NCT06397105

Feasibility and Acceptability of BRIGHT

Boosting Refugee Integration Through Psychological Intervention (BRIGHT) - a Pilot Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Refugees and asylum seekers (RAS) are often exposed not only to potentially traumatic events before and during migration but also to significant post-migration stressors. Due to this combined burden, RAS are at increased risk for developing mental health problems. In accessing mental health care in the host countries, however, they face several barriers including waitlists, stigma and communication difficulties. Consequently, RAS are frequently underdiagnosed and often do not receive adequate medical treatment despite an urgent need. To improve the access to evidence-based psychological interventions, the WHO developed a series of scalable interventions. One of these is Problem Management Plus (PM+), a brief, low-intensity psychological intervention, delivered by paraprofessionals, that addresses common mental disorders in people affected by adversity. PM+ consists of 5 sessions that comprise evidence-based techniques of (a) problem solving, (b) stress management, (c) behavioral activation, and (d) accessing social support. The present study aims at expanding the existing PM+ intervention by providing additional booster sessions and access to a digital support program. PM+ has been proven to be an effective method for reducing mental health problems and improving the psychosocial functioning of people in crisis in various countries and contexts, including Switzerland. Despite its effectiveness, far too little attention has been paid to the successful implementation of such low-intensity psychological interventions into real-world health care systems. The present pilot RCT aims to investigate the feasibility and acceptability of an augmented version of PM+ for refugees and asylum-seekers to inform a full-scale, definitive randomized controlled trial and implementation study. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, protocol adherence, study visit attendance and the time burden of parent questionnaires. These data will inform the design of a full scale randomized controlled trial to evaluate the efficacy of augmented PM+ in refugees and asylum-seekers.

Conditions

• Psychological Distress
• PTSD
• Trauma, Psychological

Interventions

Type	Name	Description
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, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines. Additionally, the original five PM+ sessions will be augmented in two ways. First, the participants will receive three 30-45-minutes telephone booster sessions 10, 22, and 34 weeks after the final original PM+ session. The second augmentation strategy will comprise a digital support program that participants can access via the internet.

Timeline

• Start date: 2024-10-07
• Primary completion: 2025-03-31
• Completion: 2025-12-01
• First posted: 2024-05-02
• Last updated: 2025-04-06

Locations

1 site across 1 country: Switzerland