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

Istanbul Sehir University642 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

642

Conditions

Stress Psychological Distress

Interventions

Self Help PlusBEHAVIORAL

5-session psychosocial intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Turkish Red Crescent

Mardin, Yenişehir, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: 6-month follow-up

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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