Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Defects, Congenital
- Sponsor
- University Health Network, Toronto
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Psychosocial Outcome Measures: Change in depression and anxiety symptoms
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Current psychotherapy or pharmacotherapy
- •Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart
- •Report of suicidal intent during screening
Outcomes
Primary Outcomes
Psychosocial Outcome Measures: Change in depression and anxiety symptoms
Time Frame: 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)
Secondary Outcomes
- 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)