Implementation of Self Help Plus in Adult Syrian Refugees in Turkey (RE-DEFINE)

Study Overview
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Brief Summary
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This study evaluates the effectiveness and cost-effectiveness of the SH+ in Arabic speaking people including Syrians under the temporary protection of Republic of Turkey and other Arabic speaking immigrants and asylum seekers with psychological distress in Turkey. Half of participants will receive Self Help Plus (SH+), while the other half will receive enhanced treatment as usual.

Detailed Description
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Background: Since the start of the war in Syria in 2011, more than 5 million Syrians had to take refuge in a safer place and they had chosen neighbouring countries including Turkey, Lebanon, Jordan, Iraq and countries in Africa including Egypt and North Africa. As a consequence of several adversities, refugees are at great risk of developing symptoms of common mental disorders, notably posttraumatic stress disorder (PTSD), depression, anxiety and related somatic health symptoms along with other forms of disabling psychological distress. The World Health Organization (WHO) has developed a new low-intensity 5-session self-help intervention called Self-Help Plus (SH+) in order to manage stress and cope with adversity (Epping-Jordan et al., 2016). SH+ is a brief and trans-diagnostic intervention which may be delivered by trained non-specialists facilitators to people with and without mental disorders. SH+ has been evaluated in RCTs in low and middle income countries. Objectives: To evaluate the effectiveness and cost-effectiveness of the Self Help Plus in Arabic speaking people including Syrians under the temporary protection of Republic of Turkey and other Arabic speaking immigrants and asylum seekers with psychological distress resettled in Turkey, as compared with enhanced treatment as usual (ETAU). The primary outcome is the reduction in the incidence of any mental disorders. Secondary outcomes are mental health symptoms, psychological functioning, well-being, drop-out rates, and economic outcomes. Design: This is a parallel-group randomized controlled trial, in which participants will have an equal probability (1:1) of being randomly allocated to the SH+ intervention or the ETAU. Methodology: Refugees who screen positive at the General Health Questionnaire (≥ 3) and without a formal diagnosis of any psychiatric disorders according to the M.I.N.I. International Neuropsychiatric Interview (M.I.N.I.) will enter the study. After random allocation they will receive the 5- session SH+ or the ETAU. Assessments will be performed by masked members of the research team immediately after intervention, at 6 months (primary outcome), and a 12 months after randomization. Time frame: The recruitment phase will last 12 months. After the screening, eligible participants will be assessed at baseline before randomization, immediately post-intervention, and at 6- and 12-month follow-up. The SH+ intervention delivery will be conducted in around 5 weeks (1 session per week). Expected outcomes: The expected outcomes are a reduction in the incidence of psychiatric diagnoses at 6-month follow-up, and a general improvement in mental health symptoms, psychological functioning, well-being, and economic outcomes at each assessment, in refugees in the SH+ intervention arm, as compared to ETAU.

Official Title
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Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions - The Turkey Site

Conditions
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Stress, Psychological Distress

Intervention / Treatment
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* Behavioral: Self Help Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or above Able to speak and understand Arabic Syrian under temporary protection status Presence of psychological distress, as shown by a score of 3 or more at the 12 item General Health Questionnaire (GHQ-12 ≥ 3) Exclusion Criteria: Presence of any mental disorders according to DSM-V and ICD-10, as shown by a positive M.I.N.I. Acute medical conditions contraindicating study participation, based on clinical judgment of the health care professional with a clinical background who performs the screening Clinical evidence of imminent suicide risk or suicide risk scored as moderate or high (or a positive suicidality behaviour disorder) by the M.I.N.I. (section SUICIDALITY) Clinical evidence that the decision-making capacity is impaired

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RE-DEFINE is a prospective, randomized, parallel-group trial that will follow study participants over a period of 12-months. Syrian refugees with psychological distress, but without a mental disorder according to the MINI International Neuropsychiatric Interview (M.I.N.I.) for DSM-V and ICD-10, will be randomly assigned to the Self Help Plus intervention or to enhanced treatment as usual (ETAU).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self Help Plus<br>SH+ programme has been developed by WHO and collaborators working in the humanitarian field, with expertise in global mental health and psychosocial interventions. SH+ programme consists of a pre-recorded audio course, complemented with bibliotherapy, and thanks to this format not requiring much time from experts for implementation. SH+ consists of 5 sessions. | Behavioral: Self Help Plus<br>* 5-session psychosocial intervention<br>|
| No Intervention: Enhanced Treatment As Usual<br>Control arm participants will receive routine social support and/or care according to ordinary practice and following local regulations. Additionally, they will receive baseline and follow-up assessments according to the study schedule, and information about freely available mental health services, social services and community networks providing support to asylum seekers and refugees, and NGOs' contact details. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric diagnosis at 6-month follow-up | The primary outcome will be the number of participants with a current psychiatric diagnosis 6 at six-month follow-up, as measured by the M.I.N.I. The M.I.N.I. was designed as a brief structured interview for the major psychiatric disorders (i.e., major depressive disorder, suicide behavior disorder, post-traumatic stress disorder, social anxiety disorder, etc.) in DSM-5 and ICD-10. The M.I.N.I. is divided into modules identified by letters, each corresponding to a diagnostic category. At the beginning of each module (except for psychotic disorders module), screening question(s) corresponding to the main criteria of the disorder are presented in a gray box. At the end of each module, diagnostic box(es) permit(s) the health care professional to indicate whether the diagnostic criteria are met. | 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological distress | Psychological distress will be measured through the General Health Questionnaire-12. The questionnaire asks whether the respondent has experienced a particular symptom or behaviour recently. Each item is rated on a four-point Likert scale (less than usual, no more than usual, rather more than usual, or much more than usual); and gives a total score of 36 or 12 based on the GHQ version and on the selected scoring methods. Higher scores indicate higher levels of mental distress. | 1-week post-intervention; 6-month and 12-month follow-ups | 
| Psychiatric diagnosis | Number of participants with a current psychiatric diagnosis as measured by the M.I.N.I. | 1-week post-intervention; 6-month and 12-month follow-ups | 
| Functioning | The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) is a generic assessment instrument assessing health and disability. It is used across all diseases, including mental, neurological and substance use disorders. It is simple to administer and applicable across cultures. WHODAS covers six domains (cognition, mobility, self-care, getting along, life activities, and participation). It assesses difficulties people have across these domains during the last 30 days. Difficulties are scored as none, mild, moderate, severe, or extreme. Higher scores indicate higher levels of disability. In the current study, 12-item interviewer-administered version will be used. Data on socio-demographic information (sex, age, education, marital status and work status) will be collected through questions A1-A5 of the WHODAS 2.0, which will be administered first. | 1-week post-intervention; 6-month and 12-month follow-ups | 
| Depressive symptoms | Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item instrument measuring the presence and severity of depression. Major depression is diagnosed if five or more of the nine depressive symptom criteria have been present at least more than half the days in the past two weeks, and one of the symptoms includes depressed mood or anhedonia. Other types of depression are diagnosed if two, three, or four depressive symptoms have been present at least more than half the days in the past two weeks, and one of the symptoms includes depressed mood or anhedonia. As a severity measure, the PHQ-9 score may range from 0 to 27, since each of the nine items can be scored from 0 (not at all) to 3 (nearly every day). Higher scores indicate worse symptomatology. The PHQ has been validated for a wide range of cultural groups. | 1-week post-intervention; 6-month and 12-month follow-ups | 
| Subjective wellbeing | WHO-5 Wellbeing index. The WHO-5 Wellbeing Index is a 5-item questionnaire measuring current psychological wellbeing and quality of life, rather than psychopathology. Each of the items is rated on a 6-point Likert scale from 0 (= not present) to 5 (= constantly present). Scores are summed up and raw scores range from 0 to 25. Then the raw scores are multiplied by 4 and transformed to 0-100. Higher scores indicate better well-being.The scale has demonstrated sensitivity to change in wellbeing and is available in numerous languages. | 1-week post-intervention; 6-month and 12-month follow-ups | 
| Self-defined psychosocial goals | The Psychological Outcome Profiles instrument (PSYCHLOPS) consists of four questions. It contains three domains: problems (2 questions), function (1 question) and wellbeing (1 question). Participants are asked to give free text responses to the problem and function domains. Responses are scored on an ordinal six-point scale ranging from zero to five, producing a maximum score of 20. Lower scores indicate a better outcome. | 1-week post-intervention; 6-month and 12-month follow-ups | 
| Symptoms of post-traumatic stress disorder | PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It takes approximately 5-10 minutes to complete. The PCL-5 can be scored in different ways: (a) a total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; (b) DSM-5 symptom cluster severity scores can be obtained by summing the scores for the items within a given cluster; (c) a provisional PTSD diagnosis can be made by treating each item rated as 2 = moderately or higher as a symptom endorsed, then following the DSM-5 diagnostic rule which requires at least: 1 B item (questions 1-5), 1 C item (questions 6-7), 2 D items (questions 8-14), 2 E items (questions 15-20). Higher scores indicate worse symptomatology. An adapted version making reference to the past week instead of the past month will be used in the current study for sensitivity reasons. | 1-week post-intervention; 6-month and 12-month follow-ups | 
| Health-related quality of life | The EuroQol-5 Dimension-3 level version (EQ-5D-3L). The EQ-5D-3L is applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys.The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | 6-month and 12-month follow-ups | 
| Cost-effectiveness | The Client Service Receipt Inventory (CSSRI): Client sociodemographic and service receipt inventory. The CSSRI is a research tool developed for collecting information that describes in detail the types and level of services that comprise the care package of each study member. | 6-month and 12-month follow-ups | 
| Proportion of participants leaving the study early | Proportion of people leaving the study prematurely at any times, and reasons for discontinuation. | 12-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distress, post-traumatic stress disorder, prevention, refugees, Self Help Plus, Turkey