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Набор скоро начнётся NCT07529652

Psychological Intervention on Cold Executive Function and Academic Performance in University Women With Insomnia

Без фазы С лечением Insomnia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Psychological Program to Improve Sleep Quality.
Кому может быть актуально
Состояния в реестре: Insomnia. Базовые параметры: 18 лет — 25 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Мексика
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Psychological Intervention in the Executive Functioning and Academic Performance of Female University Students Aged 18 to 25 Residing in the Mexicali Valley With Insomnia

Обзор

Sleep disturbances, particularly insomnia, are highly prevalent among university women and are associated with impairments in executive functioning and academic performance. Women present higher rates of insomnia due to biological and psychosocial factors. This study aims to design and evaluate a psychological intervention program to improve sleep quality and reduce insomnia symptoms in female university students aged 18-25, with the purpose of strengthening cold executive functions and analyzing its impact on academic performance.

Подробное описание

Sleep quality is a fundamental factor for the physical, emotional, and academic well-being of university students. Research indicates that this population presents high levels of sleep disturbances, particularly insomnia, fragmented sleep, and chronic sleep deprivation, which are associated with academic stress, workload, nighttime technology use, and irregular sleep habits. Globally, sleep disorders affect approximately 40% of the population, with insomnia being the most prevalent, affecting an estimated 10% to 15% of the general population.

Insomnia is characterized by dissatisfaction with sleep quantity and/or quality, difficulty initiating or maintaining sleep, early morning awakening with inability to return to sleep, and significant impairment in social, academic, or occupational functioning. For diagnosis, symptoms must occur at least three times per week for a minimum of three months, despite adequate opportunities for sleep. Importantly, insomnia is not defined solely by total sleep duration, but by the quality and restorative nature of sleep.

Scientific evidence reports significant sex differences in sleep patterns. Although adult women may show certain objective indicators of better sleep quality, they more frequently report symptoms of insomnia and daytime sleepiness. These differences are attributed to hormonal factors (menstruation, pregnancy, menopause), higher prevalence of mood disorders, psychosocial stressors, and greater vulnerability to environmental stress. In Mexico, women experience insomnia more frequently than men, making them a priority population for research.

Sleep plays an essential role in memory consolidation, learning, restorative processes, and information encoding. Chronic sleep deprivation can lead to impairments in attention, memory, cognitive flexibility, emotional regulation, and executive functioning. Among university students, insufficient sleep has been associated with lower grade point averages and reduced academic performance.

Executive functions are cognitive processes responsible for guiding, directing, and regulating goal-oriented behavior, particularly in novel or complex situations requiring problem-solving. These include working memory, inhibitory control, cognitive flexibility, and planning. A widely accepted framework distinguishes between "hot" executive functions, which involve emotion and motivation, and "cold" executive functions, which are related to purely cognitive processing. The literature indicates that insomnia particularly affects components of cold executive functions, such as working memory and cognitive flexibility.

Executive functions are key predictors of academic and professional success. Several studies have demonstrated a significant relationship between executive functions and academic performance. Academic performance is a complex construct, also referred to as scholastic achievement or academic attainment. It can be defined as the level of knowledge, skills, and competencies demonstrated by a student in a specific subject area relative to their age and educational level. Although academic performance is commonly measured through formal evaluation processes such as grades or GPA, it should not be understood solely as a numerical outcome, but rather as a multifactorial phenomenon influenced by cognitive, emotional, and contextual variables.

Regarding treatment, cognitive-behavioral therapy for insomnia (CBT-I) is considered the most effective psychological intervention. It includes psychoeducation, sleep hygiene, stimulus control, sleep restriction, cognitive restructuring, and relaxation techniques. Its effectiveness has been demonstrated in individual, group, and online formats. However, there remains a need to develop and evaluate interventions tailored to specific populations, such as female university students.

In this context, the present study aims to design and evaluate a psychological intervention program aimed at improving sleep quality and reducing insomnia symptoms in female university students aged 18 to 25. Additionally, the study seeks to strengthen cold executive functions and analyze the impact of the intervention on academic performance. This research aims to provide empirical evidence on the relationship between sleep, executive functioning, and academic performance, as well as to offer a contextually adapted, evidence-based intervention for a population at greater risk of insomnia.

Вмешательства

  • Поведенческое Psychological Program to Improve Sleep Quality
    The intervention consists of a structured psychological program designed to improve sleep quality and reduce insomnia symptoms in female university students. Sleep hygiene: Minimally invasive behavioral recommendations are implemented to establish healthy habits and routines that promote sleep onset and continuity. Relaxation techniques: Strategies are used to decrease physiological and cognitive activation prior to sleep. Stimulus control: This technique aims to reduce the negative association

Первичные конечные точки

  • Sleep Quality [Срок оценки: Pre-post intervention evaluation, after 8 weeks.]
Вторичные конечные точки (5)
  • Executive functions in higher education [Срок оценки: Pre-post intervention evaluation, after 8 weeks.]
  • Insomnia [Срок оценки: Pre-post intervention evaluation, after 8 weeks.]
  • The Card Sorting Test [Срок оценки: Pre-post intervenction assessment, after 8 weeks]
  • Working Memory [Срок оценки: Time frame: Pre- and post-intervention assessment, after 8 week]
  • Tower of Hanoi [Срок оценки: Pre-post intervention assessment, after 8 weeks]

Критерии участия

Критерии включения

  • Sex: Female
  • Age: 18-25
  • Chronic insomnia diagnosed by assessment tool.
  • Must be university students of any major.
  • Must have time available to participate in at least 80% of the sessions.
  • Must explicitly express their desire to participate by signing the informed consent form.

Критерии исключения

  • Sex: Women in transition or men.
  • Psychiatric or neurological diagnosis other than insomnia.
  • Use of psychoactive substances.
  • Under pharmacological treatment for any medical, psychiatric, or neurological condition, including insomnia.

Elimination Criteria:

  • Voluntary withdrawal
  • Absence from more than 20% of sessions.
  • Receiving a diagnosis and/or treatment that interferes with the variables evaluated and addressed.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Мексика · 1 центр
  • Universidad Autónoma de Baja California — Mexicali

Идентификаторы

NCT: NCT07529652 · MP/2026/CGV

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗