Cognitive Behavioral Therapy Following Myocardial Infarction

NCT ID: NCT04649307

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-29
• Study Completion Date: 2021-12-01

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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

MI-CBT

Intervention Type: BEHAVIORAL

Education, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention

Interventions

MI-CBT

Education, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Brjann Ljotsson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

MI-CBT

Identifier Type: -

Identifier Source: org_study_id