Tracking day-to-day experiences, activity, and biology in residents working on personal recovery
Official title: Real-Time Experiences, Physical Activity And Biological Outcomes In Personal Recovery Of Residents With Mental Disorders (EMPOWER-RES): A Non-Randomized Multicentric Clinical Trial
Run by IRCCS Centro San Giovanni di Dio Fatebenefratelli · NCT06914622 · Data updated 2026-11-12
This project will test whether a recovery-oriented program using the Mental Health Recovery Star helps adults with severe mental disorders living in supported accommodation improve clinical, biological, and daily-experience outcomes compared with standard care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli Academic / other |
| Locations | 3 sites (Brescia and 2 other locations) |
| Status | Recruiting |
| Started | January 15, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT06914622 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with a DSM-5 diagnosis of a severe mental disorder who live in participating supported accommodation in Italy and can speak and write Italian.
✕Probably not a fit
People with moderate or severe intellectual disability or those unable to communicate in Italian are unlikely to participate or benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a non-pharmacological, non-randomized intervention comparing residents in Italian mental health supported accommodation who receive a recovery-oriented program using the Mental Health Recovery Star with residents receiving standard treatment. Over three years, participants will undergo baseline and follow-up clinical assessments, biological sample collection, and real-time digital monitoring of experiences and activity, with follow-ups at six and nine months. The program includes staff training, supervision meetings, and use of the Recovery Star to guide personalized recovery plans. Data collected will include psychosocial measures, activity metrics, ecological momentary assessments, and selected biological markers.
Why it matters
Potential benefit: If successful, this approach could help residents achieve better personal recovery, daily functioning, and favorable biological indicators.
How similar studies have gone: Recovery-oriented interventions and tools like the Mental Health Recovery Star have shown psychosocial benefits in prior work, but combining real-time digital, activity, and biological outcomes in supported accommodation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
The study population will include: Patients with a mental disorder inclusion criteria: * diagnosis of a mental disorder according to DSM5TR, * receiving treatment at an SRP of the recruiting centers, * over 18 years old, willing to participate exclusion criteria: * moderate/severe intellectual disability, * inability to speak and write in Italian. Informal caregivers of patients inclusion criteria: * over 18 years old, * willing to participate, exclusion criteria: * inability to speak and write in Italian. Mental health professionals inclusion criteria: * working in SRPs of the recruiting centers as a psychiatrist, educator, nurse, social worker, OSS, ASA, or TeRP, * if part of the "personal recovery-oriented treatment" group, having specific training, exclusion criteria: * unwillingness to participate.
Where it's running
-
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy Recruiting -
Centro Sacro Cuore di Gesù, San Colombano al Lambro (MI)
Milan, Italy Recruiting -
Centro Sant'Ambrogio, Cernusco sul Naviglio (MI)
Milan, Italy Recruiting
Study contacts
- Principal investigator: Alessandra Martinelli, MD PhD — IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
- Study coordinator: Alessandra Martinelli, MD PhD
- Email: amartinelli@fatebenefratelli.eu
- Phone: +39 030 3501460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.