Adjustment disorders (F43.2 based on ICD-10 criteria) Mental and Behavioural Disorders
Conditions
Interventions
elona explore is a digital health application that provides patients with mental health disorders (depression, anxiety/panic disorders, OCD, adjustment disorders, burnout and somatoform disorders) wit
Sponsors
Elona Health GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
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 over the age of 18 years 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 5. Be willing to comply with the protocol
Exclusion criteria
Exclusion criteria: All individuals without the included ICD-10 diagnosis, as well as individuals with the following comorbid 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 Further exclusion criteria are as follows: 1. Patients who are currently undergoing psychotherapy (at the point of enrollment) 2. Patients who plan to terminate or change the dose of their current medication that was prescribed for a mental health disorder, or those who plan to start taking a prescription medication prescribed for a mental health disorder within the next 10 weeks (a stable dose of medication three months before enrollment in trial is allowed). 3. Patients who are currently using a digital health application for a mental health disorder (at the point of enrollment) 4. Individuals with acute suicidality (assessed via suicidality screening of the mini-DIPS at the initial screening) 5. If an individual is currently enrolled or is planning to participate in a potentially confounding drug or device trial during the study, enrollment into this study is not possible. 6. If an individual underwent psychotherapy three months prior to enrolling, study participation is not possible. 7. It should be noted that the influence of concomitant treatments (especially psychotherapy) is intended to be reduced. Therefore, patients should not be recruited from an existing waiting list.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Updated 30/01/2026. Previous key secondary outcomes: 1. Symptoms of anxiety measured using the Generalized Anxiety Disorder-7 (GAD-7) total score at baseline (T0), 5 weeks after treatment start (T1) and 10 weeks after treatment start (T2) 2. Symptoms of depression measured using Patient Health Questionnaire (PHQ-9) total score at baseline (T0), 5 weeks after treatment start (T1) and 10 weeks after treatment start (T2) 3. Therapist-rated overall functioning level of the patient measured using the Global Assessment of Functioning (GAF) score at baseline (T0), 5 weeks after treatment start (T1) and 10 weeks after treatment start (T2) 4. Therapist-reported symptoms of depression measured using the Montgomery-Asberg Depression Rating Scale (MADRS) total score at baseline (T0), 5 weeks after treatment start (T1) and 10 weeks after treatment start (T2) 5. Quality of life measured using the World Health Organization Wohlbefindensindex (WHO-5) total score at baseline (T0), 5 weeks after treatment start (T1) and 10 weeks after treatment start (T2) 6. Work and social maladjustment measured using the Work and Social Adjustment Scale (WSAS) total score at baseline (T0), 5 weeks after treatment start (T1) and 10 weeks after treatment start (T2) 7. Therapist-rated overall symptom level measured using the Clinical Global Impression- Improvement (CGI-I) score at baseline (T0), 5 weeks after treatment start (T1) and 10 weeks after treatment start (T2) 8. Therapist-rated overall symptom improvement measured using the Clinical Global Impression- Severity (CGI-S) score at baseline (T0), 5 weeks after treatment start (T1) and 10 weeks after treatment start (T2) | — |
Countries
Germany
Contacts
Public ContactAnika Meißner
Outcome results
None listed