InsomniaLUNA MUJERNCT07529652
Psychological Intervention on Cold Executive Function and Academic Performance in University Women With Insomnia
A study testing Psychological Program to Improve Sleep Quality in people with Insomnia, run by Universidad Autonoma de Baja California at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- Psychological Program to Improve Sleep Quality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- 30 Aug 2026to 15 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Universidad Autónoma de Baja California
Mexicali, Estado de Baja California, 21820
About this study
Official 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
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Psychological Program to Improve Sleep Quality
- Keywords
- Insomnia, Cold-Executive-Functions, Academic-Performance, Woman
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Program to Improve Sleep QualityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Psychological Program to Improve Sleep Quality |
| control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
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
Measured: Pre-post intervention evaluation, after 8 weeks.
Secondary outcomes (5)
Executive functions in higher education
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.
Measured: Pre-post intervention evaluation, after 8 weeks.
Insomnia
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).
Measured: Pre-post intervention evaluation, after 8 weeks.
The Card Sorting Test
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).
Measured: Pre-post intervenction assessment, after 8 weeks
Working Memory
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).
Measured: Time frame: Pre- and post-intervention assessment, after 8 week
Tower of Hanoi
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).
Measured: Pre-post intervention assessment, after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilberto Galindo, Universidad Autonoma de Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529652
- Sponsor's protocol ID
- MP/2026/CGV
- Acronym
- LUNA MUJER
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07529652
- Acronym / sponsor ID
- LUNA MUJER / MP/2026/CGV
- Conditions
- Insomnia
- Keywords
- Insomnia, Cold-Executive-Functions, Academic-Performance, Woman
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Psychological Program to Improve Sleep QualityParticipants 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. |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Voluntary withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological Program to Improve Sleep QualityThe 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. | Behavioural | Intervention Group |
Primary outcome
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
5 secondary outcomes
Executive functions in higher education
Time frame: Pre-post intervention evaluation, after 8 weeks.
Insomnia
Time frame: Pre-post intervention evaluation, after 8 weeks.
The Card Sorting Test
Time frame: Pre-post intervenction assessment, after 8 weeks
Working Memory
Time frame: Time frame: Pre- and post-intervention assessment, after 8 week
Tower of Hanoi
Time frame: Pre-post intervention assessment, after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Program to Improve Sleep Quality in people with Insomnia, run by Universidad Autonoma de Baja California at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CASANDRA GUTIERREZ VILLEGAS, Mastery (+52 6863530714, casandra.gutierrez@uabc.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Pre-post intervention evaluation, after 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.