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Recruiting Not applicable

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

NCT06914622 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2026-01-15
Last updated
2025-12-18

Condition(s) studied

Severe Mental DisorderSevere Mental Illness

Investigational drug(s) / intervention(s)

Mental Health Recovery Star (MHRS)

Mental Health Recovery Star (MHRS): The personal recovery-oriented treatment is the Mental Health Recovery Star (MHRS), a recovery-oriented tool developed in England to support and monitor personal recovery. It features a 10-point star representing life dimensions grouped into four areas: health, functioning, self-image, and social networks. Residents assess their progress on each point using a "Scale of Change " with five recovery stages, from feeling stuck to self-reliance. After assessment, residents and professionals set recovery goals (up to three at a time) and create a shared care plan. The MHRS shows good psychometric properties, with strong validity, consistency, and ease of use, despite some inter-rater reliability issues. It is best suited for shared rehabilitation plans rather than clinical monitoring. Peer review meetings will be provided. The personal recovery-oriented treatment will last six months and will be considered complete upon follow-up evaluation.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Psychosocial functioning — at baseline and at 6 and 9 months follow-up
    Personal and Social Functioning Scale (FPS): assesses four key domains (socially useful activities, personal and social relationships, self-care and hygiene, and disruptive/aggressive behaviors) with scores ranging from 0 to 100, where higher scores indicate better functioning.

Trial sites (3)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06914622 on ClinicalTrials.gov ↗ ← All trials in Italy