This study aims to explore the efficiency of a digital, Smartphone-delivered intervention for improving the quality of REM sleep on the mental health, emotion regulation and overall life quality of users.
age at least 18;
the ability to provide consent;
the absence of neurocognitive and severe psychiatric disorders.
the presence of severe cognitive impairment;
the presence of psychosis;
inability to understand the informed consent and complete questionnaires.
Parallel
Mobile smartwatch application.
DeviceAn integrated system will be utilized, consisting of a mobile and Apple Watch application available in TestFlight (Apple's testing framework), comprising several components: the Sleep Data Collection Module, the Sleep Data Analysis Module, the Specific Sleep Cycle Detection Module, the Integration Module between sleep analysis and the haptic engine of the wearable device used, the Software Module for controlling the haptic engine and generating vibrations, and the Post-Haptic Intervention (vibration-based) Sleep Data Analysis Module.
The Kessler Psychological Distress Scale (K10)
The Kessler Psychological Distress Scale (K10) measure adjustment difficulties, including 10 items. In the present study, it will be used as a screening tool, higher levels indicating elevated distress, as follows: scores between 20-24 indicate the likelihood to present a mild disorder, scores between 25 and 29 indicate the likelihood to present a moderate disorder, while scores above 30 mean the possibility of a severe disorder.
The World Health Organization Quality of Life Scale - Abbreviated Form (WHOQOL-Bref)
The World Health Organization Quality of Life Scale - Abbreviated Form (WHOQOL-Bref) is a measure of life quality, comprising multiple subscales like physical health, psychological health, social relationships and environment. The raw scores ranges are the following: between 7 and 35 for Physical Health, between 6 and 30 for Psychological Health, between 3 and 15 for Social relationships, along with 8 and 40 for Environment. Also, a transformed score involves a wide range between 0 and 100. Higher scores represent a higher quality of life for the specific evaluated field.
The PROMIS Scale
The PROMIS Scale is a measure of the degree to which responders present sleeping difficultiesThe total scores ranges between 8 and 40, higher scores indicating the increased severity of sleep disturbances. The raw scores are then converted to T scores, which can be interpreted as follows: final T score between 55 and 59 indicates mild intensity, between 60 and 69 moderate intensity, while T scores over 70 are equivalent to high severity.
The Difficulties in Emotion Regulation Scale (DERS)
The Difficulties in Emotion Regulation Scale (DERS) constitutes a measure of various aspects of one's ability to modulate emotions, specifically emotional awareness and acceptance. Raw scores range from 36 to 180, higher scores suggesting increased emotion regulation difficulties. Severity categories are based on percentiles, responders presenting levels that correspond to the 96th percentile or above indicating very high emotion regulation difficulties.
The PERMA Profiler
The PERMA Profiler is a measure of well-being, involving six subscales, as follows: positive and negative emotions, engagement, relationships, meaning, accomplishment, as well as health. Each item is rated using a scale from 0 to 10, the subscale scores being calculated as the mean of individual items. A total score of minimum 9 is considered an indicator of very good functioning, while a score below 5 is thought to be a hallmark of malfunctioning.
Click on the lead sponsor to view all of their trials.
