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Completed

NCT Number: NCT05727865

Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery

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.

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Key information

Conditions

Cardiac Surgery Anxiety Disorders Behavior Behavioral Symptoms Depression Fatigue Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 12-Item Short-Form Health Survey

    Time frame: Baseline to 2 months

    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

  2. Acceptability: Client satisfaction Questionnaire

    Time frame: Baseline to 5 weeks.

    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.

  3. Percentage of enrolled participants who complete the treatment

    Time frame: Baseline to 5 weeks

    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.

  4. Adverse events

    Time frame: Baseline to 5 weeks

    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').

Secondary outcomes

  1. 12-Item Short-Form Health Survey

    Time frame: Baseline to 5 weeks

    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

  2. 12-Item Short-Form Health Survey

    Time frame: Baseline to 7 months

    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

  3. Cardiac anxiety questionnaire

    Time frame: Baseline to 5 weeks

    Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

  4. Cardiac anxiety questionnaire

    Time frame: Baseline to 2 months

    Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

  5. Cardiac anxiety questionnaire

    Time frame: Baseline to 7 months

    Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.

  6. Patient Health Questionnaire-9

    Time frame: Baseline to 5 weeks

    Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression

  7. Patient Health Questionnaire-9

    Time frame: Baseline to 2 months

    Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression

  8. Patient Health Questionnaire-9

    Time frame: Baseline to 7 months

    Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression

  9. Generalized Anxiety Disorder 7-item

    Time frame: Baseline to 5 weeks

    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

  10. Generalized Anxiety Disorder 7-item

    Time frame: Baseline to 2 months

    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

  11. Generalized Anxiety Disorder 7-item

    Time frame: Baseline to 7 months

    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.

  12. Brief Pain Inventory Short Form

    Time frame: Baseline to 5 weeks

    Measure of pain interference and severity, with a higher score indicating more pain.

  13. Brief Pain Inventory Short Form

    Time frame: Baseline to 2 months

    Measure of pain interference and severity, with a higher score indicating more pain.

  14. Brief Pain Inventory Short Form

    Time frame: Baseline to 7 months

    Measure of pain interference and severity, with a higher score indicating more pain.

  15. Multidimensional fatigue inventory

    Time frame: Baseline to 5 weeks

    Measure of fatigue, with a higher score indicating more fatigue.

  16. Multidimensional fatigue inventory

    Time frame: Baseline to 2 months

    Measure of fatigue, with a higher score indicating more fatigue.

  17. Multidimensional fatigue inventory

    Time frame: Baseline to 7 months

    Measure of fatigue, with a higher score indicating more fatigue.

  18. Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)

    Time frame: Baseline to 5 weeks

    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

  19. Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)

    Time frame: Baseline to 2 months

    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

  20. Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)

    Time frame: Baseline to 7 months

    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

  21. The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity

    Time frame: Baseline to weeks

    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

  22. The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity

    Time frame: Baseline to 2 months

    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

  23. The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity

    Time frame: Baseline to 7 months

    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

  24. University of Toronto Atrial fibrillation Severity Scale (AFSS)

    Time frame: Baseline to 5 weeks

    3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.

  25. University of Toronto Atrial fibrillation Severity Scale (AFSS)

    Time frame: Baseline to 2 months

    3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.

  26. University of Toronto Atrial fibrillation Severity Scale (AFSS)

    Time frame: Baseline to 7 months

    3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.

Other outcomes

  1. Adverse events

    Time frame: Baseline to 2 months

    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').

  2. Adverse events

    Time frame: Baseline to 7 months

    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').

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Acronym: TRACS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 14, 2023
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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