- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05128981
Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction (MI-CBT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden
- Karolinska Institutet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
( - )MI ≥ 6 months before assessment ( - )Age 18-75 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: MI-CBT via the Internet
The MI-specific CBT will consist of 8 modules delivered via the Internet with home assignments that can be reviewed and reported in the research groups secure platform.
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Education of MI and common reactions, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
12-Item Short-Form Health Survey (SF-12)
Time Frame: Baseline
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General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. |
Baseline
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12-Item Short-Form Health Survey (SF-12)
Time Frame: 2 months from baseline
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General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. |
2 months from baseline
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12-Item Short-Form Health Survey (SF-12)
Time Frame: 8 months from baseline
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General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. |
8 months from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac anxiety questionnaire
Time Frame: Baseline
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Measure of cardiac anxiety, fear, avoidance and attention.
The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
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Baseline
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Cardiac anxiety questionnaire
Time Frame: 2 months from baseline
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Measure of cardiac anxiety, fear, avoidance and attention.
The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
|
2 months from baseline
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Cardiac anxiety questionnaire
Time Frame: 8 months from baseline
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Measure of cardiac anxiety, fear, avoidance and attention.
The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
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8 months from baseline
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Body Sensation Questionnaire
Time Frame: Baseline
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Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. |
Baseline
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Body Sensation Questionnaire
Time Frame: 2 months from baseline
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Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. |
2 months from baseline
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Body Sensation Questionnaire
Time Frame: 8 months from baseline
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Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations. |
8 months from baseline
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Patient Health Questionnaire-9
Time Frame: Baseline
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Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
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Baseline
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Patient Health Questionnaire-9
Time Frame: 2 months from baseline
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Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
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2 months from baseline
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Patient Health Questionnaire-9
Time Frame: 8 months from baseline
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Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression
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8 months from baseline
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Generalized Anxiety Disorder 7-item
Time Frame: Baseline
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General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
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Baseline
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Generalized Anxiety Disorder 7-item
Time Frame: 2 months from baseline
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General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
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2 months from baseline
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Generalized Anxiety Disorder 7-item
Time Frame: 8 months from baseline
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General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
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8 months from baseline
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The Godin Leisure-time Exercise
Time Frame: Baseline
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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.
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Baseline
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The Godin Leisure-time Exercise
Time Frame: 2 months from baseline
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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.
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2 months from baseline
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The Godin Leisure-time Exercise
Time Frame: 8 months from baseline
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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.
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8 months from baseline
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Tampas Scale for Kinesophobia-Heart version
Time Frame: Baseline
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Fear of physical activity.
The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
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Baseline
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Tampas Scale for Kinesophobia-Heart version
Time Frame: 2 months from baseline
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Fear of physical activity.
The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
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2 months from baseline
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Tampas Scale for Kinesophobia-Heart version
Time Frame: 8 months from baseline
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Fear of physical activity.
The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
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8 months from baseline
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Client satisfaction Questionnaire
Time Frame: Baseline
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Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
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Baseline
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Client satisfaction Questionnaire
Time Frame: 2 months from baseline
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Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
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2 months from baseline
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Adverse events
Time Frame: 2 months from treatment
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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').
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2 months from treatment
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Adverse events
Time Frame: 8 months from treatment
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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').
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8 months from treatment
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Symptom Checklist (SCL)
Time Frame: Baseline
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Measures frequency and severity of 16 cardiac-related symptoms.
Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms
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Baseline
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Symptom Checklist (SCL)
Time Frame: 2 months from baseline
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Measures frequency and severity of 16 cardiac-related symptoms.
Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms
|
2 months from baseline
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Symptom Checklist (SCL)
Time Frame: 8 months from baseline
|
Measures frequency and severity of 16 cardiac-related symptoms.
Scoring range from 0 to 64 for frequency with a greater score indicating more frequent symptoms, and from range from 0 to 48 for severity, with a greater score indicating more severe symptoms
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8 months from baseline
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Perceived stress scale (4-item version)
Time Frame: Baseline
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Stress reactivity.
A greater score indicate more perceived stress.
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Baseline
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Perceived stress scale (4-item version)
Time Frame: 2 months from Baseline
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Stress reactivity.
A greater score indicate more perceived stress.
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2 months from Baseline
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Perceived stress scale (4-item version)
Time Frame: 8 months from Baseline
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Stress reactivity.
A greater score indicate more perceived stress.
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8 months from Baseline
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Insomnia Severity Index
Time Frame: Baseline
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Measurement of sleep
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Baseline
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Insomnia Severity Index
Time Frame: 2 months from Baseline
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Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia
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2 months from Baseline
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Insomnia Severity Index
Time Frame: 8 months from Baseline
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Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia
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8 months from Baseline
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The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: Baseline
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Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.
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Baseline
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The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: 2 months from Baseline
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Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.
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2 months from Baseline
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The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: 8 months from Baseline
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Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.
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8 months from Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBT-MI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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