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

NARecruitingINTERVENTIONAL
Enrollment

237

Participants

Timeline

Start Date

April 9, 2025

Primary Completion Date

November 30, 2026

Study Completion Date

April 30, 2027

Conditions
Distress, PsychologicalDistress, 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.

Trial Locations (1)

37135

RECRUITING

WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy., Verona

All Listed Sponsors
collaborator

University of Roma La Sapienza

OTHER

lead

Universita di Verona

OTHER