Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery

Last updated: June 20, 2024
Sponsor: Karolinska Institutet
Overall Status: Completed

Phase

N/A

Condition

Cardiac Surgery

Treatment

Online CBT following cardiac surgery

Clinical Study ID

NCT05727865
TRACS-PILOT
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (A) Cardiac surgery (i.e., CABG, heart valve repair/replacement, aortic repair orcombined CABG and valve repair/replacement) ≥ eight weeks to nine months beforeassessment

  • (B) Age 18 years and above;

  • (C) Endorses postoperative psychological distress and/or interference with dailylife

  • (D) On medical treatment for the cardiac condition according to clinical guidelines;

  • (E) Ability to read and write in Swedish

Exclusion

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.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Online CBT following cardiac surgery
Phase:
Study Start date:
February 17, 2023
Estimated Completion Date:
December 22, 2023

Study 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.

Connect with a study center

  • Karolinska Institutet

    Stockholm,
    Sweden

    Site Not Available

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