Boosting Refugee Integration Through Psychological Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Zurich
About this 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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Problem Management Plus
BehavioralProblem 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 in two ways. First, the participants will receive three 30-45-minutes telephone booster sessions 10, 22, and 34 weeks after the final original PM+ session. The second augmentation strategy involves handouts and homework reminders.
Treatment groups
1,200 Participants
are divided into 3 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: waitlist control groupOther 1 intervention
Group C: observational control groupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline assessment, 3 month FU assessment (3 months after baseline)Secondary 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.
Time frame
6 month FU assessment (6 months after baseline), 12 months FU assessment (12 months after baseline)2
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.
Time frame
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.)3
General psychological distress
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).
Time frame
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)4
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.
Time frame
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.)Other outcomes
1
Use of health care services and medications
Investigators will complement the self-reported survey-based health measures with register data from the major health insurance providers in Switzerland covering the RAS population to explore the use and involved costs of health care services and medications.
Time frame
Two years before (or since arrival in Switzerland if less than two years) to four years after study inclusion2
Impact of asylum process on mental health
To explore the consequences of the length of the asylum process on mental health outcomes (and the potential of PM+ to alleviate them), register information on the length of the asylum process, defined as the days between the submission of the asylum application and the date of the (initial) decision by the State Secretariat of Migration (SEM), will be used.
Time frame
Two years before (or since arrival in Switzerland if less than two years) to four years after study inclusion3
Labour market integration
To assess labour market integration investigators will leverage data from the AHV-insurance to obtain information on participants' employment, considered a sign of successful integration in the labour market. The data indicates periods of employment and levels of earnings for each individual working in Switzerland.
Time frame
Two years before (or since arrival in Switzerland if less than two years) to four years after study inclusion4
Impact of residence status
To assess the impact of residence status, population and household data will be obtained which records movements within Switzerland, individuals' resident status and changes of the latter. They are important factors impacting mental health and integration that need to be included in the analysis.
Time frame
Two years before (or since arrival in Switzerland if less than two years) to four years after study inclusionSponsors and contacts
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Source ClinicalTrials.gov