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van CCT (UK)

STRENGTHS: Fostering responsive mental health systems in the Syrian refugee crisis

- candidate number28235
- NTR NumberNTR6842
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-nov-2017
- Secondary IDsMETC protocol no NL61361.029.17 (phase 2) 
- Public TitleSTRENGTHS: Fostering responsive mental health systems in the Syrian refugee crisis
- Scientific TitleImplementation of Problem Management Plus in Syrian refugees: pilot RCT
- hypothesisThe pilot RCT has a pre-post study design with the objective to inform the definitive RCT about drop-out rates and estimated effect sizes. We expect a decrease in psychological distress (HSCL-25).
- Healt Condition(s) or Problem(s) studiedAnxiety, Depression, Post-traumatic stress disorder,, Refugees, Mental problems
- Inclusion criteria- Adults of 18 years or above
- Syrian refugee status
- Arabic-speaking
- Elevated levels of psychological distress (K10 >15.9) and reduced psychosocial functioning (WHODAS 2.0 >16)
- Exclusion criteria- Acute medical conditions
- Imminent suicide risk or expressed acute needs/protection risks (e.g., a young woman who expresses that she is at acute risk of being assaulted or killed)
- Severe mental disorder (psychotic disorders, substance-dependence)
- Severe cognitive impairment (e.g., severe intellectual disability or dementia)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-apr-2018
- planned closingdate31-dec-2019
- Target number of participants60
- InterventionsThere are two arms in this study:
1. Comparison group: Care as usual (CAU) only
2. Treatment group: CAU with Problem Management Plus (PM+)

Care as usual (CAU):
CAU ranges from community care (e.g., social work, POH-GGZ, NGO buddy systems) to specialized psychological treatment programs.
Currently, waitlists for mental health services hamper access for Syrian refugees who do not master the Dutch language, due to a lack of Arabic speaking mental health care professionals.

Problem Management Plus (PM+):
The World Health Organization (WHO) has developed the low-intensity PM+ programs, a new generation of shorter, less expensive and trans-diagnostic (i.e., not condition-specific, but targeted at a broader set of symptoms of common mental disorders) programs to reduce common mental health symptoms and improve psychosocial functioning. It is based on the WHO treatment guidelines for conditions related to stress (WHO, 2013).
PM+ is a 5-sessions intervention (Dawson et al., 2015) that reduces symptoms of depression, anxiety, PTSD, and related conditions. It is delivered by trained non-specialized workers or lay people, and is available in individual and group delivery formats for both children and adults. It comprises evidence-based techniques, such as (a) problem solving, (b) stress management, (c) behavioral activation, and (d) accessing social support.
PM+ has been proven to be effective in two randomized controlled trials (RCTs) in Kenya and Pakistan (Bryant, Dawson, Schafer, Sijbrandij, & van Ommeren, 2016; Rahman, Hamdani, Awan, Bryant, Dawson, Khan, Mukhtar-ul-Haq Azeemi, et al., 2016).
- Primary outcomePsychological distress: HSCL-25
- Secondary outcomePTSD symptoms: PCL-5
Self-identified problems: PSYCHLOPS
Cost of care: CSRI schedule
Access to health care: own questionnaire
- Timepoints- Baseline
- 1 week post-intervention assessment (6 weeks after baseline)
- 3 month post-intervention assessment (4-4.5 months after baseline)
- Trial web
- statusplanned
- Sponsor/Initiator Vrije Universiteit Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
European Union Horizon 2020 Research and Innovation Programme
- PublicationsDawson, K. S., Bryant, R. A., Harper, M., Kuowei Tay, A., Rahman, A., Schafer, A., & Van Ommeren, M. (2015). Problem Management Plus (PM+): A WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry, 14(3), 354357. Dawson, K. S., Schafer, A., Anjuri, D., Ndogoni, L., Musyoki, C., Sijbrandij, M., Bryant, R. A. (2016). Feasibility trial of a scalable psychological intervention for women affected by urban adversity and gender-based violence in Nairobi. BMC Psychiatry, 16(1), 410. Rahman, A., Hamdani, S. U., Awan, N. R., Bryant, R. A., Dawson, K. S., Khan, M. F., Van Ommeren, M. (2016). Effect of a multicomponent behavioral intervention in adults impaired by psychological distress in a conflict-affected area of Pakistan. A randomized clinical trial. JAMA, 316(24), 26092617.
- Brief summaryThe current refugee crisis across the Middle East and Europe has large effects on individual refugees' psychological wellbeing, as well as on the healthcare systems of countries housing refugees. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a brief (5 sessions), low-intensity psychological intervention, delivered by trained non-specialized workers, that addresses common mental disorders in persons affected by adversity.

The primary objective of STRENGTHS is to evaluate the feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted PM+ intervention for Syrian refugees in The Netherlands. The current trial registration is for the pilot trial to investigate the feasibility and acceptability (e.g., obtain estimates of drop-out rates), to inform a full-scale, definitive randomized controlled trial.

Study participants include adult Syrian refugees (18 years and older) in The Netherlands with self-reported functional impairment (WHODAS 2.0 >16) and elevated psychological distress (K10 >15.9). Participants in the treatment group will receive five sessions of PM+ and care-as-usual (CAU). Participants in the comparison group will receive CAU only.

The main study parameter will be the decrease in psychological distress from baseline to three-month post-intervention assessment, measured through the Hopkins Symptoms Checklist (HSCL-25).
- Main changes (audit trail)
- RECORD20-nov-2017 - 29-apr-2018

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