Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery

NCT05727865 | Completed

• 1 other identifier: TRACS-PILOT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery

Keywords

Psychological distress; Cognitive behavioral therapy; Fatigue; Depression; Anxiety

Outcome Measures

Primary Outcomes (4)

• 12-Item Short-Form Health Survey

  General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life

  Baseline to 2 months

• Acceptability: Client satisfaction Questionnaire

  Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.

  Baseline to 5 weeks.

• Percentage of enrolled participants who complete the treatment

  Feasibility of the intervention components will be assessed by \>60% assessed as treatment completers. Descriptive analysis will also provide number of messages and therapist time.

  Baseline to 5 weeks

• Adverse events

  Potential adverse reactions to the treatment. Participants will be asked to report and rate the short- and long term discomfort of the adverse event on a scale from 0 ('did not affect me at all') and 3 ('affected me very negatively').

  Baseline to 5 weeks

Secondary Outcomes (26)

• 12-Item Short-Form Health Survey

  Baseline to 5 weeks

• 12-Item Short-Form Health Survey

  Baseline to 7 months

• Cardiac anxiety questionnaire

  Baseline to 5 weeks

• Cardiac anxiety questionnaire

  Baseline to 2 months

• Cardiac anxiety questionnaire

  Baseline to 7 months

Other Outcomes (2)

• Adverse events

  Baseline to 2 months

• Adverse events

  Baseline to 7 months

Study Arms (1)

Online CBT following cardiac surgery

EXPERIMENTAL

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.

Behavioral: Online CBT following cardiac surgery

Interventions

Online CBT following cardiac surgery BEHAVIORAL

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. Labeling (i.e., describing post-operative and/or cardiac-related symptoms, thoughts, and feelings) will be used continuously during treatment to enhance the effect of exposure and pain management

Online CBT following cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Fatigue; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Josefin Särnholm, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Lic. Psychologist

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 14, 2023
• Study Start: February 17, 2023
• Primary Completion: September 22, 2023
• Study Completion: December 22, 2023
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

SE (1)