Clinical trial NCT05727865: Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery
Official title: Online Cognitive Behavioral Therapy for Rehabilitation After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Psychological distress
Cognitive behavioral therapy
Fatigue
Depression
Anxiety
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
First posted: 2023-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 12-Item Short-Form Health Survey
timeFrame: Baseline to 2 months
measure: Acceptability: Client satisfaction Questionnaire
timeFrame: Baseline to 5 weeks.
measure: Percentage of enrolled participants who complete the treatment
timeFrame: Baseline to 5 weeks
measure: Adverse events
timeFrame: Baseline to 5 weeks
Secondary outcomes:
measure: 12-Item Short-Form Health Survey
timeFrame: Baseline to 5 weeks
measure: 12-Item Short-Form Health Survey
timeFrame: Baseline to 7 months
measure: Cardiac anxiety questionnaire
timeFrame: Baseline to 5 weeks
measure: Cardiac anxiety questionnaire
timeFrame: Baseline to 2 months
measure: Cardiac anxiety questionnaire
timeFrame: Baseline to 7 months
measure: Patient Health Questionnaire-9
timeFrame: Baseline to 5 weeks
measure: Patient Health Questionnaire-9
timeFrame: Baseline to 2 months
measure: Patient Health Questionnaire-9
timeFrame: Baseline to 7 months
measure: Generalized Anxiety Disorder 7-item
timeFrame: Baseline to 5 weeks
measure: Generalized Anxiety Disorder 7-item
timeFrame: Baseline to 2 months
measure: Generalized Anxiety Disorder 7-item
timeFrame: Baseline to 7 months
measure: Brief Pain Inventory Short Form
timeFrame: Baseline to 5 weeks
measure: Brief Pain Inventory Short Form
timeFrame: Baseline to 2 months
measure: Brief Pain Inventory Short Form
timeFrame: Baseline to 7 months
measure: Multidimensional fatigue inventory
timeFrame: Baseline to 5 weeks
measure: Multidimensional fatigue inventory
timeFrame: Baseline to 2 months
measure: Multidimensional fatigue inventory
timeFrame: Baseline to 7 months
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: Baseline to 5 weeks
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: Baseline to 2 months
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: Baseline to 7 months
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to weeks
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 2 months
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 7 months
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: Baseline to 5 weeks
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: Baseline to 2 months
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: Baseline to 7 months
Other outcomes:
measure: Adverse events
timeFrame: Baseline to 2 months
measure: Adverse events
timeFrame: Baseline to 7 months
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Josefin Särnholm, PhD
role: PRINCIPAL_INVESTIGATOR
References: