Internet-based Cognitive Behavioural Therapy for Cardiac Patients

NCT ID: NCT04053244

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-26
• Study Completion Date: 2020-12-31

Brief Summary

Our overall objective is to evaluate the efficacy of therapist-assisted, internet-based cognitive-behavioural therapy (iCBT) for depressed cardiac patients with respect to clinical outcomes, and the feasibility of the program. Our primary outcome will be depression severity; secondary outcomes will be hospitalization for a cardiac cause, recurrent myocardial infarction or revascularization. The study will inform a proposal to incorporate iCBT into the resources routinely available to cardiac patients following hospitalization for a cardiac event.

Detailed Description

We are planning we are planning a single-arm, open label trial to evaluate the feasibility, acceptability and efficacy of iCBT among persistently depressed cardiac patients. Cardiac patients will be recruited from inpatient units in a university-affiliated hospital and screened for depression at 4 and possibly 8 or 12 weeks following discharge. Eligible patients will be enrolled in the iCBT program.Data regarding the primary outcome, improvement in depression severity, will be collected at completion of the intervention and at 8 weeks after completion. In addition to depression severity data, we will also obtain other data related to clinical feasibility, such as treatment adherence and the acceptability of the intervention to patients. Self-reported rates of hospital readmission or emergency visits for a cardiac cause will also be tracked.

Conditions

Depression; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment

all participants will be assigned to the treatment, consisting of therapist-assisted iCBT.

Group Type: EXPERIMENTAL

internet-based cognitive behavioural therapy

Intervention Type: BEHAVIORAL

Designed for general clinical use (but not specifically cardiac patients), it consists of 5 online modules outlining cognitive-behavioural skills for depression, completed over 7-8 weeks. The participants will be guided step-wise through the modules by the therapist. Participants can work more or less at their own pace, but are expected to proceed to the next module within 1-2 weeks. Because the content is identical for each participant, fidelity to the web-based component of the intervention is ensured.

Interventions

internet-based cognitive behavioural therapy

Designed for general clinical use (but not specifically cardiac patients), it consists of 5 online modules outlining cognitive-behavioural skills for depression, completed over 7-8 weeks. The participants will be guided step-wise through the modules by the therapist. Participants can work more or less at their own pace, but are expected to proceed to the next module within 1-2 weeks. Because the content is identical for each participant, fidelity to the web-based component of the intervention is ensured.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• admitted to one of study units with any cardiac diagnosis OR cardiac procedure on this admission
• able to speak and read English
• able to provide informed consent and participate in therapy
• access to and ability to use a computer with internet access.

Between 4 and 12 weeks after discharge, consenting participants will be required to meet a further inclusion criterion of:

• current depressive symptoms of at least mild severity on 2 successive assessments, 4 weeks apart or a single assessment of mild symptoms at 12 weeks post-discharge.

Exclusion Criteria

Applied at screening (and criteria 1 and 2 reapplied before enrolment):

1. active suicidal ideation (since this requires immediate referral for intense psychiatric care)

2. previous suicide attempt

3. currently undergoing psychotherapy for depression

4. receiving antidepressant medication that has been initiated or adjusted within previous 3 months

5. concurrent psychiatric disorder, other than anxiety;

6. self-reported substance misuse within past 6 months

7. concurrent terminal illness

8. clinical status interfering with ability to independently engage in iCBT.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Martha Mackay

Cardiac Clinical Nurse Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha H Mackay, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Martha H Mackay, PhD

Role: CONTACT

mmackay@providencehealth.bc.ca

6046822344 ext. 63127

Facility Contacts

Martha Mackay, PhD

Role: primary

mmackay@providencehealth.bc.ca

6046822344 ext. 63127

Other Identifiers

H19-01695

Identifier Type: -

Identifier Source: org_study_id