Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions - The Turkey Site
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 642
- 试验地点
- 2
- 主要终点
- Psychiatric diagnosis at 6-month follow-up
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Psychiatric diagnosis at 6-month follow-up
时间窗: 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.
次要结局
- Subjective wellbeing(1-week post-intervention; 6-month and 12-month follow-ups)
- Psychiatric diagnosis(1-week post-intervention; 6-month and 12-month follow-ups)
- Symptoms of post-traumatic stress disorder(1-week post-intervention; 6-month and 12-month follow-ups)
- Psychological distress(1-week post-intervention; 6-month and 12-month follow-ups)
- Depressive symptoms(1-week post-intervention; 6-month and 12-month follow-ups)
- Self-defined psychosocial goals(1-week post-intervention; 6-month and 12-month follow-ups)
- Functioning(1-week post-intervention; 6-month and 12-month follow-ups)
- Proportion of participants leaving the study early(12-month follow-up)
- Health-related quality of life(6-month and 12-month follow-ups)
- Cost-effectiveness(6-month and 12-month follow-ups)
研究者
Ceren Acarturk
Principal Investigator
Istanbul Sehir University