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

Heart Defects, Congenital Clinical Trial

— ACHD-CARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881893
• Other study ID #: MOP 123251
• Status: Completed
• Phase: N/A
• First received: May 31, 2013
• Last updated: December 23, 2015
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Congenital Cardiac Clinic for Adults, Peter Munk Cardiac Centre, Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Psychological Outcome Measures: Social functioning	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).	Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up	No
Secondary	Psychosocial Outcome Measures: Resilience	This psychosocial outcome will be measured by the Resilience Scale (RS).	Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up	No
Secondary	Psychosocial Outcome Measures: Quality of Life and health status	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.	Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up	No