Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery (TRACS)

Karolinska Institute

Status: Completed

Conditions: Cardiac Surgery

Treatments: Behavioral: Online CBT following cardiac surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05727865

TRACS-PILOT

Details and patient eligibility

About

The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early following cardiac surgery.

Full description

Cardiac surgery is a major surgical procedure used to treat for example coronary artery disease (CAD). The intervention increases survival rates and reduces cardiac symptom burden in cardiac patients. However, cardiac surgery is associated with elevated symptoms of psychological distress, which are related to several negative outcomes, such as poorer health-related quality of life (QoL) and response to treatment. There is a clear need to develop a brief psychological intervention that can be provided early in the clinical course after cardiac surgery to reduce psychological distress.

The purpose of this pilot study is to evaluate the feasibility and potential efficacy of a brief, exposure-based internet-delivered CBT protocol provided early after cardiac surgery. This is an uncontrolled pilot study with a pretest-posttest design. The study will include 30 participants. Assessments will be conducted pre-treatment, post-treatment, one- and six months after treatment. The one-month follow-up is the primary endpoint.

The treatment lasts for five weeks and will be provided as an early intervention following cardiac surgery ≥ eight weeks to nine months before assessment. It will include psychoeducation, behavioral activation to address post-operative fatigue and depression, interoceptive exposure to reduce fear of cardiac-related symptoms and in-vivo exposure to reduce avoided situations, and activities to enhance physical activity and wellbeing.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (A) Cardiac surgery (i.e., CABG, heart valve repair/replacement, aortic repair or combined CABG and valve repair/replacement) ≥ eight weeks to nine months before assessment
• (B) Age 18 years and above;
• (C) Endorses postoperative psychological distress and/or interference with daily life
• (D) On medical treatment for the cardiac condition according to clinical guidelines;
• (E) Ability to read and write in Swedish

Exclusion criteria

• (F) Prior cardiac surgery with ventricular assist device or heart transplant;
• (G) Hospitalized or living in a care facility;
• (H) Any medical restriction to be physical active;
• (I) Severe medical illness i.e., terminal cancer ;
• (J) Severe psychiatric disorder or risk of suicide;
• (K) Alcohol dependency;
• (L) Ongoing psychological treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Online CBT following cardiac surgery

Experimental group

Description:

The treatment lasts for five weeks and will be provided as an early intervention following cardiac surgery ≥ eight weeks to nine months before assessment. The intervention is psychologist-guided (clinical psychologist and/or resident psychologist under supervision) and delivered via text-based interactive online treatment modules, where patients complete weekly homework assignments and have regular online contact with psychologists with training in CBT for cardiac disease.

Treatment:

Behavioral: Online CBT following cardiac surgery