Online Personalized Psychological Intervention for Patients With Heart Disease and Depression or Anxiety (MY-CHOICE)

NCT07569458 | Recruiting

• 2 other identifiers: 12.414S-20200112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Ischemic Heart Disease (IHD); Anxiety; Depression

Keywords

online intervention; psychological intervention; ischemic heart disease; treatment of anxiety and depression

Outcome Measures

Primary Outcomes (1)

• Drop-out rate

  From enrollment to end of treatment i.e., from 0 to 13 weeks

Secondary Outcomes (6)

• Limited efficacy on depression (HADS-D)

  From baseline to completion of 3-month follow-up which is administered after 13 weeks.

• Limited efficacy Anxiety (HADS-A)

  From completion of baseline questionnaire to completion of post intervention questionnaire administered 13 weeks after enrollment.

• Patient satisfaction with intervention

  Administered in the FU-questionnaire 13 weeks after enrollment

• adherence to intervention

  immediately after completion of intervention. i.e. between 6 and 12 weeks depending on the length of intervention. Possibly sooner if a patient drops out.

• Limited efficacy on stress

  Administered in the FU-questionnaire 13 weeks after enrollment

Study Arms (1)

Psychological intervention

EXPERIMENTAL

Online psychological intervention for anxiety and depression, tailored to the patients´ individual needs. Duration 6-12 weeks. The psychological intervention is provided as add-on to treatment as usual (i.e., the patients´ individual medical treatment and rehabilitation program.)

Other: Online psychological therapy

Interventions

Online psychological therapy OTHER

Online psychological treatment of anxiety and depression for patients with ischemic heart disease tailored to individual needs. The treatment includes access to an online treatment platform offering psychological content and written communication with the therapist and telephone-video conversations with the therapist. The intervention is tailored to meet the patients´ individual needs.

Psychological intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Aarhus University Hospital Skejby: collaborator
• Aalborg University Hospital: collaborator
• Zealand University Hospital: collaborator

Study Sites (3)

Aalborg University Hospital, Department of Cardiology

Aalborg, 9000, Denmark

RECRUITING

Aarhus University Hospital, Department of Cardiology

Aarhus, 8200, Denmark

RECRUITING

Zealand University Hospital, Roskilde, Department of Cardiology

Roskilde, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: May 6, 2026
• Study Start: July 4, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)