title: Adult Congenital Heart Disease-Coping And REsilience (ACHD-CARE): Rationale and methodology of a pilot randomized controlled trial.
abstract: BACKGROUND
  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
  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.
  
  
  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. 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.
authors.affiliation: Peter Munk Cardiac Centre, University Health Network, 585 University Ave, 5N-523, Toronto, ON M5G 2N2, Canada. Electronic address: adrienne.kovacs@uhn.ca.
authors.forename: Adrienne H
authors.initials: AH
authors.lastname: Kovacs
authors.affiliation: Peter Munk Cardiac Centre, University Health Network, 585 University Ave, 5N-523, Toronto, ON M5G 2N2, Canada.
authors.forename: Mimi
authors.initials: M
authors.lastname: Bandyopadhyay
authors.affiliation: Peter Munk Cardiac Centre, University Health Network, 585 University Ave, 5N-523, Toronto, ON M5G 2N2, Canada; York University, 4700 Keele St, Toronto, ON M3J1P3, Canada.
authors.forename: Sherry L
authors.initials: SL
authors.lastname: Grace
authors.affiliation: School of Arts and Sciences, MCPHS University, 179 Longwood Ave, Boston, MA 02115, USA.
authors.forename: Amanda C
authors.initials: AC
authors.lastname: Kentner
authors.affiliation: Peter Munk Cardiac Centre, University Health Network, 585 University Ave, 5N-523, Toronto, ON M5G 2N2, Canada.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Nolan
authors.affiliation: Peter Munk Cardiac Centre, University Health Network, 585 University Ave, 5N-523, Toronto, ON M5G 2N2, Canada.
authors.forename: Candice K
authors.initials: CK
authors.lastname: Silversides
authors.affiliation: York University, 4700 Keele St, Toronto, ON M3J1P3, Canada.
authors.forename: M Jane
authors.initials: MJ
authors.lastname: Irvine
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D000328:Adult; D001008:Anxiety Disorders / Q000453:epidemiology / Q000628:therapy*; D001364:Awareness; D005240:Feasibility Studies; D005260:Female; D006266:Health Education; D006330:Heart Defects, Congenital / Q000453:epidemiology / Q000523:psychology*; D006801:Humans; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D019964:Mood Disorders / Q000453:epidemiology / Q000628:therapy*; D010865:Pilot Projects; D011788:Quality of Life; D012107:Research Design; D055500:Resilience, Psychological; D055815:Young Adult
keywords: Anxiety; Congenital heart disease; Depression; Feasibility; Intervention