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

Phase 4

• Conditions: Mild to moderate mental health impairment

• Registration Number: DRKS00022531
• Lead Sponsor: Freie Universität Berlin, Fachbereich Erziehungswissenschaften und Psychologie, Arbeitsbereich Klinisch-Psychologische Intervention

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-28
• Study Completion: 2021-11-16
• Results First Posted: 2023-11-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1043

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 < 18.5 OR critical weight loss AND weight and shape concern
Adjustment disorder: At least 5 symptoms
Sleep disorders: RIS score > 12

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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) <br><br>Quality of Life: Assessment of Quality of Life - 8 Dimensions version (AQoL-8D) <br><br>at post-intervention and follow-up