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App-Based Unguided Self-Management for People With Mild to Moderate Mental Health Impairment

App-Based Unguided Self-Management for People With Mild to Moderate Mental Health Impairment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00022531
Enrollment
1113
Registered
2020-09-28
Start date
2021-03-16
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate mental health impairment

Interventions

Group 1: App-based unguided self-management, recommended duration of use at least 8 weeks. The application has four interconnected core components: 1. Continuous monitoring of symptoms of common menta

Sponsors

Freie Universität Berlin, Fachbereich Erziehungswissenschaften und Psychologie, Arbeitsbereich Klinisch-Psychologische Intervention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Access to a smartphone (iOS or Android) and the internet; Permanent residence in Germany; Symptoms of internalizing disorders indicated by scoring above the cutoff on one or more of the following scales: PHQ-9 score > 4 GAD-7 score > 4 MINI-SPIN score > 6 PHQ-15 score > 4 Eating disorders: binge eating or compensatory behaviors > once/week OR BMI 12

Exclusion criteria

Exclusion criteria: Current inpatient treatment; Any ongoing psychotherapeutic treatment; Reported history of bipolar disorder, psychotic disorder, substance use disorder; Acute suicidality: Score > 1 on PHQ-9 item 9 or answer “yes” to acute suicidality screening question PHQ-9 > 19 (severe depression according to Kroenke et al., 2001) GAD-7 > 15 (severe anxiety disorder according to Schalet et al., 2014) PHQ-15 score > 14 (severe symptoms according to Kroenke et al., 2002) BMI < 15

Design outcomes

Primary

MeasureTime frame
Mental health literacy: The Mental Health Literacy Questionnaire (MHLq) Patient empowerment: Assessment of Mental Health-Related Patient Sovereignty and Self Management Strategies, Client Satisfaction Questionnaire adapted to Internet-based interventions (CSQ-I) Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) after 8 weeks and additional questions on treatment-seeking behavior after six months.

Secondary

MeasureTime frame
Psychological distress: Composite score of the Patient Health Questionnaire 9 (PHQ-9), the Generalized Anxiety Disorder 7 (GAD-7) and the Patient Health Questionnaire 15 (PHQ-15), Regensburger Insomnie Skala (RIS) Quality of Life: Assessment of Quality of Life - 8 Dimensions version (AQoL-8D) at post-intervention and follow-up

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 15, 2026