Internet-based Cognitive Behavioural Therapy for Cardiac Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Cardiovascular Diseases
• Intervention / Treatment: Behavioral: internet-based cognitive behavioural therapy

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martha H Mackay, PhD; Phone Number: 63127 6046822344; Email: mmackay@providencehealth.bc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • Recruiting
      • St. Paul's Hospital, Providence Health Care
      • Contact: Martha Mackay, PhD; Phone Number: 63127 6046822344; Email: mmackay@providencehealth.bc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Martha H Mackay, PhD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: depression; cognitive behavioural therapy; iCBT; cardiac event
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Cardiovascular Diseases
• Other Study ID Numbers: H19-01695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We would share all of our de-identified, individual-level data with any credentialed researcher.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No