Internet-based Cognitive Behavioural Therapy for Cardiac Patients

NCT04053244 | Unknown

• 1 other identifier: H19-01695
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Cardiovascular Diseases

Keywords

iCBT; cardiac event; cognitive behavioural therapy; depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• major adverse cardiac events

  completion of treatment, average of 8 weeks

• Treatment Satisfaction Questionnaire

  completion of treatment, average of 8 weeks

• Web-Based Program Usability Questionnaire

  completion of treatment, average of 8 weeks

Study Arms (1)

treatment

EXPERIMENTAL

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

Behavioral: internet-based cognitive behavioural therapy

Interventions

internet-based cognitive behavioural therapy BEHAVIORAL

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.

treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Depression; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Martha H Mackay, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha H Mackay, PhD

CONTACT

6046822344; mmackay@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Clinical Nurse Specialist

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

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 12, 2019
• Study Start: August 26, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CA (1)