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Group Therapy and Aury - Blended Care Intervention Study

Group Therapy and Aury - Blended Care Intervention Study - GAIN-Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033550
Enrollment
120
Registered
2024-07-30
Start date
2025-01-07
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Mild depressive episode (F32.0) Moderate depressive episode (F32.1) Severe depressive episode without psychotic symptoms (F32.2) Other depressive episodes (F32.8) Depressive episode, unspecified (F32.9) Recurrent depressive disorder, current episode mild (F33.0) Recurrent depressive disorder, current episode moderate (F33.1) Recurrent depressive disorder, current episode severe (F33.2) Other recurrent depressive disorders (F33.8) Recurrent depressive disorder, unspecified (F33.9) Dysthymia (F34.

Interventions

Group 1: intervention group Study participants in the intervention group take part in transdiagnostic group therapy over five weekly sessions of 100 minutes each and use a chatbot between sessions to

Sponsors

Humboldt-Universität zu Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Ability to consent -German-speaking -Psychopathology: Scores = 10 on at least one subscale (Depression, Anxiety, Somatization) of the Patient Health Questionnaire – D (PHQ-D), or a score >10 on the Insomnia Severity Index (ISI).

Exclusion criteria

Exclusion criteria: - Psychopathology: Indication for inpatient treatment (acute psychosis, suspected danger to self or others, substance dependence self-harm or danger to others, substance dependence (F1X.2), serious psychopathology), clinical impression of inadequately treated borderline personality disorder, pronounced personality disorders which, according to clinical impression limits group ability - No willingness to participate in group therapy - No willingness to use the digital chatbot - No willingness to participate in the study in case of randomized allocation to the waiting control group - Start of guideline psychotherapy (excluding probationary sessions) in the intervention period

Design outcomes

Primary

MeasureTime frame
The primary outcome is the symptom burden of the study participants and is assessed at the time of informed consent (T1), after the five-week intervention (T2) and after 12 weeks in the follow-up (T3). Symptom burden is assessed using the Patient Health Questionnaire (PHQ-D) resp. the Insomnia Severity Index (ISI) for study participants with a diagnosis of a non-organic sleeping disorder.

Secondary

MeasureTime frame
As a secondary endpoint, changes in the resources and self-management skills of the study participants will also be assessed. These will be assessed at the time of informed consent (T1), after the five-week intervention (T2) and after 12 weeks in the follow-up (T3) using the questionnaire for the assessment of resources and self-management skills (FERUS). Furthermore, change mechanisms after the five-week intervention (T2) are recorded as a secondary endpoint using the General Change Mechanisms Questionnaire (GCMQ-20). In addition, attitudes and experiences of group therapy and digital interventions are recorded at the time of informed consent (T1). This is done purely descriptively using a short, non-psychometrically tested questionnaire developed in-house.

Countries

Germany

Contacts

Public ContactUlrike Lüken

Humboldt-Universität Berlin, Institut für Psychologie, Lehrstuhl für Psychotherapie

ulrike.lueken@hu-berlin.de(030)2093-9307

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026