Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-03-02 @ 11:04 PM
Study NCT ID:
NCT03109028
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2017-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Health in Refugees and Asylum Seekers
Sponsor:
Charite University, Berlin, Germany
Organization:
Study Overview
Official Title:
Stepped Care Model Supporting Mental Health in Refugees and Asylum Seekers
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEHIRA
Brief 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.
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: