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
|Condition or disease||Intervention/treatment||Phase|
|Affective Disorders||Behavioral: Peer-to-Peer-Groupintervention Behavioral: Smartphone-based-Intervention Behavioral: Gendersensitive-Groupintervention Behavioral: Empowerment-Groupintervention Behavioral: Adolescent-Groupintervention Other: Treatment as Ususal||Not Applicable|
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:
- Beck Depressions Inventory
- Montgomery Asberg Rating Scale
Following clinical measurement tools will be used at Baseline (T1):
- Childhood Trauma Questionnaire
- Harvard Trauma Questionnaire
- 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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||952 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stepped Care Model Supporting Mental Health in Refugees and Asylum Seekers|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
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.
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.
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.
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.
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;
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)
- 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)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109028
|Contact: Malek Bajbouj, Prof. Dr. med.||+49 firstname.lastname@example.org|
|Contact: Kerem Böge||+49 email@example.com|
|Principal Investigator:||Malek Bajbouj, Prof. Dr. med.||Charite University, Berlin, Germany|