Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial

University Health Network, Toronto

Status: Completed

Conditions: Heart Defects, Congenital

Treatments: Behavioral: ACHD-CARE Program

Study type: Interventional

Funder types: Other

Identifiers

NCT01881893

MOP 123251

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Patients in this arm of the study will continue to receive their regular level of care.

ACHD-CARE Program

Experimental group

Description:

Group based psychosocial intervention. * Educational: congenital heart disease information * Behavioral: cognitive behavioral therapy * Behavioral: social interactions and communication skills

Treatment:

Behavioral: ACHD-CARE Program