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

NCT07209306 | Recruiting DMC

• 2 other identifiers: 101080323European Commission
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Migrant populations; Psychological distress; Psychological wellbeing; WHO psychological interventions; Effectiveness; Implementation; Self-Help Plus; Doing What Matters in Times of Stress

Outcome Measures

Primary Outcomes (1)

• PHQ-ADS at T2

  The primary endpoint will be the symptoms of depression and anxiety measured with the PHQ-ADS scale administered by a masked trained assessor.

  T2: 3 months after randomization (1 week after the booster session)

Secondary Outcomes (14)

• 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)

Study Arms (3)

Self-Help Plus and booster session

EXPERIMENTAL

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.

Other: Experimental: Self-Help Plus and booster session

Doing What Matters in Times of Stress and booster session

EXPERIMENTAL

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.

Other: Doing What Matters in Times of Stress and booster session

Psychological placebo

PLACEBO COMPARATOR

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.

Other: Psychological Placebo

Interventions

Experimental: Self-Help Plus and booster session OTHER

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.

Self-Help Plus and booster session

Doing What Matters in Times of Stress and booster session OTHER

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.

Doing What Matters in Times of Stress and booster session

Psychological Placebo OTHER

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.

Psychological placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

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, Italy, 37135, Italy

RECRUITING

Study Officials

• Corrado Barbui, MD, Full professor

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianna Purgato, PhD, Associate professor

CONTACT

+390458124884; marianna.purgato@univr.it

Corrado Barbui, MD, Full professor

CONTACT

corrado.barbui@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: October 6, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IT (1)