Feasibility and Outcomes in a Pilot Randomized Controlled Trial of a Psychosocial Intervention for Adults With Congenital Heart Disease

Abstract

Background: North American adults with congenital heart disease (CHD) are known to be at elevated risk of mood and anxiety disorders. This was the first trial of a group psychosocial intervention targeting this patient population.

Methods: Within this feasibility study, we conducted a 2-arm pilot randomized controlled trial (RCT) in which patients were randomized to Usual Care or an 8-session group psychosocial intervention (Adult Congenital Heart Disease-Coping and Resilience [ACHD-CARE]). Here, we report feasibility outcomes in accordance with published recommendations: (1) process, (2) resources, (3) management, (4) acceptability of the intervention, and (5) scientific outcomes (for which the primary outcome measures were anxiety and depression symptoms).

Results: Forty-two patients were randomized in the pilot RCT. The study was executable within a realistic timeline and revealed no significant human and data-management problems. The intervention was determined to be acceptable and highly valued by participants who participated in the ACHD-CARE program. The main challenges were practical barriers (eg, transportation, scheduling group sessions in-person given competing schedules) and retention. With regard to scientific outcomes, there were no adverse outcomes, and treatment fidelity was confirmed. Although not powered to test efficacy, there was a medium effect size (in favour of the intervention group) for depression symptoms.

Conclusions: We determined it would be feasible to conduct a full-scale trial of a psychosocial intervention targeting adults with CHD, although with modifications to address practical barriers to participation. Should this intervention prove effective, a manualized intervention could be made be available.