NCT03109028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
584

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

1.8 years

First QC Date

April 6, 2017

Last Update Submit

February 2, 2022

Conditions

Affective Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Response and remission rates measured by the Mannheimer Modul Ressourcenverbrauch (MRV)

    Baseline, 12, 24 and 48 weeks after randomization

  • Traumatic events measured by the Child and Adoleszent Trauma Screening (CATS)

    Baseline, 12, 24 and 48 weeks after randomization

Study Arms (2)

Treatment as Usual

ACTIVE COMPARATOR

Regular standard psychiatric health care including all feasible interventions including medication, psychotherapy and social work.

Other: Treatment as Ususal

Stepped and Collaborative Care Modell

EXPERIMENTAL

A stepped and collaborative treatment model with varying stepped psychotherapeutic interventions for adult and adolescent refugees.

Behavioral: Peer-to-Peer-GroupinterventionBehavioral: Smartphone-based-InterventionBehavioral: Gendersensitive-GroupinterventionBehavioral: Empowerment-GroupinterventionBehavioral: Adolescent-Groupintervention

Interventions

Peer-to-Peer-GroupinterventionBEHAVIORAL

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.

Stepped and Collaborative Care Modell
Smartphone-based-InterventionBEHAVIORAL

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.

Stepped and Collaborative Care Modell
Gendersensitive-GroupinterventionBEHAVIORAL

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.

Stepped and Collaborative Care Modell
Empowerment-GroupinterventionBEHAVIORAL

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;

Stepped and Collaborative Care Modell
Adolescent-GroupinterventionBEHAVIORAL

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)

Stepped and Collaborative Care Modell
Treatment as UsusalOTHER

Participants will receive the currently conducted routine and standard psychiatric health care. This involves ambulatory and stationary treatment by board certificated psychiatrists and psychotherapists.

Treatment as Usual

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • An existing schizophrenia or degenerative disorder
  • Missing informed consent
  • Possible suicidality
  • Uncertain residence status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Mental Health

Mannheim, Germany

Location

Related Publications (2)

  • Strupf M, Hoell A, Bajbouj M, Boge K, Wiechers M, Karnouk C, Kamp-Becker I, Banaschewski T, Meyer-Lindenberg A, Rapp M, Hasan A, Falkai P, Habel U, Heinz A, Plener P, Kaiser F, Weigold S, Mehran N, Ubleis A, Padberg F. Shared sorrow, shared costs: cost-effectiveness analysis of the Empowerment group therapy approach to treat affective disorders in refugee populations. BJPsych Open. 2023 Jun 22;9(4):e113. doi: 10.1192/bjo.2023.504.

    PMID: 37345544DERIVED

  • Boge K, Karnouk C, Hoell A, Tschorn M, Kamp-Becker I, Padberg F, Ubleis A, Hasan A, Falkai P, Salize HJ, Meyer-Lindenberg A, Banaschewski T, Schneider F, Habel U, Plener P, Hahn E, Wiechers M, Strupf M, Jobst A, Millenet S, Hoehne E, Sukale T, Dinauer R, Schuster M, Mehran N, Kaiser F, Brocheler S, Lieb K, Heinz A, Rapp M, Bajbouj M. Effectiveness and cost-effectiveness for the treatment of depressive symptoms in refugees and asylum seekers: A multi-centred randomized controlled trial. Lancet Reg Health Eur. 2022 Jun 6;19:100413. doi: 10.1016/j.lanepe.2022.100413. eCollection 2022 Aug.

    PMID: 35694653DERIVED

MeSH Terms

Conditions

Mood Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Malek Bajbouj, Prof. Dr. med.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 11, 2017

Study Start

March 1, 2018

Primary Completion

December 31, 2019

Study Completion

March 1, 2020

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

DE(1)