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

Primary Purpose

Online CBT Targeting Cardiac Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MI-CBT
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Online CBT Targeting Cardiac Anxiety focused on measuring Myocardial infarction, Cardiac Anxiety, internet-CBT, Secondary prevention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Online CBT targeting cardiac anxiety

Waitlist control

Arm Description

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.

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 Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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
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.
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
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
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
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
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
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.
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.
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.
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.
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.
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.
Myocardial infarction behavior questionnaire
MI-related avoidance questionnaire behaviors developed by the research group
Myocardial infarction behavior questionnaire
MI-related avoidance questionnaire behaviors developed by the research group
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.
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.
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.
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Body Sensation Questionnaire
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
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
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
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
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
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
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Patient Health Questionnaire-9
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Generalized Anxiety Disorder 7-item
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Perceived stress scale 4-item
Stress reactivity. A greater score indicate more perceived stress.
Perceived stress scale 4-item
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Perceived stress scale 4-item
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Perceived stress scale 4-item
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Perceived stress scale 4-item
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
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
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
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
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
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
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.

Full Information

First Posted
October 7, 2022
Last Updated
January 9, 2023
Sponsor
Karolinska Institutet
Collaborators
Swedish Heart Lung Foundation, The Swedish Research Council, Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT05580718
Brief Title
Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety
Acronym
MI-CBT
Official Title
Online Cognitive Behavioral Therapy Targeting Cardiac Anxiety Following Myocardial Infarction: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
July 14, 2024 (Anticipated)
Study Completion Date
July 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Swedish Heart Lung Foundation, The Swedish Research Council, Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Online CBT Targeting Cardiac Anxiety
Keywords
Myocardial infarction, Cardiac Anxiety, internet-CBT, Secondary prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online CBT targeting cardiac anxiety
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
MI-CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Seattle Angina Questionnaire
Description
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.
Time Frame
From baseline to 5 months
Secondary Outcome Measure Information:
Title
Seattle Angina Questionnaire
Description
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.
Time Frame
From baseline to 8 weeks
Title
Seattle Angina Questionnaire
Description
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.
Time Frame
Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
Title
Seattle Angina Questionnaire
Description
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.
Time Frame
From baseline to 1 year and 2 months
Title
Seattle Angina Questionnaire
Description
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
Time Frame
From baseline to 2 years and 2 months
Title
Seattle Angina Questionnaire
Description
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.
Time Frame
From baseline to 5 years and 2 months
Title
12-Item Short-Form Health Survey
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Time Frame
From baseline to 8 weeks
Title
12-Item Short-Form Health Survey
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Time Frame
From baseline to 5 months
Title
12-Item Short-Form Health Survey
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Time Frame
From baseline to 1 year and 2 months
Title
12-Item Short-Form Health Survey
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Time Frame
From baseline to 2 year and 2 months
Title
12-Item Short-Form Health Survey
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life
Time Frame
From baseline to 5 year and 2 months
Title
Cardiac anxiety questionnaire
Description
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time Frame
From baseline to 8 weeks
Title
Cardiac anxiety questionnaire
Description
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time Frame
Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
Title
Cardiac anxiety questionnaire
Description
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time Frame
From baseline to 5 months
Title
Cardiac anxiety questionnaire
Description
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time Frame
From baseline to 1 year and 2 months
Title
Cardiac anxiety questionnaire
Description
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time Frame
From baseline to 2 year and 2 months
Title
Cardiac anxiety questionnaire
Description
Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
Time Frame
From baseline to 5 year and 2 months
Title
Myocardial infarction behavior questionnaire
Description
MI-related avoidance questionnaire behaviors developed by the research group
Time Frame
From baseline to 8 weeks
Title
Myocardial infarction behavior questionnaire
Description
MI-related avoidance questionnaire behaviors developed by the research group
Time Frame
From baseline to 5 months
Title
Myocardial infarction behavior questionnaire
Description
MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.
Time Frame
From baseline to 1 year and 2 months
Title
Myocardial infarction behavior questionnaire
Description
MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.
Time Frame
From baseline to 2 years and 2 months
Title
Myocardial infarction behavior questionnaire
Description
MI-related avoidance questionnaire behaviors developed by the research group. score ranging from 0 to 68 . Higher scores indicate more avoidance behavior.
Time Frame
From baseline to 5 years and 2 months
Title
Body Sensation Questionnaire
Description
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time Frame
From baseline to 8 weeks
Title
Body Sensation Questionnaire
Description
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time Frame
From baseline to 5 months
Title
Body Sensation Questionnaire
Description
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time Frame
From baseline to 1 year and 2 months
Title
Body Sensation Questionnaire
Description
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time Frame
From baseline to 2 years and 2 months
Title
Body Sensation Questionnaire
Description
Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Time Frame
From baseline to 5 years and 2 months
Title
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Description
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
Time Frame
From baseline to 8 weeks
Title
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Description
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
Time Frame
From baseline to 5 months
Title
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Description
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
Time Frame
From baseline to 1 year and 2 months
Title
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Description
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
Time Frame
From baseline to 2 years and 2 months
Title
Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease)
Description
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
Time Frame
From baseline to 5 years and 2 months
Title
Patient Health Questionnaire-9
Description
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Time Frame
From Baseline to 8 weeks
Title
Patient Health Questionnaire-9
Description
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Time Frame
From Baseline to 5 months
Title
Patient Health Questionnaire-9
Description
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Time Frame
From Baseline to 1 year and 2 months
Title
Patient Health Questionnaire-9
Description
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Time Frame
From Baseline to 2 years and 2 months
Title
Patient Health Questionnaire-9
Description
Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
Time Frame
From Baseline to 5 years and 2 months
Title
Generalized Anxiety Disorder 7-item
Description
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time Frame
From Baseline to 8 weeks
Title
Generalized Anxiety Disorder 7-item
Description
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time Frame
From Baseline to 5 months
Title
Generalized Anxiety Disorder 7-item
Description
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time Frame
From Baseline to 1 year and 2 months
Title
Generalized Anxiety Disorder 7-item
Description
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time Frame
From Baseline to 2 years and 2 months
Title
Generalized Anxiety Disorder 7-item
Description
General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
Time Frame
From Baseline to 5 years and 2 months
Title
Perceived stress scale 4-item
Description
Stress reactivity. A greater score indicate more perceived stress.
Time Frame
Baseline to 8 weeks
Title
Perceived stress scale 4-item
Description
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Time Frame
Baseline to 5 months
Title
Perceived stress scale 4-item
Description
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Time Frame
Baseline to 1 year and 2 months
Title
Perceived stress scale 4-item
Description
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Time Frame
Baseline to 2 years and 2 months
Title
Perceived stress scale 4-item
Description
Stress reactivity. Score ranges 0-16 and a greater score indicate more perceived stress.
Time Frame
Baseline to 5 years and 2 months
Title
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Description
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
Time Frame
Baseline to 8 weeks
Title
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Description
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
Time Frame
Baseline to 5 months
Title
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Description
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
Time Frame
Baseline to 1 year and 2 months
Title
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Description
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
Time Frame
Baseline to 2 years and 2 months
Title
The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity
Description
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
Time Frame
Baseline to 5 years and 2 months
Title
Lifestyle factors: The national Board of health and Welfare questionnaire
Description
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Time Frame
Baseline to 8 weeks
Title
Lifestyle factors: The national Board of health and Welfare questionnaire
Description
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Time Frame
Baseline to 5 months
Title
Lifestyle factors: The national Board of health and Welfare questionnaire
Description
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Time Frame
Baseline to 1 year and 2 months
Title
Lifestyle factors: The national Board of health and Welfare questionnaire
Description
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Time Frame
Baseline to 2 years and 2 months
Title
Lifestyle factors: The national Board of health and Welfare questionnaire
Description
Questionnaire regarding diet (5 item), tobacco (2 item) and alcohol (3 item) diet (5 item), tobacco (2 item) and alcohol (3 item) and BMI.
Time Frame
Baseline to 5 years and 2 months
Title
Healthcare consumption and work loss:Tic-P
Description
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).
Time Frame
From baseline to 8 weeks
Title
Healthcare consumption and work loss:Tic-P
Description
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).
Time Frame
From baseline to 5 months
Title
Healthcare consumption and work loss:Tic-P
Description
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).
Time Frame
From baseline to 1 year and 2 months
Title
Healthcare consumption and work loss:Tic-P
Description
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).
Time Frame
From baseline to 2 years and 2 months
Title
Healthcare consumption and work loss:Tic-P
Description
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).
Time Frame
From baseline to 5 years and 2 months
Title
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Description
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Time Frame
From Baseline to 8 weeks
Title
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Description
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Time Frame
From Baseline to 5 months
Title
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Description
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Time Frame
From Baseline to 1 year and 2 months
Title
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Description
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Time Frame
From Baseline to 2 years and 2 months
Title
University of Toronto Atrial fibrillation Severity Scale (AFSS)
Description
3 item on cardiac-specific healthcare consumption. Scores ranges 0-15 with a higher score indicating more cardiac-related healthcare consumption.
Time Frame
From Baseline to 5 years and 2 months
Other Pre-specified Outcome Measures:
Title
Number of Participants With Abnormal Laboratory Values
Description
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
Time Frame
From Baseline to 8 weeks
Title
Number of Participants With Abnormal Laboratory Values
Description
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
Time Frame
From Baseline to 5 months
Title
Algometry (Somedic AB, Hörby, Sweden)
Description
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.
Time Frame
From Baseline to 8 weeks
Title
Algometry (Somedic AB, Hörby, Sweden)
Description
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.
Time Frame
From Baseline to 5 months
Title
Accelerometer (Actigraf®)
Description
An Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week
Time Frame
Baseline to 8 weeks
Title
Accelerometer (Actigraf®)
Description
An Accelerometer (Actigraf®) will be carried on the wrist over to measure physical activity over 1 week week at each assessment
Time Frame
Baseline to 5 months
Title
Adverse events
Description
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').
Time Frame
From Baseline to 8 weeks
Title
Adverse events
Description
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').
Time Frame
8 measurement points measured from baseline and weekly for 8 weeks during treatment
Title
Adverse events
Description
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').
Time Frame
From Baseline to 5 months
Title
Adverse events
Description
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').
Time Frame
From Baseline to 1 year and 2 months
Title
Adverse events
Description
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').
Time Frame
From Baseline to 2 years and 2 months
Title
Adverse events
Description
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').
Time Frame
From Baseline to 5 years and 2 months
Title
Client satisfaction Questionnaire
Description
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Time Frame
Baseline to 8 weeks
Title
Treatment Credibility Scale
Description
Measures treatment credibility
Time Frame
1-2 weeks from baseline
Title
Working Alliance Inventory
Description
Measures therapeutic alliance with the psychologist
Time Frame
1-2 weeks from baseline
Title
Follow-up questions on health changes
Description
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
Time Frame
Baseline to 8 weeks
Title
Follow-up questions on health changes
Description
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
Time Frame
Baseline to 5 months
Title
Follow-up questions on health changes
Description
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
Time Frame
Baseline to 1 year and 2 months
Title
Follow-up questions on health changes
Description
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
Time Frame
Baseline to 2 years and 2 months
Title
Follow-up questions on health changes
Description
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
Time Frame
Baseline to 5 years and 2 months
Title
AFFS/SCL-4
Description
4 items derived from the Symptoms Checklist (SCL) and the Atrial Fibrillation Severity Scale (AFSS) measuring disabling cardiac symptoms
Time Frame
Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
Title
MI-behavior Questionnaire
Description
5 items measuring avoidance behavior from the MI-related avoidance questionnaire behaviors developed by the research group
Time Frame
Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment
Title
Perceived stress scale 4-item
Description
Measure of perceived stress and stress reactivity. Score ranging 0 -16 with a higher score indicating more perceived stress.
Time Frame
Change over 8 measurement points measured from baseline and weekly for 8 weeks during treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josefin Särnholm, Lic psychologist, PhD
Phone
+ 46 852483258
Email
josefin.sarnholm@ki.se
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
11635
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josefin Särnholm, Phd

12. IPD Sharing Statement

Plan to Share IPD
No

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