Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 459
- 试验地点
- 2
- 主要终点
- Psychiatric diagnosis at 6-month follow-up
研究概览
简要总结
Background The flow of asylum seekers and refugees moving to European and bordering countries has progressively increased in the last years. This population is exposed to physical and mental challenges before and during displacement, and suffer continuing hardships after arrival in a High-Income Country. As a consequence, asylum seekers and refugees are extremely vulnerable to some common mental health conditions, i.e., post-traumatic stress disorder, anxiety, depression and other forms of disabling psychological distress. The World Health Organization has developed a new 5-session self-help intervention called Self-Help Plus (SH+) for managing stress and coping with adversity. SH+ has been evaluated in RCTs in low- and middle-income countries, however, there is no rigorous evidence on its cost-effectiveness in preventing the onset of mental disorders in HIC.
Objectives To evaluate the effectiveness and cost-effectiveness of the SH+ in asylum seekers and refugees with psychological distress resettled in six sites of five European countries (Italy, Austria, Germany, Finland, and two sites in the UK), 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 multicentre parallel-group randomized controlled trial, in which participants will have an equal probability (1:1) of being randomly allocated to the SH+ or the ETAU.
Methodology Asylum seekers and 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 will enter the study. After random allocation they will receive the SH+ or the ETAU. Assessments will be performed by masked assessors immediately after intervention, at 6 months, 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, post-intervention, and at 6- and 12-month follow-up. The SH+ delivery will be conducted in around 5 weeks.
Expected outcomes 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.
详细描述
Asylum seekers and refugees will be randomized to receive the SH+ intervention or Enhanced Treatment as Usual. The SH+ has been developed by WHO and collaborators working in the humanitarian field, with expertise in global mental health and psychosocial interventions. SH+ consists of a pre-recorded audio course, delivered by facilitators in a group setting and complemented with an illustrated self-help book. SH+ was designed to be relevant for large adversity-affected populations: it is transdiagnostic, easily adaptable to different cultures and languages, and both meaningful and safe for people with and without mental disorders. The format of SH+ is innovative in that it seeks to ensure that key intervention components are delivered as intended without the burden of extensive facilitator training. SH+ programme is based on acceptance and commitment therapy (ACT), a form of cognitive-behavioral therapy, with distinct features. SH+ programme has two components: a pre-recorded course and an illustrated self-help book. Pre-recorded audio material (culturally adapted) is delivered across five 2-hour sessions to groups of up to 30 people. The audio material imparts key information about stress management and guides participants through individual exercises and small group discussions. To augment the audio recordings, an illustrated self-help book reviews all essential content and concepts 19. Written manuals help briefly-trained, non-specialist facilitators to conduct the course using the pre-recorded audio. The SH+ intervention will be delivered by briefly-trained, non-specialist facilitators.
The control intervention will receive Enhanced Treatment as Usual.
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 the target languages: Arabic, and/or Urdu, and/or Dari, and/or English;
- •Asylum seeker or refugee;
- •Presence of psychological distress, as shown by a score of 3 or more at the 12 item General Health Questionnaire (GHQ-12 ≥ 3);
- •Both oral and written informed consent to enter the study.
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.
次要结局
- Proportion of participants leaving the study early(This information will be collecfted at any time.)
- Functioning(Post-intervention; 6-month and 12-month follow-ups)
- Subjective wellbeing(Post-intervention; 6-month and 12-month follow-ups)
- Self-defined psychosocial goals(Post-intervention; 6-month and 12-month follow-ups)
- Cost-effectiveness(6-month and 12-month follow-ups)
- Psychological distress(Post-intervention; 6-month and 12-month follow-ups)
- Psychiatric diagnosis(Post-intervention; 6-month and 12-month follow-ups)
- Depressive symptoms(Post-intervention; 6-month and 12-month follow-ups)
- Symptoms of Post traumatic stress disorder(Post-intervention; 6-month and 12-month follow-ups)
- Health-related quality of life(6-month and 12-month follow-ups)
研究者
Marianna Purgato
Principal Investigator, PhD, Clinical researcher
Universita di Verona