Mental Health in Refugees and Asylum Seekers

NCT03109028 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 584

Last updated 2022-02-18

No results posted yet for this study

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.

Conditions

  • Affective Disorders

Interventions

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-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;

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.

Sponsors & Collaborators

  • Zentralinstitut für Seelische Gesundheit Mannheim

    collaborator OTHER
  • University of Potsdam

    collaborator OTHER
  • University of Ulm

    collaborator OTHER
  • Philipps University Marburg

    collaborator OTHER
  • RWTH Aachen University

    collaborator OTHER
  • Ludwig-Maximilians - University of Munich

    collaborator OTHER
  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Malek Bajbouj, Prof. Dr. med. · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-12-31
Completion
2020-03-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109028 on ClinicalTrials.gov