Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction

Myocardial Infarction Clinical Trial

— MI-CBT  

Official title:

Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128981
• Other study ID #: CBT-MI
• Status: Completed
• Phase: N/A
• Start date: October 28, 2021
• Est. completion date: December 10, 2022

Study information

• Verified date: January 2023
• 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 10, 2022
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Anxiety
• CBT
• Exposure
• Infarction
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; 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.	Baseline
Primary	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.; 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.	2 months from baseline
Primary	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.; 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.	8 months from baseline
Secondary	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
Secondary	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
Secondary	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	Body Sensation Questionnaire	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.	Baseline
Secondary	Body Sensation Questionnaire	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.	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.; 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.	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 from baseline
Secondary	Client satisfaction Questionnaire	Treatment satisfaction, score ranging from 0 to 32, with a higher score indication more satisfaction with the treatment.	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 treatment
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 treatment
Secondary	Symptom Checklist (SCL)	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	Baseline
Secondary	Symptom Checklist (SCL)	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	2 months from baseline
Secondary	Symptom Checklist (SCL)	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	8 months from baseline
Secondary	Perceived stress scale (4-item version)	Stress reactivity. A greater score indicate more perceived stress.	Baseline
Secondary	Perceived stress scale (4-item version)	Stress reactivity. A greater score indicate more perceived stress.	2 months from Baseline
Secondary	Perceived stress scale (4-item version)	Stress reactivity. A greater score indicate more perceived stress.	8 months from Baseline
Secondary	Insomnia Severity Index	Measurement of sleep	Baseline
Secondary	Insomnia Severity Index	Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia	2 months from Baseline
Secondary	Insomnia Severity Index	Measure of insomnia, score ranging from 0-20, with a higher score indicating more severe insomnia	8 months from Baseline
Secondary	The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.	Baseline
Secondary	The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.	2 months from Baseline
Secondary	The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Measure of post traumatic stress, score ranging from 0-80, with a higher score indicating more post traumatic stress.	8 months from Baseline