Psychological Intervention on Cold Executive Function and Academic Performance in University Women With Insomnia (LUNA MUJER)

April 10, 2026 updated by: Gilberto Galindo, Universidad Autonoma de Baja California

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

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Estado de Baja California
      • Mexicali, Estado de Baja California, Mexico, 21820
        • Universidad Autónoma de Baja California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants in this group will receive a structured psychological intervention aimed at improving sleep quality and reducing insomnia symptoms. The program includes sleep hygiene education, relaxation techniques, and stimulus control strategies. The intervention will be delivered in weekly group sessions lasting approximately one hour during 7 weeks.
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.
No Intervention: control group
Participants in this group will not receive the psychological intervention during the study period. This group will serve as a comparison group to evaluate changes in sleep quality, insomnia symptoms, executive functioning, and academic performance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Pre-post intervention evaluation, after 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-post intervention evaluation, after 8 weeks.
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).

Pre-post intervention evaluation, after 8 weeks.
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).
Pre-post intervenction assessment, after 8 weeks
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).

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 30, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

March 15, 2028

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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