Treatment of adjustment disorders in patients on the waiting list for the outpatient psychotherapeutic treatment Mental and Behavioural Disorders
Conditions
Sponsors
Elona Health GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessments will take place at baseline (T0), 5 weeks after treatment start (T1), and 10 weeks after treatment start (T2): Primary effectiveness objective: Perceived stress measured using PSS-10 Primary safety objective: Number and seriousness of adverse events measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessments will take place at baseline (T0), 5 weeks after treatment start (T1), and 10 weeks after treatment start (T2): 1. Symptoms of depression measured with the PHQ-9 2. Symptoms of generalized anxiety measured with the GAD-7 2. Psychological health measured with the psychological health subscale of the WHOQOL-BREF 3. Work and social maladjustment measured with the WSAS 4. Self-efficacy measured with the GSE 5. Mental health literacy measured with the MHLS | — |
Countries
Germany
Outcome results
None listed