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

Summary

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.

Conditions

• Distress, Psychological
• Distress, Emotional

Interventions

OTHER

Experimental: Self-Help Plus and booster session

The SH+ programme, developed by WHO is a five-session stress management course. Supervised non-specialist facilitators will deliver it in a group setting in person. SH+ is intended to be transdiagnostic, easily adaptable to different cultures and languages and both meaningful and safe for people with and without mental disorders. Booster session: The booster session of SH+ will be provided individually to participants in an online format. It will last approximately 45 minutes, and it will contain a summary of the main contents of the five sessions. The booster session has been developed according to WHO manuals and will be delivered by a trained facilitator. All participants in the three arms will receive 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, etc.

OTHER

Doing What Matters in Times of Stress and booster session

Arm Description: The DWM program has been developed by WHO as a stress management guide for coping with adversity. DWM contains the same content as the SH+ illustrated guide, training the five basic stress management skills with standalone audio. Additionally, participants are guided by a briefly trained helper. In this study, the DWM program will be delivered individually as an online guided intervention. The DWM intervention has been adapted for use on a smartphone or other device with internet access. In the online application tool, a new module (i.e., section) is released every week so participants will be asked to go through the entire DWM intervention within five weeks, with guidance from a helper through brief we brief weekly phone or text-based contacts of approximately 15 minutes. Booster session: The booster session will be provided online individually. It has been developed according to the WHO manual, and it contains a summary of the main contents of the online sessions.

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. In the first part of the call participants will be reminded about locally available social, health, legal and education services. In the second part of the call participants will choose a discussion topic from topics presented in a list prepared by the research team . 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.

Sponsors & Collaborators

• University of Roma La Sapienza

  collaborator OTHER

• Universita di Verona

  lead OTHER

Principal Investigators

• Corrado Barbui, MD, Full professor · Universita di Verona

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-09

Primary Completion

2026-11-30

Completion

2027-04-30

Countries

• Italy

Study Locations