Back to resultsCognitive Behavioral Therapy Following Myocardial Infarction (MI-CBT)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MI-CBT
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring CBT, Cardiac anxiety, Quality of Life, Physical activity
Eligibility Criteria
Inclusion Criteria:
( - )MI ≥ 6 months before assessment (type 1 STEMI/NSTEMI) ( - )Age 18-69 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (Cardiac Anxiety Questionnaire (CAQ); score ≥20) ( - ) On optimal medical treatment ( - )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 other invasive therapy ( - ) other severe medical illness ( - )any medical restriction to physical exercise ( - )severe psychiatric disorder, severe depression, or risk of suicide ( - )alcohol dependency.
Sites / Locations
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MI-CBT
Arm Description
The treatment will be based on the AF treatment developed by the research group and further be developed and adapted during the course the study, based on the clinical presentation of the MI patients and their response to the CBT interventions detailed below. The MI-specific CBT will consist of 8 weekly face-to face digital video sessions with home assignments that can be reviewed and reported in the research groups secure platform. CBT for MI primarily targets two processes of disability; cardiac anxiety, and depressive inactivity
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
12-Item Short-Form Health Survey (SF-12)
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 (SF-12)
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 (SF-12)
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
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.
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.
The Godin Leisure-time Exercise
Level of physical activity. 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.
The Godin Leisure-time Exercise
Level of physical activity. 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.
The Godin Leisure-time Exercise
Level of physical activity. 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.
Tampas Scale for Kinesophobia-Heart version
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Tampas Scale for Kinesophobia-Heart version
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Tampas Scale for Kinesophobia-Heart version
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Client satisfaction Questionnaire
Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the 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').
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').
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04649307
Brief Title
Cognitive Behavioral Therapy Following Myocardial Infarction
Acronym
MI-CBT
Official Title
Cognitive Behavioral Therapy Following Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 29, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event. The purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (Q oL) in patients following MI.
Detailed Description
The study will include 20 patients. The MI-specific CBT lasts for 8 weeks and is delivered face-to-face via a secure digital video solution (to minimize cancelled sessions because of the COVID-19 pandemic) or at the Karolinska Universitetssjukhuset cardiac research unit, by licensed psychologists with expertise in CBT for cardiac disease. During treatment, the psychologists will have direct access to a cardiologist assigned to the project and treatments are conducted in close interdisciplinary collaboration to ensure patient safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
CBT, Cardiac anxiety, Quality of Life, Physical activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MI-CBT
Arm Type
Other
Arm Description
The treatment will be based on the AF treatment developed by the research group and further be developed and adapted during the course the study, based on the clinical presentation of the MI patients and their response to the CBT interventions detailed below. The MI-specific CBT will consist of 8 weekly face-to face digital video sessions with home assignments that can be reviewed and reported in the research groups secure platform. CBT for MI primarily targets two processes of disability; cardiac anxiety, and depressive inactivity
Intervention Type
Behavioral
Intervention Name(s)
MI-CBT
Intervention Description
Education, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention
Primary Outcome Measure Information:
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
baseline
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
2 months from baseline
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
8 months from baseline
Secondary Outcome Measure Information:
Title
12-Item Short-Form Health Survey (SF-12)
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Time Frame
Baseline
Title
12-Item Short-Form Health Survey (SF-12)
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Time Frame
2 months from baseline
Title
12-Item Short-Form Health Survey (SF-12)
Description
General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Time Frame
8 months from baseline
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
Baseline
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
2 months from baseline
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
8 months from baseline
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
Baseline
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
2 months from Baseline
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
8 months from Baseline
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
Baseline
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
2 months from baseline
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
8 months from baseline
Title
The Godin Leisure-time Exercise
Description
Level of physical activity. 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.
Time Frame
Baseline
Title
The Godin Leisure-time Exercise
Description
Level of physical activity. 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.
Time Frame
2 months from Baseline
Title
The Godin Leisure-time Exercise
Description
Level of physical activity. 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.
Time Frame
8 months from Baseline
Title
Tampas Scale for Kinesophobia-Heart version
Description
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Time Frame
Baseline
Title
Tampas Scale for Kinesophobia-Heart version
Description
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Time Frame
2 months from Baseline
Title
Tampas Scale for Kinesophobia-Heart version
Description
Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Time Frame
8 months form Baseline
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
2 months from Baseline
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
2 months from baseline
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 months from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
( - )MI ≥ 6 months before assessment (type 1 STEMI/NSTEMI) ( - )Age 18-69 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (Cardiac Anxiety Questionnaire (CAQ); score ≥20) ( - ) On optimal medical treatment ( - )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 other invasive therapy ( - ) other severe medical illness ( - )any medical restriction to physical exercise ( - )severe psychiatric disorder, severe depression, or risk of suicide ( - )alcohol dependency.
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Behavioral Therapy Following Myocardial Infarction
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