Actively Recruiting
Real-Time Experiences, Physical Activity And Biological Outcomes In Personal Recovery Of Residents With Mental Disorders (EMPOWER-RES): A Non-Randomized Multicentric Clinical Trial
Led by IRCCS Centro San Giovanni di Dio Fatebenefratelli · Updated on 2025-12-18
72
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with severe mental disorders living in supported accommodations in Italy. The study aims to compare a personal recovery-oriented treatment approach, which uses the Mental Health Recovery Star tool to help patients set and monitor recovery goals, with standard treatment. This non-randomized trial explores whether focusing on personal recovery can improve the overall well-being of patients, caregivers, and professionals involved in their care. The study will last about three years and includes two groups: one receiving the recovery-oriented treatment and another receiving standard care. The recovery treatment involves a six-month use of the Mental Health Recovery Star, a tool representing life areas such as health and social networks, helping patients and professionals track progress and set goals. Standard treatment includes personalized medical, psychological, and social care aimed at improving symptoms and functioning. The recovery-oriented treatment group’s professionals have received specific training to support this approach. Participants will be assessed at the start of the study and followed up at six and nine months. Data collection includes clinical assessments, biological samples, physical activity monitoring, and digital tools to capture real-time experiences. Researchers will measure psychosocial functioning and multiple related aspects such as rehabilitation goals, stress, quality of life, and caregiver experiences. The study includes supervision meetings and ongoing analysis to ensure the correct use of tools and to report interim and final findings.
CONDITIONS
Brief Title
Real-time Experiences, Physical Activity and Biological Outcomes in Personal Recovery Residents (EMPOWER-RES)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of a mental disorder according to DSM-5-TR
- Receiving treatment at a supported residential program of the recruiting centers
- Age 18 years or older
- Willing to participate
- Informal caregivers must be 18 years or older and willing to participate
- Mental health professionals working in supported residential programs, including psychiatrists, educators, nurses, social workers, OSS, ASA, or TeRP
- Professionals in the recovery-oriented group must have completed specific training on personal recovery
You will not qualify if you...
- Moderate or severe intellectual disability
- Inability to speak and write in Italian
- Mental health professionals unwilling to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants complete clinical assessments and provide biological and digital data before starting the treatment.
1 baseline visit (in-person)
Duration - 6 months
Participants receive either a six-month personal recovery-oriented treatment using the Mental Health Recovery Star (MHRS) or standard residential treatment. The treatment supports personal recovery through goal-setting and shared care plans.
Regular visits throughout 6 months depending on treatment group
Duration - 3 months (from 6 to 9 months post-baseline)
Participants undergo follow-up clinical assessments and data collection at six and nine months after baseline to evaluate treatment outcomes.
2 follow-up visits (in-person) at 6 and 9 months
Trial Site Locations
Total: 3 locations
1
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy
Actively Recruiting
2
Centro Sacro Cuore di Gesù, San Colombano al Lambro (MI)
Milan, Italy
Actively Recruiting
3
Centro Sant'Ambrogio, Cernusco sul Naviglio (MI)
Milan, Italy
Actively Recruiting
Research Team
A
Alessandra Martinelli, MD PhD
A
Amalia Research Office Manager, Morelli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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