Real-Time Experiences, Physical Activity And Biological Outcomes In Personal Recovery Of Residents With Mental Disorders (EMPOWER-RES): A Non-Randomized Multicentric Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 72
- Locations
- 3
- Primary Endpoint
- Psychosocial functioning
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The study population will include:
- •Patients with a mental disorder inclusion criteria:
- •diagnosis of a mental disorder according to DSM5TR,
- •receiving treatment at an SRP of the recruiting centers,
- •over 18 years old, willing to participate
Exclusion Criteria
- •moderate/severe intellectual disability,
- •inability to speak and write in Italian.
- •Informal caregivers of patients inclusion criteria:
- •over 18 years old,
- •willing to participate, exclusion criteria:
- •inability to speak and write in Italian.
- •Mental health professionals inclusion criteria:
- •working in SRPs of the recruiting centers as a psychiatrist, educator, nurse, social worker, OSS, ASA, or TeRP,
- •if part of the "personal recovery-oriented treatment" group, having specific training, exclusion criteria:
- •unwillingness to participate.
Arms & Interventions
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.
Intervention: Mental Health Recovery Star (MHRS) (Behavioral)
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.
Outcomes
Primary Outcomes
Psychosocial functioning
Time Frame: at baseline and at 6 and 9 months follow-up
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(at baseline and at 6-9 months follow-up)
- Stress-related parameters(at baseline and at 6-9 months follow-up)
- Real-time experiences(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(for 1 week at baseline and at 6-9 months follow-up)
- Working alliance(at baseline and at 6-9 months follow-up)
- Psychopathology(at baseline and at 6-9 months follow-up)
- Psychipathology and fucntioning in residential facility(at baseline and at 6-9 months follow-up)
- Needs for care(at baseline and at 6-9 months follow-up)
- Functional autonomy in residential facility(at baseline and at 6-9 months follow-up)
- Personal recovery -short(at baseline and at 6-9 months follow-up)
- Personal recovery(at baseline and at 6-9 months follow-up)
- Quality of life and exploitation(at baseline and at 6-9 months follow-up)
- Perceived functioning/disability(at baseline and at 6-9 months follow-up)
- Stigma(at baseline and at 6-9 months follow-up)
- Perceived loneliness(at baseline and at 6-9 months follow-up)
- Therapeutic alliance(at baseline and at 6-9 months follow-up)
- Service satisfaction(at baseline and at 6-9 months follow-up)
- Burnout Assessment Tool (BAT)(at baseline and at 6- 9 months follow-up)
- Perceived stress(at baseline and at 6-9 months follow-up)
- Job satisfaction(at baseline and at 6-9 months follow-up)
- Distress(at baseline and at 6-9months follow-up)
- Experiences of caregiving(at baseline and at 6-9 months follow-up)
- Circadian rythm- related parameters(one week at baseline and at 6-9 months follow-up)
- Specific Levels of Functioning Scale (SLOF)(at baseline and at 6 and 9 months follow-up)
- Triadic Interaction, aAliance, and Dynamic evaluation (TRIADE)(at baseline and at 6 and 9 months follow-up)
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(at baseline and at 6-9 months follow-up)
- Resilience Scale - 14 item (RS-14):(at baseline and at 6 and 9 months follow-up)
- Quality Indicator for Rehabilitative Care - Short Assessment (QuIRC-SA)(once in 6 months from the baseline)
- WHO Quality of Life-Brief scale (WHOQOL-Brief)(at baseline and at 6 and 9 months follow-up)
- Zarit Burden Interview (ZBI)(at baseline and at 6 and 9 months follow-up)
Investigators
Alessandra Martinelli
MD PhD Psychiatrist and clinical researcher
IRCCS Centro San Giovanni di Dio Fatebenefratelli