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NCT Number: NCT06914622

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

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.

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Key information

Conditions

Severe Mental Disorder Mental Disorders Severe Mental Illness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mental Health Recovery Star (MHRS)

Behavioral

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.

Primary outcomes

  1. 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

  1. Rehabilitation goals

    Time frame: at baseline and at 6-9 months follow-up

    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.

  2. Stress-related parameters

    Time frame: at baseline and at 6-9 months follow-up

    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).

  3. Real-time experiences

    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

    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.

  4. Physical Activity-Related Parameters

    Time frame: for 1 week at baseline and at 6-9 months follow-up

    Changes in physical activity will be assessed using an accelerometer (worn for one week)

  5. Working alliance

    Time frame: at baseline and at 6-9 months follow-up

    The working alliance between patients and mental health professionals will be assessed using the Working Alliance Scale (WAI 41) at BL and FU.

  6. Psychopathology

    Time frame: at baseline and at 6-9 months follow-up

    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.

  7. Psychipathology and fucntioning in residential facility

    Time frame: at baseline and at 6-9 months follow-up

    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).

  8. Needs for care

    Time frame: at baseline and at 6-9 months follow-up

    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).

  9. Functional autonomy in residential facility

    Time frame: at baseline and at 6-9 months follow-up

    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.

  10. Personal recovery -short

    Time frame: at baseline and at 6-9 months follow-up

    Hope, Agency and Opportunity (HAO): A 4-item questionnaire monitoring personal recovery, with higher scores indicating more favorable recovery outcomes.

  11. Personal recovery

    Time frame: at baseline and at 6-9 months follow-up

    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.

  12. Quality of life and exploitation

    Time frame: at baseline and at 6-9 months follow-up

    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.

  13. Perceived functioning/disability

    Time frame: at baseline and at 6-9 months follow-up

    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.

  14. Stigma

    Time frame: at baseline and at 6-9 months follow-up

    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.

  15. Perceived loneliness

    Time frame: at baseline and at 6-9 months follow-up

    UCLA Loneliness Scale: A 20-item scale measuring perceived loneliness, rated on a 4-point Likert scale, with higher scores indicating greater loneliness.

  16. Therapeutic alliance

    Time frame: at baseline and at 6-9 months follow-up

    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.

  17. Service satisfaction

    Time frame: at baseline and at 6-9 months follow-up

    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.

  18. Burnout Assessment Tool (BAT)

    Time frame: at baseline and at 6- 9 months follow-up

    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.

  19. Perceived stress

    Time frame: at baseline and at 6-9 months follow-up

    Perceived Stress Scale (PSS): A 10-item self-report questionnaire measuring perceived stress over the last 30 days.

  20. Job satisfaction

    Time frame: at baseline and at 6-9 months follow-up

    Ad-hoc questionnaire: Evaluates job satisfaction. 11 items. higher scores indicate greater job satisfaction.

  21. Distress

    Time frame: at baseline and at 6-9months follow-up

    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.

  22. Experiences of caregiving

    Time frame: at baseline and at 6-9 months follow-up

    Positive Aspects of Caregiving (PAC): Measures the positive experiences and benefits of caregiving, including feelings of usefulness, appreciation, and meaning in the caregiving relationship.

  23. Circadian rythm- related parameters

    Time frame: one week at baseline and at 6-9 months follow-up

    Changes in circadian rythm will be assessed using an accelerometer

  24. Specific Levels of Functioning Scale (SLOF)

    Time frame: at baseline and at 6 and 9 months follow-up

    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.

  25. Triadic Interaction, aAliance, and Dynamic evaluation (TRIADE)

    Time frame: at baseline and at 6 and 9 months follow-up

    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)

  26. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: at baseline and at 6-9 months follow-up

    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.

  27. Resilience Scale - 14 item (RS-14):

    Time frame: at baseline and at 6 and 9 months follow-up

    Resilience Scale - 14 item (RS-14): Measures personal resilience across 14 items; higher scores indicate greater resilience.

  28. Quality Indicator for Rehabilitative Care - Short Assessment (QuIRC-SA)

    Time frame: once in 6 months from the baseline

  29. WHO Quality of Life-Brief scale (WHOQOL-Brief)

    Time frame: at baseline and at 6 and 9 months follow-up

    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).

  30. Zarit Burden Interview (ZBI)

    Time frame: at baseline and at 6 and 9 months follow-up

    Zarit Burden Interview (ZBI): Measures caregiver burden (29 items, 6 domains, 0-4 Likert scale; higher scores indicate greater burden).

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra Martinelli, MD PhD

CONTACT

[email protected]

+39 030 3501460

Amalia Research Office Manager, Morelli

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Other

Registry information

Official study 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

Acronym: EMPOWER-RES

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 6, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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