Clinical trial NCT05128981: Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction
Official title: Internet-delivered Cognitive Behavioral Therapy Following Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Cardiac Anxiety
CBT
Exposure
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 12-Item Short-Form Health Survey (SF-12)
timeFrame: Baseline
measure: 12-Item Short-Form Health Survey (SF-12)
timeFrame: 2 months from baseline
measure: 12-Item Short-Form Health Survey (SF-12)
timeFrame: 8 months from baseline
Secondary outcomes:
measure: Cardiac anxiety questionnaire
timeFrame: Baseline
measure: Cardiac anxiety questionnaire
timeFrame: 2 months from baseline
measure: Cardiac anxiety questionnaire
timeFrame: 8 months from baseline
measure: Body Sensation Questionnaire
timeFrame: Baseline
measure: Body Sensation Questionnaire
timeFrame: 2 months from baseline
measure: Body Sensation Questionnaire
timeFrame: 8 months from baseline
measure: Patient Health Questionnaire-9
timeFrame: Baseline
measure: Patient Health Questionnaire-9
timeFrame: 2 months from baseline
measure: Patient Health Questionnaire-9
timeFrame: 8 months from baseline
measure: Generalized Anxiety Disorder 7-item
timeFrame: Baseline
measure: Generalized Anxiety Disorder 7-item
timeFrame: 2 months from baseline
measure: Generalized Anxiety Disorder 7-item
timeFrame: 8 months from baseline
measure: The Godin Leisure-time Exercise
timeFrame: Baseline
measure: The Godin Leisure-time Exercise
timeFrame: 2 months from baseline
measure: The Godin Leisure-time Exercise
timeFrame: 8 months from baseline
measure: Tampas Scale for Kinesophobia-Heart version
timeFrame: Baseline
measure: Tampas Scale for Kinesophobia-Heart version
timeFrame: 2 months from baseline
measure: Tampas Scale for Kinesophobia-Heart version
timeFrame: 8 months from baseline
measure: Client satisfaction Questionnaire
timeFrame: Baseline
measure: Client satisfaction Questionnaire
timeFrame: 2 months from baseline
measure: Adverse events
timeFrame: 2 months from treatment
measure: Adverse events
timeFrame: 8 months from treatment
measure: Symptom Checklist (SCL)
timeFrame: Baseline
measure: Symptom Checklist (SCL)
timeFrame: 2 months from baseline
measure: Symptom Checklist (SCL)
timeFrame: 8 months from baseline
measure: Perceived stress scale (4-item version)
timeFrame: Baseline
measure: Perceived stress scale (4-item version)
timeFrame: 2 months from Baseline
measure: Perceived stress scale (4-item version)
timeFrame: 8 months from Baseline
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Insomnia Severity Index
timeFrame: 2 months from Baseline
measure: Insomnia Severity Index
timeFrame: 8 months from Baseline
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: Baseline
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: 2 months from Baseline
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: 8 months from Baseline
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References: