WHO Psychological Interventions for Mental Health Outcomes in Migrants Resettled in Italy: the ADVANCE Trial

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:

Primary objective: The primary aim of this RCT is to evaluate the efficacy and implementability of three intervention strategies:

1. The culturally and contextually adapted WHO intervention programme SH+, delivered in groups of up to 20 people, in person, and complemented with a booster session; 2. The culturally and contextually adapted WHO intervention programme DWM, delivered as a guided online individual intervention, and complemented with a booster session; 3. A psychological placebo condition, administered online individually with the same frequency and dosage of the WHO intervention programmes, and consisting of phone calls or online meetings with a helper.

This evaluation specifically targets the adult migrant population resettled in Italy, focusing on the reduction of psychological distress.

Secondary objective: the secondary objective of this trial is to conduct a comprehensive economic evaluation to assess the economic costs, cost-effectiveness, extended cost-effectiveness, and budget impact of implementing the two aforementioned interventions (SH+ with a booster session and DWM with a booster session) compared to the psychological placebo condition. The cost-effectiveness will relate the costs to the health effects of delivering the two interventions in relation to the psychological placebo condition to determine whether the interventions present a more efficient use of resources. Additionally, the extended cost-effectiveness analysis will relate costs to the non-health effects of the interventions (e.g. improvement of financial health protection measured as reduction in out-of-pocket expenditure for care services) and examines the intervention effects on equity by quantifying how the effects are distributed across different socio-economic groups. The findings of the economic evaluation are expected to inform the decisions on adoption and scaling up of SH+ and DWM for the prevention and promotion of mental health among the migrant population in Italy and similar European countries.

STUDY DESIGN: This is a hybrid efficacy-implementation RCT comparing different implementation strategies of WHO psychosocial interventions against a psychological placebo. The study will compare the SH+ intervention with a booster session, the DWM with a booster session, and psychological placebo. Participants will be adult migrants (\> 18 years) screened for elevated psychological distress (Kessler Psychological Distress Scale \> 15.9) resettled in Italy. Before random allocation, all participants eligible for inclusion will receive Psychological First Aid according to the WHO protocol. Then, participants will be randomly allocated to receive SH+ with a booster session (intervention group 1), DWM with a booster session (Intervention group 2), or psychological placebo with an online additional session (intervention group 3).

All participants will also receive enhanced care as usual (ECAU) consisting of information materials (i.e., flyers) about locally available referral options, and social and legal services for migrant population groups resettled in Italy.

STUDY POPULATION: Population: Participants will be adult migrants (\> 18 years) resettled in Italy. Recruitment will be conducted in Verona and Rome. Participants will be recruited through (a) local organizations, including governmental and non-governmental organizations (NGOs), (b) target social media recruitment (e.g., Facebook, Instagram, TikTok), and word of mouth, (c) other community-based organizations offering legal, social, administrative, psychological, or religious support for this vulnerable group.

Inclusion criteria: Participants will be eligible to participate in the study if they meet the following criteria: * 18 years or older * Living in Italy temporarily or permanently as a migrant, including asylum seekers, refugees, labor migrants ((IOM), 2019); * 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.

Exclusion criteria: Potential participants who meet the inclusion criteria will be excluded from participation in this study if they meet any of the following criteria: * 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.

Sample size calculation: A total number of 237 participants will be included. Based on findings from previous SH+ studies, a Cohen's f effect size of .34 for the time-by-treatment interaction at post-intervention is hypothesized between each active arm (SH+ and DWM) and the psychological placebo arm at 3 months post randomization based on the primary outcome PHQ-ADS. The PHQ-ADS is the combined sum score of depression and anxiety symptoms of the PHQ-9 and GAD-7 respectively and has shown good internal consistency (α = .88 to .92).

The Benjamini-Hochberg correction for multiplicity will be applied. Power calculations for the ANOVA within-between interaction are based on the case of lack of significance of the other intervention, thus a p-value of 0.025 was considered. To guarantee a 90% power for each test, 55 participants per study arm will be required. Finally, to take a 30% attrition into account, 79 participants per arm will be needed, thus a 3-armed RCT with 237 participants will be conducted.

INTERVENTIONS:

Psychological First Aid (PFA) (All participants):

Before randomization, all eligible participants will be offered individual Psychological First Aid (PFA) through a face-to-face or teleconferencing meeting. PFA is a WHO developed support strategy that involves humane, supportive, and practical help for individuals suffering from serious humanitarian crises. PFA does not necessarily involve a discussion of the event(s) that cause the distress but aims particularly at five basic elements that are crucial to promote in the aftermath of crises, i.e., a sense of safety, calm, self- and community efficacy, connectedness, and hope. PFA consists of a (telephone) conversation (approximately 30-45 minutes) that a helper has with a participant. The helper provides non-intruding practical care and support, assesses needs and concerns, helps people to address basic needs (e.g., information), listens to people without pressuring them to talk, comforts people and helps them to feel calm, helps people to connect to information, services and social support, and protects people from further harm.

Enhanced Care-as-usual (ECAU) (All participants):

In addition to PFA, all participants in the three arms will receive Enhanced Care As Usual (ECAU) that will include an information flyer about locally available services for migrants (education, health, social and legal support), and may include community care, social/legal support, and psychoeducation.

Because migrants may have a lack of knowledge of the Italian health care system and therefore may not utilize health care, flyers will be distributed to provide information about the Italian health care system and locally available referral options. For all participants, information on whether they have a general practitioner will be collected, provided consent for this recording is obtained. In case the participant gives approval, name and contact details will be recorded.

Self Help Plus (SH+) (Intervention arm 1):

The SH+ programme, developed by WHO and humanitarian collaborators, is a five-session stress management course. Supervised non-specialist facilitators will deliver it in a group setting in person. SH+ was designed to be relevant for large segments of adversity-affected populations: it is intended to be transdiagnostic, easily adaptable to different cultures and languages and both meaningful and safe for people with and without mental disorders.

Based on Acceptance and Commitment Therapy (ACT), a form of Cognitive-Behavioral Therapy (CBT), SH+ emphasized the concept that ongoing attempts to suppress unwante

• PHQ-ADS at T3 [Time frame: T3: 6 months after randomization (3 months after the booster session)]
• PHQ-9 at T2 and T3 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session)]
• Intervention appropriateness measure (IAM) at T2 and T3 [Time frame: T2: 3 months after randomization (1 week after the booster session) T3: 6 months after randomization (3 months after the booster session)]