Prader-Willi SyndromePROPSICOPWSNCT06295315
Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome
An observational study of Prader-Willi Syndrome, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Prader-Willi Syndrome
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2023to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects with a genetic diagnosis of PWS, hospitalized at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo-Verbania (Italy) for a 3-week body weight reduction program
Inclusion Criteria: subjects with a genetic diagnosis of PWS capable of understanding the questionnaires
Exclusion Criteria: subjects with a genetic diagnosis of PWS with cognitive problems (evaluated throughout the Mini-Mental State Examination)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Auxologico Italiano IRCCS, site Piancavallo
Oggebbio, Verbania, 28824
About this study
The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated.
Read the detailed description
The observational study will be carried out at the U.O. of Auxology, Istituto Auxologico Italiano, IRCCS, Piancavallo.
36 subjects with a genetic diagnosis of PWS, of both sexes and aged between 18 and 55, and their caregivers will be taken into consideration.
In subjects affected by PWS, the following variables will be investigated:
- anthropometric parameters (height, weight, BMI, waist circumference);
- socio-demographic conditions (gender, age, origin, level of education, family composition)
- concomitant hormonal and psychiatric therapies
- intellectual profile through the Mini-Mental State Examination (MMSE), a neuropsychological test consisting of 30 items that refer to the following cognitive areas: orientation in time, orientation in space, word recording, attention and calculation, recall, language, constructional praxis.
- psychological well-being through the Psychological General Well-Being Index (PGWBI), a questionnaire made up of 22 items that measure the following dimensions: anxiety, depression, positivity and well-being, self-control, general state of health, and vitality.
- perception of life quality through the 36-Item Short Form Survey (SF-36), a questionnaire composed of 36 items that investigates the perception of quality of life in relation to: physical functioning, limitations due to physical health, limitations due to emotions, energy and fatigue, emotional well-being, social activities, pain, general health perception
- mental distress through the Symptom Checklist-90-R (SCL-90-R), a questionnaire made up of 90 items capable of investigating the presence and severity of symptoms of mental distress related to nine psychopathological dimensions: somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, anger-hostility, phobic anxiety, paranoid ideation, psychoticism.
The following variables will be investigated in the parents or caregivers of subjects with PWS:
- psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21), a questionnaire composed of 21 items aimed at investigating experiences of anxiety, depression, and stress
- psychological well-being through the Psychological General Well-Being Index (PGWBI), a questionnaire made up of 22 items that measure the following dimensions: anxiety, depression, positivity and well-being, self-control, general state of health, and vitality.
- coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version). It is a questionnaire made up of 60 items aimed at investigating how often the subject implements - in difficult or stressful situations - different coping strategies to deal with stressful daily situations.
- hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ), a questionnaire to be administered to parents or caregivers of reference consisting of 11 items capable of investigating the hyperphagia of subjects affected by PWS.
- Conditions
- Prader-Willi Syndrome
- Keywords
- Prader-Willy syndrome, Psychological well-being, Quality of life, Psychological distress
- Medical subject headings
- Prader-Willi Syndrome, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological well-being through the Psychological General Well-Being Index (PGWBI)
A neuropsychological test consisting of 30 items that refer to the following cognitive areas: orientation in time, orientation in space, word recording, attention and calculation, recall, language, constructional praxis.
Measured: Baseline
Perception of life quality through the 36-Item Short Form Survey (SF-36)
A questionnaire composed of 36 items that investigates the perception of quality of life in relation to: physical functioning, limitations due to physical health, limitations due to emotions, energy and fatigue, emotional well-being, social activities, pain, general health perception
Measured: Baseline
Mental distress through the Symptom Checklist-90-R (SCL-90-R)
A questionnaire made up of 90 items capable of investigating the presence and severity of symptoms of mental distress related to nine psychopathological dimensions: somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, anger-hostility, phobic anxiety, paranoid ideation, psychoticism.
Measured: Baseline
Secondary outcomes (3)
Psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21)
A questionnaire composed of 21 items aimed at investigating experiences of anxiety, depression, and stress
Measured: Baseline (investigated in the parents or caregivers of subjects with PWS)
Coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version).
A questionnaire made up of 60 items aimed at investigating how often the subject implements - in difficult or stressful situations - different coping strategies to deal with stressful daily situations.
Measured: Baseline (investigated in the parents or caregivers of subjects with PWS)
Hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ)
A questionnaire to be administered to parents or caregivers of reference consisting of 11 items capable of investigating the hyperphagia of subjects affected by PWS.
Measured: Baseline (investigated in the parents or caregivers of subjects with PWS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start21 Apr 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295315
- Sponsor's protocol ID
- 01C310
- Acronym
- PROPSICOPWS
- Status last verified
- Apr 2025
- First submitted
- 28 Feb 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT06295315
- Acronym / sponsor ID
- PROPSICOPWS / 01C310
- Conditions
- Prader-Willi Syndrome
- Keywords
- Prader-Willy syndrome, Psychological well-being, Quality of life, Psychological distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the present study is to investigate the psychological profile of adult patients with PWS and the fatigue experienced by family members. Specifically, the level of psychological well-being, the subjective perception of life quality, and the main characteristics present in terms of psychopathological functioning of subjects with PWS will be investigated. These variables will be investigated in order to detect their presence and the main bonds of interaction, either between them or with other socio-demographic data, in a sample of adults with PWS. At the same time, the presence of psychological distress, levels of well-being quality of life, and coping strategies in family members and caregivers of individuals with PWS will be investigated.
Detailed description
The observational study will be carried out at the U.O. of Auxology, Istituto Auxologico Italiano, IRCCS, Piancavallo.
36 subjects with a genetic diagnosis of PWS, of both sexes and aged between 18 and 55, and their caregivers will be taken into consideration.
In subjects affected by PWS, the following variables will be investigated:
- anthropometric parameters (height, weight, BMI, waist circumference);
- socio-demographic conditions (gender, age, origin, level of education, family composition)
- concomitant hormonal and psychiatric therapies
- intellectual profile through the Mini-Mental State Examination (MMSE), a neuropsychological test consisting of 30 items that refer to the following cognitive areas: orientation in time, orientation in space, word recording, attention and calculation, recall, language, constructional praxis.
- psychological well-being through the Psychological General Well-Being Index (PGWBI), a questionnaire made up of 22 items that measure the following dimensions: anxiety, depression, positivity and well-being, self-control, general state of health, and vitality.
- perception of life quality through the 36-Item Short Form Survey (SF-36), a questionnaire composed of 36 items that investigates the perception of quality of life in relation to: physical functioning, limitations due to physical health, limitations due to emotions, energy and fatigue, emotional well-being, social activities, pain, general health perception
- mental distress through the Symptom Checklist-90-R (SCL-90-R), a questionnaire made up of 90 items capable of investigating the presence and severity of symptoms of mental distress related to nine psychopathological dimensions: somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, anger-hostility, phobic anxiety, paranoid ideation, psychoticism.
The following variables will be investigated in the parents or caregivers of subjects with PWS:
- psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21), a questionnaire composed of 21 items aimed at investigating experiences of anxiety, depression, and stress
- psychological well-being through the Psychological General Well-Being Index (PGWBI), a questionnaire made up of 22 items that measure the following dimensions: anxiety, depression, positivity and well-being, self-control, general state of health, and vitality.
- coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version). It is a questionnaire made up of 60 items aimed at investigating how often the subject implements - in difficult or stressful situations - different coping strategies to deal with stressful daily situations.
- hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ), a questionnaire to be administered to parents or caregivers of reference consisting of 11 items capable of investigating the hyperphagia of subjects affected by PWS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects with a genetic diagnosis of PWS, hospitalized at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo-Verbania (Italy) for a 3-week body weight reduction program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychological well-being through the Psychological General Well-Being Index (PGWBI)
Time frame: Baseline
A neuropsychological test consisting of 30 items that refer to the following cognitive areas: orientation in time, orientation in space, word recording, attention and calculation, recall, language, constructional praxis.
Perception of life quality through the 36-Item Short Form Survey (SF-36)
Time frame: Baseline
A questionnaire composed of 36 items that investigates the perception of quality of life in relation to: physical functioning, limitations due to physical health, limitations due to emotions, energy and fatigue, emotional well-being, social activities, pain, general health perception
Mental distress through the Symptom Checklist-90-R (SCL-90-R)
Time frame: Baseline
A questionnaire made up of 90 items capable of investigating the presence and severity of symptoms of mental distress related to nine psychopathological dimensions: somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, anger-hostility, phobic anxiety, paranoid ideation, psychoticism.
3 secondary outcomes
Psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21)
Time frame: Baseline (investigated in the parents or caregivers of subjects with PWS)
Coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version).
Time frame: Baseline (investigated in the parents or caregivers of subjects with PWS)
Hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ)
Time frame: Baseline (investigated in the parents or caregivers of subjects with PWS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prader-Willi Syndrome, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological well-being through the Psychological General Well-Being Index (PGWBI) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.