Randomized controlled clinical trial of the efficacy of the digital self-help program edupression.com® in mild-to-moderate unipolar depressive patients

Phase 3

• Conditions: F32.0; F33.0; Mild depressive episode; Recurrent depressive disorder, current episode mild; Recurrent depressive disorder, current episode moderate; F32.1; F33.1; Moderate depressive episode

• Registration Number: DRKS00032121
• Lead Sponsor: Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-07-04
• Study Start: 2023-08-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

•Age 18-65 years
•ICD-107 diagnosis of a mild to moderate depressive episode (F32.0, F32.1) or recurrent depressive disorder (F33.0, F33.1) based the M.I.N.I. diagnostic interview.
•PHQ-9 depression severity score =5
•available internet access
•ability to be managed as outpatient.
•informed consent and willingness to follow the study protocol including the ability to understand the instructions provided by 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
•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
•inability to comply with the study protocol or to follow the instructions of the investigating team in accordance with the Declaration of Helsinki

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary aim is to investigate the clinical efficacy (symptom change within 3 months) of edupression.com® in mild-to-moderate unipolar depressive patients.<br><br>Primary outcome – Reduction of Depression Severity: Depression severity improvement (PHQ-9 score change) from baseline to EOS [Time Frame: 3 months] compared between treatment vs. control arm measured with the Patient Health Questionnaire (PHQ-9).

Secondary Outcome Measures

Name	Time	Method
Secondary aims comprise possible positive healthcare effects of edupression.com®. Secondary endpoints will only be analyzed in case of the significance of the primary outcome within this hierarchical order.<br><br>Secondary outcome A – Improvement of Depression Literacy: Change of Depression Literacy (D-Lit) from baseline to End of Study (EOS) [Time Frame: 3 months].<br><br>Secondary outcome B – Improvement of Quality of Life: Change of Quality of Life from baseline to End of Study (EOS) in four domains physical health, mental well-being, social relationships and environment assessed by the World Health Organization quality of life scale (WHOQOL-BREF) [Time Frame: 3 months].<br><br>Secondary outcome C - Improvement in illness model: change in sum score representing perception of illness from baseline to EOS [time period: 3 months], as measured by the short version of the Illness Perception Questionnaire (B-IPQ).