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Mental Health in Refugees and Asylum Seekers (MEHIRA)

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ClinicalTrials.gov Identifier: NCT03109028
Recruitment Status : Not yet recruiting
First Posted : April 11, 2017
Last Update Posted : January 24, 2018
Sponsor:
Collaborators:
Zentralinstitut für Seelische Gesundheit Mannheim
University of Potsdam
University of Ulm
Philipps University Marburg Medical Center
RWTH Aachen University
Ludwig-Maximilians - University of Munich
Information provided by (Responsible Party):
Malek Bajbouj, Charite University, Berlin, Germany

April 6, 2017
April 11, 2017
January 24, 2018
February 2018
April 2020   (Final data collection date for primary outcome measure)
Depression severity measured by the Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: 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)
Same as current
Complete list of historical versions of study NCT03109028 on ClinicalTrials.gov Archive Site
Traumatic events measured by the Child and Adoleszent Trauma Screening (CATS) [ Time Frame: 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)
Same as current
Not Provided
Not Provided
 
Mental Health in Refugees and Asylum Seekers
Stepped Care Model Supporting Mental Health in Refugees and Asylum Seekers
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.

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:

  • RHS-15
  • PHQ-9
  • Beck Depressions Inventory
  • Montgomery Asberg Rating Scale

Following clinical measurement tools will be used at Baseline (T1):

  • Childhood Trauma Questionnaire
  • Harvard Trauma Questionnaire
  • M.I.N.I.
  • PTSD Symptom Scale
  • Strength and Difficulties Questionnaire (SDQ)
  • Child & Adolescent Trauma Screening (CATS)
  • Self-Injurious Thoughts and Behaviour Interview

Following clinical measurement tools will be used at Baseline (T) and after 48 weeks (T4)

  • Brief Resilience Scale
  • Generalized Self-Efficacy scale
  • Integration and Acculturation Questionnaires
  • The World Health Organization Quality of Life Questionnaire (WHOQol)
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Affective Disorders
  • Behavioral: Peer-to-Peer-Groupintervention

    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.

  • Behavioral: Smartphone-based-Intervention

    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.

  • Behavioral: Gendersensitive-Groupintervention

    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.

  • Behavioral: Empowerment-Groupintervention

    Target group: Gender-balanced group with mild to moderate depressive symptoms. Therapists: Psychologists and doctors in psychotherapeutic advanced training; The therapist-training lasts for two 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;

  • Behavioral: Adolescent-Groupintervention

    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)

  • Other: Treatment as Ususal
    Participants will receive the currently conducted routine and standard psychiatric health care. This involves ambulatory and stationary treatment by board certificated psychiatrists and psychotherapists.
  • Active Comparator: Treatment as Usual
    Regular standard psychiatric health care including all feasible interventions including medication, psychotherapy and social work.
    Intervention: Other: Treatment as Ususal
  • Experimental: Stepped and Collaborative Care Modell
    A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees.
    Interventions:
    • Behavioral: Peer-to-Peer-Groupintervention
    • Behavioral: Smartphone-based-Intervention
    • Behavioral: Gendersensitive-Groupintervention
    • Behavioral: Empowerment-Groupintervention
    • Behavioral: Adolescent-Groupintervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
952
Same as current
April 2020
April 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obtained a statutory health insurance
  • Approved residence status as a refugee, asylum seeker or asylee
  • Mother tongue in Arabic or Farsi/Urdu
  • Age between 16-65 years
  • Diagnosed with either a major depression, a persistent depressive disorder, a disruptive mood dysregulation disorder or an adjustment disorder with depressed mood according to DSM V criteria

Exclusion Criteria:

  • An existing schizophrenia or degenerative disorder
  • Missing informed consent
  • Possible suicidality
  • Uncertain residence status
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult, Older Adult)
No
Contact: Malek Bajbouj, Prof. Dr. med. +49 30450517542 malek.bajouj@charite.de
Contact: Kerem Böge +49 30450517542 kerem.boege@charite.de
Not Provided
 
 
NCT03109028
01VSF16061
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Malek Bajbouj, Charite University, Berlin, Germany
Charite University, Berlin, Germany
  • Zentralinstitut für Seelische Gesundheit Mannheim
  • University of Potsdam
  • University of Ulm
  • Philipps University Marburg Medical Center
  • RWTH Aachen University
  • Ludwig-Maximilians - University of Munich
Principal Investigator: Malek Bajbouj, Prof. Dr. med. Charite University, Berlin, Germany
Charite University, Berlin, Germany
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP