Clinical trial NCT05580718: Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety
Official title: Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Online CBT Targeting Cardiac Anxiety
Keywords: Myocardial infarction
Cardiac Anxiety
internet-CBT
Secondary prevention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Swedish Heart Lung Foundation
name: The Swedish Research Council
name: Sahlgrenska University Hospital
First posted: 2022-10-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Seattle Angina Questionnaire
timeFrame: From baseline to 5 months
Secondary outcomes:
measure: Seattle Angina Questionnaire
timeFrame: From baseline to 8 weeks
measure: Seattle Angina Questionnaire
timeFrame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
measure: Seattle Angina Questionnaire
timeFrame: From baseline to 1 year and 2 months
measure: Seattle Angina Questionnaire
timeFrame: From baseline to 2 years and 2 months
measure: Seattle Angina Questionnaire
timeFrame: From baseline to 5 years and 2 months
measure: 12-Item Short-Form Health Survey
timeFrame: From baseline to 8 weeks
measure: 12-Item Short-Form Health Survey
timeFrame: From baseline to 5 months
measure: 12-Item Short-Form Health Survey
timeFrame: From baseline to 1 year and 2 months
measure: 12-Item Short-Form Health Survey
timeFrame: From baseline to 2 year and 2 months
measure: 12-Item Short-Form Health Survey
timeFrame: From baseline to 5 year and 2 months
measure: Cardiac anxiety questionnaire
timeFrame: From baseline to 8 weeks
measure: Cardiac anxiety questionnaire
timeFrame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
measure: Cardiac anxiety questionnaire
timeFrame: From baseline to 5 months
measure: Cardiac anxiety questionnaire
timeFrame: From baseline to 1 year and 2 months
measure: Cardiac anxiety questionnaire
timeFrame: From baseline to 2 year and 2 months
measure: Cardiac anxiety questionnaire
timeFrame: From baseline to 5 year and 2 months
measure: Myocardial infarction behavior questionnaire
timeFrame: From baseline to 8 weeks
measure: Myocardial infarction behavior questionnaire
timeFrame: From baseline to 5 months
measure: Myocardial infarction behavior questionnaire
timeFrame: From baseline to 1 year and 2 months
measure: Myocardial infarction behavior questionnaire
timeFrame: From baseline to 2 years and 2 months
measure: Myocardial infarction behavior questionnaire
timeFrame: From baseline to 5 years and 2 months
measure: Body Sensation Questionnaire
timeFrame: From baseline to 8 weeks
measure: Body Sensation Questionnaire
timeFrame: From baseline to 5 months
measure: Body Sensation Questionnaire
timeFrame: From baseline to 1 year and 2 months
measure: Body Sensation Questionnaire
timeFrame: From baseline to 2 years and 2 months
measure: Body Sensation Questionnaire
timeFrame: From baseline to 5 years and 2 months
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: From baseline to 8 weeks
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: From baseline to 5 months
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: From baseline to 1 year and 2 months
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: From baseline to 2 years and 2 months
measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
timeFrame: From baseline to 5 years and 2 months
measure: Patient Health Questionnaire-9
timeFrame: From Baseline to 8 weeks
measure: Patient Health Questionnaire-9
timeFrame: From Baseline to 5 months
measure: Patient Health Questionnaire-9
timeFrame: From Baseline to 1 year and 2 months
measure: Patient Health Questionnaire-9
timeFrame: From Baseline to 2 years and 2 months
measure: Patient Health Questionnaire-9
timeFrame: From Baseline to 5 years and 2 months
measure: Generalized Anxiety Disorder 7-item
timeFrame: From Baseline to 8 weeks
measure: Generalized Anxiety Disorder 7-item
timeFrame: From Baseline to 5 months
measure: Generalized Anxiety Disorder 7-item
timeFrame: From Baseline to 1 year and 2 months
measure: Generalized Anxiety Disorder 7-item
timeFrame: From Baseline to 2 years and 2 months
measure: Generalized Anxiety Disorder 7-item
timeFrame: From Baseline to 5 years and 2 months
measure: Perceived stress scale 4-item
timeFrame: Baseline to 8 weeks
measure: Perceived stress scale 4-item
timeFrame: Baseline to 5 months
measure: Perceived stress scale 4-item
timeFrame: Baseline to 1 year and 2 months
measure: Perceived stress scale 4-item
timeFrame: Baseline to 2 years and 2 months
measure: Perceived stress scale 4-item
timeFrame: Baseline to 5 years and 2 months
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 8 weeks
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 5 months
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 1 year and 2 months
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 2 years and 2 months
measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
timeFrame: Baseline to 5 years and 2 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 5 months
measure: Lifestyle factors: The national Board of health and Welfare questionnaire
timeFrame: Baseline to 1 year and 2 months
measure: Lifestyle factors: The national Board of health and Welfare questionnaire
timeFrame: Baseline to 2 years and 2 months
measure: Lifestyle factors: The national Board of health and Welfare questionnaire
timeFrame: Baseline to 5 years and 2 months
measure: Healthcare consumption and work loss:Tic-P
timeFrame: From baseline to 8 weeks
measure: Healthcare consumption and work loss:Tic-P
timeFrame: From baseline to 5 months
measure: Healthcare consumption and work loss:Tic-P
timeFrame: From baseline to 1 year and 2 months
measure: Healthcare consumption and work loss:Tic-P
timeFrame: From baseline to 2 years and 2 months
measure: Healthcare consumption and work loss:Tic-P
timeFrame: From baseline to 5 years and 2 months
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: From Baseline to 8 weeks
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: From Baseline to 5 months
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: From Baseline to 1 year and 2 months
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: From Baseline to 2 years and 2 months
measure: University of Toronto Atrial fibrillation Severity Scale (AFSS)
timeFrame: From Baseline to 5 years and 2 months
Other outcomes:
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: From Baseline to 8 weeks
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: From Baseline to 5 months
measure: Algometry (Somedic AB, Hörby, Sweden)
timeFrame: From Baseline to 8 weeks
measure: Algometry (Somedic AB, Hörby, Sweden)
timeFrame: From Baseline to 5 months
measure: Accelerometer (Actigraf®)
timeFrame: Baseline to 8 weeks
measure: Accelerometer (Actigraf®)
timeFrame: Baseline to 5 months
measure: Adverse events
timeFrame: From Baseline to 8 weeks
measure: Adverse events
timeFrame: 8 measurement points measured from baseline and weekly for 8 weeks during treatment
measure: Adverse events
timeFrame: From Baseline to 5 months
measure: Adverse events
timeFrame: From Baseline to 1 year and 2 months
measure: Adverse events
timeFrame: From Baseline to 2 years and 2 months
measure: Adverse events
timeFrame: From Baseline to 5 years and 2 months
measure: Client satisfaction Questionnaire
timeFrame: Baseline to 8 weeks
measure: Treatment Credibility Scale
timeFrame: 1-2 weeks from baseline
measure: Working Alliance Inventory
timeFrame: 1-2 weeks from baseline
measure: Follow-up questions on health changes
timeFrame: Baseline to 8 weeks
measure: Follow-up questions on health changes
timeFrame: Baseline to 5 months
measure: Follow-up questions on health changes
timeFrame: Baseline to 1 year and 2 months
measure: Follow-up questions on health changes
timeFrame: Baseline to 2 years and 2 months
measure: Follow-up questions on health changes
timeFrame: Baseline to 5 years and 2 months
measure: AFFS/SCL-4
timeFrame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
measure: MI-behavior Questionnaire
timeFrame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
measure: Perceived stress scale 4-item
timeFrame: Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References: