Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03109028 |
Other study ID # |
01VSF16061 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2018 |
Est. completion date |
March 1, 2020 |
Study information
Verified date |
February 2022 |
Source |
Charite University, Berlin, Germany |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to investigate a stepped and collaborative care model (SCCM)
for adolescent and adult refugees suffering from depression living in Germany.
Description:
A prospective, cluster-randomized intervention study, conducted in seven German cities and
comprising a total of 476 patients, should compare effectiveness and efficiency of this SCCM
as compared to a 'Treatment as Usual' (TAU) condition. The fundamental principle of the
examined care model is to provide patients with mild and moderate depression with accessible
and affordable treatments, which are located outside the usual psychiatric-psychotherapeutic
institutions (e.g. peer-to-peer-approaches or smartphone based interventions).
The acquired insights from the stepped care model, as well as concerning the individual low
barrier interventions for adolescents and adults, can be used immediately for benefitting the
provision of care of refugees but also for improving care of other communities with lacking
access to health care systems. The generated disease figures from the nationwide screening
process can be utilized directly to manage the provision of mental health fostering offers
for refugees by federal institutions and social health insurance companies.
In both treatment arms (SCCM and TAU) and independent of intervention form participants will
be assessed at four time periods after the initial screening process: Baseline (T1), after
week 12 (T1), after week 24 (T2), after week 48 (T3).
Following clinical measurement tools will be used at all time periods:
- Refugee Health Screener (RHS-15)
- Patient Health Questionnaire (PHQ-9)
- Patient Health Questionnaire-Adapted (PHQ-A) *
- Montgomery-Åsberg Depression Scale (MÅDRS)
- Mannheimer Modul Ressourcenverbrauch (MRV)
- Brief Resilience Scale (BRS)
- General Self-Efficacy Scale (GSE)
- World Health Organization Quality of Life (WHOQOL-BREF)
- Child & Adolescent Trauma Screening (CATS)*
Following clinical measurement tools will be used at Baseline (T1):
- Demographics / Migration Questionnaires
- M.I.N.I. International Neuropsychiatric Interview
- M.I.N.I. KID International Neuropsychiatric Interview*
- Harvard Trauma Questionnaire (HTQ)
Following clinical measurement tools will be used at Baseline (T0) and after
Post-Intervention (T1):
- Cultural Differences Subscale
- Credibility / Expectancy Questionnaire
Following clinical measurement tools will be used at Baseline (T0), after Post-Intervention
(T1) and Follow-Up 1 (T3):
- Strengths and Difficulties Questionnaire (SDQ)
*Adolescents only