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

Real-Time Experiences, Physical Activity And Biological Outcomes In Personal Recovery Of Residents With Mental Disorders (EMPOWER-RES): A Non-Randomized Multicentric Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Severe Mental Disorder; Severe Mental Illness
• Intervention / Treatment: Behavioral: Mental Health Recovery Star (MHRS)

Detailed Description

Interventional Study Design Primary Purpose Treatment: A personal recovery-oriented intervention is being evaluated for treating people with severe mental disorders living in mental health supported accommodations Study Phase

The project will last three years and will follow these phases:

• Phase 1: Ethical committee approval, development of the assessment manual, and training sessions for professionals. Preparation of entry and exit questionnaires for clinical and biological data collection. Establishing procedures for biological sample preparation, storage, and shipment. Conducting focus groups with patients to develop ESM questions. Setting up digital platforms and acquiring necessary materials and software. (0-8 months)
• Phase 2: Recruitment of patients, professionals, and informal caregivers at participating centers. (7-24 months)
• Phase 3: Clinical assessments and collection of biological and digital data at baseline. (7-24 months)
• Phase 4: Follow-up clinical assessments and collection of biological and digital data after six and nine months. (13-30 months)
• Phase 5: Implementation of a recovery-oriented treatment approach. (7-30 months)
• Phase 6: Supervision meetings to ensure the correct use of assessment tools. (7-30 months)
• Phase 7: Preliminary reports on interim findings, including sample description, correlation between personal recovery data and clinical variables, and initial analysis of biological and digital data. (24-30 months)
• Phase 8: Data analysis and dissemination of results through conferences, workshops, and publications. (24-36 months) Interventional Study Model Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study Model Description A group of residents receiving a personal recovery-oriented treatment (N=36) will be compared to a matched group of residents receiving standard treatment (N=36). Patients in the recovery-oriented treatment group will be those whose assigned professionals have completed specific training on personal recovery.

Patients will be matched based on sex, age range (e.g., 18-25, 26-40, 41-60, 61-70), and diagnostic group according to the DSM-5-TR (schizophrenia spectrum disorders, mood disorders, personality disorders, other). Regardless of the number of patients recruited for each diagnostic category, all patients will be included in the sample, as literature indicates that residing in a specific type of residential facility makes them comparable in terms of functioning and care needs.

Assessments will be conducted at baseline (BL) and at two follow-up time points: six months and nine months (FU).

Number of Arms Two arms. Masking No masking Allocation Nonrandomized: Participants are expressly assigned to intervention groups through a non-random method, such as those whose assigned professionals have completed or not a specific training on personal recovery.

Enrollment 72 participants: 36 for the experimental group and 36 for the control group.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessandra Martinelli, MD PhD; Phone Number: +39 030 3501460; Email: amartinelli@fatebenefratelli.eu
• Study Contact Backup: Name: Amalia Research Office Manager, Morelli; Email: amorelli@fatebenefratelli.eu

Study Locations

• Italy
  • Brescia, Italy
    • Recruiting
    • IRCCS Centro San Giovanni di Dio Fatebenefratelli
    • Contact: Alessandra Martinelli; Phone Number: 030 3501460; Email: amartinelli@fatebenefratelli.eu
  • Milan, Italy
    • Recruiting
    • Centro Sacro Cuore di Gesù, San Colombano al Lambro (MI)
    • Contact: Alessandra Martinelli; Email: amartinelli@fatebenefratelli.eu
    • Contact: Phone Number: 030 3501460
  • Milan, Italy
    • Recruiting
    • Centro Sant'Ambrogio, Cernusco sul Naviglio (MI)
    • Contact: Alessandra Martinelli; Phone Number: 030 3501460; Email: amartinelli@fatebenefratelli.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recovery-oriented treatment; 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); 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.
No Intervention: Standard treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rehabilitation goals	Valutazione delle Attività e Definizione degli Obiettivi (VADO) [Assessment of Activities and Goal Setting]: Includes the Rehabilitation Areas Module (28 items, rated on a 4-point Likert scale), where higher scores indicate higher professional interventions.	at baseline and at 6-9 months follow-up
Stress-related parameters	Biological changes related to stress will be assessed through the collection of saliva samples (for three consecutive days) and blood samples to investigate High-sensitivity CRP, and pro-inflammatory cytokines IL-6, TNF-alpha, IL-1, IL-4, IL-10, hormone panel (Testosterone, E2, FSH, LH, SHBG, P4, PRL), concentration and size of extracellular vesicles (EVs).	at baseline and at 6-9 months follow-up
Real-time experiences	A focus group with the patients will be conducted to collaboratively define the questions for the Experience Sampling Method (ESM) questionnaire about psychopathology, involvement in productive activities, diet, use of social media, and interpersonal relationships. Data will be explored ecologically, in real-time, and longitudinally through a custom-designed app for the project, which will send daily notifications with a brief questionnaire to be developed and administered to patients via mobile app.	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	Changes in physical activity will be assessed using an accelerometer (worn for one week)	for 1 week at baseline and at 6-9 months follow-up
Working alliance	The working alliance between patients and mental health professionals will be assessed using the Working Alliance Scale (WAI 41) at BL and FU.	at baseline and at 6-9 months follow-up
Psychopathology	Brief Psychiatric Rating Scale (BPRS): Evaluates psychopathology severity through 24 items rated on a 7-point Likert scale, covering five symptom categories (depression/anxiety, excitement, positive symptoms, negative symptoms, and cognitive symptoms). Higher scores indicate greater symptom severity.	at baseline and at 6-9 months follow-up
Psychipathology and fucntioning in residential facility	Health of the Nation Outcome Scale - Residential Facility (HoNOS-RF): Measures personal and interpersonal functioning, environment, medical aspects, cognitive problems, and psychiatric symptoms. The 33 items are rated on a 0-4 Likert scale (higher scores indicate greater severity).	at baseline and at 6-9 months follow-up
Needs for care	Camberwell Assessment of Need (CAN): Evaluates needs for care through a 22-item interview for both staff (CAN-S) and patients (CAN-P), rated on a 3-point scale (0 = no problem, 1 = problem managed with intervention, 2 = unmet need).	at baseline and at 6-9 months follow-up
Functional autonomy in residential facility	Monitoring of Pathway of Rehabilitation (MPR): Assesses functional autonomy across 10 skill areas (self-care, living space maintenance, nutrition, orientation/movement, other autonomies, social skills, socio-recreational abilities, occupational skills, health management). Scores range from 0 to 12, with higher scores indicating greater functional autonomy.	at baseline and at 6-9 months follow-up
Personal recovery -short	Hope, Agency and Opportunity (HAO): A 4-item questionnaire monitoring personal recovery, with higher scores indicating more favorable recovery outcomes.	at baseline and at 6-9 months follow-up
Personal recovery	Recovery Assessment Scale - Domains and Stages (RAS-DS): Measures personal recovery through four key areas (hope and optimism, sense of belonging and social support, life goals and future orientation, illness management and coping skills) and five stages reflecting progress in the recovery process.	at baseline and at 6-9 months follow-up
Quality of life and exploitation	Manchester Short Assessment of Quality of Life (MANSA): explores the patient's perception about its living situation and health. Higher scores reflect better quality of life.	at baseline and at 6-9 months follow-up
Perceived functioning/disability	WHO Disability Assessment Schedule (WHODAS 2.0): Evaluates perceived functioning through a 12-item scale rated on a 5-point Likert scale, with higher scores indicating greater disability.	at baseline and at 6-9 months follow-up
Stigma	Discrimination and Stigma Scale - Ultra Short (DISC-US): Measures perceived stigma through an 11-item questionnaire rated on a 4-point Likert scale, where higher scores indicate greater perceived discrimination.	at baseline and at 6-9 months follow-up
Perceived loneliness	UCLA Loneliness Scale: A 20-item scale measuring perceived loneliness, rated on a 4-point Likert scale, with higher scores indicating greater loneliness.	at baseline and at 6-9 months follow-up
Therapeutic alliance	Working Alliance Inventory - Short Form (WAI): Assesses therapeutic alliance using 12 items rated on a 7-point Likert scale, where higher scores indicate a stronger alliance.	at baseline and at 6-9 months follow-up
Service satisfaction	Verona Service Satisfaction Scale - Residential Facilities (VSSS-RF): Measures service satisfaction from the patient's and informal caregiver perspective using a 24-item questionnaire rated on a 5-point Likert scale, covering overall satisfaction, staff competence, intervention effectiveness, information, access, and family involvement.	at baseline and at 6-9 months follow-up
Burnout Assessment Tool (BAT)	Burnout Assessment Tool (BAT): The BAT is a psychometrically valid tool, recently developed and not subject to a paid license, making it more accessible for non-profit multicenter studies.	at baseline and at 6- 9 months follow-up
Perceived stress	Perceived Stress Scale (PSS): A 10-item self-report questionnaire measuring perceived stress over the last 30 days.	at baseline and at 6-9 months follow-up
Job satisfaction	Ad-hoc questionnaire: Evaluates job satisfaction. 11 items. higher scores indicate greater job satisfaction.	at baseline and at 6-9 months follow-up
Distress	Patient Health Questionnaire-4 (PHQ-4): A 4-item screening tool for anxiety and depression symptoms, with higher scores indicating greater distress and functional impairment.	at baseline and at 6-9months follow-up
Experiences of caregiving	Positive Aspects of Caregiving (PAC): Measures the positive experiences and benefits of caregiving, including feelings of usefulness, appreciation, and meaning in the caregiving relationship.	at baseline and at 6-9 months follow-up
Circadian rythm- related parameters	Changes in circadian rythm will be assessed using an accelerometer	one week at baseline and at 6-9 months follow-up
Specific Levels of Functioning Scale (SLOF)	Specific Levels of Functioning Scale (SLOF): Assesses psychosocial functioning. It consists of 43 items rated on a 5-point Likert scale, with total scores ranging from 43 to 215, where higher scores indicate better psychosocial functioning.	at baseline and at 6 and 9 months follow-up
Triadic Interaction, aAliance, and Dynamic evaluation (TRIADE)	Triadic Interaction, aAliance, and Dynamic evaluation (TRIADE): tool for assessing the alliance and reciprocal influence within the triadic care system (25 items, 1-7 likert scale; higher scores indicate stronger influence; validation ongoing)	at baseline and at 6 and 9 months follow-up
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): Assesses cognitive functions through 12 subtests grouped into 5 index scores. Scores below the mean indicate cognitive difficulties or possible impairment.	at baseline and at 6-9 months follow-up
Resilience Scale - 14 item (RS-14):	Resilience Scale - 14 item (RS-14): Measures personal resilience across 14 items; higher scores indicate greater resilience.	at baseline and at 6 and 9 months follow-up
Quality Indicator for Rehabilitative Care - Short Assessment (QuIRC-SA)		once in 6 months from the baseline
WHO Quality of Life-Brief scale (WHOQOL-Brief)	WHO Quality of Life-Brief scale (WHOQOL-Brief): Assesses quality of life (26 items, 4 domains, 5-point Likert scale, range 0-100; higher scores indicate better quality of life).	at baseline and at 6 and 9 months follow-up
Zarit Burden Interview (ZBI)	Zarit Burden Interview (ZBI): Measures caregiver burden (29 items, 6 domains, 0-4 Likert scale; higher scores indicate greater burden).	at baseline and at 6 and 9 months follow-up

Collaborators and Investigators

• Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Investigators: Principal Investigator: Alessandra Martinelli, MD PhD, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: rehabilitation; personal recovery; severe mental disorder; mental health supported accommodation; bio-psychosocial
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 0012699/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: To promote open, transparent, and collaborative science, the raw data from all studies conducted at the IRCCS Fatebenefratelli will be published in publicly accessible repositories, as required by the scientific community and funding bodies, including the Ministry of Health and the European Commission. The raw clinical and biological data related to participants in this research, a non-randomized multicenter non-pharmacological clinical trial, will be published in a form that ensures the protection of participants' privacy in accordance with current regulations. Repositories will be selected that allow access to the information only after authentication of the access request and validation by the study responsible (or a designated representative) of the reasons for the request. The public repository will also be chosen based on the cybersecurity and data protection guarantees it offers.
• IPD Sharing Time Frame: From December 2028 to Dcember 2029

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No