Effect of a Sleep Hygiene-based Intervention on Sleep Quality and Mental Health in Medical Students

NCT07043530 | Not Yet Recruiting

• 1 other identifier: Fmed-07-25
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate whether an online sleep hygiene programm is as effective as a face-to-face programm in improving sleep quality and mental health in medical students.

Conditions

Sleep Quality; Mental Health; Students, Medical

Keywords

Sleep hygiene; Sleep quality; Mental health; Medical students; Online intervention

Outcome Measures

Primary Outcomes (2)

• Sleep quality

  This outcome will be measured by means of the Pittsburgh Sleep Quality Index, which is a self-administered 19-item questionnaire regarding perceived sleep quality, sleep latency, sleep duration, sleep efficiency, sleep alterations, sleep medication use and daytime sleepiness. A score under 6 points suggests good sleep quality, while a score greater or equal to 6 point suggests poor sleep quality.

  6 months

• Mental health

  This outcome will be measured by means of the Positive Mental Health Scale (PMHS) and Symptom Checklist 90 Revised (SCL-90-R). The PMHS is a self-administered 83-item questionnaire regarding cognitive and emotional well-being, environmental mastery, social abilities, social sensitivity and empathy, physical well-being, self-reflection, psychological discomfort. The minimum score is 83 and the maximum score is 415; a higher score mean higher positive mental health. The SCL-90-R is a self-administered 90-item questionnaire regarding somatization, obssesive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism. Each dimension is independently scored, with a higher grade meaning the pressence of psychological disorders in the evaluated dimension.

  6 months

Other Outcomes (1)

• Sleep hygiene

  6 months

Study Arms (2)

In-person intervention

ACTIVE COMPARATOR

Behavioral: In-person sleep hygiene-based intervention

Online intervention

EXPERIMENTAL

Behavioral: Online sleep hygiene-based intervention

Interventions

In-person sleep hygiene-based intervention BEHAVIORAL

The in-person sleep hygiene-based intervention will be delivered in 8 sessions by an sleep expert using digital resources, previously designed and expert validated. During the intervention, the following topics will be covered: (1) sleep hygiene generalities, (2) sleep and environment, (3) sleep and technology, (4) sleep and diet, (5) sleep and excercise, (6) sleep and stimulus control, (7) breathing techniques, (8) mindfulness. The sessions will be delivered twice a week with an approximated duration of 45 minutes each, until completed.

In-person intervention

Online sleep hygiene-based intervention BEHAVIORAL

The online sleep hygiene-based intervention will be delivered in 8 sessions through a self-paced educational platform; the content will be the same as in the in-person intervention, but tailored for use in digital learning platforms. The suggest completion time for each session will be 45 minutes. Although its self-paced nature, participants are required to complete it within one month, following the same timeline as the face-to-face arm.

Online intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a medical student enrolled in the Universidad Autonoma de Yucatan.
• Having poor sleep quality according to the Pittsburgh Sleep Quality Index.
• Having at least one electronic device with Internet access.
• Having time availability.
• Having signed the informed consent.

You may not qualify if:

• Being in their year of Internship or Social Service.
• Being pregnant.
• Having children of any age.
• Being under psychological therapy.
• Regulary consuming sleep, depression or anxiety medication.
• Working the night shift.

Sponsors & Collaborators

• Universidad Autónoma de Yucatán: lead

Study Sites (1)

Universidad Autónoma de Yucatán

Mérida, Mexico

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Well-Being; Sleep Hygiene

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior; Health Behavior

Study Officials

• Héctor A Rubio-Zapata, Dr.

  Universidad Autónoma de Yucatán

  STUDY DIRECTOR

• Damaris F Estrella-Castillo, Dr.

  Universidad Autónoma de Yucatán

  STUDY DIRECTOR

Central Study Contacts

Andrea Morales-Robles, M.Sc.

CONTACT

+529993630074; andreamoralesrobles@outlook.com

Héctor A Rubio-Zapata, Dr.

CONTACT

hector.rubio@correo.uady.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. student

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

ME (1)