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

INTRODUCTION 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.

• Publication year

  2015

• Venue

  Contemporary Clinical Trials

• Publication date

  2015-11-01

• Fields of study

  Medicine, Psychology

• Identifiers
  DOI 10.1016/j.cct.2015.11.002PMID 26546067
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• Eligible participants are adults with congenital heart disease aged 18 years or older, without planned surgery, and with symptoms suggestive of a mood and/or anxiety disorder.

  Confidence 0.95

  박진우 (dztg5apj7m) extractionB (s683577b42) reviewq (76h6bfydm6) review
• Feasibility is assessed across process, resources, management, scientific outcomes, and intervention acceptability.

  Confidence 0.96

  박진우 (dztg5apj7m) extractionB (s683577b42) reviewq (76h6bfydm6) review
• Evaluation uses a 2-parallel arm non-blinded pilot randomized controlled trial with 1:1 allocation to ACHD-CARE or Usual Care.

  Confidence 0.97

  박진우 (dztg5apj7m) extractionB (s683577b42) reviewq (76h6bfydm6) review
• ACHD-CARE is a group psychosocial intervention designed to improve psychosocial functioning, quality of life, and resilience in adults with congenital heart disease.

  Confidence 0.98

  박진우 (dztg5apj7m) extractionB (s683577b42) reviewq (76h6bfydm6) review

• achd-care intervention

  intervention

  The adult congenital heart disease coping and resilience group psychosocial program developed for the pilot trial.

  Aliases: ACHD-CARE, Adult CHD-Coping And REsilience

  박진우 (dztg5apj7m) extractionB (s683577b42) reviewq (76h6bfydm6) review
• adults with congenital heart disease

  population

  The adult patient population with congenital heart disease targeted by the intervention and pilot trial.

  Aliases: adult CHD, ACHD

  박진우 (dztg5apj7m) extractionB (s683577b42) reviewq (76h6bfydm6) review
• feasibility domains

  assessment domain

  The set of trial dimensions used to judge whether a full-scale randomized controlled trial is workable.

  Aliases: feasibility outcomes

  박진우 (dztg5apj7m) extractionB (s683577b42) reviewq (76h6bfydm6) review
• pilot randomized controlled trial

  trial design

  A small preliminary randomized trial used to test the feasibility of the intervention study design.

  Aliases: pilot RCT, RCT

  박진우 (dztg5apj7m) extractionB (s683577b42) reviewq (76h6bfydm6) review
• symptoms suggestive of a mood and/or anxiety disorder

  eligibility criterion

  The screening criterion indicating participants may have mood or anxiety symptoms relevant for enrollment.

  Aliases: mood and/or anxiety symptoms

  박진우 (dztg5apj7m) extractionB (s683577b42) reviewq (76h6bfydm6) review
• usual care

  comparator

  The comparator condition representing standard care given to participants assigned to the control arm.

  Aliases: control arm

  박진우 (dztg5apj7m) extractionB (s683577b42) reviewq (76h6bfydm6) review

• Lifetime Prevalence of Congenital Heart Disease in the General Population From 2000 to 2010

  2014cited by this paper
• Psychological interventions for depression in adolescent and adult congenital heart disease.

  2013cited by this paper
• Audio recordings of mindfulness-based stress reduction training to improve cancer patients’ mood and quality of life—a pilot feasibility study

  2012cited by this paper
• How do psychosocial challenges associated with living with congenital heart disease translate into treatment interests and preferences? A qualitative approach

  2012influential reference
• An individual‐based versus group‐based exercise and counselling intervention for improving quality of life in breast cancer survivors. A feasibility and efficacy study

  2012cited by this paper
• Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial.

  2011cited by this paper
• A Randomized Controlled Trial of Cognitive Behavior Therapy Tailored to Psychological Adaptation to an Implantable Cardioverter Defibrillator

  2011cited by this paper
• [Effects of laughter therapy on depression, quality of life, resilience and immune responses in breast cancer survivors].

  2011cited by this paper
• Parental Overprotection and Heart-Focused Anxiety in Adults with Congenital Heart Disease

  2011cited by this paper
• A methodological review of resilience measurement scales

  2011cited by this paper
• Activity restriction and depression in medical patients and their caregivers: a meta-analysis.

  2011cited by this paper
• The relationship between resilience and levels of anxiety, depression, and obsessive-compulsive symptoms in adolescents.

  2011cited by this paper
• Quality of life of patients with congenital heart diseases

  2011cited by this paper
• Feasibility of an expressive‐disclosure group intervention for post‐treatment colorectal cancer patients

  2011cited by this paper
• Exploring the roles of approach and avoidance in depression: an integrative model.

  2011cited by this paper
• Formal feasibility studies in palliative care: why they are important and how to conduct them.

  2011cited by this paper
• Pre-intervention distress moderates the efficacy of psychosocial treatment for cancer patients: a meta-analysis

  2010cited by this paper
• How does mindfulness-based cognitive therapy work?

  2010cited by this paper
• What is a pilot or feasibility study? A review of current practice and editorial policy

  2010cited by this paper
• Exercise training in adults with congenital heart disease: feasibility and benefits.

  2010cited by this paper
• Improving depression and enhancing resilience in family dementia caregivers: a pilot randomized placebo-controlled trial of escitalopram.

  2010cited by this paper
• Is cognitive-behavioral therapy more effective than other therapies? A meta-analytic review.

  2010cited by this paper
• Requirements for Quality-Of-Life Reports

  2010cited by this paper
• A tutorial on pilot studies: the what, why and how

  2010cited by this paper
• Acceptability of a Cognitive Behavior Therapy Intervention to Implantable Cardioverter Defibrillator Recipients

  2010cited by this paper
• Changing mortality in congenital heart disease.

  2010cited by this paper
• A Randomized Controlled Trial of Secondary Prevention of Anxiety and Distress in a German Sample of Patients With an Implantable Cardioverter Defibrillator

  2010cited by this paper
• What is behavioral activation? A review of the empirical literature.

  2010cited by this paper
• Mortality in adult congenital heart disease.

  2010cited by this paper
• Factors influencing depression in adolescents with congenital heart disease.

  2009cited by this paper
• Increasing psychological well-being and resilience by psychotherapeutic methods.

  2009cited by this paper
• Cognitive-behavioral therapy for adult anxiety disorders in clinical practice: a meta-analysis of effectiveness studies.

  2009cited by this paper
• A group social skills intervention program for survivors of childhood brain tumors.

  2009cited by this paper
• Adults with congenital heart disease: psychological needs and treatment preferences.

  2009cited by this paper
• Healthy hearts--and the universal benefits of being physically active: physical activity and health.

  2009cited by this paper
• Depression and anxiety in adult congenital heart disease: predictors and prevalence.

  2009cited by this paper
• How we design feasibility studies.

  2009cited by this paper
• Developing and evaluating complex interventions: the new Medical Research Council guidance

  2008cited by this paper
• The brief resilience scale: Assessing the ability to bounce back

  2008cited by this paper
• DISORDERS : A META-ANALYSIS OF RANDOMIZED PLACEBO-CONTROLLED TRIALS

  2008cited by this paper
• Are children with congenital cardiac malformations at increased risk of deficits in social cognition?

  2008cited by this paper
• Profile of Adults with Congenital Heart Disease Having a Good, Moderate, or Poor Quality of Life: A Cluster Analytic Study

  2008cited by this paper
• Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials.

  2008cited by this paper
• Meta-analysis of cognitive-behavioral interventions on HIV-positive persons' mental health and immune functioning.

  2008cited by this paper
• Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.

  2008cited by this paper
• Cognitive Behavioural Therapy for Depression

  2008cited by this paper
• Efficacy of cognitive behavioral therapy for chronic fatigue syndrome: a meta-analysis.

  2008cited by this paper
• Considerations in determining sample size for pilot studies.

  2008cited by this paper
• Treatment integrity in psychotherapy research: analysis of the studies and examination of the associated factors.

  2007cited by this paper
• Psychological treatment of cardiac patients: a meta-analysis.

  2007cited by this paper
• The ICD Shock and Stress Management Program: A Randomized Trial of Psychosocial Treatment to Optimize Quality of Life in ICD Patients

  2007cited by this paper
• Usual care as the control group in clinical trials of nonpharmacologic interventions.

  2007cited by this paper
• Physical activity levels in adults with congenital heart disease

  2007cited by this paper
• Predictors of Treatment Response for Depression and Inadequate Social Support – The ENRICHD Randomized Clinical Trial

  2007cited by this paper
• Young adult patients with a history of pediatric disease: impact on course of life and transition into adulthood.

  2006cited by this paper
• Cognitive Behavioral Therapy Techniques for Distress and Pain in Breast Cancer Patients: A Meta-Analysis

  2006cited by this paper
• Scholarly literature review: Efficacy of psychological interventions for pediatric chronic illnesses.

  2006cited by this paper
• Efficacy of psychosocial interventions in cancer care: Evidence is weaker than it first looks

  2006cited by this paper
• Recommendations for participation in competitive and leisure sports in patients with congenital heart disease: a consensus document

  2006cited by this paper
• Cognitive Behavioural Therapy for Depression, Panic Disorder and Generalized Anxiety Disorder: A Meta-Regression of Factors that May Predict Outcome

  2006cited by this paper
• Quality of life and health status in adults with congenital heart disease: a direct comparison with healthy counterparts

  2006cited by this paper
• Anxiety and depression in primary care patients: predictors of symptom severity and developmental correlates.

  2006cited by this paper
• Is the severity of congenital heart disease associated with the quality of life and perceived health of adult patients?

  2005cited by this paper
• Recommended effect size statistics for repeated measures designs

  2005cited by this paper
• Feasibility and preliminary outcomes from a pilot study of a brief psychological intervention for families of children newly diagnosed with cancer.

  2005cited by this paper
• The adult with congenital heart disease: born to be bad?

  2005cited by this paper
• Individual quality of life in adults with congenital heart disease: a paradigm shift.

  2005cited by this paper
• The spectrum of adult congenital heart disease in Europe: morbidity and mortality in a 5 year follow-up period. The Euro Heart Survey on adult congenital heart disease.

  2005cited by this paper
• Biopsychosocial experiences of adults with congenital heart disease: review of the literature.

  2005cited by this paper
• Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life?

  2004cited by this paper
• Cognitive-behavioural rehabilitation programme for patients with an implanted cardioverter defibrillator: a pilot study.

  2004cited by this paper
• Management of grown up congenital heart disease.

  2003cited by this paper
• Reliability, Validity, and Responsiveness of the Short Form 12-Item Survey (SF-12) in Patients With Back Pain

  2003cited by this paper
• Development of a new resilience scale: The Connor‐Davidson Resilience Scale (CD‐RISC)

  2003cited by this paper
• Generalized eta and omega squared statistics: measures of effect size for some common research designs.

  2003cited by this paper
• The prevalence of treated and untreated mental disorders in five countries.

  2003cited by this paper
• Depression and anxiety in adults with congenital heart disease: a pilot study.

  2003cited by this paper
• Effects of treating depression and low perceived social support on clinical events after myocardial infarction: the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) Randomized Trial.

  2003cited by this paper
• Psychological assessments for cardiac rehabilitation patients.

  2003cited by this paper
• Comparison of the short form (SF)-12 health status instrument with the SF-36 in patients with coronary heart disease

  2003cited by this paper
• A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory.

  2003cited by this paper
• The validity of the Hospital Anxiety and Depression Scale. An updated literature review.

  2002cited by this paper
• Comprehensive Care for Adults with Congenital Heart Disease: Expanding Roles for Nurses

  2002cited by this paper
• Employment in adults with congenital heart disease.

  2002cited by this paper
• Mindfulness-Based Cognitive Therapy for Depression: A New Approach to Preventing Relapse

  2001cited by this paper
• A life less ordinary: growing up and coping with congenital heart disease

  2001cited by this paper
• Are cyanosed adults with congenital cardiac malformations depressed?

  2001cited by this paper
• The Effect of Psychological Intervention on Patients' Long‐Term Adjustment to the ICD: A Prospective Study

  2000cited by this paper
• Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy.

  2000cited by this paper
• Psychosocial profile of adults with complex congenital heart disease.

  2000influential reference
• Measuring the health related quality of life of people with ischaemic heart disease

  2000cited by this paper
• A meta-analysis of psychoeduational programs for coronary heart disease patients.

  1999cited by this paper
• A meta-analysis of psychoeducational programs for coronary heart disease patients.

  1999cited by this paper
• Effect of Guided Imagery on Quality of Life for Patients With Chronic Tension‐Type Headache

  1999cited by this paper
• Canadian Consensus Conference on Adult Congenital Heart Disease 1996.

  1998cited by this paper
• Behavioral and psychosocial effects of intensive lifestyle management for women with coronary heart disease.

  1998cited by this paper
• Management of adults with congenital heart disease: an increasing problem.

  1997cited by this paper
• Prediction of Quality of Life after Coronary Artery Bypass Graft Surgery: A Review and Evaluation of Multiple, Recent Studies

  1997cited by this paper
• The effect of a home-based, case-managed, multifactorial risk-reduction program on reducing psychological distress in patients with cardiovascular disease.

  1997cited by this paper
• Randomised trial of home-based psychosocial nursing intervention for patients recovering from myocardial infarction.

  1997cited by this paper

• Group Psychological Therapy Program in Adult Patients with Congenital Heart Disease and Anxious–Depressive Symptoms

  2025cites this paper
• EMBRACE Study: Outcomes of a Randomized, Mindfulness-Based Intervention for Adults with Congenital Heart Disease

  2025cites this paper
• Longitudinal assessment of health-related quality of life in patients with adult congenital heart disease undergoing cardiac surgery

  2024cites this paper
• Mental Health Care for Children with Heart Disease and Their Families: Practical Approaches and Considerations for the Pediatric and Pediatric Cardiology Clinician

  2024cites this paper
• From worries to resilience: a qualitative study of the psychosocial experiences of diverse adolescents and young adults with heart failure and their caregivers.

  2024cites this paper
• Return to work after Post-COVID: describing affected employees' perceptions of personal resources, organizational offerings and care pathways

  2023cites this paper
• Psychological interventions for depression in adolescent and adult congenital heart disease.

  2023cites this paper
• Adult Congenital Heart Disease in the Aging and Elderly Population

  2023cites this paper
• Empirical findings on associations between anxiety, depression, and congenital heart disease in adults – A systematic review and meta-analysis

  2023cites this paper
• Neuromental health aspects in adults with CHD after cardiopulmonary bypass intervention during childhood.

  2023cites this paper
• Resilient Hearts: Measuring Resiliency in Young People With Congenital Heart Disease

  2023cites this paper
• Videoconference-delivered Mind-Body Resiliency Training in Adults with congenital heart disease: A pilot feasibility trial

  2022cites this paper
• Socio-demographic parameters and non-cardiac comorbidity related to self-perceived quality of life in young adults after neonatal arterial switch operation for transposition of the great arteries

  2022cites this paper
• A group resilience training program for people with multiple sclerosis: Study protocol of a multi-centre cluster-randomized controlled trial (multi-READY for MS)

  2022cites this paper
• Stigmatization and resilience in inflammatory bowel disease patients at one-year follow-up

  2022cites this paper
• Effectiveness of a group resilience intervention for people with multiple sclerosis delivered via frontline services

  2021cites this paper
• Neurodevelopmental and psychosocial interventions for individuals with CHD: a research agenda and recommendations from the Cardiac Neurodevelopmental Outcome Collaborative.

  2021cites this paper
• It's part of who I am: The impact of congenital heart disease on adult identity and life experience

  2021cites this paper
• Understanding the Educational Support and Psychosocial Needs of Parents and Adolescents With Kawasaki's Disease and Coronary Artery Aneurysms.

  2021cites this paper
• Neuropsychiatric Aspects of Congenital Heart Disease: A Review of Current Literatures

  2021cites this paper
• Resilience as a Mediator of the Association Between Perceived Stigma and Quality of Life Among People With Inflammatory Bowel Disease

  2021cites this paper
• Psychological and pharmacological interventions for depression in patients with coronary artery disease.

  2021cites this paper
• Neurodevelopmental and psychosocial interventions for individuals with congenital heart disease: A research agenda and recommendations from the Cardiac Neurodevelopmental Outcome Collaborative

  2021cites this paper
• Resilience-building by community health organizations: a guiding model for practice

  2020cites this paper
• Adult congenital heart care in the COVID-19 era, and beyond: A call for action

  2020cites this paper
• Forms of Emotional Health and Coping with Stress in People with Cardiovascular Diseases

  2020cites this paper
• A resilience group training program for people with multiple sclerosis: Results of a pilot single-blind randomized controlled trial and nested qualitative study

  2020cites this paper
• Neuropsychological Outcomes and Posttraumatic Stress Disorder in Adults with Congenital Heart Disease

  2019cites this paper
• Psychological Interventions for People Affected by Childhood-Onset Heart Disease: A Systematic Review

  2019cites this paper
• Social Workers' Experiences With Interventions for Clients With Congenital Heart Disease

  2019influential citation
• Executive Function and Internalizing Symptoms in Adolescents and Young Adults With Congenital Heart Disease: The Role of Coping

  2018cites this paper
• Body and Mind: Psychosocial Interventions for Adults With Congenital Heart Disease.

  2018cites this paper
• Current research status on the psychological situation of adults with congenital heart disease.

  2018cites this paper
• Resilience of patients with chronic diseases: A systematic review.

  2018cites this paper
• Depressive and Anxiety Symptoms in Adult Congenital Heart Disease: Prevalence, Health Impact and Treatment.

  2018cites this paper
• The Role of Clinical Psychology and Peer to Peer Support in the Management of Chronic Medical Conditions – A Practical Example With Adults With Congenital Heart Disease

  2018cites this paper
• Feasibility and Outcomes in a Pilot Randomized Controlled Trial of a Psychosocial Intervention for Adults With Congenital Heart Disease.

  2018cites this paper
• Diagnosis and Management of Noncardiac Complications in Adults With Congenital Heart Disease: A Scientific Statement From the American Heart Association.

  2017cites this paper