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

NCT06914622 | Recruiting

• 1 other identifier: 0012699/25
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Severe Mental Disorder; Severe Mental Illness

Keywords

mental health supported accommodation; personal recovery; severe mental disorder; bio-psychosocial; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Psychosocial functioning

  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.

  at baseline and at 6 and 9 months follow-up

Secondary Outcomes (30)

• Rehabilitation goals

  at baseline and at 6-9 months follow-up

• Stress-related parameters

  at baseline and at 6-9 months follow-up

• Real-time experiences

  at baseline and at 6-9 months follow-up for 1 week, and partly for 6 months along the experimental or control treatment

• Physical Activity-Related Parameters

  for 1 week at baseline and at 6-9 months follow-up

• Working alliance

  at baseline and at 6-9 months follow-up

Study Arms (2)

Recovery-oriented treatment

EXPERIMENTAL

A group of residents will receive a personal recovery-oriented treatment (N=36) whose key professionals have participated in specific training on personal recovery.

Behavioral: Mental Health Recovery Star (MHRS)

Standard treatment

NO INTERVENTION

A group of residents will receive standard treatment (N=36). Standard residential treatment for individuals with mental disorders includes medical, psychological, and social interventions aimed at improving symptoms, quality of life, and functioning. The approach is personalized based on the individual's diagnosis, symptoms, and community resources. Most SAs offer personalized care plans, designated key professionals, regular individual and group activities, medication management support, and healthy lifestyle promotion. However, few facilities provide continuous psychological, vocational, and social support, adequately addressing patients' real needs.

Interventions

Mental Health Recovery Star (MHRS) BEHAVIORAL

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.

Recovery-oriented treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of a mental disorder according to DSM5TR,
• receiving treatment at an SRP of the recruiting centers,

You may not qualify if:

• moderate/severe intellectual disability,
• inability to speak and write in Italian.
• over 18 years old,
• inability to speak and write in Italian.
• working in SRPs of the recruiting centers as a psychiatrist, educator, nurse, social worker, OSS, ASA, or TeRP,
• unwillingness to participate.

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (3)

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

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Alessandra Martinelli, MD PhD

  IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Martinelli, MD PhD

CONTACT

+39 030 3501460; amartinelli@fatebenefratelli.eu

Amalia Research Office Manager, Morelli

CONTACT

amorelli@fatebenefratelli.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD Psychiatrist and clinical researcher

Model Details: The study design is a non-randomized clinical trial. A group of residents receiving personal recovery-oriented treatment (N=36) will be compared to a matched group of residents receiving standard treatment (N=36). Residents in the recovery-oriented treatment group are those whose key professionals have completed specific training on personal recovery. Residents will be matched by gender, age range, and DSM-5-TR diagnostic group. Regardless of the number of residents recruited in each diagnostic category, all matched residents will be included, as their placement in the same type of supported accommodation ensures comparability in functioning and care needs. Bio-psychosocial assessments of residents, their key professionals, and informal caregivers will be conducted at baseline and at two follow-up time points: six months and nine months.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 6, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From December 2028 to Dcember 2029
• Access Criteria: De-identified clinical and biological data from this non-randomized multicenter trial will be available in secure public repositories to support open science. * Eligibility: Access is granted for research aligned with study objectives, including secondary and meta-analyses. Requests must detail statistical methods, subject to independent review. * Privacy \& Security: Data will comply with protection regulations, stored only in repositories with strong cybersecurity measures. * Access Process: Researchers must submit a formal request and sign a Data Sharing Agreement (DSA) before access is granted. Authentication via the repository's system is required. * Review \& Approval: Requests will be evaluated by the study lead (or representative) based on scientific merit, ethical compliance, and feasibility.

Locations

IT (3)