NCT06914622

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-15
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-04-06
• Last updated: 2025-12-18

Locations

3 sites across 1 country: Italy