Internet-based Cognitive Behavioural Therapy for Cardiac Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy for Cardiac Patients With Depression

Conditions
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Depression, Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: internet-based cognitive behavioural therapy


Participation Criteria
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Eligibility Criteria
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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): active suicidal ideation (since this requires immediate referral for intense psychiatric care) previous suicide attempt currently undergoing psychotherapy for depression receiving antidepressant medication that has been initiated or adjusted within previous 3 months concurrent psychiatric disorder, other than anxiety; self-reported substance misuse within past 6 months concurrent terminal illness clinical status interfering with ability to independently engage in iCBT.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>all participants will be assigned to the treatment, consisting of therapist-assisted iCBT. | Behavioral: internet-based cognitive behavioural therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iCBT, cardiac event, cognitive behavioural therapy, depression