Recruiting

Cognitive Behavioural Therapy

Sponsor:

University of British Columbia

Code:

NCT04053244

Conditions

Depression

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

internet-based cognitive behavioural therapy

Study Details

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

Study ID

NCT04053244

Start date

Aug 26, 2019

Status verified date

Oct, 2019

Completion date

Dec, 2020

Anticipated

Primary completion date

Jun 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: treatment

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

Interventions

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.

Primary outcome measure

  • Depression Severity [ Time Frame: baseline, completion of treatment (average of 12 weeks), study completion (treatment completion + 8 weeks) ]

Central Contacts and Locations

Central contacts

Martha H Mackay, PhD

6046822344mmackay@providencehealth.bc.ca

Locations

St. Paul's Hospital, Providence Health Care

Recruiting

Vancouver, British Columbia, Canada, V6Z1Y6

Contacts

Martha Mackay, PhD

6046822344mmackay@providencehealth.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Oct 3, 2019

Last verified

Oct, 2019

Keywords

  • iCBT
  • cardiac event
  • cognitive behavioural therapy
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2019-10-03.