Real-time Experiences, Physical Activity and Biological Outcomes in Personal Recovery Residents (EMPOWER-RES)
NCT ID: NCT06914622
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
72 participants
INTERVENTIONAL
2026-01-15
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* receiving treatment at an SRP of the recruiting centers,
* over 18 years old,
* working in SRPs of the recruiting centers as a psychiatrist, educator, nurse, social worker, OSS, ASA, or TeRP,
Exclusion Criteria
* inability to speak and write in Italian.
* inability to speak and write in Italian.
* unwillingness to participate.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Centro San Giovanni di Dio Fatebenefratelli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alessandra Martinelli
MD PhD Psychiatrist and clinical researcher
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alessandra Martinelli, MD PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, , Italy
Centro Sacro Cuore di Gesù, San Colombano al Lambro (MI)
Milan, , Italy
Centro Sant'Ambrogio, Cernusco sul Naviglio (MI)
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Alessandra Martinelli
Role: primary
Alessandra Martinelli
Role: primary
Role: backup
Alessandra Martinelli
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0012699/25
Identifier Type: -
Identifier Source: org_study_id