Efficacy of Edupression.Com® in Depressive Patients (eFICASY)

  • STATUS
    Recruiting
  • End date
    Apr 14, 2023
  • participants needed
    154
  • sponsor
    Medical University of Vienna
Updated on 4 June 2022

Summary

The aim of the study is to investigate the efficacy and adherence of the digital self-help programme edupression.com®.

Description

The edupression.com® self-help app is an evidence-based low-level psychosocial intervention, which a can be used as as monotherapy as first-line treatment in mild to moderate depressive patients or as complimentary treatment independent of previous therapy response or depression severity. The two foundations of edupression.com® are evidence-based psychoeducation with CBT elements, as well as self-monitoring in the mood chart. Evidence for the efficacy of this approach stems from a large body of literature regarding eHealth (healthcare services provided electronically via the internet) applications in depression.

This study's aim is to investigate edupression.com®'s capability to improve the illness course directly by reducing depressive symptoms (primary objective) and indirectly by fostering illness perception and daily functioning. The reduction of relapse risk and other preventive effects expected from other studies are beyond the time frame of this study. Beyond the evaluation of edupression.com®, this study could elucidate the general role of psychoeducation and mood tracking in online mental health to improve depression symptoms and adherence.

Objectives: The primary objective is to test the clinical efficacy (at least 50% symptom reduction over a 3-month period) of edupression.com® in mild to moderate unipolar depressed patients.

Study Design: The study design of this clinical trial is consistent with a monocentric, prospective, longitudinal, randomized controlled clinical trial. Patients, currently diagnosed with a mild to moderate major depressive episode (MDE) will be invited to use the digital self-help programme.

Following the inclusion procedure, patients will be randomly assigned in a 1:1 ratio to two different treatment arms (A vs. B). Participants of the intervention arm will get full access to the edupression.com® website, while participants of the control arm will get access to a control version of edupression.com® limited to medically useful tips, that have not been shown to be effective in improving depressive symptoms in randomized controlled trials (RCTs).

Details
Condition Depressive; Episode, Major, Recurrent Depressive Disorder, Current Episode Moderate, Recurrent Depressive Disorder, Current Episode Mild
Treatment surveys, edupression.com®, Health tips, Popular psychological interventions
Clinical Study IdentifierNCT04839822
SponsorMedical University of Vienna
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male/female
Age 18-65 years
ICD-10 diagnosis F32.0 & F32.1, depressive episode mild & moderate & F33.0 & F33.1, Recurrent depressive disorder mild & moderate (M.I.N.I.)
PHQ-9 (Patient Health Questionnaire-9) score ≥5
ability to be managed as outpatients
adherence to the study protocol incl. willingness and minimal experience to understand instructions for edupression.com®

Exclusion Criteria

previous or concurrent major medical or neurological illness
any history of non-response to either psychotherapy/eHealth interventions (min. 3 month) or medication (min. 6 weeks, adequate antidepressive drug dosing) or any kind of therapy resistance
participants in the active phase of other interventional studies
ICD-10 diagnosis of substance dependence within the past year, except for caffeine or nicotine or current substance abuse
ICD-10 diagnosis of schizophrenia, schizoaffective disorder, bipolar affective disorder, persistent mood disorders, or an anxiety disorder
being acutely suicidal either indicated by a score ≥3 on item 9 (suicidal thoughts) on the PHQ-9 or according to the investigator´s opinion
failures to comply with the study protocol or to follow the instructions of the investigating team
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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