Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety (MI-CBT)

Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Online CBT Targeting Cardiac Anxiety
• Intervention / Treatment: Behavioral: MI-CBT

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 Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11635
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: MI-CBT; Education Common reactions following MI and general lifestyle advice on e.g., physical activity. The role of cardiac anxiety and avoidance behavior on quality of life and physical health. Brief training in self-observation.; Goal setting Identifying life areas impaired by MI-related disability or symptom fear. Set health behavioral goals i.e., increased physical activity and gradually take steps towards them.; Exposure therapy Exposure to physical sensations (e.g., palpitations due to physical activity) to reduce fear of these symptoms. Gradual exposure to avoided situations, activities and increase in physical activity.; Relapse prevention Prevention of relapse into avoidance behaviors by identifying risk situations and conduct a plan forward on maintaining a healthy physically and active lifestyle.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to 8 weeks
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.	Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
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.	From baseline to 1 year and 2 months
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	From baseline to 2 years and 2 months
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.	From baseline to 5 years and 2 months
12-Item Short-Form Health Survey	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	From baseline to 8 weeks
12-Item Short-Form Health Survey	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	From baseline to 5 months
12-Item Short-Form Health Survey	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	From baseline to 1 year and 2 months
12-Item Short-Form Health Survey	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	From baseline to 2 year and 2 months
12-Item Short-Form Health Survey	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life	From baseline to 5 year and 2 months
Cardiac anxiety questionnaire	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	From baseline to 8 weeks
Cardiac anxiety questionnaire	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
Cardiac anxiety questionnaire	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	From baseline to 5 months
Cardiac anxiety questionnaire	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	From baseline to 1 year and 2 months
Cardiac anxiety questionnaire	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	From baseline to 2 year and 2 months
Cardiac anxiety questionnaire	Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.	From baseline to 5 year and 2 months
Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group	From baseline to 8 weeks
Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group	From baseline to 5 months
Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.	From baseline to 1 year and 2 months
Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.	From baseline to 2 years and 2 months
Myocardial infarction behavior questionnaire	MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.	From baseline to 5 years and 2 months
Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	From baseline to 8 weeks
Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	From baseline to 5 months
Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	From baseline to 1 year and 2 months
Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	From baseline to 2 years and 2 months
Body Sensation Questionnaire	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.	From baseline to 5 years and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)	Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms	From baseline to 8 weeks
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)	Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms	From baseline to 5 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)	Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms	From baseline to 1 year and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)	Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms	From baseline to 2 years and 2 months
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)	Cardiac-related symptoms in two sub scales A) frequency: score ranging from 0-48, with higher score indicating higher frequency of symptoms, B) severity of experienced symptom: score ranging from 0- 48, with a higher score indicating more severe symptoms	From baseline to 5 years and 2 months
Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	From Baseline to 8 weeks
Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	From Baseline to 5 months
Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	From Baseline to 1 year and 2 months
Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	From Baseline to 2 years and 2 months
Patient Health Questionnaire-9	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression	From Baseline to 5 years and 2 months
Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	From Baseline to 8 weeks
Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	From Baseline to 5 months
Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	From Baseline to 1 year and 2 months
Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	From Baseline to 2 years and 2 months
Generalized Anxiety Disorder 7-item	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.	From Baseline to 5 years and 2 months
Perceived stress scale 4-item	Stress reactivity. A greater score indicate more perceived stress.	Baseline to 8 weeks
Perceived stress scale 4-item	Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.	Baseline to 5 months
Perceived stress scale 4-item	Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.	Baseline to 1 year and 2 months
Perceived stress scale 4-item	Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.	Baseline to 2 years and 2 months
Perceived stress scale 4-item	Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.	Baseline to 5 years and 2 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity	Level of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity	Baseline to 8 weeks
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity	Level of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity	Baseline to 5 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity	Level of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 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	Level of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity	Baseline to 2 years and 2 months
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity	Level of physical activity and inactivity: On the Godin leisure-time excercise: The participant rate numbers of time per week that they engage in physical activity. The numb ers are the categorized in to low, moderate, and high levels of physical activity. And from International Physical Activity Questionnaire we will use 1 item on inactivity	Baseline to 5 years and 2 months
Lifestyle factors: The national Board of health and Welfare questionnaire	Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.	Baseline to 8 weeks
Lifestyle factors: The national Board of health and Welfare questionnaire	Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.	Baseline to 5 months
Lifestyle factors: The national Board of health and Welfare questionnaire	Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.	Baseline to 1 year and 2 months
Lifestyle factors: The national Board of health and Welfare questionnaire	Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.	Baseline to 2 years and 2 months
Lifestyle factors: The national Board of health and Welfare questionnaire	Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.	Baseline to 5 years and 2 months
Healthcare consumption and work loss:Tic-P	The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).	From baseline to 8 weeks
Healthcare consumption and work loss:Tic-P	The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).	From baseline to 5 months
Healthcare consumption and work loss:Tic-P	The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).	From baseline to 1 year and 2 months
Healthcare consumption and work loss:Tic-P	The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).	From baseline to 2 years and 2 months
Healthcare consumption and work loss:Tic-P	The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry assesses societal cost during the last month. These costs include the participant's health care consumption (direct medical costs), time spent in other health promoting activities (direct non-medical costs), and sick leave, unemployment, and reduced work capacity at work and in the domestic realm (indirect non-medical costs).	From baseline to 5 years and 2 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.	From Baseline to 8 weeks
University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.	From Baseline to 5 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.	From Baseline to 1 year and 2 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.	From Baseline to 2 years and 2 months
University of Toronto Atrial fibrillation Severity Scale (AFSS)	3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.	From Baseline to 5 years and 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Abnormal Laboratory Values	Venous blood will be collected for local analyses of fasting plasma glucose, HbA1c, plasma total cholesterol, LDL, HDL, triglycerides, hsCRP, creatinine, stress-related hormones such as cortisol, copeptin and vasopressin	From Baseline to 8 weeks
Number of Participants With Abnormal Laboratory Values	Venous blood will be collected for local analyses of fasting plasma glucose, HbA1c, plasma total cholesterol, LDL, HDL, triglycerides, hsCRP, creatinine, stress-related hormones such as cortisol, copeptin and vasopressin	From Baseline to 5 months
Algometry (Somedic AB, Hörby, Sweden)	A pain sensitivity measurement with algometry (Somedic AB, Hörby, Sweden); consisting of a handle with a 1 cm rubber plate at the end will be used. Algometers are used to measure pressure pain thresholds, the exact pressure (kPa) is registered in the algometer and thus a measure of a person's pain threshold can be assessed.	From Baseline to 8 weeks
Algometry (Somedic AB, Hörby, Sweden)	A pain sensitivity measurement with algometry (Somedic AB, Hörby, Sweden); consisting of a handle with a 1 cm rubber plate at the end will be used. Algometers are used to measure pressure pain thresholds, the exact pressure (kPa) is registered in the algometer and thus a measure of a person's pain threshold can be assessed.	From Baseline to 5 months
Accelerometer (Actigraf®)	An Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week	Baseline to 8 weeks
Accelerometer (Actigraf®)	An Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week week at each assessment	Baseline to 5 months
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').	From Baseline to 8 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').	8 measurement points measured from baseline and weekly for 8 weeks during treatment
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').	From Baseline to 5 months
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').	From Baseline to 1 year and 2 months
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').	From Baseline to 2 years and 2 months
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').	From Baseline to 5 years and 2 months
Client satisfaction Questionnaire	Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.	Baseline to 8 weeks
Treatment Credibility Scale	Measures treatment credibility	1-2 weeks from baseline
Working Alliance Inventory	Measures therapeutic alliance with the psychologist	1-2 weeks from baseline
Follow-up questions on health changes	We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication	Baseline to 8 weeks
Follow-up questions on health changes	We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication	Baseline to 5 months
Follow-up questions on health changes	We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication	Baseline to 1 year and 2 months
Follow-up questions on health changes	We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication	Baseline to 2 years and 2 months
Follow-up questions on health changes	We will ask participant to describe if they have experienced any psychosocial stressors, changes in physical health, such as invasive therapy and changes of medication	Baseline to 5 years and 2 months
AFFS/SCL-4	4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms	Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
MI-behavior Questionnaire	5 items measuring avoidance behavior from the MI-related avoidance questionnaire behaviors developed by the research group	Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
Perceived stress scale 4-item	Measure of perceived stress and stress reactivity. Score ranging 0 -16 with a higher score indicating more perceived stress.	Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: The Swedish Research Council; Sahlgrenska University Hospital, Sweden; Swedish Heart Lung Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): March 14, 2025
• Study Completion (Estimated): March 14, 2025

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Myocardial infarction; Secondary prevention; Cardiac Anxiety; internet-CBT
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: MI-RCT1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No