Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Behavioral: Online CBT following cardiac surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online CBT following cardiac surgery<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 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 2 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 7 months | 
| 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 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 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 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 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 2 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 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychological distress, Cognitive behavioral therapy, Fatigue, Depression, Anxiety