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NCT Number: NCT07529652

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

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.

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Key information

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Autónoma de Baja California

Mexicali, Estado de Baja California, 21820, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Psychological Program to Improve Sleep Quality

Behavioral

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 between the bedroom and difficulty sleeping. The intervention is delivered in a structured and supervised format, with the goal of promoting sustainable behavioral and cognitive changes that improve sleep quality. The intervention will be conducted weekly in group sessions lasting approximately one hour. The researcher will administer the intervention.

Primary outcomes

  1. Sleep Quality

    Time frame: Pre-post intervention evaluation, after 8 weeks.

    Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989) is a self-report instrument designed to assess sleep quality and sleep disturbances over the past month. It evaluates seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. These components generate an overall score that allows differentiation between people who sleep well and people who sleep poorly. Its psychometric properties have demonstrated adequate levels of reliability and validity. Furthermore, it exhibits good sensitivity and specificity for identifying clinically significant sleep problems and is therefore considered a valid and reliable instrument for assessing sleep quality. It evaluates sleep over the past month using 19 self administered questions, with a total score ranging from 0 to 21 points. An overall score > 5 indicates poor sleep quality while a score ≤ 5 suggests adequate sleep quality

Secondary outcomes

  1. Executive functions in higher education

    Time frame: Pre-post intervention evaluation, after 8 weeks.

    The Executive Functions in Higher Education Scale (EFEES) (Zamora-Lugo et al., 2025) is a self-report instrument designed to assess perceived executive functioning in university students within the academic context. The scale evaluates four domains: organization, self-control, attentional and inhibitory control, and planning and time management. It consists of 70 items rated on a six-point Likert scale ranging from 0 ("I do not remember") to 5 ("It describes me perfectly"). Higher scores indicate greater perceived executive functioning in academic activities. Responses are interpreted based on academic work completed during the previous six months. According to the authors, the scale shows adequate internal consistency and evidence of structural validity, supporting its reliability and usefulness for assessing executive functioning in Mexican university populations.

  2. Insomnia

    Time frame: Pre-post intervention evaluation, after 8 weeks.

    The Athens Insomnia Scale (AIS; Soldatos et al., 2000) is a self-report instrument designed to assess the presence and severity of insomnia based on international diagnostic criteria (ICD-10). It consists of eight items that explore difficulties related to sleep onset, nighttime awakenings, early morning awakening, total sleep duration, sleep quality, daytime well-being, physical and mental functioning, and daytime sleepiness. The scale is designed for adults and has been used in both clinical and research settings. It demonstrates adequate internal consistency and good convergent validity with other sleep measures, as well as appropriate sensitivity and specificity for detecting clinical cases of insomnia. Therefore, it is considered a valid and reliable instrument.

    A total score of 6 or more points (out of 24) usually indicates suspected insomnia. It is classified as: absence (0-5), mild insomnia (6-9), moderate insomnia (10-15), and severe insomnia (16-24).

  3. The Card Sorting Test

    Time frame: Pre-post intervenction assessment, after 8 weeks

    The neuropsychological assessment to measure changes in the functioning of cognitive processes of interest, such as executive functions, will use the following instrument: Neuropsychological Battery of Executive Functions and Frontal Lobes, 3rd edition (BANFE-3) (Flores-Lázaro, et al. 2021). The card sorting test will be assessed using the standardized BANFE executive functions test, taking into account response accuracy, perseverations, time, and errors. The total score will be converted to a standardized score of 0 to 19 (with a mean of 10 ± 3 SD, 4-6 low performance, 14-19 high performance).

  4. Working Memory

    Time frame: Time frame: Pre- and post-intervention assessment, after 8 week

    Neuropsychological assessment to measure changes in the functioning of cognitive processes of interest, such as executive functions, will use the following assessment instrument: Neuropsychological Battery of Executive Functions and Frontal Lobes, 3rd Edition (BANFE-3) (Flores-Lázaro, et al. 2021).

    Working Memory Working memory will be measured using the standardized BANFE executive function test, with response accuracy as the scoring criterion. The total score is converted to a normalized score of 0 to 19 (with a mean of 10 ± 3 SD, 4-6 low performance, 14-19 high performance).

  5. Tower of Hanoi

    Time frame: Pre-post intervention assessment, after 8 weeks

    Neuropsychological assessment to measure changes in the functioning of cognitive processes of interest, such as executive functions, will use the following assessment instrument: Neuropsychological Battery of Executive Functions and Frontal Lobes, 3rd Edition (BANFE-3) (Flores-Lázaro, et al. 2021). The Tower of Hanoi puzzle, using the number of moves and the time taken, will be measured by calculating the executive function quotients from the standardized BANFE test. The total score will be converted into normalized points from 0 to 19 (with a mean of 10 ± 3 SD, 4-6 low performance, 14-19 high performance).

Study contacts

Contact information is provided by the study sponsor or research team.

CASANDRA GUTIERREZ VILLEGAS, Mastery

CONTACT

[email protected]

+52 6863530714

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Baja California

Other

Registry information

Official study title

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

Acronym: LUNA MUJER

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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