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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05128981
Other study ID # CBT-MI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 28, 2021
Est. completion date December 10, 2022

Study information

Verified date January 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

The study will include 30 patients. The MI-specific CBT lasts for 8 weeks and is therapist guided and delivered via internet via a secure digital platform by licensed psychologists expertise in CBT for cardiac disease or final year psychologist under supervision. 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


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date December 10, 2022
Est. primary completion date December 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MI-CBT
Education of MI and common reactions, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention

Locations

Country Name City State
Sweden Karolinska Institutet Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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
Primary 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.
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
Primary 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.
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
Secondary 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. Baseline
Secondary 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. 2 months from baseline
Secondary 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. 8 months from baseline
Secondary Body Sensation Questionnaire 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
Secondary Body Sensation Questionnaire 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
Secondary Body Sensation Questionnaire 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
Secondary Patient Health Questionnaire-9 Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression Baseline
Secondary Patient Health Questionnaire-9 Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression 2 months from baseline
Secondary Patient Health Questionnaire-9 Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression 8 months from baseline
Secondary Generalized Anxiety Disorder 7-item General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. Baseline
Secondary Generalized Anxiety Disorder 7-item General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. 2 months from baseline
Secondary Generalized Anxiety Disorder 7-item General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry. 8 months from baseline
Secondary 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. Baseline
Secondary 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. 2 months from baseline
Secondary 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. 8 months from baseline
Secondary 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. Baseline
Secondary 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. 2 months from baseline
Secondary 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. 8 months from baseline
Secondary Client satisfaction Questionnaire Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. Baseline
Secondary Client satisfaction Questionnaire Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment. 2 months from baseline
Secondary 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'). 2 months from treatment
Secondary 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 months from treatment
Secondary Symptom Checklist (SCL) 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 Baseline
Secondary Symptom Checklist (SCL) 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
Secondary Symptom Checklist (SCL) 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 8 months from baseline
Secondary Perceived stress scale (4-item version) Stress reactivity. A greater score indicate more perceived stress. Baseline
Secondary Perceived stress scale (4-item version) Stress reactivity. A greater score indicate more perceived stress. 2 months from Baseline
Secondary Perceived stress scale (4-item version) Stress reactivity. A greater score indicate more perceived stress. 8 months from Baseline
Secondary Insomnia Severity Index Measurement of sleep Baseline
Secondary Insomnia Severity Index Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia 2 months from Baseline
Secondary Insomnia Severity Index Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia 8 months from Baseline
Secondary The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress. Baseline
Secondary The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress. 2 months from Baseline
Secondary The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress. 8 months from Baseline
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