Schizophrenia spectrum disorders (SSD) Mental and Behavioural Disorders Schizophrenia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All groups: 1. Aged between 20-55 years old 2. Good knowledge of the Italian language G1 and G2: 1. SSD diagnoses according to DSM-5 (APA, 2013) 2. Being a patient living in an RF or an outpatient during recruitment
Exclusion criteria
Exclusion criteria: All groups: 1. Inability to provide informed consent (because of low education, or cognitive impairment) 2. Severe cognitive deficit (MMMSE equal or lower than 24.0) 3. A diagnosis of substance use disorder in the last year according to DSM-5 criteria (APA, 2013) 4. History of clinically significant head injury 5. Cerebrovascular, neurological disease 6. Expected discharge from the RF within 1 month G3b and G3c: 1. Being an RF inpatient or being a DMH’s outpatient during recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective 1: 1. Daily use of time (e.g., use of time spent in different activities) of patients with SSD living in RFs, compared to SSD outpatients and to a large sample of the general population, measured via a daily diary (TUS) for two days over a 7-day period after baseline assessment 2. Time perception measured using Zimbardo Time Perspective (ZTPI) at baseline assessment Objective 2: 1. Quality of staff-patients’ relationships for patients living in RFs, measured with Working Alliance Inventory Short Patient and Therapist versions (WAI-PT and WAI-TP) at baseline assessment 2. Staff well-being measured with General Health Questionnaire (GHQ-12) at baseline assessment 3. Burnout measured with Maslach Burnout Inventory (MBI) at baseline assessment Objective 3: 1. Real-time ESM data (e.g., daily time use, with specifications, such as sleep, work, transportation, hobbies, etc; mood and perceived level of energy) collected via a smartphone app over a 7-day period (8 times a day in semi-random intervals) at least 2 weeks after TUS administration 2. Levels of physical activity in three groups (e.g., RF patients and outpatients with SSD, compared to healthy subjects) assessed via a multi-sensor monitor (actigraphy) over a 7-day period at least 2 weeks after TUS administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective 1: 1. Severity of psychiatric symptoms (in particular negative symptoms) measured using Brief Psychiatric Rating Scale (BPRS); The Brief Negative Symptom Scale (BNSS); Specific Levels of Functioning Scale (SLOF); World Health Organization Quality of Life Brief version (WHOQOL-bref; WHODAS 2.0) at baseline assessment 2. Amount of time spent doing nothing and being sedentary (number of hours) measured via a daily diary (TUS) for two days over a 7-day period after baseline assessment Objective 2: 1. Quality of RFs measured using Quality Indicator for Rehabilitative Care (QuIRC-SA) at baseline assessment 2. Patients' needs and satisfaction assessed using Camberwell Assessment of Need Patient and Staff versions (CAN); Ward Atmosphere Scale (WAS), Verona Service Satisfaction Scale (VSSS) at baseline assessment Objective 3: Comparison of real-time ESM data about daily time use (measured via smartphone app) with retrospective paper-and-pencil assessments (measured with TUS) at least 2 weeks after TUS administration | — |
Countries
Italy