Clinical trial NCT06776523: Boosting Refugee Integration Through Psychological Intervention
Official title: Boosting Refugee Integration Through Psychological Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
PTSD
Trauma
Common Mental Health Problems
Keywords: Problem Management Plus
Psychological Distress
Mental Health Care
Refugees
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich
name: The University of New South Wales
First posted: 2025-01-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The RCT will inform us about the effectiveness of PM+ under usual practice conditions.

After the screening and baseline assessment, thousand five hundred participants (N = 1500) will be involved in the RCT (assigned to either receiving the PM+ intervention right after the baseline assessment (N = 750) or twelve months later (N = 750)). Participants who scored below the K10 cut-off will be assigned to an observational control group receiving no intervention (N = 500).
Primary purpose: TREATMENT

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 present study aims at expanding the existing PM+ intervention by providing additional booster sessions and homework reminders while evaluating its effectiveness and implementation in the public health system.

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 homework reminders.

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.

To address this gap, the present study aims to evaluate the effectiveness of augmented PM+ on mental health outcomes over 3 months under usual practice conditions and its implementation in the public health care system by using a pragmatic randomized clinical trial design.

Eligibility criteria: The inclusion criteria for participating in the study are:

* 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.

The exclusion criteria for participating in the study are:

* 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).

Primary outcomes:
measure: Change in psychological distress
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline)
Secondary outcomes:
measure: Change in psychological distress
timeFrame: 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)
measure: Change in posttraumatic stress disorder symptoms
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after b.), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)
measure: General psychological distress
timeFrame: Screening, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline)
measure: Somatic symptoms
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after b.), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)
measure: Reduction of post-migration stressors
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after b.), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)
measure: Exposure to potentially traumatic events
timeFrame: Baseline assessment
measure: Level of integration
timeFrame: Baseline assessment, 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after b.), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)
measure: Suicidal Ideation
timeFrame: Screening, 6 month follow-up assessment (6 months after baseline), 36 month follow-up assessment (36 months after baseline)
measure: Self-efficacy
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline)
measure: Prolonged Grief
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline)
measure: Assessing the extent to which the strategies taught in PM+ are used before and after the study participation with the Reducing Tension Checklist
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline)
measure: Anger
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline), 6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)]
measure: Time and risk preferences
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline)
measure: Facial Expression
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline)
measure: Assessment of Coping Strategies
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline)
measure: Counterfactual Comparisons
timeFrame: Baseline assessment, 3 month FU assessment (3 months after baseline)
Other outcomes:
measure: Use of health care services and medications
timeFrame: Two years before (or since arrival in Switzerland if less than two years) to four years after study inclusion
measure: Impact of asylum process on mental health
timeFrame: Two years before (or since arrival in Switzerland if less than two years) to four years after study inclusion
measure: Labour market integration
timeFrame: Two years before (or since arrival in Switzerland if less than two years) to four years after study inclusion
measure: Impact of residence status
timeFrame: Two years before (or since arrival in Switzerland if less than two years) to four years after study inclusion
measure: Impact of cantonal regulations
timeFrame: Two years before (or since arrival in Switzerland if less than two years) to four years after study inclusion
measure: Integration
timeFrame: Two years before (or since arrival in Switzerland if less than two years) to four years after study inclusion
Locations:
city: Zurich
country: Switzerland
facility: Klinik für Konsiliarpsychiatrie und Psychosomatik
Study officials:
affiliation: Klinik für Konsiliarpsychiatrie und Psychosomatik
name: Naser Morina, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.