Online Personalized Psychological Intervention for Patients With Heart Disease and Depression or … (NCT07569458) | Clinical Trial Compass
RecruitingNot Applicable
Online Personalized Psychological Intervention for Patients With Heart Disease and Depression or Anxiety (MY-CHOICE)
Denmark30 participantsStarted 2025-07-04
Plain-language summary
The goal of this feasibility study is to assess if the personalised online psychological intervention MY-CHOICE is acceptable to adults with ischemic heart disease and anxiety or depression. It will also examine the reasons for drop-out. The main questions the study aims to answer are:
How many participants complete the intervention and what are the reasons for drop-out. And what are the pre-post change scores on anxiety and depression.
Participants will:
Complete the MY-CHOICE intervention consisting of 6-12 weeks with online modules on various topics based on individual needs in combination with video- or telephone calls with a therapist (psychologist or a trained master student in Psychology) on a need-to basis.
Answer a set of questionnaires pre and post intervention. Participate in a brief interview post intervention.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Drop-out rate
Timeframe: From enrollment to end of treatment i.e., from 0 to 13 weeks