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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01881893
First received: May 31, 2013
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Heart Defects, Congenital
Behavioral: ACHD-CARE Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Psychosocial Outcome Measures: Change in depression and anxiety symptoms [ Time Frame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up ] [ Designated as safety issue: No ]
    Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)


Secondary Outcome Measures:
  • Psychological Outcome Measures: Social functioning [ Time Frame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up ] [ Designated as safety issue: No ]
    Two metrics will be used to assess social functioning; the Social Functioning subscale of the Short Form Health Status Survey (SF-12v2) and the Enhanced Recovery in Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI).

  • Psychosocial Outcome Measures: Resilience [ Time Frame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up ] [ Designated as safety issue: No ]
    This psychosocial outcome will be measured by the Resilience Scale (RS).

  • Psychosocial Outcome Measures: Quality of Life and health status [ Time Frame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up ] [ Designated as safety issue: No ]
    The quality of life of the participants will be measured using the Satisfaction with Life Scales (SWLS) and the Linear Analogue Scale (LAS). Health status will be assessed using the SF-12v2.


Estimated Enrollment: 40
Study Start Date: June 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Patients in this arm of the study will continue to receive their regular level of care.
Experimental: ACHD-CARE Program

Group based psychosocial intervention.

  • Educational: congenital heart disease information
  • Behavioral: cognitive behavioral therapy
  • Behavioral: social interactions and communication skills
Behavioral: ACHD-CARE Program
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Current psychotherapy or pharmacotherapy
  • Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart
  • Report of suicidal intent during screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881893

Contacts
Contact: Adrienne Kovacs, PhD 416-340-4800 ext 6257 adrienne.kovacs@uhn.ca

Locations
Canada, Ontario
Toronto Congenital Cardiac Clinic for Adults, Peter Munk Cardiac Centre, Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2N2
Principal Investigator: Adrienne Kovacs, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Adrienne H Kovacs, PhD University Health Network, Toronto
Principal Investigator: Jane Irvine, PhD University Health Network, York University
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01881893     History of Changes
Other Study ID Numbers: MOP 123251
Study First Received: May 31, 2013
Last Updated: August 6, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University Health Network, Toronto:
Quality of life
Psychosocial Support Systems
Randomized Controls as Topic
Cognitive Therapy
Feasibility Studies

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014