Outpatient psychotherapeutic treatment of unipolar depression Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 10/08/2023:
elona therapy (Depression module) is a digital health application that supports patients in outpatient psychotherapy for unipolar depression through the deliver
bCBT). The other group (active control group) will receive face-to-face CBT for 12 weeks (treatment as u
Sponsors
Heinrich-Heine-Universität Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. All participants must have been diagnosed with one of the following ICD-10 diagnoses: F32: Depressive episode F32.0: Mild depressive episode F32.1: Moderate depressive episode F32.2: Severe depressive episode without psychotic symptoms F33: Recurrent depressive disorder F33.0: Recurrent depressive disorder, current episode mild F33.1: Recurrent depressive disorder, current episode moderate F33.2: Recurrent depressive disorder, current episode severe without psychotic symptoms F34.1: Dysthymia 2. Between the age of 18 and 65 years 3. Sufficient German language skills (in writing and reading) 4. Possess a smartphone (iOS or Android operating system) with internet access 5. Provide signed and dated informed consent, and be willing to comply with the protocol
Exclusion criteria
Exclusion criteria: 1. 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 2. Individuals with acute suicidality (assessed via clinical assessment by the responsible therapist), 3. Individuals without any access to a smartphone (iOS or Android operating system) with internet access, and 4. Individuals with insufficient German language proficiency are excluded from this study 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. Participants will also be excluded for the respective measurement point if they fail to complete the study questionnaires within 14 days after having received them
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 17/08/2023: Assessments will take place at baseline (T0) and 12 weeks after treatment start (T1): Primary efficacy objective Depressive symptoms (PHQ-9) Primary safety objective Number or seriousness of adverse events measured using patient records Previous primary outcome measure as of 10/08/2023 to 17/08/2023: Assessments will take place at baseline (T0), 6 weeks after treatment start (T1) and 10 weeks after treatment start (T2): Primary efficacy objective Depressive symptoms (PHQ-9) Primary safety objective Number or seriousness of adverse events measured using patient records Previous primary outcome measure: Assessments will take place at baseline (T0) and 12-week after treatment start (T1): Primary efficacy objective Depressive symptoms (PHQ-9) Primary safety objective Number or seriousness of adverse events measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessments will take place at baseline (T0) and 12-week after treatment start (T1): 1. Generalized anxiety symptoms (measured with the GAD-7) 2. Psychological health (measured with the psychological health subscale of the WHOQOL-BREF) 3. Depression literacy (measured with the D-Lit) 4. Self efficacy (GSE) 5. Overall therapist-rated symptoms (measured with the Clinical Global Impression (CGI) Scale Item 1, CGI-S (Severity), and Item 2, CGI-I (Improvement)). 6. Adherence (assessed with a 4-item scale from the patient and therapist perspective) 7. Proportion of patients experiencing clinically significant improvements (i.e., = 50% symptom reduction on the PHQ-9; Israel, 2006; Keller, 2003; McMillan et al., 2010) | — |
Countries
Germany
Outcome results
None listed