Tracking day-to-day experiences, activity, and biology in residents working on personal recovery
Real-Time Experiences, Physical Activity And Biological Outcomes In Personal Recovery Of Residents With Mental Disorders (EMPOWER-RES): A Non-Randomized Multicentric Clinical Trial
NA · IRCCS Centro San Giovanni di Dio Fatebenefratelli · NCT06914622
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Centro San Giovanni di Dio Fatebenefratelli (other) |
| Locations | 3 sites (Brescia and 2 other locations) |
| Trial ID | NCT06914622 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Brescia and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Severe Mental Disorder, Severe Mental Illness, mental health supported accommodation, personal recovery, severe mental disorder, bio-psychosocial, rehabilitation