Severe Mental DisorderEMPOWER-RESNCT06914622
Real-time Experiences, Physical Activity and Biological Outcomes in Personal Recovery Residents (EMPOWER-RES)
A study testing Mental Health Recovery Star (MHRS) in people with Severe Mental Disorder and Severe Mental Illness, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 3 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Mental Disorder, Severe Mental Illness
- What is being tested?
- Mental Health Recovery Star (MHRS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Amalia Research Office Manager, Morelli contact
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia
Alessandra Martinelli, 030 3501460, amartinelli@fatebenefratelli.eu
- Recruiting
Centro Sacro Cuore di Gesù, San Colombano al Lambro (MI)
Milan
Alessandra Martinelli, amartinelli@fatebenefratelli.eu
030 3501460
- Recruiting
Centro Sant'Ambrogio, Cernusco sul Naviglio (MI)
Milan
Alessandra Martinelli, 030 3501460, amartinelli@fatebenefratelli.eu
About this study
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
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.
Read the 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.
- Conditions
- Severe Mental Disorder, Severe Mental Illness
- Being tested
- Mental Health Recovery Star (MHRS)
- Keywords
- mental health supported accommodation, personal recovery, severe mental disorder, bio-psychosocial, rehabilitation
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Recovery Star (MHRS)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline and at 6 and 9 months follow-up
Secondary outcomes (30)
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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at baseline and at 6-9 months follow-up
Circadian rythm- related parameters
Changes in circadian rythm will be assessed using an accelerometer
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: at baseline and at 6 and 9 months follow-up
Quality Indicator for Rehabilitative Care - Short Assessment (QuIRC-SA)
Measured: 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).
Measured: 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).
Measured: at baseline and at 6 and 9 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start15 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Martinelli, IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Investigators
- Alessandra Martinelli, MD PhD, Principal investigator, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914622
- Sponsor's protocol ID
- 0012699/25
- Acronym
- EMPOWER-RES
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06914622
- Acronym / sponsor ID
- EMPOWER-RES / 0012699/25
- Conditions
- Severe Mental Disorder, Severe Mental Illness
- Keywords
- mental health supported accommodation, personal recovery, severe mental disorder, bio-psychosocial, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Recovery-oriented treatment | Experimental | Behavioral: Mental Health Recovery Star (MHRS)A group of residents will receive a personal recovery-oriented treatment (N=36) whose key professionals have participated in specific training on personal recovery. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Recovery-oriented treatment |
Primary outcome
Psychosocial functioning
Time frame: 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.
30 secondary outcomes
Rehabilitation goals
Time frame: at baseline and at 6-9 months follow-up
Stress-related parameters
Time frame: at baseline and at 6-9 months follow-up
Real-time experiences
Time frame: 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
Time frame: for 1 week at baseline and at 6-9 months follow-up
Working alliance
Time frame: at baseline and at 6-9 months follow-up
Psychopathology
Time frame: at baseline and at 6-9 months follow-up
Psychipathology and fucntioning in residential facility
Time frame: at baseline and at 6-9 months follow-up
Needs for care
Time frame: at baseline and at 6-9 months follow-up
Functional autonomy in residential facility
Time frame: at baseline and at 6-9 months follow-up
Personal recovery -short
Time frame: at baseline and at 6-9 months follow-up
Personal recovery
Time frame: at baseline and at 6-9 months follow-up
Quality of life and exploitation
Time frame: at baseline and at 6-9 months follow-up
Perceived functioning/disability
Time frame: at baseline and at 6-9 months follow-up
Stigma
Time frame: at baseline and at 6-9 months follow-up
Perceived loneliness
Time frame: at baseline and at 6-9 months follow-up
Therapeutic alliance
Time frame: at baseline and at 6-9 months follow-up
Service satisfaction
Time frame: at baseline and at 6-9 months follow-up
Burnout Assessment Tool (BAT)
Time frame: at baseline and at 6- 9 months follow-up
Perceived stress
Time frame: at baseline and at 6-9 months follow-up
Job satisfaction
Time frame: at baseline and at 6-9 months follow-up
Distress
Time frame: at baseline and at 6-9months follow-up
Experiences of caregiving
Time frame: at baseline and at 6-9 months follow-up
Circadian rythm- related parameters
Time frame: one week at baseline and at 6-9 months follow-up
Specific Levels of Functioning Scale (SLOF)
Time frame: at baseline and at 6 and 9 months follow-up
Triadic Interaction, aAliance, and Dynamic evaluation (TRIADE)
Time frame: at baseline and at 6 and 9 months follow-up
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: at baseline and at 6-9 months follow-up
Resilience Scale - 14 item (RS-14):
Time frame: at baseline and at 6 and 9 months follow-up
Quality Indicator for Rehabilitative Care - Short Assessment (QuIRC-SA)
Time frame: once in 6 months from the baseline
WHO Quality of Life-Brief scale (WHOQOL-Brief)
Time frame: at baseline and at 6 and 9 months follow-up
Zarit Burden Interview (ZBI)
Time frame: at baseline and at 6 and 9 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness
Severe Mental Illness, Hospitalizations Psychiatric
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Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
Schizophenia Disorder, Severe Mental Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amalia Research Office Manager, Morelli contact
Alessandra Martinelli, MD PhD principal investigator
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health Recovery Star (MHRS) in people with Severe Mental Disorder and Severe Mental Illness, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Martinelli, MD PhD (+39 030 3501460, amartinelli@fatebenefratelli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial functioning (time frame: at baseline and at 6 and 9 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.