Mental Health in Refugees and Asylum Seekers
- Conditions
- Affective Disorders
- Interventions
- Behavioral: Peer-to-Peer-GroupinterventionOther: Treatment as UsusalBehavioral: Smartphone-based-InterventionBehavioral: Gendersensitive-GroupinterventionBehavioral: Empowerment-GroupinterventionBehavioral: Adolescent-Groupintervention
- Registration Number
- NCT03109028
- Lead Sponsor
- Charite University, Berlin, Germany
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 584
- 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
- An existing schizophrenia or degenerative disorder
- Missing informed consent
- Possible suicidality
- Uncertain residence status
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stepped and Collaborative Care Modell Peer-to-Peer-Groupintervention A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees. Treatment as Usual Treatment as Ususal Regular standard psychiatric health care including all feasible interventions including medication, psychotherapy and social work. Stepped and Collaborative Care Modell Smartphone-based-Intervention A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees. Stepped and Collaborative Care Modell Gendersensitive-Groupintervention A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees. Stepped and Collaborative Care Modell Adolescent-Groupintervention A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees. Stepped and Collaborative Care Modell Empowerment-Groupintervention A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees.
- Primary Outcome Measures
Name Time Method Depression severity measured by the Patient Health Questionnaire - 9 (PHQ-9) 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 Outcome Measures
Name Time Method Response and remission rates measured by the Mannheimer Modul Ressourcenverbrauch (MRV) Baseline, 12, 24 and 48 weeks after randomization Exploreing the superiority of broader effectiveness parameters, such as response and remission rates measured by the MRV between the SCCM and TAU condition.
Traumatic events measured by the Child and Adoleszent Trauma Screening (CATS) Baseline, 12, 24 and 48 weeks after randomization Significant reduction in emotional stress experienced by traumatic experiences as measured by the Child and Adoleszent Trauma Screening (CATS) in adolescents refugees from baseline to post intervention in the experimental condition (SCCM) compared to the active control condition (TAU)
Trial Locations
- Locations (1)
Central Institute of Mental Health
🇩🇪Mannheim, Germany