Clinical trial NCT01881893: Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial
Official title: Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Defects, Congenital
Keywords: Quality of life
Psychosocial Support Systems
Randomized Controls as Topic
Cognitive Therapy
Feasibility Studies
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Psychosocial Outcome Measures: Change in depression and anxiety symptoms
timeFrame: 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:
measure: Psychological Outcome Measures: Social functioning
timeFrame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
measure: Psychosocial Outcome Measures: Resilience
timeFrame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
measure: Psychosocial Outcome Measures: Quality of Life and health status
timeFrame: Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Congenital Cardiac Clinic for Adults, Peter Munk Cardiac Centre, Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Adrienne H Kovacs, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, York University
name: Jane Irvine, PhD
role: PRINCIPAL_INVESTIGATOR
References: