Treatment of unipolar depression as part of treatment as usual Mental and Behavioural Disorders
Conditions
Interventions
The elona explore is a digital health application that provides patients with mental health disorders (depression, anxiety/panic disorders, OCD, adjustment disorders, and somatoform disorders) with in
Sponsors
Elona Health GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion 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 between the ages of 18 and 65 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. And be willing to comply with the protocol
Exclusion criteria
Exclusion criteria: All individuals without the included ICD-10 diagnoses, 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 the 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. Individuals without any access to a smartphone (iOS or Android operating system) with internet access 6. Individuals with insufficient German language proficiency 7. 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. 8. If an individual underwent psychotherapy three months prior to enrolling, study participation is not possible. 9. 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
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 efficacy objective Change of symptoms of depression measured using the Patient Health Questionnaire (PHQ-9) Safety objective Adverse events and serious adverse events measured using data collected in case reports | — |
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. Change of therapist-reported symptoms of depression measured using the Montgomery Asberg Depression Rating Scale (MADRS) from T0 to T2 2. Change of patients’ therapist-rated overall functioning level measured using the Global Assessment of Functioning (GAF) from T0 to T2 3. Change of symptoms of anxiety measured using the Generalized Anxiety Disorder-7 (GAD-7) from T0 to T2 4. Change of quality of life measured using the World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Psychological health subscale from T0 to T2 (exploratory) 5. Change of general self-efficacy measured using the General Self Efficacy Scale (GSE) from T0 to T2 (exploratory) 6. Change of depression literacy measured using the Depression Literacy Scale Revised (D-Lit-R) from T0 to T2 (exploratory) 7. Change of work and social maladjustment measured using the Work and Social Adjustment Scale (WSAS) from T0 to T2 (week 10) (exploratory) | — |
Countries
Germany
Contacts
Public ContactAndre Pittig
Outcome results
None listed