Feasibility and Acceptability of BRIGHT

NCT06397105 | Completed DMC

• 1 other identifier: BASEC-2023-00857-pilot
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Problem Management Plus; Psychological Distress; Mental Health Care; Refugees

Outcome Measures

Primary Outcomes (1)

• Change in psychological distress

  Change in psychological distress will be measured with the Hopkins Symptom Checklist (HSCL-25). Items are rated on a scale from 1 to 4. Higher scores indicate more pronounced symptom severity.

  Baseline assessment, 3 month FU assessment (3 months after baseline)

Secondary Outcomes (9)

• Change in posttraumatic stress disorder symptoms

  Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment

• General psychological distress

  Screening, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment

• Somatic symptoms

  Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment

• Reduction of post-migration stressors

  Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment

• Exposure to potentially traumatic events

  Baseline assessment

Study Arms (3)

Problem Management Plus

EXPERIMENTAL

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.

Behavioral: Problem Management Plus

waitlist control group

OTHER

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

Behavioral: Problem Management Plus

observational control group

NO INTERVENTION

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

Interventions

Problem Management Plus BEHAVIORAL

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.

Problem Management Plus; waitlist control group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Zurich: lead
• ETH Zurich: collaborator
• The University of New South Wales: collaborator

Study Sites (1)

Klinik für Konsiliarpsychiatrie und Psychosomatik, Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Related Publications (4)

• Spaaij J, Kiselev N, Berger C, Bryant RA, Cuijpers P, de Graaff AM, Fuhr DC, Hemmo M, McDaid D, Moergeli H, Park AL, Pfaltz MC, Schick M, Schnyder U, Wenger A, Sijbrandij M, Morina N. Feasibility and acceptability of Problem Management Plus (PM+) among Syrian refugees and asylum seekers in Switzerland: a mixed-method pilot randomized controlled trial. Eur J Psychotraumatol. 2022 Jan 31;13(1):2002027. doi: 10.1080/20008198.2021.2002027. eCollection 2022.

  PMID: 35126880 BACKGROUND

• de Graaff AM, Cuijpers P, Twisk JWR, Kieft B, Hunaidy S, Elsawy M, Gorgis N, Bouman TK, Lommen MJJ, Acarturk C, Bryant R, Burchert S, Dawson KS, Fuhr DC, Hansen P, Jordans M, Knaevelsrud C, McDaid D, Morina N, Moergeli H, Park AL, Roberts B, Ventevogel P, Wiedemann N, Woodward A, Sijbrandij M; STRENGTHS Consortium; STRENGTHS consortium. Peer-provided psychological intervention for Syrian refugees: results of a randomised controlled trial on the effectiveness of Problem Management Plus. BMJ Ment Health. 2023 Feb;26(1):e300637. doi: 10.1136/bmjment-2022-300637. Epub 2023 Feb 8.

  PMID: 36789918 BACKGROUND

• Dawson KS, Bryant RA, Harper M, Kuowei Tay A, Rahman A, Schafer A, van Ommeren M. Problem Management Plus (PM+): a WHO transdiagnostic psychological intervention for common mental health problems. World Psychiatry. 2015 Oct;14(3):354-7. doi: 10.1002/wps.20255. No abstract available.

  PMID: 26407793 BACKGROUND

• Steel Z, Chey T, Silove D, Marnane C, Bryant RA, van Ommeren M. Association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis. JAMA. 2009 Aug 5;302(5):537-49. doi: 10.1001/jama.2009.1132.

  PMID: 19654388 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Naser Morina, PD Dr.

  Klinik für Konsiliarpsychiatrie und Psychosomatik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All instruments and questions of the screening and baseline assessment will be assessed as an assisted self-assessment in the presence of a trained assessor fluent in the participant's mother tongue blind to the allocation status of the participants.The follow-up assessments are administered either as an online self-assessment, as an assisted online self-assessment or as an self-assessment in presence. In either case, the trained assessors are blind to the allocation status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The pilot RCT will inform us about the feasibility of PM+ under usual practice conditions.

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: October 15, 2024
• Primary Completion: March 19, 2025
• Study Completion: December 19, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CH (1)