Clinical trial NCT06914622: Real-time Experiences, Physical Activity and Biological Outcomes in Personal Recovery Residents (EMPOWER-RES)
Official title: Real-Time Experiences, Physical Activity And Biological Outcomes In Personal Recovery Of Residents With Mental Disorders (EMPOWER-RES): A Non-Randomized Multicentric Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Severe Mental Disorder
Severe Mental Illness
Keywords: mental health supported accommodation
personal recovery
severe mental disorder
bio-psychosocial
rehabilitation
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a non-randomized clinical trial. A group of residents receiving personal recovery-oriented treatment (N=30) will be compared to a matched group of residents receiving standard treatment (N=30). Residents in the recovery-oriented treatment group will be those whose key professionals have participated in specific training on personal recovery.

Residents will be matched by gender, age range, and diagnostic group according to the DSM-5-TR . Regardless of the number of residents recruited for each diagnostic category, all residents will be included in the sample since, as described in the literature, their residence in the specific type of SA makes them comparable in terms of functioning and needs of care.

Bio-psychosocial assessments of residents, their key professionals and informal caregivers will be conducted at baseline and at a six-month follow-up.
Primary purpose: TREATMENT

Brief summary: The project focuses on patients with severe mental disorders (SMD) residing in Italian mental health supported accommodation (SAs). Although the goal of SAs 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 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=30) will be compared to a matched group of residents receiving standard treatment (N=30). 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 a six-month follow-up (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 60 participants: 30 for the experimental group and 30 for the control group.

Eligibility 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.

Primary outcomes:
measure: Psychosocial functioning
timeFrame: at baseline and at 6-months follow-up
Secondary outcomes:
measure: Rehabilitation goals
timeFrame: at baseline and at 6-months follow-up
measure: Stress-related parameters
timeFrame: at baseline and at 6-months follow-up
measure: Real-time experiences
timeFrame: at baseline and at 6-months follow-up for 1 week, and partly for 6 months along the experimental or control treatment
measure: Physical Activity-Related Parameters
timeFrame: for 1 week at baseline and at 6-months follow-up
measure: Working alliance
timeFrame: at baseline and at 6-months follow-up
measure: Personal and Social Functioning
timeFrame: at baseline and at 6-months follow-up
measure: Psychopathology
timeFrame: at baseline and at 6-months follow-up
measure: Psychipathology and fucntioning in residential facility
timeFrame: at baseline and at 6-months follow-up
measure: Needs for care
timeFrame: at baseline and at 6-months follow-up
measure: Functional autonomy in residential facility
timeFrame: at baseline and at 6-months follow-up
measure: Personal recovery -short
timeFrame: at baseline and at 6-months follow-up
measure: Personal recovery
timeFrame: at baseline and at 6-months follow-up
measure: Quality of life and exploitation
timeFrame: at baseline and at 6-months follow-up
measure: Perceived functioning/disability
timeFrame: at baseline and at 6-months follow-up
measure: Stigma
timeFrame: at baseline and at 6-months follow-up
measure: Perceived loneliness
timeFrame: at baseline and at 6-months follow-up
measure: Therapeutic alliance
timeFrame: at baseline and at 6-months follow-up
measure: Service satisfaction
timeFrame: at baseline and at 6-months follow-up
measure: Burnout
timeFrame: at baseline and at 6-months follow-up
measure: Perceived stress
timeFrame: at baseline and at 6-months follow-up
measure: Job satisfaction
timeFrame: at baseline and at 6-months follow-up
measure: Distress
timeFrame: at baseline and at 6-months follow-up
measure: Experiences of caregiving
timeFrame: at baseline and at 6-months follow-up
measure: Circadian rythm- related parameters
timeFrame: one week at baseline and at 6-months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
name: Alessandra Martinelli, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: