Clinical trial NCT03109028: Mental Health in Refugees and Asylum Seekers
Official title: Stepped Care Model Supporting Mental Health in Refugees and Asylum Seekers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Affective Disorders
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Zentralinstitut für Seelische Gesundheit Mannheim
name: University of Potsdam
name: University of Ulm
name: Philipps University Marburg
name: RWTH Aachen University
name: Ludwig-Maximilians - University of Munich
First posted: 2017-04-11
Enrollment: 584
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Depression severity measured by the Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Baseline,12, 24 and 48 weeks after randomization
Secondary outcomes:
measure: Response and remission rates measured by the Mannheimer Modul Ressourcenverbrauch (MRV)
timeFrame: Baseline, 12, 24 and 48 weeks after randomization
measure: Traumatic events measured by the Child and Adoleszent Trauma Screening (CATS)
timeFrame: Baseline, 12, 24 and 48 weeks after randomization
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Central Institute of Mental Health
Study officials:
affiliation: Charite University, Berlin, Germany
name: Malek Bajbouj, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boge K, Karnouk C, Hoell A, Tschorn M, Kamp-Becker I, Padberg F, Ubleis A, Hasan A, Falkai P, Salize HJ, Meyer-Lindenberg A, Banaschewski T, Schneider F, Habel U, Plener P, Hahn E, Wiechers M, Strupf M, Jobst A, Millenet S, Hoehne E, Sukale T, Dinauer R, Schuster M, Mehran N, Kaiser F, Brocheler S, Lieb K, Heinz A, Rapp M, Bajbouj M. Effectiveness and cost-effectiveness for the treatment of depressive symptoms in refugees and asylum seekers: A multi-centred randomized controlled trial. Lancet Reg Health Eur. 2022 Jun 6;19:100413. doi: 10.1016/j.lanepe.2022.100413. eCollection 2022 Aug.