Cognitive Behavioral Therapy Following Myocardial Infarction

Myocardial Infarction Clinical Trial

— MI-CBT  

Official title:

Cognitive Behavioral Therapy Following Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649307
• Other study ID #: MI-CBT
• Status: Completed
• Phase: N/A
• Start date: December 29, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• MI-CBT
Education, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Baseline
Secondary	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.	2 months from baseline
Secondary	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.	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.	Baseline
Secondary	Body Sensation Questionnaire	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.	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 form 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 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').	8 months from baseline