ISRCTN16971578Active, not recruitingUnknown
A randomized controlled study to evaluate a digital intervention for the treatment of adjustment disorders in adults
Elona Health GmbH0 sites158 target enrollmentStarted: July 6, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 158
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •All subjects must have been diagnosed with the following ICD-10 diagnosis:
- •F43.2: Adjustment disorders
- •Subjects further need to:
- •1. Be at least 18 years old
- •2. Possess sufficient German language skills (in writing and reading)
- •3. Possess a smartphone (iOS or Android operating system) with internet access
- •4. Provide signed and dated informed consent and be willing to comply with the protocol
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 under the age of 18, subjects without any access to a smartphone (iOS or Android operating system) with internet access
- •3. Subjects without German language proficiency
- •If a subject is currently enrolled or is planning to participate in a potentially confounding drug or device trial during the study, enrollment into this study needs to be pre-approved by the principal investigator.
Investigators
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