Mental Health in Refugees and Asylum Seekers
Condition: Affective Disorders
MeSH terms: Mood Disorders
Study type: Interventional

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
    

Intervention name(s): Peer-to-Peer-Groupintervention; Smartphone-based-Intervention; Gendersensitive-Groupintervention; Empowerment-Groupintervention; Adolescent-Groupintervention; Treatment as Ususal
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Other
Intervention description(s): 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.; 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.; 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.; 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;; 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); Participants will receive the currently conducted routine and standard psychiatric health care. This involves ambulatory and stationary treatment by board certificated psychiatrists and psychotherapists.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment