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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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.
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Italy
RECRUITINGCentro Sacro Cuore di Gesù, San Colombano al Lambro (MI)
Milan, Italy
RECRUITINGCentro Sant'Ambrogio, Cernusco sul Naviglio (MI)
Milan, Italy
RECRUITINGPsychosocial 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.
Time frame: at baseline and at 6 and 9 months follow-up
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.
Time frame: 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).
Time frame: 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.
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
Changes in physical activity will be assessed using an accelerometer (worn for one week)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at baseline and at 6-9 months follow-up
Circadian rythm- related parameters
Changes in circadian rythm will be assessed using an accelerometer
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
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)
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).
Time frame: 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).
Time frame: at baseline and at 6 and 9 months follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.