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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | all participants will be assigned to the treatment, consisting of therapist-assisted iCBT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| internet-based cognitive behavioural therapy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Severity | change in severity of depression as measured by Patient Health Questionnaire-9 | baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiac events | death, myocardial infarction, revascularization, hospitalization for a cardiac cause | completion of treatment, average of 8 weeks |
| Treatment Satisfaction Questionnaire |
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Inclusion Criteria:
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):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martha H Mackay, PhD | Contact | 6046822344 | 63127 | mmackay@providencehealth.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Martha H Mackay, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital, Providence Health Care | Recruiting | Vancouver | British Columbia | V6Z1Y6 | Canada |
We would share all of our de-identified, individual-level data with any credentialed researcher.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy
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participants' satisfaction with treatment
| completion of treatment, average of 8 weeks |
| Web-Based Program Usability Questionnaire | participants' experience with using the web-based program | completion of treatment, average of 8 weeks |