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Psychological DistressNCT06397105

Feasibility and Acceptability of BRIGHT

A study testing Problem Management Plus in people with Psychological Distress and PTSD, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Problem Management Plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteSwitzerland
Study dates
15 Oct 2024to 19 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Switzerland1 site

  • Klinik für Konsiliarpsychiatrie und Psychosomatik, Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Problem Management Plus
Keywords
Problem Management Plus, Psychological Distress, Mental Health Care, Refugees
Medical subject headings
Stress Disorders, Post-Traumatic, Psychological Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Problem Management PlusBehavioural

    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.

Study groups in NCT06397105
Study groupRoleWhat they receive
Problem Management PlusExperimentalThe 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.
Receives: Behavioral: Problem Management Plus
waitlist control groupOtherThe control group will receive the augmented PM+ intervention 12 months after the baseline assessment.
Receives: Behavioral: Problem Management Plus
observational control groupNo interventionParticipants who scored below 20 on the K10 will will only be part of the baseline assessments and receive no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)

  1. Change in posttraumatic stress disorder symptoms

    Change in posttraumatic stress disorder symptoms will be assessed using the 4-item short form of the PCL-5. Items are rated on a scale from 0 to 4 with higher scores indicating more pronounced symptom severity.

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

  2. General psychological distress

    General psychological distress will be measured with the Kessler Psychological Distress Scale - K10 (Kessler et al., 2002), a brief screening questionnaire assessing general psychological distress in the past 30 days. It consists of ten items (e.g., "During the last 30 days, about how often did you feel tired out for no good reason?") rated on a 5-point Likert scale (1 = "none of the time" to 5 = "all of the time"), before summation (range 10-50).

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

  3. Somatic symptoms

    Somatic symptoms will be assessed using the Somatic Symptom Scale (SSS-8). Items are rated on a scale from 0 to 4 with higher scores indicating higher symptom severity.

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

  4. Reduction of post-migration stressors

    Changes in post-migration stressors will be assessed using a 9-item version of the Post Migration Living Difficulties Checklist (PMLDC). Items are rated on a scale from 0 to 4 with lower scores representing fewer post-migration stressors.

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

  5. Exposure to potentially traumatic events

    Exposure to potentially traumatic events is indexed using a list of seven traumatic experiences. Overall trauma exposure is represented by a count of the number of traumatic event types (ranging from 0 to 7) experienced by each participant; higher scores indicate experience of more forms of traumatic events.

    Measured: Baseline assessment

  6. Level of integration

    Level of integration will be measured using the Immigration Policy Lab Integration Index (IPL-24). Items are rated between one and five points. Higher scores indicate more pronounced symptom severity.

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

  7. Suicidal Ideation

    Suicidal Ideation is measured using the Suicidal Ideation Attribution Scale (SIDAS), a brief measure of severity of suicidal ideation assessing frequency, controllability, closeness to attempt, level of distress associated with the thoughts and impact on daily functioning. It consists of five items rated on a 11-point scale (0 = "Never" to 10 = "Always").

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

  8. 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.

    Measured: 6 month FU assessment (6 months after baseline), 12 months FU assessment

  9. Feasibility of PM+ by the number of dropouts

    Monitoring of the dropouts by number of participants

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start15 Oct 2024
  3. Primary completion19 Mar 2025
  4. Study completion19 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The pilot RCT will inform us about the feasibility of PM+ under usual practice conditions.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06397105
Sponsor's protocol ID
BASEC-2023-00857-pilot
Status last verified
Apr 2026
First submitted
29 Apr 2024
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35126880

  • 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.

    PubMed 36789918

  • 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.

    PubMed 26407793

  • 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.

    PubMed 19654388

Questions about this trial

What is this clinical trial studying?

A study testing Problem Management Plus in people with Psychological Distress and PTSD, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in psychological distress (time frame: Baseline assessment, 3 month FU assessment (3 months after baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06397105, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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