A randomized controlled study to evaluate a digital intervention for treating unipolar depression in adults

INTERVENTION: 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 interventions, techniques, helpful activities, exercises, and psychoeducational resources for the period they are on the waiting list for outpatient psychotherapy. By retrieving regular check‐ups, elona explore responds individually to patients’ mood records and adjusts the content accordingly. The application is intended for independent use by the patient and to assist in the self‐management of symptoms of the patient’s mental disorder. The treatment elements of elona explore are in line with current recommendations for the psychotherapeutic treatment of common mental disorders. To test the effectiveness and safety of elona explore, a randomized controlled trial (RCT) with patients who are on the waiting list for outpatient psychotherapy with a clinical diagnosis of depression (including F32. Xand F33. Xbased on ICD‐10 criteria) is planned. The RCT comprises two arms. Randomization will be achieved 1:1 and stratified according to the severity of patients’ depressive episodes (Group 1: F32.0 and F33.0, Group 2: F32.1 and F33.1, Group 3: F32.2 and F33.2). Participants assigned to the IG will receive access to the elona explore digital application in addition to the treatment as usual (TAU) for 10 weeks. Within TAU, patients are not restricted in the use of medical or psychological services that are available as usual care. The CG will receive only TAU for 10 weeks. The CG will receive access to the elona explore application after the study period. For evaluating the primary and secondary objectives of this study (see below) a 2 (group: IG, CG) X2 (time: pre, post) design will CONDITION: Treatment of unipolar depression in patients on the waiting list for the outpatient psychotherapeutic treatment ; Mental and Behavioural Disorders PRIMARY OUTCOME: Assessments will take place at baseline (T0), 5 weeks after treatment start (T1), and 10 weeks after treatment start (T2):; ; Primary effectiveness objective:; Symptoms of depression measured using PHQ‐9; ; Primary safety objective:; Number or seriousness of adverse events measured using patient records SECONDARY OUTCOME: Assessments will take place at baseline (T0), 5 weeks after treatment start (T1), and 10 weeks after treatment start (T2):; 1. 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. Depression literacy measured with the D‐Lit 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 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