Experimental Design
Recruitment and informed consent
The study will focus on refugees and asylum seekers (RAS) who speak at least one of 12 languages (German, English, French, Arabic, Farsi, Kurdish, Tigrinya, Turkish, Ukrainian, Russian, Tamil and Pashto), covering approximately 80% of individuals with a refugee background in Switzerland (State Secretariat for Migration, 2020). Study participants will be recruited through the implementation project SPIRIT in various local sites in the cantons that agreed to participate in the experimental study BRIGHT. The implementation project SPIRIT offers PM+ as a standard low-intensity mental health service to eligible participants in various local sites in the six asylum regions of Switzerland (State Secretariat for Migration, 2023). The cantons that agreed to participate in the experimental study currently include Schwyz, Thurgau, and Zurich. The recruitment will target RAS who reside in these cantons and are aged 16 or older.
Eligibility to participate in the experimental study will be assessed during an initial screening meeting held in person by a trained assessor who is fluent in the participant’s mother tongue. The screening and all subsequent assessments will rely on a digital platform set up for the project. Eligibility will be based on several inclusion and exclusion criteria (see the supporting document “Eligibility criteria” for a detailed description of the eligibility criteria). The main inclusion criterium is based on the score obtained 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. This study will use a score equal to or greater than 20 as an indication of moderate to high levels of psychological distress. Participants with a K10 score equal to or higher than this cut-off value will be considered eligible to participate. In addition to the K10 score, several exclusion criteria will be assessed in the screening meeting. These include:
- 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, World Health Organization WHO, 2016);
- 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).
The study will rely on two parallel channels to recruit participants. First, interested RAS can register for the initial screening meeting online, by filling out a form on the website of our field partners or on the central landing page of the SPIRIT project website. Second, several field partners will provide contact lists of RAS they are working with. The study coordinators of the field partners will then try to schedule a screening meeting with all persons on the contact lists. The combination of these two approaches is aimed at increasing the representativeness of the study sample by reducing self-selection while allowing all interested RAS to participate in the initial screening.
During the screening meeting, interested RAS will be asked to provide their consent to participation. The informed consent will entail a two-step procedure: a written informed consent form for the screening and baseline assessment, provided at the beginning of the screening meeting; a second informed consent form for taking part in the PM+ program and in follow-up assessments, provided only to eligible participants. At the beginning of the screening session, the assessor will cover the content of the first IC form: they will explain the nature of the study, its purpose, the steps involved, the expected duration, the data confidentiality, the potential risks and benefits and any discomfort it may entail. Each participant is informed that participation in the study is voluntary, that they may withdraw from the study at any time, and that withdrawal of consent will not affect their subsequent medical assistance and treatment. The subjects are informed that they can ask any question during the study and consult with family members, friends, their treating physicians, or other experts before deciding on their participation in the study. Enough time will be given to the subjects to make an informed decision about their participation in this study. Only if participants agree to and sign the IC form will they proceed to the screening and baseline assessment.
With the first consent form, all subjects will be asked to consent to the following (“IC for the screening and baseline assessment”):
1. Participation in the screening and baseline assessments
2. Sharing their external health insurance provider data
3. Linking their survey data and linked insurance provider data with administrative data (data on the asylum process, characteristics of the asylum seekers, population data, AHV contributions, and income) collected by government agencies (State Secretariat for Migration, Federal Statistical Office, Central Compensation Office)
Subjects eligible to receive the intervention will additionally be asked to consent to the following (“IC for the intervention”):
4. Being randomized into the treatment (PM+ now) or control (PM+ later) group
5. Voluntarily participating in the PM+ intervention
6. Being invited to multiple follow-up assessments
Randomization samples and treatment assignment
The study will rely on a randomized phase-in design. All eligible participants who meet the inclusion criteria, do not meet any of the exclusion criteria, and provide consent to participate in the BRIGHT experimental study, will be randomly assigned to one of the two intervention groups:
1. Treatment group (Group A) which receives the augmented PM+ from the beginning: the first PM+ session will be scheduled to take place within two weeks from the baseline assessment.
2. Control group (Group B) which receives the augmented PM+ 12 months later: the first PM+ session will be scheduled to take place approximately 12 months after the baseline assessment.
This experimental design allows for studying the causal effects of the augmented PM+ intervention over the course of 12 months by comparing treated participants with a pure control group. At the same time, all eligible participants will be able to benefit from the intervention, as those assigned to the control group gain access to it after 12 months.
Participants in Group A and Group B will then be randomly assigned to one of the following two groups:
1. Subsample 1 which additionally receives questions on risk and time preferences (global preferences survey) and questions on the practice of PM+ strategies.
2. Subsample 2 which additionally receives questions on self-efficacy and prolonged grief.
Within Subsample 1, respondents from the Treatment (Group A) and Control (Group B) groups will be cross-randomized to receive either the positive or the negative emotional prime before the risk and time preference questions.
Outcome Data Collection
The research team will collect outcome data from surveys and administrative data sources (see supporting documents “Survey questions and schedule” and “Administrative data sources”). The first (screening) survey will be administered before randomization. This first survey will be administered by an assessor fluent in the study language selected by the participant. This survey will serve the purpose of assessing the eligibility of respondents to participate in the study. Randomization of eligible participants who consent to participate in the experimental study takes place at the end of the screening survey and is followed by the baseline assessment.
The baseline assessment is self-administered online while the assessor stays present and remains available to address any questions that may arise as participants complete the questionnaires. The administration of the baseline assessment is conditional on participants not meeting any of the exclusion criteria. Participants with a K10 score below 20 who do not meet any of the exclusion criteria will still receive the baseline assessment but will then no longer be part of the study. Their baseline data, complemented with register data, will be used to conduct additional analyses based on non-experimental causal inference techniques, such as RDD.
Subsequently, follow-up assessments for participants in the two experimental groups will occur according to a pre-specified schedule (3 – 6 – 12 months after the baseline survey) and will be self-administered online as a default. At the end of the screening and baseline meeting, assessors will indicate whether a respondent requires assistance for the follow-up surveys, in which case the surveys will be administered either in person or online with the provision of assistance from an assessor.