Brief Internet-delivered CBT After ACS

NCT05607992 | Completed

• 1 other identifier: P30AG064198
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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).

Conditions

Psychological Trauma; Acute Coronary Syndrome

Keywords

Acute coronary syndrome; Posttraumatic stress disorder; Cardiac anxiety; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (4)

• Seattle Angina Questionnaire

  A measure of coronary artery disease on five scales: physical limitation scale, anginal stability scale, anginal frequency scale, treatment satisfaction scale, and the disease perception scale. With a score ranging from 0 to 100. A higher score indicating a better quality of life.

  Baseline to 3 months

• Acceptability: Client satisfaction Questionnaire

  Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.

  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.

  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').

  Baseline to 5 weeks

Secondary Outcomes (41)

• Seattle Angina Questionnaire

  Baseline to 5 weeks

• Seattle Angina Questionnaire

  Baseline to 7 months

• Seattle Angina Questionnaire

  Change over 5 measurement points measured from baseline and weekly for 5 weeks during treatment

• The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5

  Baseline to 5 weeks

• The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5

  Baseline to 3 months

Other Outcomes (4)

• Adverse events

  Baseline to 3 months

• Adverse events

  Baseline to 7 months

• Adverse events

  5 measurement points measured from baseline and weekly for 5 weeks during treatment

Study Arms (2)

Brief exposure-based CBT

EXPERIMENTAL

* Patient education: Common reactions following ACS. The role of PTS, cardiac anxiety and avoidance behavior on quality of life and physical health and health behaviors. * Labeling i.e., describe cardiac-related symptoms, thoughts, and feelings. * Imaginal exposure to reduce PTSS: Imaginal processing and revisiting of the memory of the ACS * Interoceptive exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. * Gradual exposure in-vivo to avoided situations, activities and physical activity. Continuously use labeling while conducting exposure exercises. * Relapse prevention: Prevention of relapse into avoidance behaviors by identifying risk situations and encouragement of maintaining a healthy physically active lifestyle.

Behavioral: Brief exposure-based CBT

Waitlist control

NO INTERVENTION

The waitlist control will be offered an opportunity to participate in the intervention after the 2-month intervention evaluation period.

Interventions

Brief exposure-based CBT BEHAVIORAL

The 5-week intervention is psychologist-guided and delivered via text-based interactive online treatment modules, where patients complete weekly homework assignments and have regular online contact with psychologists with training in CBT for cardiac disease. Key components include imaginal exposure of the ACS event, interoceptive exposure through at home physical activity that stimulats the CV system, exposure in-vivo to reduce avoided situations, and activities to enhance physical activity wellbeing. Labeling (i.e., describing cardiac-related symptoms, thoughts, and feelings) will be used continuously during treatment to enhance the effect of exposure.

Brief exposure-based CBT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Columbia University: collaborator

Study Sites (2)

Karolinska University Hospital

Stockholm, 11635, Sweden

Location

Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Psychological Trauma; Acute Coronary Syndrome; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD, Lic. psychologist

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 7, 2022
• Study Start: May 18, 2023
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)