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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Online psychological therapy

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Psychological interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Drop-out rate

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

Secondary outcomes

1

Limited efficacy on depression (HADS-D)

Limited efficacy: changes from baseline to 3 months follow-up on Hospital Anxiety and Depression Scale - Depression (HADS-D) will be analyzed, focusing on mean change scores as well as the proportion of study participants achieving a change score of at least 2-points in any direction. HADS-D have a score range of 0-21 with lower score indicating better outcome.

Time frame
From baseline to completion of 3-month follow-up which is administered after 13 weeks.
2

Limited efficacy Anxiety (HADS-A)

Limited efficacy: changes from baseline to 3 months follow-up on Hospital Anxiety and Depression Scale - Anxiety (HADS-A) will be analyzed, focusing on mean change scores as well as the proportion of study participants achieving a change score of at least 2-points. HADS-A have a score range of 0-21 with lower score indicating better outcome.

Time frame
From completion of baseline questionnaire to completion of post intervention questionnaire administered 13 weeks after enrollment.
3

Patient satisfaction with intervention

Patient satisfaction with the eHealth intervention will be assessed using the 6-item Internet evaluation and usability questionnaire. (Range 0-24 and higher score indication higher satisfaction)

Time frame
Administered in the FU-questionnaire 13 weeks after enrollment
4

adherence to intervention

Adherence will be evaluated based on participants´ engagement with the intervention. Each intervention module assigned to the individual patient will be rated as either completed or not by the therapist based on patients' activity on the platform and information from the video-/phone therapy sessions.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern Denmark

Lead sponsor

Aarhus University Hospital Skejby

Collaborator

Aalborg University Hospital

Collaborator

Zealand University Hospital

Collaborator