Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial

NCT01881893 | Completed

• 1 other identifier: MOP 123251
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The psychosocial development of adults with congenital heart disease (CHD) can be challenged by many issues including family overprotection, impaired peer relationships, delayed progression into independent adulthood, and difficulties with career and future planning. One-third of patients have diagnosable mood or anxiety disorders and the prevalence of depression is 3 times that of the general Canadian population. Unfortunately, most adults with CHD and significant depression or anxiety do not receive mental health treatment. Despite an increasing awareness of the unique psychosocial concerns of this patient population by both health care providers and patients, there have been no interventions targeting psychosocial outcomes in the adult CHD population. Our quantitative and qualitative research suggests that patients themselves are very interested in psychological services that target their distinctive life experiences, are provided in a group setting, and emphasize coping and resilience. The overarching aim of this proposal is to assess the feasibility of a full-scale randomized controlled trial of a group intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD.

Conditions

Heart Defects, Congenital

Keywords

Quality of life; Psychosocial Support Systems; Randomized Controls as Topic; Cognitive Therapy; Feasibility Studies

Outcome Measures

Primary Outcomes (1)

• Psychosocial Outcome Measures: Change in depression and anxiety symptoms

  Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)

  Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up

Secondary Outcomes (3)

• Psychological Outcome Measures: Social functioning

  Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up

• Psychosocial Outcome Measures: Resilience

  Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up

• Psychosocial Outcome Measures: Quality of Life and health status

  Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up

Study Arms (2)

Usual Care

NO INTERVENTION

Patients in this arm of the study will continue to receive their regular level of care.

ACHD-CARE Program

EXPERIMENTAL

Group based psychosocial intervention. * Educational: congenital heart disease information * Behavioral: cognitive behavioral therapy * Behavioral: social interactions and communication skills

Behavioral: ACHD-CARE Program

Interventions

ACHD-CARE Program BEHAVIORAL

The ACHD-CARE program will be provided in eight 90-minute weekly sessions. The intervention includes information about living with congenital heart disease, cognitive behavioral therapy (CBT) and coping techniques, and opportunities for peer interaction.

ACHD-CARE Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented congenital heart disease (CHD), as confirmed by echocardiogram, cardiac catheterization, or previous surgery
• Age greater than or equal to 18 years
• English-language proficiency sufficient to read and complete the consent form and questionnaires and participate in an English-language group
• No planned surgery during patient's participation in the study
• Clinically-elevated score (i.e \>=8) on the Hospital Anxiety and Depression Scale depression (HADS-D) or anxiety (HADS-A) subscale

You may not qualify if:

• Current psychotherapy or pharmacotherapy
• Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart
• Report of suicidal intent during screening

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Congenital Cardiac Clinic for Adults, Peter Munk Cardiac Centre, Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Adrienne H Kovacs, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Jane Irvine, PhD

  University Health Network, York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 20, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

CA (1)