screening
研究组 & 干预措施
Usual Care
Patients in this arm of the study will continue to receive their regular level of care.
ACHD-CARE Program
Group based psychosocial intervention.
- Educational: congenital heart disease information
- Behavioral: cognitive behavioral therapy
- Behavioral: social interactions and communication skills
干预措施: ACHD-CARE Program (Behavioral)
结局指标
主要结局
Psychosocial Outcome Measures: Change in depression and anxiety symptoms
时间窗: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)
次要结局
- Psychosocial Outcome Measures: Resilience(Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up)
- Psychosocial Outcome Measures: Quality of Life and health status(Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up)
- Psychological Outcome Measures: Social functioning(Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up)