Clinical trial NCT05607992: Brief Internet-delivered CBT After ACS
Official title: Brief Internet-delivered Exposure-based Therapy to Reduce Post-traumatic Stress Symptoms and Cardiac Anxiety After Acute Coronary Syndrome: a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Trauma
Acute Coronary Syndrome
Keywords: Acute coronary syndrome
Posttraumatic stress disorder
Cardiac anxiety
Cognitive behavioral therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2022-11-07
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 after acute coronary syndrome (ACS).

Detailed description: Acute coronary syndrome (ACS; myocardial infarction (MI) or unstable angina (UA)) is one of the leading causes of mortality and health loss globally. ACS is a stressful and potentially life-threatening cardiovascular event, and many patients develop symptoms of post-traumatic stress (PTSS) and cardiac anxiety post ACS, which have been shown to negatively affect patients' long-term cardiovascular prognosis.The aim of the proposed pilot study is to develop and evaluate a brief internet-delivered exposure-based CBT intervention provided early following ACS to reduce ACS-related PTSS, cardiac anxiety. and increase physical activity and quality of life. Patients with recent ACS (≥ 4 weeks to 6 months) and with elevated PTSS and anxiety will be eligible. After informed consent, patients will be randomized to internet-delivered CBT (N=15) or to a wait-list control group (N=15). The treatment is a 5 week, therapist-guided, internet-delivered intervention which includes imaginal exposure, interoceptive exposure, and exposure in-vivo. Assessments will be conducted at baseline, immediate post-treatment, and 2- and 6- months after treatment. The wait-list will be crossed over to CBT after completion of the 2 month follow-up.

Eligibility criteria: Inclusion Criteria:

* (A) ACS ≥ four weeks to six months before assessment (MI type 1 STEMI/NSTEMI and UA)
* (B) Age 18-80 years
* (C) Symptoms of PTSD and/or cardiac anxiety that leads to distress and/or interferes with daily life (PCL5; ≥ 10, CAQ: ≥20)
* (D) On standard of care medical treatment for the cardiac condition according to Swedish cardiovascular guidelines
* (E) Ability to read and write in Swedish.

Exclusion Criteria:

* (F) Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%)
* (G) Significant valvular disease
* (H) Planned coronary artery bypass surgery or percutaneous interventions
* (I) Any medical restriction to physical exercise
* (J) Severe uncontrolled medical illness i.e., advanced cancer
* (K) Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
* (L) Severe psychiatric disorder, active suicidal ideations or cognitive impairment that precludes provision of informed consent or study activities
* (M) Alcohol dependency
* (N) Ongoing psychological treatment.

Primary outcomes:
measure: Seattle Angina Questionnaire
timeFrame: Baseline to 3 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: Seattle Angina Questionnaire
timeFrame: Baseline to 5 weeks
measure: Seattle Angina Questionnaire
timeFrame: Baseline to 7 months
measure: Seattle Angina Questionnaire
timeFrame: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
timeFrame: Baseline to 5 weeks
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
timeFrame: Baseline to 3 months
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
timeFrame: Baseline to 7 months
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5
timeFrame: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
measure: Cardiac anxiety questionnaire
timeFrame: Baseline to 5 weeks
measure: Cardiac anxiety questionnaire
timeFrame: Baseline to 3 months
measure: Cardiac anxiety questionnaire
timeFrame: Baseline to 7 months
measure: Cardiac anxiety questionnaire
timeFrame: Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment
measure: Myocardial infarction behavior questionnaire
timeFrame: Baseline to 8 weeks.
measure: Myocardial infarction behavior questionnaire
timeFrame: Baseline to 3 months
measure: Myocardial infarction behavior questionnaire
timeFrame: Baseline to 7 months
measure: Body Sensation Questionnaire
timeFrame: Baseline to 8 weeks
measure: Body Sensation Questionnaire
timeFrame: Baseline to 3 months
measure: Body Sensation Questionnaire
timeFrame: Baseline to 7 months
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: Baseline to 8 weeks.
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: Baseline to 3 months
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: Baseline to 7 months
measure: 12-Item Short-Form Health Survey
timeFrame: Baseline to 5 weeks
measure: 12-Item Short-Form Health Survey
timeFrame: Baseline to 3 months
measure: 12-Item Short-Form Health Survey
timeFrame: Baseline to 7 months
measure: Patient Health Questionnaire-9
timeFrame: Baseline to 5 weeks
measure: Patient Health Questionnaire-9
timeFrame: Baseline to 3 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 3 months
measure: Generalized Anxiety Disorder 7-item
timeFrame: Baseline to 7 months
measure: Perceived stress scale 4-item
timeFrame: Baseline to 5 weeks
measure: Perceived stress scale 4-item
timeFrame: Baseline to 3 months
measure: Perceived stress scale 4-item
timeFrame: Baseline to 7 months
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 5 weeks
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 3 months
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 7 months
measure: Lifestyle factors: The national Board of health and Welfare questionnaire
timeFrame: Baseline to 8 weeks
measure: Lifestyle factors: The national Board of health and Welfare questionnaire
timeFrame: Baseline to 3 months
measure: Lifestyle factors: The national Board of health and Welfare questionnaire
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 3 months
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: Baseline to 7 months
Other outcomes:
measure: Adverse events
timeFrame: Baseline to 3 months
measure: Adverse events
timeFrame: Baseline to 7 months
measure: Adverse events
timeFrame: 5 measurement points measured from baseline and weekly for 5 weeks during treatment
measure: AFFS/SCL-4
timeFrame: Change over 5 measurement points measured from baseline and weekly for 8 weeks during treatment ]
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References: