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Internet-based Cognitive Behavioural Therapy for Cardiac Patients

Primary Purpose

Depression, Cardiovascular Diseases

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

internet-based cognitive behavioural therapy

About this trial

This is an interventional treatment trial for Depression focused on measuring iCBT, cardiac event, cognitive behavioural therapy, depression

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

St. Paul's Hospital, Providence Health CareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Depression Severity

change in severity of depression as measured by Patient Health Questionnaire-9

Secondary Outcome Measures

major adverse cardiac events

death, myocardial infarction, revascularization, hospitalization for a cardiac cause

Treatment Satisfaction Questionnaire

participants' satisfaction with treatment

Web-Based Program Usability Questionnaire

participants' experience with using the web-based program

Full Information

NCT ID

NCT04053244

First Posted

August 7, 2019

Last Updated

October 1, 2019

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT04053244

Brief Title

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

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 26, 2019 (Actual)

Primary Completion Date

June 1, 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Cardiovascular Diseases

Keywords

iCBT, cardiac event, cognitive behavioural therapy, depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

internet-based cognitive behavioural therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Depression Severity

Description

change in severity of depression as measured by Patient Health Questionnaire-9

Time Frame

baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks)

Secondary Outcome Measure Information:

Title

major adverse cardiac events

Description

death, myocardial infarction, revascularization, hospitalization for a cardiac cause

Time Frame

completion of treatment, average of 8 weeks

Title

Treatment Satisfaction Questionnaire

Description

participants' satisfaction with treatment

Time Frame

completion of treatment, average of 8 weeks

Title

Web-Based Program Usability Questionnaire

Description

participants' experience with using the web-based program

Time Frame

completion of treatment, average of 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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): 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Martha H Mackay, PhD

Phone

6046822344

Ext

63127

mmackay@providencehealth.bc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martha H Mackay, PhD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Paul's Hospital, Providence Health Care

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z1Y6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martha Mackay, PhD

Phone

6046822344

Ext

63127

mmackay@providencehealth.bc.ca

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We would share all of our de-identified, individual-level data with any credentialed researcher.

Learn more about this trial

Internet-based Cognitive Behavioural Therapy for Cardiac Patients

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