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

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Status: Enrolling

Conditions: Severe Mental Illness; Severe Mental Disorder

Treatments: Behavioral: Mental Health Recovery Star (MHRS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06914622

0012699/25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Recovery-oriented treatment

Experimental group

Description:

A group of residents will receive a personal recovery-oriented treatment (N=36) whose key professionals have participated in specific training on personal recovery.

Treatment:

Behavioral: Mental Health Recovery Star (MHRS)

Standard treatment

No Intervention group

Description:

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.