Clinical trial NCT04053244: Internet-based Cognitive Behavioural Therapy for Cardiac Patients
Official title: A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy for Cardiac Patients With Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Cardiovascular Diseases
Keywords: iCBT
cardiac event
cognitive behavioural therapy
depression
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A Single-Centre, Open-Label Trial of Therapist-Assisted Internet-Based Cognitive Behaviour Therapy
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Depression Severity
timeFrame: baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks)
Secondary outcomes:
measure: major adverse cardiac events
timeFrame: completion of treatment, average of 8 weeks
measure: Treatment Satisfaction Questionnaire
timeFrame: completion of treatment, average of 8 weeks
measure: Web-Based Program Usability Questionnaire
timeFrame: completion of treatment, average of 8 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital, Providence Health Care
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Martha H Mackay, PhD
role: PRINCIPAL_INVESTIGATOR
References: