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Clinical Trials/NCT03109028
NCT03109028
Completed
N/A

Stepped Care Model Supporting Mental Health in Refugees and Asylum Seekers

Charite University, Berlin, Germany1 site in 1 country584 target enrollmentMarch 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Affective Disorders
Sponsor
Charite University, Berlin, Germany
Enrollment
584
Locations
1
Primary Endpoint
Depression severity measured by the Patient Health Questionnaire - 9 (PHQ-9)
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
March 1, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Malek Bajbouj

Prof. Dr. med.

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • Obtained a statutory health insurance
  • Approved residence status as a refugee, asylum seeker or asylee
  • Mother tongue in Arabic or Farsi/Urdu or speaks English or German fluently
  • Age between 16-65 years
  • Participants shows relevant depressive symptoms measured by the PHQ-9 or PHQ-A

Exclusion Criteria

  • An existing schizophrenia or degenerative disorder
  • Missing informed consent
  • Possible suicidality
  • Uncertain residence status

Outcomes

Primary Outcomes

Depression severity measured by the Patient Health Questionnaire - 9 (PHQ-9)

Time Frame: Baseline,12, 24 and 48 weeks after randomization

Significant reduction in depression severity as measured by the Patient Health Questionnaire - 9 (PHQ-9) from baseline to post intervention in the experimental condition (SCCM) compared to the active control condition (TAU)

Secondary Outcomes

  • Response and remission rates measured by the Mannheimer Modul Ressourcenverbrauch (MRV)(Baseline, 12, 24 and 48 weeks after randomization)
  • Traumatic events measured by the Child and Adoleszent Trauma Screening (CATS)(Baseline, 12, 24 and 48 weeks after randomization)

Study Sites (1)

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