Inclusion of all ICD-10 diagnoses from the field of mental and behavioral disorders, with the exception of: schizophrenia, schizotypal or delusional disorders (F20–F29)
Conditions
Interventions
Group 1: The intervention group (DiGA-group) is given access to the digital health application (DiGA) "elona explore" and instructed to use it for at least 60 minutes per week for ten weeks while wai
Sponsors
Georg-August-Universität Göttingen
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Adults aged between 18 and 65 years with a suspected diagnosis of a mental disorder according to the International Classification of Diseases, 10th Revision (ICD-10, GM; Dilling & Freyberger, 2019); ownership of a smartphone (Android/iOS) with internet access; sufficient German language skills to participate in psychotherapy; informed consent.
Exclusion criteria
Exclusion criteria: Participants will be excluded if they present with acute suicidality; are under 18 years of age; have no access to a smartphone (Android/iOS) with internet connection; have insufficient German language skills; are currently undergoing psychotherapeutic treatment; underwent psychotherapeutic treatment within three months prior to the start of the study; are already using a DiGA for mental health conditions at the start of the study; start psychotherapeutic treatment during the study period; start using an additional DiGA for a mental disorder during the study period; plan to discontinue, change the dosage of, or start taking psychopharmacological medication during the study period. Patients with the following ICD-10 diagnoses will also be excluded: schizophrenia, schizotypal, or delusional disorders (F20–F29); manic episode (F30); bipolar affective disorder with hypomanic or manic episodes (F31.1, F31.2, F31.5, F31.6, F31.8, F31.9); depressive episodes with psychotic symptoms (F32.3, F33.3); dementia in Alzheimer’s disease (F00); and mental and behavioral disorders due to psychoactive substance use (F10–F19, except F17).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is symptom severity, assessed using the Brief Symptom Inventory-18 (BSI-18; Derogatis, 2000). Symptom severity will be measured at baseline (T0), five weeks after study start (T1), and ten weeks after study start (T2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include psychological burden assessed with the Questionnaire for the Evaluation of Psychotherapy Processes (FEP-2; Lutz & Böhnke, 2008), perceived stress measured with the Perceived Stress Scale (PSS-10; Cohen et al., 1983), quality of life assessed using the World Health Organization Quality of Life – BREF (WHOQOL-BREF; WHO, 1998), stress regulation skills measured with the Stress and Coping Inventory – Coping subscale (SCI; Satow, 2012), emotional competencies assessed with the Self-Assessment of Emotional Competencies Questionnaire (SEK-27; Berking & Znoj, 2008), and mental health literacy measured with the Mental Health Literacy Scale (MHLS; O’Connor & Casey, 2015). Participants in the DiGA intervention group will additionally complete the Attitudes Towards Psychological Online Interventions Questionnaire (APOI; Schröder et al., 2015). Assessments will be conducted at baseline (T0), five weeks after study start (T1), and ten weeks after study start (T2). | — |
Countries
Germany
Contacts
Public ContactAnika Meißner
Georg-August-Universität Göttingen
Outcome results
None listed