Clinical trial NCT03587896: Implementation of Self Help Plus in Adult Syrian Refugees in Turkey (RE-DEFINE)
Official title: Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions - The Turkey Site
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress
Psychological Distress
Keywords: distress
post-traumatic stress disorder
prevention
refugees
Self Help Plus
Turkey
Lead sponsor: Istanbul Sehir University
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Universita di Verona
First posted: 2018-07-16
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychiatric diagnosis at 6-month follow-up
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Psychological distress
timeFrame: 1-week post-intervention; 6-month and 12-month follow-ups
measure: Psychiatric diagnosis
timeFrame: 1-week post-intervention; 6-month and 12-month follow-ups
measure: Functioning
timeFrame: 1-week post-intervention; 6-month and 12-month follow-ups
measure: Depressive symptoms
timeFrame: 1-week post-intervention; 6-month and 12-month follow-ups
measure: Subjective wellbeing
timeFrame: 1-week post-intervention; 6-month and 12-month follow-ups
measure: Self-defined psychosocial goals
timeFrame: 1-week post-intervention; 6-month and 12-month follow-ups
measure: Symptoms of post-traumatic stress disorder
timeFrame: 1-week post-intervention; 6-month and 12-month follow-ups
measure: Health-related quality of life
timeFrame: 6-month and 12-month follow-ups
measure: Cost-effectiveness
timeFrame: 6-month and 12-month follow-ups
measure: Proportion of participants leaving the study early
timeFrame: 12-month follow-up
Other outcomes:
Locations:
city: Mardin
country: Turkey
facility: Turkish Red Crescent
state: Yenişehir
Study officials:
affiliation: Koç University
name: Zeynep Ceren Acartürk, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epping-Jordan JE, Harris R, Brown FL, Carswell K, Foley C, Garcia-Moreno C, Kogan C, van Ommeren M. Self-Help Plus (SH+): a new WHO stress management package. World Psychiatry. 2016 Oct;15(3):295-296. doi: 10.1002/wps.20355. No abstract available.
citation: Purgato M, Carswell K, Acarturk C, Au T, Akbai S, Anttila M, Baumgartner J, Bailey D, Biondi M, Bird M, Churchill R, Eskici S, Hansen LJ, Heron P, Ilkkursun Z, Kilian R, Koesters M, Lantta T, Nose M, Ostuzzi G, Papola D, Popa M, Sijbrandij M, Tarsitani L, Tedeschi F, Turrini G, Uygun E, Valimaki MA, Wancata J, White R, Zanini E, Cuijpers P, Barbui C, Van Ommeren M. Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials. BMJ Open. 2019 May 14;9(5):e030259. doi: 10.1136/bmjopen-2019-030259.