Evaluation of the Psychological Profile of Adult Patients With Prader-Willi Syndrome

NCT06295315 | Completed

• 1 other identifier: 01C310
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Prader-Willi Syndrome

Keywords

Prader-Willy syndrome; Psychological well-being; Quality of life; Psychological distress

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  Baseline

Secondary Outcomes (3)

• Psychological distress through the Depression, Anxiety, and Stress Scale (DASS-21)

  Baseline (investigated in the parents or caregivers of subjects with PWS)

• Coping strategies through Coping Orientation to Problem Experienced (COPE-new Italian version).

  Baseline (investigated in the parents or caregivers of subjects with PWS)

• Hyperphagia of subjects with PWS through the Hyperphagia Questionnaire (HQ)

  Baseline (investigated in the parents or caregivers of subjects with PWS)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS, site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

MeSH Terms

Conditions

Prader-Willi Syndrome; Psychological Well-Being

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Personal Satisfaction; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: April 21, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

IT (1)