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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Online psychological therapy
Other interventionOnline 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
Trial outcomes
Primary outcomes
Drop-out rate
Secondary outcomes
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.
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.
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)
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.
Sponsors and contacts
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University of Southern Denmark
Lead sponsor
Aarhus University Hospital Skejby
Collaborator
Aalborg University Hospital
Collaborator
Zealand University Hospital
Collaborator