NCT05607992Completed
Brief Internet-delivered CBT After ACS
Brief Internet-delivered Exposure-based Therapy to Reduce Post-traumatic Stress Symptoms and Cardiac Anxiety After Acute Coronary Syndrome: a Pilot Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 27 Aug 2024
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 27 Oct 2022
- Start date
- 18 May 2023
- Primary completion date
- 21 Aug 2024
- Lead sponsor
- Karolinska Institutet
- Diseases
- Coronary artery disease
- NCT number
- NCT05607992
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 18 May 2023 to the primary completion date, 21 Aug 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- (H) Planned coronary artery bypass surgery or percutaneous interventions
Other illness
- (G) Significant valvular disease
- (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
Lab values
- (F) Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%)
Other
- (I) Any medical restriction to physical exercise
- (M) Alcohol dependency
- (N) Ongoing psychological treatment.
Who the study is looking for
- (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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska Institutet Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.