Mental Health in Refugees and Asylum Seekers (MEHIRA)

Charité University Medicine Berlin

Status: Completed

Conditions: Affective Disorders

Treatments: Behavioral: Gendersensitive-Groupintervention; Behavioral: Peer-to-Peer-Groupintervention; Behavioral: Smartphone-based-Intervention; Other: Treatment as Ususal; Behavioral: Adolescent-Groupintervention; Behavioral: Empowerment-Groupintervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03109028

01VSF16061

Details and patient eligibility

About

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.

Full 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

Enrollment: 584 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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584 participants in 2 patient groups

Treatment as Usual

Active Comparator group

Description:

Regular standard psychiatric health care including all feasible interventions including medication, psychotherapy and social work.

Treatment:

Other: Treatment as Ususal

Stepped and Collaborative Care Modell

Experimental group

Description:

A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees.

Treatment:

Behavioral: Smartphone-based-Intervention

Behavioral: Adolescent-Groupintervention

Behavioral: Empowerment-Groupintervention

Behavioral: Gendersensitive-Groupintervention

Behavioral: Peer-to-Peer-Groupintervention