Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03109028
Study type Interventional
Source Charite University, Berlin, Germany
Contact
Status Completed
Phase N/A
Start date March 1, 2018
Completion date March 1, 2020

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03608449 - Doing More With Less": Optimizing Psychotherapeutic Services in the Mental Health System N/A
Completed NCT02752295 - Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients N/A
Completed NCT00163865 - A Pilot Study of Boredom in a Community Sample of Adolescents and a Clinical Sample of Adolescents N/A
Completed NCT03033420 - Reducing the Rate and Duration of Re-ADMISsions Among Patients With Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - The RADMIS Trials N/A
Completed NCT01125579 - Effectiveness of NEURAPAS Balance in Children With Nervous Restlessness
Completed NCT03667729 - The Effects of Progressive Muscle Relaxation Therapy in Patients With Schizophrenia N/A
Not yet recruiting NCT02095457 - Routine Outcome Monitoring in Mental Health Outpatient N/A
Completed NCT01815398 - Cognitive Skills Training for Homeless Youth N/A
Completed NCT02675257 - Depression and Diabetes Control Trial N/A
Completed NCT05379244 - Better Sleep in Psychiatric Care - Depression, Anxiety and Trauma, Pilot Study N/A
Completed NCT03335696 - Predicting MRI Abnormalities With Longitudinal Data of the Whitehall II Substudy
Completed NCT00288782 - PET Neuroimaging of [11C]Mirtazapine Phase 4
Completed NCT00199940 - Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness Phase 4
Recruiting NCT01182012 - Reduction of Cardiovascular Risk in Severe Mental Illness Phase 4
Completed NCT00340379 - Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression Phase 2/Phase 3