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

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• 作者：Adrienne H. Kovacs^a ; ^{adrienne.kovacs@uhn.ca" class="auth_mail" title="E-mail the corresponding author} ; Mimi Bandyopadhyay^a ; Sherry L. Grace^a ; ^b ; Amanda C. Kentner^c ; Robert P. Nolan^a ; Candice K. Silversides^a ; M. Jane Irvine^b
• 关键词：ACHD-CARE ; Adult Congenital Heart Disease-Coping and Resilience ; CHD ; Congenital Heart Disease ; CBT ; Cognitive Behavioral Therapy ; HADS ; Hospital Anxiety and Depression Scale ; HADS-A ; Hospital Anxiety and Depression Scale &ndash ; Anxiety subscale ; HADS-D ; Hospital Anxiety and Depression Scale &ndash ; Depression subscale ; QOL ; Quality of Life ; RCT ; Randomized Controlled Trial ; SF-12v2 ; Short-Form Health Status Survey
• 刊名：Contemporary Clinical Trials
• 出版年：2015
• 出版时间：November 2015
• 年：2015
• 卷：45
• 期：part_PB
• 页码：385-393
• 全文大小：382 K

文摘

One-third of North American adults with congenital heart disease (CHD) have diagnosable mood or anxiety disorders and most do not receive mental health treatment. There are no published interventions targeting the psychosocial needs of patients with CHD of any age. We describe the development of a group psychosocial intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD and the design of a study protocol to determine the feasibility of a potential full-scale randomized controlled trial (RCT).

Methods/design

Drawing upon our quantitative and qualitative research, we developed the Adult CHD-Coping And REsilience (ACHD-CARE) intervention and designed a feasibility study that included a 2-parallel arm non-blinded pilot RCT. Eligible participants (CHD, age ≥ 18 years, no planned surgery, symptoms suggestive of a mood and/or anxiety disorder) were randomized to the ACHD-CARE intervention or Usual Care (1:1 allocation ratio). The group intervention was delivered during eight 90-minute weekly sessions. Feasibility will be assessed in the following domains: (i) process (e.g. recruitment and retention), (ii) resources, (iii) management, (iv) scientific outcomes, and (v) intervention acceptability.

Discussion

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. At study conclusion, we will be poised to make one of three determinations for a full-scale RCT: (1) feasible, (2) feasible with modifications, or (3) not feasible. This study will guide the future evaluation and provision of psychosocial treatment for adults with CHD.