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Feasibility and Acceptability of BRIGHT

NCT06397105 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-04-20

No results posted yet for this study

Summary

Refugees and asylum seekers (RAS) face numerous stressors and adversities which put them at risk for developing mental health problems. However, access to adequate mental health care in host countries is limited. To address this problem, the World Health Organization (WHO) introduced Problem Management Plus (PM+), a short, low-intensity psychological intervention administered by non-professionals, aiming to alleviate common mental disorders among crisis-affected communities.

The objective of this pilot RCT is to assess the feasibility and acceptability of an adapted version of PM+ for refugees and asylum-seekers. This will inform the design of a definitive RCT and implementation study.

Conditions

  • Psychological Distress
  • PTSD
  • Trauma, Psychological

Interventions

BEHAVIORAL

Problem Management Plus

Problem Management Plus (PM+) is a brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, and accessing social support. These elements have been recommended in recent WHO guidelines. Additionally, the original five PM+ sessions will be augmented by additional booster sessions. Participants will receive three 30-45-minutes telephone booster sessions 10, 22, and 34 weeks after the final original PM+ session.

Sponsors & Collaborators

  • ETH Zurich

    collaborator OTHER

  • The University of New South Wales

    collaborator OTHER

  • University of Zurich

    lead OTHER

Principal Investigators

  • Naser Morina, PD Dr. · Klinik für Konsiliarpsychiatrie und Psychosomatik

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2025-03-19
Completion
2025-12-19

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06397105 on ClinicalTrials.gov