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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Behavioral: Online CBT following cardiac surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Online CBT following cardiac surgery; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac anxiety questionnaire	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	Baseline to 5 weeks
Cardiac anxiety questionnaire	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	Baseline to 7 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)	Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms	Baseline to 7 months
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 5 weeks
Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	Baseline to 5 weeks
Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	Baseline to 7 months
Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	Baseline to 7 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.	Baseline to 5 weeks
University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.	Baseline to 7 months
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 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 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 7 months
Cardiac anxiety questionnaire	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	Baseline to 2 months
Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	Baseline to 2 months
Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	Baseline to 5 weeks
Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	Baseline to 2 months
Brief Pain Inventory Short Form	Measure of pain interference and severity, with a higher score indicating more pain.	Baseline to 5 weeks
Brief Pain Inventory Short Form	Measure of pain interference and severity, with a higher score indicating more pain.	Baseline to 2 months
Brief Pain Inventory Short Form	Measure of pain interference and severity, with a higher score indicating more pain.	Baseline to 7 months
Multidimensional fatigue inventory	Measure of fatigue, with a higher score indicating more fatigue.	Baseline to 5 weeks
Multidimensional fatigue inventory	Measure of fatigue, with a higher score indicating more fatigue.	Baseline to 2 months
Multidimensional fatigue inventory	Measure of fatigue, with a higher score indicating more fatigue.	Baseline to 7 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)	Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms	Baseline to 5 weeks
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)	Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms	Baseline to 2 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity	evel of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity	Baseline to weeks
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity	evel of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity	Baseline to 2 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity	evel of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity	Baseline to 7 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.	Baseline to 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 7 months
Adverse events	otential 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 2 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital
• Investigators: Principal Investigator: Josefin Särnholm, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Actual): September 22, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Cognitive behavioral therapy; Fatigue; Psychological distress
• Other Study ID Numbers: TRACS-PILOT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No