Efficacy of Edupression.Com® in Depressive Patients (NCT04839822) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Edupression.Com® in Depressive Patients
Austria250 participantsStarted 2021-04-28
Plain-language summary
The aim of the study is to investigate the efficacy and adherence of the digital self-help programme edupression.com®.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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