Mental Health in Refugees and Asylum Seekers

Study 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

Official Title
-----------------
Stepped Care Model Supporting Mental Health in Refugees and Asylum Seekers

Conditions
-----------------
Affective Disorders

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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as Usual<br>Regular standard psychiatric health care including all feasible interventions including medication, psychotherapy and social work. | Other: Treatment as Ususal<br>* Participants will receive the currently conducted routine and standard psychiatric health care. This involves ambulatory and stationary treatment by board certificated psychiatrists and psychotherapists.<br>|
| Experimental: Stepped and Collaborative Care Modell<br>A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees. | Behavioral: Peer-to-Peer-Groupintervention<br>* Target group: Adult participants with mild to moderate depressive symptoms who prefer therapists with the same cultural background. Therapists: Recruitment of psychosocial counselors within refugee community who have sufficient German or English language knowledge. Counselors will be trained for a time period of two months. Content: Vulnerability and resilience factors; Self-efficacy strategies; Causes and consequences of stress; Possibilities on accelerating the integration process; Strategies preventing violence and radicalization Form of therapy: Group-based intervention for a time period of three months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants; Headed by two psychosocial counselors.<br>Behavioral: Smartphone-based-Intervention<br>* Target group: Participants with moderate depressive symptoms who prefer an internet-based intervention. Content: Five modules with 20 exercises elaborating on psycho-education, treatment options, self-management and diagnostics. Form of therapy: Participants receive regular emails and sms to encourage steady participation via the internet-based smartphone-application. Weekly questionnaires ascertain the degree of participants symptomatology.<br>Behavioral: Gendersensitive-Groupintervention<br>* Target group: Vulnerable group of adult women while taking cultural characteristics into account Therapists: Recruitment of psychosocial counselors (similar to Peer-to-Peer-Intervention); Training and supervision of gender-specific aspects. Content: Focus on psycho-education which consider women specific topics such as gender-differences in symptoms and prevalence in psychic stress related and trauma disorders; physical, psychic and psychosocial consequences of traumatic and violent experiences; gender-specific risk and safety factors; stress and emotional self-regulation Form of therapy: Group-based intervention for a time period of three months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants; Headed by two female psychosocial counselors.<br>Behavioral: Empowerment-Groupintervention<br>* Target group: Gender-sensitive group with mild to moderate depressive symptoms. Therapists: Psychologists and doctors in psychotherapeutic advanced training; The therapist-training lasts for three months with continued supervision during the intervention. Content: Low-threshold intervention based on the treatment of depression; psycho-education about psychic burdens, trauma, stress and grief as well as vulnerability and resilience factors; Problem solving and self-actualization strategies. Form of therapy: Group-based intervention for a time period of two months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants;<br>Behavioral: Adolescent-Groupintervention<br>* Target group: Adolescent participants with moderate depressive symptoms. Therapists: Two child and adolescent psychiatrists with translators or two native speaking child and adolescent psychotherapists. Content: Elements which are based on the START-Manual13 teaching emotion recognition and emotion regulation; Foundations are based on Dialetical behavior therapy; Specific focus lies on the use of mindfulness; Additionally the social network of the participants will receive psycho-education; Professional helpers in facilities will acquire E-learning elements of the SHELTER-program (Safety and Help for Early Adverse Life events and Traumatic Experiences in minor refugees)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression severity measured by the Patient Health Questionnaire - 9 (PHQ-9) | 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) | Baseline,12, 24 and 48 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response and remission rates measured by the Mannheimer Modul Ressourcenverbrauch (MRV) | Exploreing the superiority of broader effectiveness parameters, such as response and remission rates measured by the MRV between the SCCM and TAU condition. | Baseline, 12, 24 and 48 weeks after randomization | 
| Traumatic events measured by the Child and Adoleszent Trauma Screening (CATS) | 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) | Baseline, 12, 24 and 48 weeks after randomization |