Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Seattle Angina Questionnaire
Study Overview
Brief Summary
The purpose of the present study is to evaluate an internet-delivered exposure-based cognitive behavioral therapy (CBT) protocol tailored for patients following myocardial infaction (MI) to increase Quality of Life (Qol) and physical activity by reducing cardiac anxiety.
Detailed Description
In the present research project, the investigators have tailored a CBT protocol to target the hypothesized mechanisms of how cardiac anxiety affects the clinical course of MI; by using exposure therapy to reduce fear, hypervigilance, and misinterpretations of cardiac symptoms to reduce MI-related avoidance and increasing physical activity.
Participants (estimated N=100) are randomized to internet-delivered CBT for 8 weeks or to a waitlist offered treatment as usual. Patients in the control arm will be crossed over to CBT treatment 3 months after the experimental group has completed treatment. Assessments will be conducted pre-treatment, post-treatment, 3 months (primary endpoint), 1-, 2 - and 5 years after treatment. These measurement points will also include the control group as it is crossed over to CBT after the 3-month follow-up
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion criteria:
- •Myocardial infarction ≥ 6 months before assessment (type 1 STEMI/NSTEMI)
- •Age 18-80 years;
- •Clinically significant cardiac anxiety that leads to severe distress and/or interferes with daily life
- •On adequate medical treatment(21); (E) Able to read and write in Swedish.
Exclusion Criteria
- •heart failure with severe systolic dysfunction (ejection fraction ≤ 35%)
- •Significant valvular disease
- •Planned coronary artery bypass surgery or percutaneous interventions
- •Any medical restriction to physical exercise
- •Severe medical illness
- •Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
- •Severe psychiatric disorder or risk of suicide
- •Alcohol dependency
- •Ongoing psychological treatment.
Arms & Interventions
Online CBT targeting cardiac anxiety
CBT for MI primarily targets two processes of MI-related disability: fear of cardiac-related symptoms avoidance behavior and physical inactivity. The CBT is therapist-guided and lasts for 8 weeks.
Intervention: MI-CBT (Behavioral)
Waitlist control
Participants randomised to waitlist can have no other concurrent psychological treatment but are free to use any medical treatment as usual. Participants on the waitlist also complete pre- and post-treatment, the follow-up measurement as well as weekly instruments (with exception of the treatment process measures Credibility scale and WAI). After the 3-month follow-up assessments, participants will receive internet-CBT for MI over 8 weeks
Outcomes
Primary Outcomes
Seattle Angina Questionnaire
Time Frame: From baseline to 5 months
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.
Secondary Outcomes
- Body Sensation Questionnaire(From baseline to 5 years and 2 months)
- Seattle Angina Questionnaire(From baseline to 5 years and 2 months)
- University of Toronto Atrial fibrillation Severity Scale (AFSS)(From Baseline to 5 years and 2 months)
- Cardiac anxiety questionnaire(From baseline to 5 year and 2 months)
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)(From baseline to 5 years and 2 months)
- Perceived stress scale 4-item(Baseline to 5 years and 2 months)
- Generalized Anxiety Disorder 7-item(From Baseline to 5 years and 2 months)
- 12-Item Short-Form Health Survey(From baseline to 5 year and 2 months)
- Myocardial infarction behavior questionnaire(From baseline to 5 years and 2 months)
- Lifestyle factors: The national Board of health and Welfare questionnaire(Baseline to 5 years and 2 months)
- Healthcare consumption and work loss:Tic-P(From baseline to 5 years and 2 months)
- Patient Health Questionnaire-9(From Baseline to 5 years and 2 months)
- The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity(Baseline to 5 years and 2 months)
- Seattle Angina Questionnaire(From baseline to 8 weeks)
- Seattle Angina Questionnaire(Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment)
- Seattle Angina Questionnaire(From baseline to 1 year and 2 months)
- Seattle Angina Questionnaire(From baseline to 2 years and 2 months)
- 12-Item Short-Form Health Survey(From baseline to 8 weeks)
- 12-Item Short-Form Health Survey(From baseline to 5 months)
- 12-Item Short-Form Health Survey(From baseline to 1 year and 2 months)
- 12-Item Short-Form Health Survey(From baseline to 2 year and 2 months)
- Cardiac anxiety questionnaire(From baseline to 8 weeks)
- Cardiac anxiety questionnaire(Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment)
- Cardiac anxiety questionnaire(From baseline to 5 months)
- Cardiac anxiety questionnaire(From baseline to 1 year and 2 months)
- Cardiac anxiety questionnaire(From baseline to 2 year and 2 months)
- Myocardial infarction behavior questionnaire(From baseline to 8 weeks)
- Myocardial infarction behavior questionnaire(From baseline to 5 months)
- Myocardial infarction behavior questionnaire(From baseline to 1 year and 2 months)
- Myocardial infarction behavior questionnaire(From baseline to 2 years and 2 months)
- Body Sensation Questionnaire(From baseline to 8 weeks)
- Body Sensation Questionnaire(From baseline to 5 months)
- Body Sensation Questionnaire(From baseline to 1 year and 2 months)
- Body Sensation Questionnaire(From baseline to 2 years and 2 months)
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)(From baseline to 8 weeks)
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)(From baseline to 5 months)
- Patient Health Questionnaire-9(From Baseline to 2 years and 2 months)
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)(From baseline to 1 year and 2 months)
- Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)(From baseline to 2 years and 2 months)
- Patient Health Questionnaire-9(From Baseline to 8 weeks)
- Patient Health Questionnaire-9(From Baseline to 5 months)
- Patient Health Questionnaire-9(From Baseline to 1 year and 2 months)
- Generalized Anxiety Disorder 7-item(From Baseline to 8 weeks)
- Generalized Anxiety Disorder 7-item(From Baseline to 5 months)
- Generalized Anxiety Disorder 7-item(From Baseline to 1 year and 2 months)
- Generalized Anxiety Disorder 7-item(From Baseline to 2 years and 2 months)
- Perceived stress scale 4-item(Baseline to 8 weeks)
- Perceived stress scale 4-item(Baseline to 5 months)
- Perceived stress scale 4-item(Baseline to 1 year and 2 months)
- Perceived stress scale 4-item(Baseline to 2 years and 2 months)
- The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity(Baseline to 8 weeks)
- The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity(Baseline to 5 months)
- The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity(Baseline to 1 year and 2 months)
- The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity(Baseline to 2 years and 2 months)
- Lifestyle factors: The national Board of health and Welfare questionnaire(Baseline to 8 weeks)
- Lifestyle factors: The national Board of health and Welfare questionnaire(Baseline to 5 months)
- Lifestyle factors: The national Board of health and Welfare questionnaire(Baseline to 1 year and 2 months)
- Lifestyle factors: The national Board of health and Welfare questionnaire(Baseline to 2 years and 2 months)
- Healthcare consumption and work loss:Tic-P(From baseline to 8 weeks)
- Healthcare consumption and work loss:Tic-P(From baseline to 5 months)
- Healthcare consumption and work loss:Tic-P(From baseline to 1 year and 2 months)
- Healthcare consumption and work loss:Tic-P(From baseline to 2 years and 2 months)
- University of Toronto Atrial fibrillation Severity Scale (AFSS)(From Baseline to 8 weeks)
- University of Toronto Atrial fibrillation Severity Scale (AFSS)(From Baseline to 5 months)
- University of Toronto Atrial fibrillation Severity Scale (AFSS)(From Baseline to 1 year and 2 months)
- University of Toronto Atrial fibrillation Severity Scale (AFSS)(From Baseline to 2 years and 2 months)
Investigators
Josefin Särnholm
Principal Investigator, PhD
Karolinska Institutet