Adult Congenital Heart Disease-Coping And REsilience (ACHD-CARE): Rationale and methodology of a pilot randomized controlled trial

Background and Aim: As a result of significant advances in diagnosis and treatment, approximately 90% of infants born with congenital heart disease (CHD) are now expected to reach adulthood. However, an increased risk of cardiac sequelae necessitates lifelong cardiac surveillance and can significantly impact psychosocial development. One-third of North American adults with CHD have diagnosable mood or anxiety disorders and most do not receive appropriate mental health treatment. There are currently no published trials investigating psychological interventions for this unique patient population. It is thus important to establish the feasibility of conducting a psychological intervention trial in this population. In this methods paper, we describe (1) the development of a group psychosocial intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD, and (2) the design of a study to determine the feasibility of a future full-scale randomized controlled trial. Methods: Based upon quantitative and qualitative (focus group) research, we developed an 8-session Adult CHD–Coping And REsilience (ACHD-CARE) Program. We subsequently designed a 2-parallel arm non-blinded pilot randomized trial with a 1:1 individual patient allocation ratio. Inclusion criteria are documented CHD, age >18 years, English-language proficiency, no planned surgery, and clinically-elevated score (i.e., >8) on the Hospital Anxiety and Depression Scale depression (HADS-D) or anxiety (HADS-A) subscale. Exclusion criteria are current psychotherapy, reported suicidal intent, or significant cognitive impairment, psychosis, or personality disorder. Patients from a single tertiary centre are randomized to the ACHD-CARE intervention or Usual Care. The intervention is delivered during 90-minute sessions held weekly in small groups. Feasibility is assessed in the following five domains:(i) process (e.g., participant recruitment and retention), (ii) resources, (iii) management, (iv)scientific outcomes, and (v) acceptability of the intervention. Results: Our initial experiences indicate that the study design is feasible and acceptable to stakeholders. We have been able to successfully recruit and retain participants, although travel distance and competing time demands are barriers for many potential study participants. There have been no insurmountable challenges in study management. At the conclusion of the study, we will be poised to make one of three determinations: (1) a full-scale RCT is feasible, (2) a full-scale RCT is feasible with modifications, or (3) a full-scale RCT is not feasible. Conclusions: This study underscores the importance of carefully developing and testing the feasibility of psychosocial interventions in medical populations before moving to full-scale clinical trials. Feasibility outcomes from this study will guide the future evaluation and provision of psychological treatment for adults with CHD.