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