Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction

Not Applicable

Completed

• Conditions: Cardiac Anxiety; Myocardial Infarction; CBT; Exposure
• Interventions: Behavioral: MI-CBT

• Registration Number: NCT05128981
• 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 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

Study Timeline

• Study Start: 2021-10-28
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Primary Completion: 2022-12-10
• Study Completion: 2022-12-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-09
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MI-CBT via the Internet	MI-CBT	The MI-specific CBT will consist of 8 modules delivered via the Internet with home assignments that can be reviewed and reported in the research groups secure platform.

Primary Outcome Measures

Name	Time	Method
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.; 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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
Symptom Checklist (SCL)	8 months from baseline	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
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.; 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.
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
Tampas Scale for Kinesophobia-Heart version	8 months from baseline	Fear of physical activity. The total score varies between 17 and 68, with higher values indicating more severe kinesiophobia.
Adverse events	8 months from treatment	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').
Insomnia Severity Index	8 months from Baseline	Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia
Perceived stress scale (4-item version)	8 months from Baseline	Stress reactivity. A greater score indicate more perceived stress.
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	8 months from Baseline	Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden