Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery

Cardiac Surgery Clinical Trial

— TRACS  

Official title:

Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05727865
• Other study ID #: TRACS-PILOT
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: February 17, 2024

Study information

• Verified date: May 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 17, 2024
• Est. primary completion date: February 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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.
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Brief Pain Inventory Short Form	Measure of pain interference and severity, with a higher score indicating more pain.	Baseline to 5 weeks
Secondary	Brief Pain Inventory Short Form	Measure of pain interference and severity, with a higher score indicating more pain.	Baseline to 2 months
Secondary	Brief Pain Inventory Short Form	Measure of pain interference and severity, with a higher score indicating more pain.	Baseline to 7 months
Secondary	Multidimensional fatigue inventory	Measure of fatigue, with a higher score indicating more fatigue.	Baseline to 5 weeks
Secondary	Multidimensional fatigue inventory	Measure of fatigue, with a higher score indicating more fatigue.	Baseline to 2 months
Secondary	Multidimensional fatigue inventory	Measure of fatigue, with a higher score indicating more fatigue.	Baseline to 7 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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