Clinical trial NCT04839822: Efficacy of Edupression.Com® in Depressive Patients
Official title: Efficacy of the Digital Self-help Programme Edupression.Com® Evaluated Within a Randomized Controlled Trial in Mild to Moderate Unipolar Depressive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive; Episode, Major
Recurrent Depressive Disorder, Current Episode Moderate
Recurrent Depressive Disorder, Current Episode Mild
Keywords: Depression
Internet-Based Intervention
Mobile Applications
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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 positive health care effects (secondary objective). 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. The secondary objective is to demonstrate positive health care effects within this 3-month trial period such as psychoeducation, quality of life, patient empowerment and other factors.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Therapy response
timeFrame: 3 months
Secondary outcomes:
measure: Change of Depression Literacy
timeFrame: 3 months
measure: Change of Quality of Life
timeFrame: 3 months
measure: Change of Disease Model
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Markus Dold, MD, Priv.Doz.
role: STUDY_CHAIR
affiliation: Medical University of Vienna
name: Lukas M Pezawas, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Gabriele Fischer, MD, Prof.
role: STUDY_CHAIR
affiliation: Medical University of Vienna
name: Lucie Bartova, MD
role: STUDY_CHAIR
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