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StressRE-DEFINENCT03587896

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

A study testing Self Help Plus in people with Stress and Psychological Distress, run by Istanbul Sehir University at 1 site in Turkey (Türkiye).

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stress, Psychological Distress
What is being tested?
Self Help Plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
642 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2018to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Turkish Red Crescent

    Mardin, Yenişehir, 47100

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Self Help Plus
Keywords
distress, post-traumatic stress disorder, prevention, refugees, Self Help Plus, Turkey
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self Help PlusBehavioural

    5-session psychosocial intervention

Study groups in NCT03587896
Study groupRoleWhat they receive
Self Help PlusExperimentalSH+ 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.
Receives: Behavioral: Self Help Plus
Enhanced Treatment As UsualNo interventionControl 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6-month follow-up

Secondary outcomes (10)
  1. 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.

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

  2. Psychiatric diagnosis

    Number of participants with a current psychiatric diagnosis as measured by the M.I.N.I.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

    Measured: 6-month and 12-month follow-ups

  9. 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.

    Measured: 6-month and 12-month follow-ups

  10. Proportion of participants leaving the study early

    Proportion of people leaving the study prematurely at any times, and reasons for discontinuation.

    Measured: 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2018
  2. Study start1 Sep 2018
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Why it stopped: 12-month assessment process has been stopped prematurely due to logistic reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
642 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03587896
Sponsor's protocol ID
779255
Acronym
RE-DEFINE
Status last verified
Nov 2020
First submitted
22 Jun 2018
Last updated
6 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27717271
  • 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.

    PubMed 31092670

Questions about this trial

What is this clinical trial studying?

A study testing Self Help Plus in people with Stress and Psychological Distress, run by Istanbul Sehir University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 12-month assessment process has been stopped prematurely due to logistic reasons.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychiatric diagnosis at 6-month follow-up (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03587896, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.

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