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

Istanbul Sehir University

Status: Terminated

Conditions: Psychological Distress; Stress

Treatments: Behavioral: Self Help Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT03587896

779255

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 642 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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642 participants in 2 patient groups

Self Help Plus

Experimental group

Description:

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.

Treatment:

Behavioral: Self Help Plus

Enhanced Treatment As Usual

No Intervention group

Description:

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.