- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07529652
Psychological Intervention on Cold Executive Function and Academic Performance in University Women With Insomnia (LUNA MUJER)
Psychological Intervention in the Executive Functioning and Academic Performance of Female University Students Aged 18 to 25 Residing in the Mexicali Valley With Insomnia
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: CASANDRA GUTIERREZ VILLEGAS, Mastery
- Phone Number: +52 6863530714
- Email: casandra.gutierrez@uabc.edu.mx
Study Locations
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Estado de Baja California
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Mexicali, Estado de Baja California, Mexico, 21820
- Universidad Autónoma de Baja California
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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.
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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.
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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.
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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.
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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
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Pre-post intervention evaluation, after 8 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Pre-post intervention evaluation, after 8 weeks.
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Insomnia
Time Frame: Pre-post intervention evaluation, after 8 weeks.
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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.
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The Card Sorting Test
Time Frame: Pre-post intervenction assessment, after 8 weeks
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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).
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Pre-post intervenction assessment, after 8 weeks
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Working Memory
Time Frame: Time frame: Pre- and post-intervention assessment, after 8 week
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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
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Tower of Hanoi
Time Frame: Pre-post intervention assessment, after 8 weeks
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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).
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Pre-post intervention assessment, after 8 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP/2026/CGV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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