No registrations found.
ID
Source
Brief title
Health condition
Common mental disorders; Depression; Anxiety; Posttraumatic stress disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
Psychological distress: HSCL-25
Secondary outcome
Functional impairment: WHODAS 2.0
PTSD symptoms: PCL-5
Self-identified problems: PSYCHLOPS
Cost of care: CSRI schedule (adapted)
Access to health care: health access questionnaire developed by STRENGTHS consortium
Anger: STAS
Cortisol: hair cortisol concentrations
Impact of COVID-19
Background summary
The 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), scalable psychological intervention, delivered by trained non-specialized helpers, 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 definite, single-blind randomized controlled trial (RCT) to investigate the effectiveness and cost-effectiveness of PM+ in reducing symptoms of psychological distress. This trial follows a pilot RCT (N=60) that evaluated the feasibility and acceptability of PM+ (Trial NL6665 (NTR6842)).
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). 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).
Study objective
The main hypothesis is that PM+/care-as-usual (CAU) will decrease psychological distress as compared to CAU alone.
Study design
- Baseline
- 1 week post-intervention assessment (6 weeks after baseline)
- 3 month post-intervention assessment (4.5 months after baseline)
- 12 month follow-up (12 months after baseline)
Inclusion criteria
- Adults of 18 years or above
- Syrian refugee
- Arabic-speaking
- Elevated levels of psychological distress (K10 >15) 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)
- Currently enrolled in a specialized psychological treatment program (e.g., EMDR, CBT)
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7552 |
| Other | METC VUMC : METC protocol no NL61361.029.17 (phase 4) |
Summary results
Dawson, 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), 354–357. https://doi.org/10.1002/wps.20255
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. https://doi.org/10.1186/s12888-016-1117-x
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), 2609–2617. https://doi.org/10.1001/jama.2016.17165