Personalized online psychological program for people with ischemic heart disease and anxiety or depression
Online Personalized and Patient-preferred Comprehensive Intervention for Patients With Heart Disease and Depression or Anxiety (MY-CHOICE)
This project will test a personalized, therapist-supported online program to see if it helps adults with ischemic heart disease who have anxiety or depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 3 sites (Aalborg and 2 other locations) |
| Trial ID | NCT07569458 on ClinicalTrials.gov |
What this trial studies
This feasibility study will offer a 6–12 week personalized eHealth program (MY-CHOICE) combining online modules with video or phone sessions with a psychologist or trained psychology student on an as-needed basis. Thirty patients referred to cardiac rehabilitation with a positive HADS screen (≥8) will be enrolled in a pre–post design to measure completion rates, reasons for dropout, and changes in anxiety and depression scores. Participants will complete questionnaires before and after the intervention and take part in brief post-intervention interviews, while staff feedback on recruitment and implementation will also be collected. The study will evaluate acceptability, patient satisfaction, barriers and facilitators to engagement, and procedures needed for a future randomized trial and routine implementation.
Who should consider this trial
Good fit: Adults with ischemic heart disease referred to cardiac rehabilitation who screen positive for anxiety or depression (HADS ≥8), speak Danish, have access to and can use a computer or tablet, and can commit about 3–4 hours per week are ideal candidates.
Not a fit: Patients with severe psychiatric disorders, active suicidal ideation that cannot be managed within the program, major cognitive impairment, current psychological treatment for anxiety/depression, or inability/unwillingness to use the required technology or time commitment are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could increase access to tailored mental health support for cardiac patients and reduce symptoms of anxiety and depression while lowering treatment dropout.
How similar studies have performed: Therapist-guided internet CBT has shown benefit for anxiety and depression in general populations and some cardiac eHealth programs have shown promising feasibility, but fully personalized therapist-assisted programs specifically for ischemic heart disease remain less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ischemic heart disease (diagnostic codes I20-I25), * referred for CR with a positive screen for depression and/or anxiety with the Hospital Anxiety and Depression Scale (HADS ≥ 8) * access to and ability to use a computer or tablet * proficient in the Danish language Exclusion Criteria: * Severe psychiatric disorder (i.e., borderline disorder, schizophrenia or bipolar disorder) that requires psychiatric care * severe cognitive difficulties (e.g., severe brain damage, mental retardation, or dementia) that will prevent patients from participating * endorsement of suicidal ideation with suicidal thoughts (purpose designed questions) that cannot be handled in the intervention * participation in other intervention studies focused (unless they are clinical studies) * seeing a psychologist or mental health professional for the treatment of anxiety and depression * not being able or willing to spend 3-4 hours on the intervention each week * experiencing significant life stressors that hinder adherence to the MY-CHOICE treatment
Where this trial is running
Aalborg and 2 other locations
- Aalborg University Hospital, Department of Cardiology — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital, Department of Cardiology — Aarhus, Denmark (Recruiting)
- Zealand University Hospital, Roskilde, Department of Cardiology — Roskilde, Denmark (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.