NCT07529652

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 30, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

March 25, 2026

Last Update Submit

April 10, 2026

Conditions

Keywords

InsomniaCold-Executive-FunctionsAcademic-PerformanceWoman

Outcome Measures

Primary Outcomes (1)

  • 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

    Pre-post intervention evaluation, after 8 weeks.

Secondary Outcomes (5)

  • Executive functions in higher education

    Pre-post intervention evaluation, after 8 weeks.

  • Insomnia

    Pre-post intervention evaluation, after 8 weeks.

  • The Card Sorting Test

    Pre-post intervenction assessment, after 8 weeks

  • Working Memory

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

  • Tower of Hanoi

    Pre-post intervention assessment, after 8 weeks

Study Arms (2)

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.

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.

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autónoma de Baja California

Mexicali, Estado de Baja California, 21820, Mexico

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Central Study Contacts

CASANDRA GUTIERREZ VILLEGAS, Mastery

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full time Professor

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 14, 2026

Study Start (Estimated)

August 30, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

March 15, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations