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

NCT03587896 | Terminated DMC

• 1 other identifier: 779255
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Psychological Distress

Keywords

distress; post-traumatic stress disorder; prevention; refugees; Self Help Plus; Turkey

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Psychological distress

  1-week post-intervention; 6-month and 12-month follow-ups

• Psychiatric diagnosis

  1-week post-intervention; 6-month and 12-month follow-ups

• Functioning

  1-week post-intervention; 6-month and 12-month follow-ups

• Depressive symptoms

  1-week post-intervention; 6-month and 12-month follow-ups

• Subjective wellbeing

  1-week post-intervention; 6-month and 12-month follow-ups

Study Arms (2)

Self Help Plus

EXPERIMENTAL

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

Enhanced Treatment As Usual

NO INTERVENTION

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.

Interventions

Self Help Plus BEHAVIORAL

5-session psychosocial intervention

Self Help Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Sehir University: lead
• World Health Organization: collaborator
• Universita di Verona: collaborator

Study Sites (1)

Turkish Red Crescent

Mardin, Yenişehir, 47100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 27717271 BACKGROUND

• 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.

  PMID: 31092670 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Zeynep Ceren Acartürk, Assoc. Prof.

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, facilitators, and research staff involved in the screening and baseline assessment will not be blind to the interventions provided during the trial. Outcomes assessors will be kept blind to the study conditions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 16, 2018
• Study Start: September 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)