Feasibility and Acceptability of BRIGHT

University of Zurich (UZH)

Status: Enrolling

Conditions: PTSD; Trauma, Psychological; Psychological Distress

Treatments: Behavioral: Problem Management Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT06397105

BASEC-2023-00857-pilot

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• refugees and asylum seekers (RAS) aged 16 or older;
• residing in one of the participating local sites (Swiss municipalities, namely, Gemeinden, and transitional asylum centers, namely, Durchgangszentren) where PM+ is offered and which gave their consent for participation in the RCT;
• speaking at least one of the following 12 languages: German, English, French, Arabic, Farsi, Kurdish, Tigrinya, Turkish, Ukrainian, Russian, Tamil, and Pashto;
• obtaining a score of 20 or higher on the Kessler Psychological Distress Scale (K10; Kessler et al., 2002), a brief clinically validated screening questionnaire that assesses general psychological distress in the past 30 days. A score equal to or higher than 20 is used as an indication of moderate to high levels of psychological distress.

Exclusion criteria

• significant cognitive or neurological impairment measured through specific tools developed by the WHO and integrated into the PM+ manual (impairment questionnaire);
• acute medical conditions or severe mental disorders (e.g., psychotic or substance-abuse disorders) measured through specific tools developed by the WHO and integrated into the PM+ manual (impairment questionnaire);
• acute risk of suicide as measured by the Suicidal Ideation Attribution Scale (SIDAS; van Spijker et al., 2014) and the Thoughts of Suicide Questionnaire (World Health Organization WHO, 2016).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Problem Management Plus

Experimental group

Description:

The participants who are assigned to the intervention group will receive five sessions of PM+, a psychological intervention which has been developed by the WHO. PM+ is a short, transdiagnostic (i.e., not specifically aimed at treating a certain mental disorder) program aiming to reduce common mental health symptoms and improve psychosocial functioning. In addition, participants will receive three telephone booster sessions and will have access to a digital support program.

Treatment:

Behavioral: Problem Management Plus

waitlist control group

Other group

Description:

The control group will receive the augmented PM+ intervention 12 months after the baseline assessment.

Treatment:

Behavioral: Problem Management Plus

observational control group

No Intervention group

Description:

Participants who scored below 20 on the K10 will will only be part of the baseline assessments and receive no intervention.