Testing the Effectiveness and Implementability of WHO Psychological Intervention Strategies for Improving Mental Health Outcomes in Migrant Populations Resettled in Italy: the ADVANCE Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- PHQ-ADS at T2
研究概览
简要总结
Rationale: Migrant populations face numerous mental health risk factors, including unmet expectations, inadequate support, acculturation challenges, and legal hurdles. These stressors hinder their lives during and after migration. The World Health Organization has developed scalable psychological interventions, including Self Help Plus (SH+) and its online version Doing What Matters in Times of Stress (DWM), which are designed for delivery by non-professional helpers and adaptable to various cultures and mental health issues. While initial randomized controlled trials (RCTs) show these interventions are effective, their medium to long-term efficacy, implementability and scalability have not been thoroughly evaluated.
Objectives: This study aims to examine the efficacy of SH+ and DWM versus a psychological placebo in reducing anxiety and depression symptoms among migrants experiencing elevated psychological distress. Additionally, it seeks to collect implementation outcomes to assess the feasibility and potential for scaling up these interventions.
Study design: We will conduct a hybrid three-arm efficacy-implementation randomized controlled trial.
Study population Adult asylum seekers, refugees or migrants with self-reported elevated psychological distress (K10 >15.9) (n=237).
Intervention : All participants (in the three comparison groups) will receive Psychological First Aid (PFA) and enhanced care as usual (ECAU). In addition to PFA and ECAU, the intervention group 1 will receive SH+ complemented with an online booster session (delivered 4 weeks after SH+), the intervention group 2 will receive DWM complemented with an online booster session (delivered 4 weeks after DWM), and the intervention group 3 will receive psychological placebo (PsychP) complemented with an online session with neutral contents of the same duration of groups 1 and 2 (delivered 4 weeks after PsychP).
Main study parameters/endpoints: Screening for inclusion and exclusion criteria will be interviewer-administered, in-person or through (video) calls. For all participants, online assessments will take place at baseline, at 4/6 weeks after having received DWM (which corresponds to 1 week after the booster session, and 3 months after randomization), and at 6 months after randomization. The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to three-month after randomization, measured through the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS). We expect to detect a Cohen's d effect size of 0.3 in the SH+ and DWM groups at 3 months after randomization. Additional health outcomes include level of anxiety (GAD-7) and depression (PHQ-9), functional impairment (WHODAS), wellbeing (WHO-5), quality of life (EQ-5D-5L), and cost of care (CSRI). Implementation outcomes will be measured with the Adoption of Information, Technology measure, Measure of Disseminability and Levels of Institutionalization tool, adverse events, and WHO fidelity forms. Additional study parameters include demographic data and dropouts.
详细描述
The World Health Organization (WHO) has developed a number of scalable psychological interventions for populations affected by adversity. These include Self Help Plus (SH+) and its online version Doing What Matters in Times of Stress (DWM). A core feature of all WHO scalable interventions is that they can be delivered by non-professional helpers, such as a trained peer, or helper at the workplace, or a psychosocial worker after receiving training (task-shifting). The interventions have been designed to be widely applicable to a variety of mental health conditions, such as depression, anxiety and PTSD, and easily adaptable to different populations, cultures and languages. Additionally, the interventions and their implementation materials are open access and available on the WHO website. SH+ builds on existing innovations in delivery of mental health interventions for vulnerable population groups, and focuses on psychological distress broadly, by teaching stress management skills that might be applied across a range of difficulties. It has been implemented with different populations of asylum seekers and refugees in Europe, Turkey and Northern Uganda. The online version of SH+ is called "Doing What Matters in Times of Stress" (DWM). DWM was originally designed for flexible implementation either in a group or individual format throughout a digital format. In the guided version of DWM, participants also receive support from a trained helper. DWM is based on Acceptance and Commitment therapy (ACT), a modern form of cognitive-behavioral therapy with a strong focus on mindfulness practices and includes exercises which aim to enhance stress reduction and build social support, adaptive coping and resilience. People can use the self-help intervention in their own time. The intervention consists of five weekly sessions which follow the five chapters of the SH+ book (grounding, unhooking, acting on your values, being kind and making room). Participants receive a weekly call from a so-called "helper" to support them accessing the intervention sessions, and to provide guidance in using the skills in everyday life.
The DWM version of SH+ has been tested in three RCTs focused on vulnerable populations (i.e., migrants and people in social adversity) in Europe and in one RCT involving health workers in Spain as part of the RESPOND project, and in a RCT with health workers during the COVID-19 pandemic in Italy.
Although data from RCTs indicate that these intervention strategies are initially effective, their efficacy appears to diminish over the medium to long term. Furthermore, the feasibility and potential for scaling up these interventions have not yet been formally evaluated in implementation studies.
Against this background, the present study aims to examine the efficacy of SH+ and DWM versus psychological placebo in reducing anxiety and depression symptoms in a group of migrants experiencing elevated psychological distress. Additionally, the study seeks to collect implementation outcomes to assess the feasibility and potential for scaling up these interventions.
OBJECTIVES:
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
The primary outcome will be assessed by a trained masked assessor. Secondary outcomes will be self-assessed through validated rating scales. Moreover, the statistical analysis will be masked, i.e., we will use coded groups for the trial statistician for the ITT analysis. Moreover, the trial statistician will not be involved in determining participants' eligibility, in administering the intervention, in measuring the outcomes or in entering data.
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
- •18 years or older
- •Living in Italy temporarily or permanently as a migrant, including asylum seekers, refugees, labor migrants;
- •Having elevated levels of psychological distress (K10 >15.9);
- •Sufficient mastery (written and spoken) of one of the languages the SH+/DWM intervention is being delivered in (i.e., English and/or Italian);
- •Oral and written informed consent before entering the study.
排除标准
- •Planning to permanently move back to their home country before the last follow-up assessment (at six months after randomization);
- •Having acute medical conditions (requiring hospitalization);
- •Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up based on screening tool and clinical judgement;
- •Having a severe mental disorder (e.g., psychotic disorders, substance-dependence) based on clinical judgement;
- •Having severe cognitive impairment based on clinical judgement (e.g., severe intellectual disability or dementia);
- •Currently receiving specialized psychological treatment (e.g., Cognitive Behavioral treatment (CBT), Eye Movement Desensitizing and Reprocessing (EMDR));
- •In case of current psychotropic medication use: being on an unstable dose for at least two months.
研究组 & 干预措施
Self-Help Plus and booster session
SH+ program, composed of 5 sessions, and a booster session.
All participants in the three arms will receive WHO PFA and ECAU, that will include an information flyer about locally available services for migrants.
干预措施: Experimental: Self-Help Plus and booster session (Other)
Doing What Matters in Times of Stress and booster session
DWM and booster session. All participants in the three arms will receive WHO PFA and ECAU, that will include an information flyer about locally available services for migrants.
干预措施: Doing What Matters in Times of Stress and booster session (Other)
Psychological placebo
Psychological placebo will consist of a phone call or online meetings with a helper, of the same duration of the DWM sessions.
Additional session: The additional session of psychological placebo will be provided individually in an online format. It will contain neutral contents and will be facilitated by a helper. It will have the same duration as the booster sessions.
干预措施: Psychological Placebo (Other)
结局指标
主要结局
PHQ-ADS at T2
时间窗: T2: 3 months after randomization (1 week after the booster session)
The primary endpoint will be the symptoms of depression and anxiety measured with the PHQ-ADS scale administered by a masked trained assessor.
次要结局
- Intervention appropriateness measure (IAM) at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- Implementation outcomes at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- Acceptability of intervention measure (AIM) at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- PHQ-ADS at T3(T3: 6 months after randomization (3 months after the booster session))
- PHQ-9 at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- GAD-7 at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- GHQ-12 at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- WHODAS at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- WHO-5 at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- CSRI at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- EQ 5D 5L at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- ISMI at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- Feasibility of intervention measure (FIM) at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
- Drop-outs at T2 and T3(T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session))
研究者
Corrado Barbui
Professor
Universita di Verona