The main objective of this study is to evaluate the (cost)effectiveness of the culturally adapted version of Group PM+ in adult Syrian refugees with elevated levels of psychological distress in Turkey.
Design and setting
This study is a two-arm, single-blind RCT comparing Group PM+/E-CAU with E-CAU in 380 study participants (see the flowchart in Fig. 1). It will be conducted in collaboration with the partner non-governmental organization RASASA (Refugee and Asylum Seekers Assistance and Solidarity Association) in the Sultanbeyli District of Istanbul. The Sultanbeyli District is an economically deprived area with more than 23,000 Syrians residing in overcrowded conditions in rented apartment blocks with high levels of poverty and unemployment . RASASA works for the protection of refugees and provides them with psychosocial support and legal assistance. Methods of recruitment include the distribution of various advertisements and documents such as brochures and short movies in addition to social media. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 1). Figure 1 shows the study flowchart, and Fig. 2 shows the SPIRIT figure.
Participant inclusion criteria
Participants must be adult (18 years or above) Syrians under temporary protection who are Arabic-speaking and residing in Turkey. The inclusion criteria include the following: (1) scoring greater than 16 on the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) for health and disability and (2) scoring greater than 15 on the Kessler-10 Psychological Distress Scale for psychological distress [25, 26].
Participant exclusion criteria
Participants will be excluded if they (1) present with an acute medical condition, (2) have an imminent risk of suicide, (3) have a severe mental disorder (e.g., psychotic disorders or substance dependence) or (4) show severe cognitive impairment (e.g., severe intellectual disability or dementia). Participants excluded from the study will be referred for appropriate treatment and support. Participants found to be eligible will be informed about their eligibility and will be invited to complete a baseline assessment before randomization (−T1).
Participants will be invited by the community RASASA for screening. Participants who attend the screening interview will be informed about the study and provided with an informed consent (IC) form which includes the right to withdraw. Participants will be informed about the use of their data and the possibility of sharing relevant data with others for research purposes. Biological specimens will not be collected in this trial. Written or witnessed oral consent (for illiterate participants) will be required before completing screening and baseline assessments.
Sample size and power calculations
The Vrije University (VU) University Medical Centre Department of Epidemiology and Biostatistics carried out the power calculations for this study. Considering previous studies with PM+ in Peshawar, Pakistan, and Nairobi, Kenya, we aim for a conservatively estimated small to medium Cohen’s d effect size of 0.4 in the PM+ group at the 3-month follow-up [13, 15]. Power calculations suggest a minimum sample size of 133 participants per group (power = 0.90, a = 0.05, two-sided). Considering an expected 30% attrition at the 3-month follow-up, we aim to include a total number of 380 participants (190 in the Group PM+/E-CAU group and 190 in the E-CAU group).
After baseline assessment, participants will be randomly assigned on a 1:1 basis to either Group PM+/E-CAU (n = 190) or E-CAU (n = 190) (T0). Randomization using computerized software will be carried out by an independent researcher who is not involved in the intervention delivery, clinical supervision, assessments or other aspects of the study.
There is a chance that participants of the study will be recruited from the same household, creating a risk for contamination (if family members were to be allocated to receive different treatments, namely either Group PM+ or E-CAU). To limit the likelihood of contamination, participants from the same household will be assigned to the same intervention arm.
PM+ is a brief, trans-diagnostic psychological intervention based on cognitive behavioural therapy techniques and developed by the WHO [12, 27]. It consists of five sessions delivered in five consecutive weeks and aims to reduce symptoms of depression, anxiety, PTSD and related conditions. Groups are separated by gender, and gender-matched facilitators will lead groups consisting of six to eight participants (T1). Sessions include evidence-based strategies of stress management, problem-solving, behavioural activation and strengthening social support. PM+ is designed to be delivered by non-specialist helpers who receive an 8-day training in PM+. These Arabic-speaking non-specialist helpers, who are called facilitators, are supervised by psychologists and psychiatrists who have participated in the PM+ training-of-trainers program. Supervision consists of weekly, face-to-face group supervision and individual supervision when needed.
Enhanced usual care
Syrians in Turkey have free access to mental health services in public hospitals and migrant health centres . However, owing to numerous barriers such as lack of knowledge of available mental health services or (self)stigma, the use of mental health services is low among Syrian refugees [29, 30]. Usual care will be enhanced by providing study participants with a leaflet on publicly available mental health services in the area where they live. Implementing Group PM+ or E-CAU will not require alteration to usual care pathways (including use of any medication) and these will continue for both trial arms.
All instruments will be administered by trained research staff blind to the allocation status of the participants at post-assessment (1 week after the fifth PM+ session) (T1), 3 months after the baseline (T2) and 12 months after baseline (T3).
Primary outcome measure
The primary outcome measure of this study is the Hopkins Symptom Checklist (HSCL-25). This assesses anxiety and depression symptom levels at 3-month follow-up assessment . It has 25 items, namely two sub-scales for depression (13 items) and anxiety symptoms (10 items) and two items related to somatic symptoms. These items are scored on a 4-point Likert scale.
Secondary outcome measures
The secondary outcome measures are (1) the PTSD Checklist for DSM-5 (PCL-5) to assess the severity of post-traumatic stress reactions, (2) Psychological Outcomes Profiles (PSYCHLOPS) to assess self-identified problems, (3) the Client Service Receipt Inventory (CSRI) to assess health service utilization and productivity impacts, and (4) WHODAS, which is also part of the screening and which assesses functional disability [32, 33]. In addition, perceived access to health services will be measured (see Fig. 2). The PCL-5 has 20 items scored on a 0–4 scale, adding up to a total severity score of 80, and higher scores indicate higher levels of symptomatology. PSYCHLOPS consists of four questions on three domains: problems (two questions), function (one question) and wellbeing (one question). Problem and function questions are asked in the form of free texts, and the responses are scored on an ordinal 6-point scale, producing a maximum score of 20. The CSRI includes questions about resource use for health and social care services, informal care, and productivity as a result of functionality in people with mental disorders. The CSRI has been adapted for Syrians in Turkey to match Turkish health-care services that are available to Syrians. Relevant unit costs will be attached to service utilisation to estimate changes in use of health services and health-care costs, while Turkish minimum wage rates will be used to conservatively estimate changes in costs associated with both informal family care and lost productivity by the patient from work.
A self-constructed questionnaire will be used to assess lifetime trauma exposure. This questionnaire includes items from the Harvard Trauma Questionnaire (HTQ) and the Post-traumatic Diagnostic Scale (PDS) and asks questions on specific traumatic experiences of Syrian refugees. It has 28 items scored as 0 (no) or 1 (yes), and the total score ranges from 0 to 28 [34, 35].
The Post-Migration Living Difficulties Checklist (PMLDC) will be used to assess post-migration stressors. The PMLDC has 17 items scored on a 5-point scale, ranging from 0 to 4 (0 = not a problem and 4 = very serious problem) (range 0–68). Items scored at least 2 (a moderately serious problem) are considered positive responses [36, 37].
If the validated Arabic version of the included measures is available, they will be selected and tested through cognitive interviews with Arabic-speaking adult Syrians. If the validated Arabic version of the measures is not available, these measures will be translated and back-translated in accordance with the WHO guidelines .
All randomly assigned participants, including those who discontinue, will be invited to all outcome assessments. In case participants do not attend a scheduled outcome assessment, they will be called a maximum of five times (on different days) to schedule a new appointment.
We will explore the feasibility, challenges and success of the intervention through semi-structured interviews with facilitators, PM+ participants, policy makers and health professionals. From each category, five participants will be included. Interviews will take between 30 and 60 min and will start after ICs are obtained from the participants. Moreover, PM+ dose (i.e., number of sessions completed), treatment fidelity and quality will be assessed. Participant adherence to the intervention will be monitored by recording their attendance to sessions. Attendance to fewer than three sessions will be counted as dropout. Facilitators will be allowed to deliver PM+ sessions with participants after training and a competency assessment. Facilitators receive weekly supervision to ensure that intervention content is adhered to. Moreover, facilitators will be asked to complete a structured checklist on the Group PM+ components immediately after completion of each session. Trained staff members will be present during 10% of the PM+ sessions and will score treatment fidelity by using a checklist of the required PM+ elements .
We will promote participant retention by sending text messages to participants to remind them of their appointments. We will also regularly update phone numbers and other contact information of participants. Moreover, we offer weekend and evening hours for group sessions and outcome assessments and provide a child-friendly place for children. This may facilitate treatment access and may have a positive impact on participant retention. Participants who come to group sessions and outcome assessments will be reimbursed for travel.
All data will be handled confidentially by the data monitoring committee, which consists of two researchers from Istanbul Sehir University (ISU). Quantitative data will be collected either through pen-and-paper format or through tablets. The quantitative data and the identifying key (a list connecting names to numbers) will be kept in a separate and secure locked location at the Trauma Research Lab at ISU. The data will be entered into a data-analytic computer program without the identifying key.
Qualitative interviews will be saved separately from the participants’ identifiers and will be transcribed and safely stored at the Trauma Research Lab at ISU. There will be no audio data since the Immigration Authority of Turkey does not give permission to make audio recordings in research studies with Syrian refugees (see ‘Ethics approval and consent to participate’ section).