RecruitingNot Applicable

Real-time Experiences, Physical Activity and Biological Outcomes in Personal Recovery Residents (EMPOWER-RES)

Italy72 participantsStarted 2026-01-15

Plain-language summary

The project focuses on patients with severe mental disorders (SMD) residing in Italian mental health supported accommodation (SA). Although the goal of SA is to promote personal recovery - that is, living life to the fullest of one's potential - international literature on this topic is scarce, and traditional treatments in the Italian residential system show limitations in adopting such approaches. The research hypothesis is that activating personal recovery pathways could improve the biopsychosocial outcomes of patients, caregivers, and professionals. To test this hypothesis, a non-pharmacological, non-randomized interventional trial will compare two groups: one group of individuals with SMD receiving recovery-oriented treatment, using the Mental Health Recovery Star, and another group of individuals with SMD receiving standard treatment. The Mental Health Recovery Star is a ten-pointed star-shaped tool that represents various life dimensions. Patients, together with their key professional, are expected to negotiate a score for each domain on the five-stage 'Scale of Change,' capturing and monitoring the different phases of the recovery process.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Psychosocial functioning

Timeframe: at baseline and at 6 and 9 months follow-up

Trial details

NCT IDNCT06914622

SponsorIRCCS Centro San Giovanni di Dio Fatebenefratelli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Alessandra Martinelli, MD PhD

+39 030 3501460 amartinelli@fatebenefratelli.eu

View on ClinicalTrials.gov More Severe Mental Disorder trials