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Clinical Trials/ISRCTN18035062
ISRCTN18035062
Active, not recruiting
未知

A feasibility and effectiveness trial to evaluate a digital intervention for the treatment of unipolar depression in adults

Elona Health GmbH0 sites40 target enrollmentDecember 20, 2023
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ConditionsTreatment of unipolar depression in patients on the waiting list for outpatient psychotherapeutic treatmentMental and Behavioural Disorders

Overview

Phase
未知
Intervention
Not specified
Conditions
Treatment of unipolar depression in patients on the waiting list for outpatient psychotherapeutic treatment
Sponsor
Elona Health GmbH
Enrollment
40
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 20, 2023
End Date
June 25, 2024
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Elona Health GmbH

Eligibility Criteria

Inclusion Criteria

  • •All subjects must have been diagnosed with one of the following ICD\-10 diagnoses:
  • •F32\.0: Mild depressive episode
  • •F32\.1: Moderate depressive episode
  • •F32\.2: Severe depressive episode
  • •F33\.0: Recurrent depressive disorder, current episode mild
  • •F33\.1: Recurrent depressive disorder, current episode moderate
  • •F33\.2: Recurrent depressive disorder, current episode severe
  • •Subjects further need to:
  • •1\. Be at least 18 years old
  • •2\. Possess sufficient German language skills (in writing and reading)

Exclusion Criteria

  • •All subjects without the inclusion ICD\-10 diagnosis criteria, as well as subjects with the following ICD\-10 diagnoses, are excluded:
  • •F00\-F09: Organic, including symptomatic, mental disorders
  • •F10\-F19 Mental and behavioural disorders due to psychoactive substance use (except F17\.1, F17\.2, F17\.3\)
  • •F20\-F29: Schizophrenia, schizotypal and delusional disorders
  • •F30: Manic episode
  • •F31\.0, F31\.1, F31\.2, F31\.5, F31\.6, F31\.8, F31\.9: Bipolar disorder current hypomanic or manic episode
  • •F32\.3: Severe depressive episode with psychotic symptoms
  • •F33\.3: Recurrent depressive disorder, current episode severe with psychotic symptoms
  • •1\. Subjects with acute suicidality (assessed via suicidality screening of the mini\-DIPS at the initial screening)
  • •2\. Subjects who are currently enrolled or are planning to participate in a potentially confounding drug or device trial during the study

Outcomes

Primary Outcomes

Not specified

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