An observational study in Severe Mental Illness, Schizophrenia and Bipolar Disorder, sponsored by University of the Basque Country (UPV/EHU). Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by University of the Basque Country (UPV/EHU) · Observational
People living with severe mental illness (SMI) experience substantial physical health inequalities, including an increased prevalence of cardiovascular disease, obesity, metabolic disorders, reduced physical fitness, and premature mortality. Physical inactivity, prolonged sedentary behavior, sleep disturbances, and the metabolic effects of psychiatric medications may contribute to these health problems.
The PHASMI study aims to provide a comprehensive assessment of physical health, cardiorespiratory fitness, cardiometabolic risk, physical functioning, lifestyle characteristics, emotional well-being, and health-related quality of life in adults with severe mental illness.
The primary objective is to investigate associations between sociodemographic, clinical, and lifestyle characteristics and cardiorespiratory fitness, assessed through peak oxygen uptake (VO2peak).
PHASMI is an observational, descriptive, cross-sectional study conducted in Álava, Spain. The anticipated sample comprises 275 adults aged 18 to 65 years with a diagnosis of severe mental illness according to DSM-5 criteria established by psychiatry specialists. Participants will be recruited through the Mental Health Network of Álava, including individuals receiving community-based psychiatric care and hospitalized patients.
Participants will undergo a comprehensive health assessment involving cardiopulmonary exercise testing on a treadmill using a modified Bruce protocol, the Modified Shuttle Walk Test, anthropometric measurements, body composition analysis, blood pressure measurements, electrocardiography, laboratory analyses, handgrip strength testing, and standardized assessments of physical functioning.
Physical activity, sedentary behavior, and sleep will be assessed using standardized questionnaires and a wrist-worn ActiGraph GT3X+ accelerometer over eight consecutive days. Emotional well-being and health-related quality of life will be evaluated using validated questionnaires.
The main in-person assessments will be conducted over two consecutive days at the University of the Basque Country and the Psychiatric Hospital of Álava. Written informed consent will be obtained before participation.
No experimental treatment or therapeutic intervention will be assigned. By examining associations between physical fitness, cardiometabolic health, lifestyle characteristics, and psychological well-being, PHASMI seeks to identify potentially modifiable factors associated with poorer physical health and inform future prevention and health promotion strategies for people living with severe mental illness.
BACKGROUND AND SCIENTIFIC RATIONALE
Severe mental illness (SMI) is associated with substantial inequalities in physical health, increased morbidity, and premature mortality compared with the general population. Individuals living with SMI experience a higher prevalence of cardiovascular disease, metabolic disorders, obesity, diabetes mellitus, and other chronic noncommunicable diseases.
Several interconnected factors contribute to these health inequalities, including insufficient physical activity, prolonged sedentary behavior, smoking, socioeconomic disadvantage, psychiatric symptoms, and the metabolic effects of psychotropic medications.
Despite growing recognition of the importance of physical health in psychiatric populations, systematic and comprehensive physical health assessments remain insufficiently integrated into routine mental healthcare.
The PHASMI study has been designed to provide a multidimensional characterization of physical health, cardiometabolic risk, cardiorespiratory fitness, physical functioning, lifestyle characteristics, emotional well-being, and quality of life among adults with severe mental illness.
The study combines objective physiological measurements, laboratory analyses, standardized physical performance tests, wearable activity monitoring, clinical information, and validated questionnaires.
CARDIORESPIRATORY FITNESS AND CARDIOVASCULAR HEALTH
Cardiorespiratory fitness (CRF) reflects the integrated capacity of the cardiovascular, respiratory, and muscular systems to transport and utilize oxygen during sustained physical activity. CRF is an important indicator of overall health and a predictor of cardiovascular morbidity and mortality.
Individuals with severe mental illness frequently demonstrate lower levels of cardiorespiratory fitness than the general population. Reduced fitness may be associated with physical inactivity, sedentary behavior, obesity, psychiatric symptoms, medication-related adverse effects, and limited opportunities to engage in regular physical activity.
Cardiopulmonary exercise testing (CPET) allows direct assessment of aerobic capacity through respiratory gas exchange measurements during progressively increasing exercise intensity. However, CPET requires specialized equipment and trained personnel, potentially limiting its routine implementation in mental healthcare settings.
Field-based assessments, such as the Modified Shuttle Walk Test (MSWT), offer a potentially more accessible approach to evaluating functional exercise capacity.
The PHASMI protocol includes both CPET and MSWT to characterize cardiorespiratory fitness and functional exercise capacity in adults with severe mental illness.
CARDIOMETABOLIC HEALTH AND SYSTEMIC INFLAMMATION
People with severe mental illness have an increased prevalence of cardiovascular risk factors, including hypertension, dyslipidemia, insulin resistance, diabetes mellitus, obesity, and metabolic syndrome.
Alterations in body composition, particularly increased adiposity and reduced skeletal muscle mass, may contribute to metabolic dysfunction and cardiovascular risk.
Low-grade systemic inflammation has also been proposed as a potential mechanism linking severe mental illness with chronic physical health conditions.
PHASMI will evaluate anthropometric characteristics, body composition, blood pressure, biochemical markers, metabolic indicators, and inflammatory parameters.
Cardiovascular risk will be estimated using established prediction tools, including SCORE2, the Framingham risk model, and PRIMROSE, according to their respective applicability criteria.
PHYSICAL ACTIVITY, SEDENTARY BEHAVIOR, AND SLEEP
Physical inactivity and prolonged sedentary behavior are common among people with severe mental illness and may contribute to reduced cardiorespiratory fitness, increased adiposity, cardiometabolic dysfunction, and poorer quality of life.
Sleep disturbances are also frequently reported in psychiatric populations and may interact with cardiovascular health, metabolic regulation, emotional well-being, and daily functioning.
PHASMI will combine objective accelerometry with self-reported questionnaires to characterize physical activity, sedentary behavior, and sleep.
This approach will provide complementary information regarding habitual activity patterns, sleep duration, sleep efficiency, and sedentary time.
MUSCLE STRENGTH, PHYSICAL FUNCTIONING, AND QUALITY OF LIFE
Muscle strength and physical functioning are important components of overall health and functional independence.
Reduced muscle strength and impaired physical performance may contribute to limitations in daily activities and increased vulnerability to chronic disease.
PHASMI will assess muscle strength, functional mobility, and physical performance using standardized tests.
Emotional well-being and health-related quality of life will also be assessed through validated questionnaires.
The integration of physical, psychological, and lifestyle-related variables will allow a comprehensive characterization of the health of adults with severe mental illness.
STUDY HYPOTHESIS
The primary hypothesis is that sociodemographic, clinical, and lifestyle characteristics are associated with cardiorespiratory fitness among adults with severe mental illness.
Specifically, prolonged sedentary behavior, low levels of physical activity, and cardiometabolic comorbidities are hypothesized to be associated with poorer cardiorespiratory fitness and overall physical health.
STUDY OBJECTIVES
7.1. Primary Objective
To investigate associations between sociodemographic, clinical, and lifestyle characteristics and cardiorespiratory fitness in adults with severe mental illness.
7.2. Secondary Objectives
The secondary objectives are:
STUDY DESIGN
PHASMI is a quantitative, nonexperimental, observational, descriptive, cross-sectional study.
Participants will not be randomly assigned to study groups or experimental interventions.
The study will involve comprehensive health assessments performed within a defined evaluation period.
The main in-person assessments will be conducted over two consecutive days, complemented by an eight-day period of objective physical activity and sleep monitoring.
The study is conducted through collaboration between the University of the Basque Country (EHU) and the Psychiatric Hospital of Álava, part of the Mental Health Network of Álava, Osakidetza, Spain.
STUDY POPULATION
The target population consists of adults aged 18 to 65 years with a diagnosis of severe mental illness according to DSM-5 criteria established by psychiatry specialists.
Potential participants will be identified through the Mental Health Network of Álava. Both individuals receiving community-based psychiatric care and hospitalized patients may be considered for participation.
Eligibility will be determined according to the inclusion and exclusion criteria established in the study protocol.
Participation will be voluntary, and written informed consent will be obtained from participants or their legally authorized representatives, as applicable.
The anticipated sample size is 275 participants.
STUDY PROCEDURES
The main assessments will be organized into two sessions conducted on consecutive days. Each session is expected to last approximately 90 minutes.
10.1. Day 1: University of the Basque Country
The first assessment session will take place at the Faculty of Education and Sport of the University of the Basque Country.
The following procedures will be performed:
10.2. Day 2: Psychiatric Hospital of Álava
The second assessment session will take place at the Psychiatric Hospital of Álava.
The following procedures will be performed:
CARDIORESPIRATORY FITNESS ASSESSMENT
11.1. Cardiopulmonary Exercise Testing
Cardiorespiratory fitness will be directly assessed using cardiopulmonary exercise testing performed on a treadmill.
The exercise test will follow a modified Bruce protocol, involving progressive increases in treadmill speed and inclination until peak exercise effort or test termination.
Respiratory gas exchange will be continuously assessed using a calibrated gas analysis system.
Peak oxygen uptake (VO2peak) will be defined as the highest oxygen consumption value obtained at the end of the exercise test and expressed in milliliters per kilogram of body mass per minute (mL/kg/min).
Peak exercise effort will be evaluated using established physiological and subjective criteria, including:
At least two of these criteria will be considered when determining whether peak effort has been achieved.
Electrocardiographic responses will be continuously monitored during the test. Blood pressure will be measured at regular intervals, and perceived exertion will be recorded using the Borg scale.
Additional physiological variables will include heart rate, exercise duration, peak metabolic equivalents, and ventilatory thresholds.
The first and second ventilatory thresholds will be determined using standardized gas exchange methods, including the V-slope method and ventilatory equivalents.
Post-exercise recovery measurements will also be collected.
11.2. Modified Shuttle Walk Test
Functional exercise capacity will be assessed using the Modified Shuttle Walk Test.
Participants will walk back and forth along a 10-meter course at progressively increasing speeds according to standardized external pacing signals.
Measurements will include:
The inclusion of both CPET and MSWT will provide complementary information on directly measured cardiorespiratory fitness and field-based functional exercise capacity.
ANTHROPOMETRIC MEASUREMENTS AND BODY COMPOSITION
Anthropometric measurements will include body mass, height, body mass index, waist circumference, hip circumference, and waist-to-hip ratio.
Body composition will be assessed using bioelectrical impedance analysis.
Measurements will include fat mass, fat-free mass, total body water, body fat percentage, fat-free mass percentage, phase angle, resistance, and reactance.
These measurements will provide information on adiposity, lean body mass, and body composition characteristics.
BLOOD PRESSURE ASSESSMENT
Resting blood pressure will be measured using an automated upper-arm blood pressure monitor.
Systolic and diastolic blood pressure and resting heart rate will be recorded.
Two resting measurements will be obtained according to the study protocol.
Blood pressure will also be monitored during cardiopulmonary exercise testing.
BIOCHEMICAL AND CARDIOMETABOLIC ASSESSMENT
Fasting blood samples will be collected at the Psychiatric Hospital of Álava following an overnight fast.
The protocol specifies a blood sample of approximately 10 mL.
Laboratory analyses will include:
Insulin resistance will be estimated using the homeostatic model assessment for insulin resistance (HOMA-IR), calculated from fasting glucose and insulin concentrations.
These measurements will allow the characterization of metabolic health, lipid metabolism, glycemic regulation, inflammatory status, and selected biochemical indicators.
CARDIOVASCULAR RISK ASSESSMENT
Cardiovascular risk will be estimated using three prediction models, where applicable.
15.1. SCORE2
SCORE2 will be used to estimate the 10-year risk of fatal and nonfatal atherosclerotic cardiovascular events using relevant demographic, clinical, and biochemical variables.
15.2. Framingham Risk Model
The Framingham model will be used to estimate cardiovascular risk based on established risk factors, including age, sex, blood pressure, lipid concentrations, smoking, diabetes, and antihypertensive treatment.
15.3. PRIMROSE
The PRIMROSE model will be used to estimate cardiovascular risk specifically in people with severe mental illness.
This model incorporates conventional cardiovascular risk factors together with psychiatric characteristics and psychotropic medication use.
Each risk model will be applied according to its eligibility criteria and validated age range.
PHYSICAL ACTIVITY, SEDENTARY BEHAVIOR, AND SLEEP
Objective measurements of physical activity, sedentary behavior, and sleep will be obtained using a triaxial accelerometer.
Participants will wear an ActiGraph GT3X+ accelerometer on the nondominant wrist for eight consecutive days, including during sleep, except during water-based activities.
Participants will receive instructions regarding device use and completion of the accompanying activity and sleep diary.
Accelerometer data will be processed using the manufacturer's analysis software.
Physical activity and sedentary behavior variables will include:
Sleep-related variables will include:
Sleep efficiency will be calculated as the percentage of time in bed spent asleep.
Self-reported physical activity and sedentary behavior will also be assessed using the International Physical Activity Questionnaire (IPAQ).
MUSCLE STRENGTH ASSESSMENT
17.1. Handgrip Strength
Upper-body muscle strength will be assessed using handgrip dynamometry.
Participants will perform three maximal handgrip contractions with each hand, with rest intervals between attempts.
The highest recorded value will be used as the measure of maximal handgrip strength and expressed in kilograms.
17.2. Thirty-Second Chair Stand Test
Lower-body functional strength and muscular endurance will be assessed using the 30-second Chair Stand Test.
Participants will be instructed to stand up from and sit down on a chair as many times as possible within 30 seconds without using their arms for assistance.
The total number of completed repetitions will be recorded.
17.3. Five-Repetition Sit-to-Stand Test
Lower-body functional performance will also be assessed using the Five-Repetition Sit-to-Stand Test.
Participants will be instructed to stand up and sit down five times as quickly as possible.
The total time required to complete the test will be recorded in seconds.
PHYSICAL FUNCTIONING
Physical functioning and mobility will be assessed using standardized functional performance tests, including:
These assessments will provide information on functional mobility, physical performance, and disability-related functioning.
EMOTIONAL WELL-BEING AND PSYCHOLOGICAL CHARACTERISTICS
Emotional well-being and psychological characteristics will be assessed using standardized questionnaires.
The study protocol includes:
These instruments will provide information on depressive symptoms, anxiety symptoms, stress, and perceived psychological distress.
HEALTH-RELATED QUALITY OF LIFE
Health-related quality of life will be assessed using:
The SF-36 assesses several dimensions of health-related quality of life, including physical functioning, physical role limitations, bodily pain, general health, vitality, social functioning, emotional role limitations, and mental health.
The WHOQOL-BREF assesses quality of life across physical, psychological, social relationship, and environmental domains.
SOCIODEMOGRAPHIC AND CLINICAL CHARACTERISTICS
Sociodemographic information will include age, sex, educational level, socioeconomic characteristics, marital status, employment status, and living arrangements.
Clinical information will include psychiatric diagnosis, duration of mental illness, medication use, smoking status, diabetes, and relevant medical history.
These variables will be considered when describing the study population and examining associations with cardiorespiratory fitness and other health indicators.
DATA COLLECTION AND MANAGEMENT
Study information will be collected using standardized assessment procedures.
Clinical and research data will be entered into a dedicated research database managed through the Bioaraba Health Research Institute infrastructure.
Participants will be assigned identification codes to protect confidentiality.
Access to identifiable information will be restricted to authorized research personnel.
Data handling will follow applicable European and Spanish data protection regulations, including the General Data Protection Regulation and relevant national legislation.
ETHICAL CONSIDERATIONS
The PHASMI study received a favorable opinion from the Research Ethics Committee of OSI Araba on March 27, 2026 (reference 2025-51).
Participation will be voluntary, and written informed consent will be obtained before study participation.
Participants will be informed about the study objectives, assessment procedures, potential discomforts, confidentiality measures, and their right to withdraw without consequences for their healthcare.
Potential discomforts include venous blood sampling and physical exertion during exercise testing.
Exercise assessments will be performed according to the procedures and safety considerations established in the approved protocol.
PHASMI will provide a comprehensive description of physical health, cardiorespiratory fitness, cardiometabolic risk, physical functioning, lifestyle characteristics, emotional well-being, and quality of life among adults with severe mental illness.
By integrating objective physiological measurements with clinical and self-reported information, the study may help identify patterns of physical health impairment and potentially modifiable factors associated with reduced cardiorespiratory fitness.
The results may contribute to a better understanding of the relationships between physical health, psychiatric characteristics, and lifestyle-related factors.
Furthermore, the findings may inform future research and support the development of comprehensive physical health assessment strategies in mental healthcare settings.
The study may also provide a foundation for future preventive approaches and health promotion initiatives aimed at reducing physical health inequalities among people living with severe mental illness.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 275 is above the median of 220 across 389 observational studies indexed under Mental Disorders.
Browse Mental Disorders studies →University of the Basque Country (UPV/EHU) is the lead sponsor of 39 studies on the registry; 6 are open to participants now.
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The study population will consist of adults aged 18 to 65 years with a diagnosis of severe mental illness (SMI) according to DSM-5 criteria established by psychiatry specialists. Participants will be recruited from the Mental Health Network of Álava, Osakidetza, Spain, including individuals receiving community-based psychiatric care and hospitalized psychiatric patients. Potential participants will be identified and screened by their treating psychiatry specialists to determine whether they meet the study eligibility criteria. Eligible individuals will receive information about the study objectives, procedures, potential risks, and voluntary nature of participation. Written informed consent will be obtained before enrollment. The anticipated sample size is 275 participants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults aged 18 to 65 years with a diagnosis of severe mental illness (SMI), according to DSM-5 criteria established by psychiatry specialists, recruited from the Mental Health Network of Álava, Spain. Participants may be receiving community-based psychiatric care or inpatient treatment. All participants will undergo a comprehensive observational health assessment, including cardiorespiratory fitness, body composition, cardiometabolic health, muscle strength, physical functioning, physical activity, sedentary behavior, sleep, dietary habits, emotional well-being, and health-related quality of life. No experimental treatment will be assigned.
Peak Oxygen Uptake (VO2peak) Assessed by Cardiopulmonary Exercise Testing
Cardiorespiratory fitness will be assessed by peak oxygen uptake (VO2peak), measured during a maximal cardiopulmonary exercise test (CPET) performed on a treadmill using a modified Bruce protocol. Respiratory gas exchange will be continuously measured using a calibrated gas analysis system. VO2peak will be defined as the highest oxygen uptake value obtained at the end of the exercise test and will be expressed in milliliters of oxygen per kilogram of body mass per minute (mL/kg/min). Peak effort will be evaluated using predefined physiological and perceived exertion criteria.
Time frame: Day 1 (single baseline assessment)
Distance Completed in the Modified Shuttle Walk Test
Functional exercise capacity will be assessed using the Modified Shuttle Walk Test (MSWT), performed over a 10-meter course with progressively increasing walking speeds. The outcome will be the total distance completed, expressed in meters (m).
Time frame: Day 2 (single baseline assessment)
Body Mass Index (BMI)
Body mass index will be calculated as body mass in kilograms divided by height in meters squared and expressed in kg/m². Body mass and height will be measured using standardized anthropometric procedures.
Time frame: Day 1 (single baseline assessment)
Body Fat Percentage Assessed by Bioelectrical Impedance
Body fat percentage will be assessed using bioelectrical impedance analysis and expressed as the percentage of total body mass consisting of fat tissue (%).
Time frame: Day 1 (single baseline assessment)
Maximal Handgrip Strength
Upper-body muscle strength will be assessed using a handgrip dynamometer. Participants will perform three maximal contractions with each hand. Strength will be recorded in kilograms (kg).
Time frame: Day 1 (single baseline assessment)
Number of Repetitions in the 30-Second Chair Stand Test
Lower-body functional strength and muscular endurance will be assessed using the 30-second Chair Stand Test. The outcome will be the number of complete sit-to-stand repetitions performed within 30 seconds.
Time frame: Day 2 (single baseline assessment)
Timed Up and Go Test Completion Time
Functional mobility will be assessed using the Timed Up and Go Test. The outcome will be the time required to stand from a chair, walk a standardized distance, turn, return to the chair, and sit down, expressed in seconds.
Time frame: Day 2 (single baseline assessment)
Resting Systolic Blood Pressure
Resting systolic blood pressure will be measured using an automated upper-arm blood pressure monitor and expressed in millimeters of mercury (mmHg). Two measurements will be obtained according to the study protocol.
Time frame: Day 1 (single baseline assessment)
Resting Diastolic Blood Pressure
Resting diastolic blood pressure will be measured using an automated upper-arm blood pressure monitor and expressed in millimeters of mercury (mmHg). Two measurements will be obtained according to the study protocol.
Time frame: Day 1 (single baseline assessment)
Fasting Blood Glucose Concentration
Fasting blood glucose concentration will be determined from a venous blood sample collected after an overnight fast. Results will be expressed in milligrams per deciliter (mg/dL)
Time frame: Day 2 (single baseline assessment)
Total Cholesterol Concentration
Total cholesterol concentration will be determined from a fasting venous blood sample using laboratory biochemical analysis. Results will be expressed in milligrams per deciliter (mg/dL).
Time frame: Day 2 (single baseline assessment)
Daily Physical Activity Duration Assessed by Accelerometry
Habitual physical activity will be objectively assessed using an ActiGraph GT3X+ triaxial accelerometer worn on the nondominant wrist for eight consecutive days. The outcome will be the average daily time spent in physical activity, expressed in minutes per day.
Time frame: Eight consecutive days following device provision
Daily Sedentary Time Assessed by Accelerometry
Sedentary behavior will be objectively assessed using an ActiGraph GT3X+ triaxial accelerometer worn for eight consecutive days. The outcome will be the average daily time spent in sedentary behavior, expressed in minutes per day
Time frame: Eight consecutive days following device provision
Total Sleep Time Assessed by Accelerometry
Sleep duration will be objectively assessed using wrist-worn accelerometry over eight consecutive days. Total sleep time will be estimated using the accelerometer analysis software and expressed in minutes per night.
Time frame: Eight consecutive days following device provision
Depressive Symptom Severity Assessed by the PHQ-9
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The total score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
Time frame: Day 2 (single baseline assessment)
Health-Related Quality of Life Assessed by the SF-36
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire evaluates eight health domains, with domain scores transformed to a 0-100 scale, where higher scores indicate better health-related quality of life.
Time frame: Day 2 (single baseline assessment)
Fat-Free Mass Assessed by Bioelectrical Impedance
Fat-free mass will be assessed using bioelectrical impedance analysis. The amount of body mass excluding fat will be expressed in kilograms (kg).
Time frame: Day 1 (single baseline assessment)
Waist Circumference
Waist circumference will be measured using a nonelastic anthropometric tape according to standardized procedures and expressed in centimeters (cm).
Time frame: Day 1 (single baseline assessment)
Waist-to-Hip Ratio
Waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference. Both measurements will be obtained using standardized anthropometric procedures. The outcome is dimensionless.
Time frame: Day 1 (single baseline assessment)
High-Density Lipoprotein Cholesterol Concentration
High-density lipoprotein cholesterol (HDL-C) concentration will be determined from a fasting venous blood sample using laboratory biochemical analysis. Results will be expressed in milligrams per deciliter (mg/dL).
Time frame: Day 2 (single baseline assessment)
Low-Density Lipoprotein Cholesterol Concentration
Low-density lipoprotein cholesterol (LDL-C) concentration will be determined from a fasting venous blood sample using laboratory biochemical analysis. Results will be expressed in milligrams per deciliter (mg/dL).
Time frame: Day 2 (single baseline assessment)
Fasting Triglyceride Concentration
Triglyceride concentration will be determined from a fasting venous blood sample using laboratory biochemical analysis. Results will be expressed in milligrams per deciliter (mg/dL).
Time frame: Day 2 (single baseline assessment)
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Insulin resistance will be estimated using the homeostatic model assessment of insulin resistance (HOMA-IR). The index will be calculated as fasting insulin (µU/mL) multiplied by fasting glucose (mg/dL), divided by 405. Higher values indicate greater estimated insulin resistance.
Time frame: Day 2 (single baseline assessment)
C-Reactive Protein Concentration
Systemic inflammation will be assessed by measuring C-reactive protein concentration in a fasting venous blood sample. Results will be expressed in the units reported by the clinical laboratory.
Time frame: Day 2 (single baseline assessment)
Estimated 10-Year Cardiovascular Risk Using SCORE2
The Systematic Coronary Risk Evaluation 2 (SCORE2) model will be used to estimate the 10-year probability of fatal and nonfatal atherosclerotic cardiovascular events. The risk estimate will be calculated using relevant demographic, clinical, and biochemical variables and expressed as a percentage (%).
Time frame: Day 2 (baseline assessment, using collected clinical and laboratory data)
Estimated 10-Year Cardiovascular Risk Using the Framingham Risk Score
The Framingham cardiovascular risk model will be used to estimate 10-year cardiovascular risk based on demographic, clinical, and biochemical characteristics. The estimated risk will be expressed as a percentage (%).
Time frame: Day 2 (baseline assessment, using collected clinical and laboratory data)
Estimated 10-Year Cardiovascular Risk Using PRIMROSE
The PRIMROSE cardiovascular risk prediction model will be used to estimate 10-year cardiovascular risk in people with severe mental illness. The model incorporates conventional cardiovascular risk factors and psychiatric characteristics, including psychotropic medication use. The estimated risk will be expressed as a percentage (%).
Time frame: Day 2 (baseline assessment, using collected clinical and laboratory data)
Five-Repetition Sit-to-Stand Test Completion Time
Lower-body functional performance will be assessed using the Five-Repetition Sit-to-Stand Test. Participants will be instructed to stand up from and sit down on a chair five times as quickly as possible. The total completion time will be recorded in seconds (s).
Time frame: Day 2 (single baseline assessment)
Short Physical Performance Battery Total Score
Physical performance will be assessed using the Short Physical Performance Battery (SPPB), which includes standing balance, usual gait speed over four meters, and repeated chair stands. The total score ranges from 0 to 12 points, with higher scores indicating better physical performance.
Time frame: Day 2 (single baseline assessment)
Disability Assessed by the WHO Disability Assessment Schedule 2.0
Disability and functional limitations will be assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The questionnaire evaluates cognition, mobility, self-care, getting along with others, life activities, and participation. Domain and total scores will be calculated according to the selected questionnaire version and scoring procedure, with higher scores indicating greater disability.
Time frame: Day 2 (single baseline assessment)
Self-Reported Physical Activity Assessed by the IPAQ
Self-reported physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ). Walking, moderate-intensity activity, and vigorous-intensity activity will be recorded. Physical activity volume will be calculated in metabolic equivalent minutes per week (MET-min/week) according to the questionnaire scoring guidelines.
Time frame: Day 2 (single baseline questionnaire assessment)
Sleep Efficiency Assessed by Accelerometry
Sleep efficiency will be objectively assessed using wrist-worn ActiGraph GT3X+ accelerometry over eight consecutive days. Sleep efficiency will be calculated as total sleep time divided by total time in bed, multiplied by 100, and expressed as a percentage (%).
Time frame: Eight consecutive days following device provision
Wake After Sleep Onset Assessed by Accelerometry
Sleep fragmentation will be characterized using wrist-worn accelerometry. Wake after sleep onset will be derived from the accelerometer-based sleep analysis and reported according to the scoring procedure specified in the study protocol.
Time frame: Eight consecutive days following device provision
Anxiety Symptom Severity Assessed by the GAD-7
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. The total score ranges from 0 to 21 points, with higher scores indicating greater anxiety symptom severity.
Time frame: Day 2 (single baseline assessment)
Depression, Anxiety, and Stress Assessed by the DASS-21
Depression, anxiety, and stress symptoms will be assessed using the 21-item Depression Anxiety Stress Scales (DASS-21). Three seven-item subscales will provide separate depression, anxiety, and stress scores. Higher scores indicate greater symptom severity. Scores will be calculated according to the validated scoring procedure.
Time frame: Day 2 (single baseline assessment)
Perceived Stress Assessed by the Perceived Stress Scale
Perceived psychological stress will be assessed using the Spanish validated version of the Perceived Stress Scale (PSS). The questionnaire evaluates the extent to which situations in daily life have been perceived as stressful during the preceding month. A total score will be calculated according to the version administered, with higher scores indicating greater perceived stress.
Time frame: Day 2 (single baseline assessment)
Quality of Life Assessed by the WHOQOL-BREF
Quality of life will be assessed using the 26-item World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire. Four domain scores will be calculated: physical health, psychological health, social relationships, and environment. Higher domain scores indicate better perceived quality of life. Scores will be calculated according to the validated scoring procedure.
Time frame: Day 2 (single baseline assessment)
Plan to share: No — Individual participant data will not be routinely shared, as no formal data-sharing plan has been established. The study involves sensitive clinical and mental health information, and participant confidentiality and data protection must be ensured. Any future requests for research collaboration or data sharing will be considered on a case-by-case basis, subject to applicable data protection regulations, ethical requirements, and institutional approvals.
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Started Apr 2026 (actual). Primary completion is estimated for Dec 2029, 44 months after the start.
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University of the Basque Country (UPV/EHU)