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Mental Health in Refugees and Asylum Seekers (MEHIRA)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified April 2017 by Malek Bajbouj, Charite University, Berlin, Germany
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
ClinicalTrials.gov Identifier:
NCT03109028
First received: April 6, 2017
Last updated: April 10, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Affective Disorders Behavioral: Peer-to-Peer-Groupintervention Behavioral: Smartphone-based-Intervention Behavioral: Gendersensitive-Groupintervention Behavioral: Empowerment-Groupintervention Behavioral: Adolescent-Groupintervention Other: Treatment as Ususal

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Stepped Care Model Supporting Mental Health in Refugees and Asylum Seekers

Resource links provided by NLM:


Further study details as provided by Malek Bajbouj, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 952
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment as Usual
Regular standard psychiatric health care including all feasible interventions including medication, psychotherapy and social work.
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.
Experimental: Stepped and Collaborative Care Modell
A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees.
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)


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:

  • 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)
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03109028

Contacts
Contact: Malek Bajbouj, Prof. Dr. med. +49 30450517542 malek.bajouj@charite.de
Contact: Kerem Böge +49 30450517542 kerem.boege@charite.de

Sponsors and Collaborators
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
Investigators
Principal Investigator: Malek Bajbouj, Prof. Dr. med. Charite University, Berlin, Germany
  More Information

Responsible Party: Malek Bajbouj, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03109028     History of Changes
Other Study ID Numbers: 01VSF16061
Study First Received: April 6, 2017
Last Updated: April 10, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2017