An interventional study of Psychological Program to Improve Sleep Quality in Insomnia, sponsored by Universidad Autonoma de Baja California. Not yet recruiting at 1 site in Mexico. Open to female participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Universidad Autonoma de Baja California · Not applicable, Interventional, and Treatment
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.
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.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 35 is below the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Universidad Autonoma de Baja California is the lead sponsor of 33 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Elimination Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Psychological Program to Improve Sleep Quality
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.
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.
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
Time frame: Pre-post intervention evaluation, after 8 weeks.
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Pre-post intervention assessment, after 8 weeks
Plan to share: Yes
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Start is estimated for Aug 2026; primary completion for Oct 2026, 2 months later.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 2 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Universidad Autonoma de Baja California