Cognitive Behavioral Therapy Following Myocardial Infarction

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Behavioral: MI-CBT

• Registration Number: NCT04649307
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Study Start: 2020-12-29
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MI-CBT	MI-CBT	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

Primary Outcome Measures

Name	Time	Method
Cardiac anxiety questionnaire	8 months from baseline	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

Name	Time	Method
Patient Health Questionnaire-9	8 months from Baseline	Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.
Adverse events	8 months from baseline	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').
12-Item Short-Form Health Survey (SF-12)	8 months from baseline	General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
Generalized Anxiety Disorder 7-item	8 months from baseline	General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
The Godin Leisure-time Exercise	8 months from Baseline	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.
Body Sensation Questionnaire	8 months from baseline	Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
Client satisfaction Questionnaire	2 months from Baseline	Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
Tampas Scale for Kinesophobia-Heart version	8 months form Baseline	Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden