Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

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.

More Mental Disorder trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment72 (estimated)
SponsorIRCCS Centro San Giovanni di Dio Fatebenefratelli
Academic / other
Locations3 sites (Brescia and 2 other locations)
StatusRecruiting
StartedJanuary 15, 2026
Main results expectedDecember 31, 2027
Study endsDecember 31, 2028
Registry record updatedNovember 3, 2026
Trial IDNCT06914622 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.