An interventional study of ACHD-CARE Program in Heart Defects, Congenital, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-24.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 42 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
Patients in this arm of the study will continue to receive their regular level of care.
Group based psychosocial intervention. * Educational: congenital heart disease information * Behavioral: cognitive behavioral therapy * Behavioral: social interactions and communication skills
Behavioral: ACHD-CARE Program
The ACHD-CARE program will be provided in eight 90-minute weekly sessions. The intervention includes information about living with congenital heart disease, cognitive behavioral therapy (CBT) and coping techniques, and opportunities for peer interaction.
Psychosocial Outcome Measures: Change in depression and anxiety symptoms
Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)
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
Psychological Outcome Measures: Social functioning
Two metrics will be used to assess social functioning; the Social Functioning subscale of the Short Form Health Status Survey (SF-12v2) and the Enhanced Recovery in Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI).
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
Psychosocial Outcome Measures: Resilience
This psychosocial outcome will be measured by the Resilience Scale (RS).
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
Psychosocial Outcome Measures: Quality of Life and health status
The quality of life of the participants will be measured using the Satisfaction with Life Scales (SWLS) and the Linear Analogue Scale (LAS). Health status will be assessed using the SF-12v2.
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
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto