Boosting Refugee Integration Through Psychological Intervention

Not Applicable

Recruiting

• Conditions: Psychological Distress; PTSD; Trauma; Common Mental Health Problems

• Registration Number: NCT06776523
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study First Submitted: 2024-12-18
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-09
• Study Start: 2025-01-14
• Study First Posted: 2025-01-15
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-03-20
• Study Completion: 2028-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in psychological distress	Baseline assessment, 3 month FU assessment (3 months after baseline)	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.

Secondary Outcome Measures

Name	Time	Method
Somatic symptoms	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.)	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.
Change in psychological distress	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.)	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.
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 (12 months after b.), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)	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.
General psychological distress	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)	General psychological distress will be measured with the Kessler Psychological Distress Scale (K10), 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).
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 (12 months after b.), 24 month FU assessment (24 months after b.), 36 months FU (36 months after b.)	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.
Exposure to potentially traumatic events	Baseline assessment	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.
Level of integration	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.)	Level of integration will be measured using the Immigration Policy Lab Integration Index (IPL-24).
Suicidal Ideation	Screening, 6 month follow-up assessment (6 months after baseline), 36 month follow-up assessment (36 months after baseline)	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").
Self-efficacy	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)	Self-efficacy is assessed using a subscale of the Compound Psychological Capital Scale (CPS). This subscale consists of three items (e.g., "I can solve most problems if I invest the necessary effort") of the General Self-Efficacy Scale (GSE). Each item is rated on a 6-point Likert type scale ranging from 1 = "strongly disagree" to 6 = "strongly agree".
Prolonged Grief	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)	Prolonged Grief will be assessed using a slightly adapted version of the Prolonged Grief Disorder Scale (PG-13). The items are rated on a scale from 1 to 5 with higher scores more pronounced symptom severity.
Assessing the extent to which the strategies taught in PM+ are used before and after the study participation with the Reducing Tension Checklist	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)	The outcome is measured with a nine-item scale that was developed to assess the extent to which the participants perceives that they use the specific strategies, which are trained during the study intervention. The items are rated on a scale from 0 to 4. Higher scores represent greater usage of the strategies.
Anger	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.)]	Anger will be assessed using the Dimensions of Anger Reactions Questionnaire (DAR-5). The 5 items are rated on scale from 1 to 5 with higher scores indicating worse symptomatology.
Time and risk preferences	Baseline assessment, 3 month FU assessment (3 months after baseline)	Time and risk preferences are assessed using five questions of the Global Preference Survey (GPS), an experimentally validated survey measure. It consists of one self-assessment question (rated on a scale from 0 to 10 with higher scores indicating a greater preference) and a 4-item series of interdependent binary choices between immediate and delayed financial rewards, a format commonly referred to as a "staircase" procedure. In each of the binary choice question, participants must decide between receiving a payment today or a larger payment in twelve months (time preference) or between a sure choice and a lottery (risk preference).
Facial Expression	Baseline assessment, 3 month FU assessment (3 months after baseline)	After responding to questions about positive / negative past and imagined future experiences, participants are asked to rate the emotionality of the experience they had during the speech on a 10-point scale (1 = not at all distressing, 10 = extremely distressing). Analyses will be conducted to calculate facial actions, acoustic quality, and speech content using the OpenDBM software.
Assessment of Coping Strategies	Baseline assessment, 3 month FU assessment (3 months after baseline)	Participants will also be asked about current life stressors and how they cope with these stressors. Analyses will be conducted to calculate facial actions, acoustic quality, and speech content using the OpenDBM software.
Counterfactual Comparisons	Baseline assessment, 3 month FU assessment (3 months after baseline)	To assess counterfactual comparisons regarding well-being, two items of the Comparison Standards Scale for Well-being (CSS-W) will be used. The two items of the CSS-W ask about frequency of well-being comparisons in the past three weeks on six-point Likert scales (0 = not at all to 5 = very often).

Trial Locations

Locations (1)

Klinik für Konsiliarpsychiatrie und Psychosomatik; 🇨🇭 Zurich, Switzerland