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Internet-based Cognitive Behavioural Therapy for Cardiac Patients

University of British Columbia logo

University of British Columbia

Status

Unknown

Conditions

Cardiovascular Diseases
Depression

Treatments

Behavioral: internet-based cognitive behavioural therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04053244
H19-01695

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No 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):

  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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

treatment
Experimental group
Description:
all participants will be assigned to the treatment, consisting of therapist-assisted iCBT.
Treatment:
Behavioral: internet-based cognitive behavioural therapy

Trial contacts and locations

1

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Central trial contact

Martha H Mackay, PhD

Data sourced from clinicaltrials.gov

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