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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
Karolinska Institutet
Stockholm, Sweden
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
Time frame: 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.
Time frame: 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.
Time frame: 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').
Time frame: 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
Time frame: Baseline to 5 weeks
12-Item Short-Form Health Survey
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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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 7 months
Brief Pain Inventory Short Form
Measure of pain interference and severity, with a higher score indicating more pain.
Time frame: Baseline to 5 weeks
Brief Pain Inventory Short Form
Measure of pain interference and severity, with a higher score indicating more pain.
Time frame: Baseline to 2 months
Brief Pain Inventory Short Form
Measure of pain interference and severity, with a higher score indicating more pain.
Time frame: Baseline to 7 months
Multidimensional fatigue inventory
Measure of fatigue, with a higher score indicating more fatigue.
Time frame: Baseline to 5 weeks
Multidimensional fatigue inventory
Measure of fatigue, with a higher score indicating more fatigue.
Time frame: Baseline to 2 months
Multidimensional fatigue inventory
Measure of fatigue, with a higher score indicating more fatigue.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 7 months