Internet-based Cognitive Behavioural Therapy for Cardiac Patients

Sponsor

University of British Columbia (Other)

Overall Status

Unknown status

CT.gov ID

NCT04053244

Collaborator

(none)

Enrollment

Location

Arm

15.2

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Cardiovascular Diseases	Behavioral: internet-based cognitive behavioural therapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour TherapyA Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 26, 2019

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment all participants will be assigned to the treatment, consisting of therapist-assisted iCBT.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: treatment

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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Depression Severity [baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks)]
change in severity of depression as measured by Patient Health Questionnaire-9

Secondary Outcome Measures

major adverse cardiac events [completion of treatment, average of 8 weeks]
death, myocardial infarction, revascularization, hospitalization for a cardiac cause
Treatment Satisfaction Questionnaire [completion of treatment, average of 8 weeks]
participants' satisfaction with treatment
Web-Based Program Usability Questionnaire [completion of treatment, average of 8 weeks]
participants' experience with using the web-based program

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.