Internet-based Cognitive Behavioural Therapy for Cardiac Patients

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04053244
• Other study ID #: H19-01695
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2019
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: University of British Columbia
• Contact: Martha H Mackay, PhD
• Phone: 6046822344
• Email: mmackay[@]providencehealth.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital, Providence Health Care	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	major adverse cardiac events	death, myocardial infarction, revascularization, hospitalization for a cardiac cause	completion of treatment, average of 8 weeks
Secondary	Treatment Satisfaction Questionnaire	participants' satisfaction with treatment	completion of treatment, average of 8 weeks
Secondary	Web-Based Program Usability Questionnaire	participants' experience with using the web-based program	completion of treatment, average of 8 weeks