Internet-based Cognitive Behavioural Therapy for Cardiac Patients

University of British Columbia80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression Cardiovascular Diseases

Interventions

internet-based cognitive behavioural therapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, Canada

RECRUITING

Outcomes

Primary Outcomes

Depression Severity

change in severity of depression as measured by Patient Health Questionnaire-9

Time frame: baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks)

Secondary Outcomes

major adverse cardiac events

death, myocardial infarction, revascularization, hospitalization for a cardiac cause

Time frame: completion of treatment, average of 8 weeks

Treatment Satisfaction Questionnaire

participants' satisfaction with treatment

Time frame: completion of treatment, average of 8 weeks

Web-Based Program Usability Questionnaire

participants' experience with using the web-based program

Time frame: completion of treatment, average of 8 weeks

Central Contacts

Martha H Mackay, PhD

CONTACT

6046822344 mmackay@providencehealth.bc.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.