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Clinical Trials/DRKS00032121
DRKS00032121
Completed
Phase 3

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

Medizinische Universität Wien0 sites250 target enrollmentAugust 4, 2023
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ConditionsF32.0F33.0F32.1F33.1Mild depressive episodeRecurrent depressive disorder, current episode mildModerate depressive episodeRecurrent depressive disorder, current episode moderate

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
F32.0
Sponsor
Medizinische Universität Wien
Enrollment
250
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 4, 2023
End Date
July 4, 2023
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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