Cognitive Behavioral Therapy Following Myocardial Infarction (MI-CBT)

• ClinicalTrials.gov Identifier: NCT04649307
• Recruitment Status: Recruiting
• First Posted: December 2, 2020
• Last Update Posted: January 14, 2021
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Brjann Ljotsson, Karolinska Institutet

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Myocardial Infarction	Behavioral: MI-CBT	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cognitive Behavioral Therapy Following Myocardial Infarction
• Actual Study Start Date: December 29, 2020
• Estimated Primary Completion Date: December 1, 2021
• Estimated Study Completion Date: December 1, 2021

Arms and Interventions

Arm

Intervention/treatment

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

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

Outcome Measures

Primary Outcome Measures :

1. Cardiac anxiety questionnaire [ Time Frame: baseline ]
   Measure of cardiac anxiety, fear, avoidance and attention. The score ranges between 0 and 72, with a greater score indicating elevated cardiac anxiety.
2. Cardiac anxiety questionnaire [ Time Frame: 2 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.
3. Cardiac anxiety questionnaire [ Time Frame: 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 :

1. 12-Item Short-Form Health Survey (SF-12) [ Time Frame: Baseline ]
   General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
2. 12-Item Short-Form Health Survey (SF-12) [ Time Frame: 2 months from baseline ]
   General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.
3. 12-Item Short-Form Health Survey (SF-12) [ Time Frame: 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.
4. Body Sensation Questionnaire [ Time Frame: Baseline ]
   Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
5. Body Sensation Questionnaire [ Time Frame: 2 months from baseline ]
   Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
6. Body Sensation Questionnaire [ Time Frame: 8 months from baseline ]
   Fear of bodily symptoms, score ranging from 0 to 72 . Higher scores indicate more fear of body sensations.
7. Patient Health Questionnaire-9 [ Time Frame: Baseline ]
   Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.
8. Patient Health Questionnaire-9 [ Time Frame: 2 months from Baseline ]
   Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.
9. Patient Health Questionnaire-9 [ Time Frame: 8 months from Baseline ]
   Measure of depression, score ranging 0 to 27 with a higher score indicating higher level of depression.
10. Generalized Anxiety Disorder 7-item [ Time Frame: Baseline ]
    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
11. Generalized Anxiety Disorder 7-item [ Time Frame: 2 months from baseline ]
    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
12. Generalized Anxiety Disorder 7-item [ Time Frame: 8 months from baseline ]
    General anxiety, score ranging from 0-21, with a higher score indicating more anxiety and worry.
13. The Godin Leisure-time Exercise [ Time Frame: 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.
14. The Godin Leisure-time Exercise [ Time Frame: 2 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.
15. The Godin Leisure-time Exercise [ Time Frame: 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.
16. Tampas Scale for Kinesophobia-Heart version [ Time Frame: Baseline ]
    Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
17. Tampas Scale for Kinesophobia-Heart version [ Time Frame: 2 months from Baseline ]
    Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
18. Tampas Scale for Kinesophobia-Heart version [ Time Frame: 8 months form Baseline ]
    Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
19. Client satisfaction Questionnaire [ Time Frame: 2 months from Baseline ]
    Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.
20. Adverse events [ Time Frame: 2 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').
21. Adverse events [ Time Frame: 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').

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Josefin Särnholm; 0736373295; josefin.sarnholm@ki.se

Locations

Sweden

Karolinska University Hospital; Recruiting

Stockholm, Sweden

Contact: Brjánn Ljótsson, PhD + 46 707176562 brjánn.ljótsson@ki.se

Principal Investigator: Brjánn Ljótsson, PhD

Sub-Investigator: Frieder Braunschweig, MD, PhD

Sponsors and Collaborators

Karolinska Institutet

More Information

• Responsible Party: Brjann Ljotsson, Associate Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT04649307
• Other Study ID Numbers: MI-CBT
• First Posted: December 2, 2020
• Last Update Posted: January 14, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brjann Ljotsson, Karolinska Institutet:

CBT; Cardiac anxiety; Quality of Life; Physical activity

Additional relevant MeSH terms:

Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases