Clinically relevant depressive symptoms during the waiting period for an outpatient psychotherapy, operationalized by an elevated total score (>=10) in the Patient Health Questionnaire-9 (PHQ-9) Anxiety symptoms operationalized by the GAD-7 General psychological distress operationalized by the SCL-90-R
Conditions
Interventions
Group 1: Supported Intervention Group (IG-A
n = 100): Participants who are currently on the waiting list for guideline-based outpatient psychotherapy receive access to the digital health application deprexis® for a period of 12 weeks during the
n = 100): Participants currently on the waiting list for guideline-based outpatient psychotherapy who receive access to the digital health application deprexis® for a period of 12 weeks during the wai
n = 100): Participants currently on the waiting list for guideline-based outpatient psychotherapy who receive neither access to a digital health application nor any additional intervention from the im
Sponsors
Psychotherapeutische Praxis Ehrenberg und Kollegen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Currently on the waiting list for psychotherapy of the outpatient clinic Ehrenberg & Kollegen in Wolfsburg, Germany • Clinically relevant depressive symptoms operationalized by an elevated total score on the Patient Health Questionnaire-9 (PHQ-9) • Following an initial psychotherapeutic consultation, the diagnosis of at least one mental disorder according to the ICD-10 is confirmed or suspected, for which outpatient psychotherapy is clinically indicated. • Ability to use digital applications, including sufficient German language skills and reliable internet access • Provision of written informed consent for study participation and for the use of the collected data for scientific purposes
Exclusion criteria
Exclusion criteria: • Acute suicidality • Severe mental disorders for which a purely digital self-help intervention is clinically contraindicated, including: - Psychotic disorders (ICD-10 F20–F29) - Bipolar affective disorders (ICD-10 F30–F31) - Emotionally unstable personality disorder, borderline type (ICD-10 F60.3) • Absence of written informed consent for study participation and for the use of collected data for research purposes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in depressive symptoms, anxiety symptoms, and global psychological distress during the waiting period for outpatient psychotherapy through the use of the DiGA deprexis® under real-world clinical conditions. - Outcomes will be assessed using standardized self-report questionnaires administered at multiple assessment points. Across all trial arms, a baseline assessment will be conducted prior to randomization (T1) and a final assessment will take place after twelve weeks (T4). - In the supported intervention group (IG-A), additional interim assessments are carried out after four weeks (T2) and eight weeks (T3) to record longitudinal change during DiGA use. - In the unsupported intervention group (IG-B), assessments will take place exclusively at baseline (T1) and post-intervention (T4). • In the waitlist control group (CG), assessments will also take place at T1 and T4. Assessment Instruments (Self-Report Questionnaires) • Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001) to assess the severity of depressive symptoms • Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer et al., 2006) to assess the severity of anxiety symptoms • Symptom Checklist-90-R (SCL-90-R; Derogatis, 1994) to assess global psychological distress and subjective symptom-related functional impairment | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptance, usage, and dropout patterns during the twelve-week DiGA-intervention period. The following parameters will be assessed: • Acceptance of the DiGA (e.g., user satisfaction, perceived fit, and perceived usefulness) • Usage intensity and adherence (e.g., frequency and extent of engagement) • Dropout rates, including reasons for discontinuation of DiGA-usage • Subjectively perceived effects of and subjectively perceived burden related to the intervention Secondary outcomes are assessed using study-specific standardized self-report questionnaires and structured interviews developed specifically for the study. These study-specific instruments serve scientific purposes and will undergo psychometric evaluation within the study. Exploratory Outcomes • Comparison of supported versus unsupported DiGA utilization with respect to efficacy, adherence, and attrtion • Examination of potential moderators and predictor variables (e.g., sociodemographic characteristics, baseline symptom severity, and attitudes toward digital health applications) • Evaluation of the clinical and healthcare relevance of the DiGA as a bridging intervention during the waiting time for psychotherapy within routine care settings | — |
Countries
Germany
Contacts
Public ContactAnn-Katrin Job
Universität Kassel, Institut für Psychologie, Fachgebiet Klinische Psychologie II
Outcome results
None listed