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

NCT ID: NCT01881893

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Defects, Congenital

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

ACHD-CARE Program

Group based psychosocial intervention.

* Educational: congenital heart disease information
* Behavioral: cognitive behavioral therapy
* Behavioral: social interactions and communication skills

Group Type EXPERIMENTAL

ACHD-CARE Program

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adrienne H Kovacs, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Jane Irvine, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, York University

Locations

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

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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MOP 123251

Identifier Type: -

Identifier Source: org_study_id