About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
diagnosis of a mental disorder according to DSM5TR,
receiving treatment at an SRP of the recruiting centers,
over 18 years old, willing to participate
Disqualifiers
moderate/severe intellectual disability,
inability to speak and write in Italian.
over 18 years old,
inability to speak and write in Italian.
Trial design
Parallel
Treatments tested in this trial
Mental Health Recovery Star (MHRS)
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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).
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.
Physical Activity-Related Parameters
Changes in physical activity will be assessed using an accelerometer (worn for one week)
Sponsors and contacts
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