Efficacy of a Psychoeducational Intervention to Improve Sleep Health Among University Students

NCT06963996 | Completed

• 1 other identifier: 2023-092
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy of a psychoeducational intervention targeting the determinants of university students' sleep health. It is conducted as part of a doctoral research project. The intervention consists of three structured sessions delivered over three weeks, with additional online follow-ups. Each session lasts 1.5 hours and takes place in the evening, with a one-week interval between sessions. Session 1 focuses on providing fundamental knowledge about sleep health. Session 2 introduces behavioral strategies to improve sleep health and asks participants to implement behavior change intentions. Session 3 reviews the implementation of the intention, the changes made or not, and addresses the relationship between stress and sleep, along with coping strategies. Participants are required to complete online questionnaires and a sleep diary at multiple time points: before the intervention, immediately after, and up to three months post-intervention. These assessments measure sleep habits, beliefs about sleep, and mental health indicators. Participants are randomly assigned to one of two groups: Intervention group, which receives the psychoeducational program first. Waitlist control group, which completes an additional follow-up before receiving the intervention. The study design allows for a controlled evaluation of the intervention's impact on sleep-related behaviors and mental health outcomes.

Conditions

Psychoeducational; Psychoeducational Waitlist Control

Keywords

psychoeducation; sleep; sleep hygiene; randomized controlled trial; waiting lists; control groups; sleep health; health education; intention; behavioral intention; health behavior; self-management

Outcome Measures

Primary Outcomes (6)

• RU-SATED

  RU-SATED is the instrument used to measure sleep health. Sleep health varies according to individual, social and environmental conditions, and emphasises that good sleep is not simply the result of an absence of sleep disorders. In terms of its components, sleep health relates to (1) sleep duration, or the total number of hours of sleep obtained over 24 hours, (2) sleep efficiency, corresponding to the ease or otherwise with which an individual falls asleep and returns to sleep, and (3) timing, or how our sleep fits into a 24-hour day, (4) alertness, or sleepiness, which concerns a person's ability to maintain a state of attentive wakefulness throughout the day, (5) satisfaction, or subjectively represented sleep quality, and finally (6) sleep regularity. More specifically, RU-SATED score is distributed between 0 and 12, with the higher the score, the better the person's sleep health.

  Intervention group: T0 (day 1), T1 week 4 (post 3 weeks intervention), T2 week 16 (3 months post-intervention). Waitlist control group: T0 (day 1), T1 (3 weeks later T0), T2 week 8 (post 3 weeks intervention), T3 week 20 (3 months post-intervention).

• Sleep satisfaction

  Sleep satisfaction will be assessed using a single-item question from a sleep diary completed by participants each morning for seven consecutive days. The item reads: "How would you rate the quality of your sleep?" Responses are recorded on a 5-point Likert scale ranging from 1 ("very restless") to 5 ("Very deep"). Daily scores will be summed to obtain a total sleep satisfaction score ranging from 7 to 35. Higher scores indicate a higher perceived sleep quality. The measure provides a subjective evaluation of sleep quality from the participant's perspective.

  1-week daily self-reports at each time point: T0 (day 1), T1 week 4 (post 3-week intervention), T2 week 16 (3-month follow-up); waitlist group: T0, T1 (3 weeks later), T2 week 8 (post 3-week intervention), T3 week 20 (3-month follow-up).

• Sleep timing

  Self-reported bedtime and wake-up time recorded daily in a sleep diary. Used to calculate the timing of sleep onset and wake time, as well as midpoint of sleep.

  1-week daily self-reports at each time point: T0 (day 1), T1 week 4 (post 3-week intervention), T2 week 16 (3-month follow-up); waitlist group: T0, T1 (3 weeks later), T2 week 8 (post 3-week intervention), T3 week 20 (3-month follow-up).

• Sleep efficiency

  Calculated from self-reported sleep diary entries as the ratio of total sleep time to time in bed, expressed as a percentage.

  1-week daily self-reports at each time point: T0 (day 1), T1 week 4 (post 3-week intervention), T2 week 16 (3-month follow-up); waitlist group: T0, T1 (3 weeks later), T2 week 8 (post 3-week intervention), T3 week 20 (3-month follow-up).

• Sleep duration

  Self-reported total sleep time calculated daily using sleep onset and wake-up time entries in the sleep diary.

  1-week daily self-reports at each time point: T0 (day 1), T1 week 4 (post 3-week intervention), T2 week 16 (3-month follow-up); waitlist group: T0, T1 (3 weeks later), T2 week 8 (post 3-week intervention), T3 week 20 (3-month follow-up).

• Sleep regularity

  Measured via self-reported bedtimes and wake-up times across multiple days using a sleep diary. Variability will be calculated using the standard deviation of sleep and wake times to assess sleep regularity.

  1-week daily self-reports at each time point: T0 (day 1), T1 week 4 (post 3-week intervention), T2 week 16 (3-month follow-up); waitlist group: T0, T1 (3 weeks later), T2 week 8 (post 3-week intervention), T3 week 20 (3-month follow-up).

Secondary Outcomes (3)

• Sleep hygiene beliefs

  Intervention group: T0 (day 1), T1 week 4 (post 3 weeks intervention), T2 week 16 (3 months post-intervention). Waitlist control group: T0 (day 1), T1 (3 weeks later T0), T2 week 8 (post 3 weeks intervention), T3 week 20 (3 months post-intervention).

• Sleep Hygiene Practice Scale

  Intervention group: T0 (day 1), T1 week 4 (post 3 weeks intervention), T2 week 16 (3 months post-intervention). Waitlist control group: T0 (day 1), T1 (3 weeks later T0), T2 week 8 (post 3 weeks intervention), T3 week 20 (3 months post-intervention).

• Self-efficacy

  Intervention group: T0 (day 1), T1 week 4 (post 3 weeks intervention), T2 week 16 (3 months post-intervention). Waitlist control group: T0 (day 1), T1 (3 weeks later T0), T2 week 8 (post 3 weeks intervention), T3 week 20 (3 months post-intervention).

Other Outcomes (5)

• Perceived stress

  Intervention group: T0 (day 1), T1 week 4 (post 3 weeks intervention), T2 week 16 (3 months post-intervention). Waitlist control group: T0 (day 1), T1 (3 weeks later T0), T2 week 8 (post 3 weeks intervention), T3 week 20 (3 months post-intervention).

• Anxiety

  Intervention group: T0 (day 1), T1 week 4 (post 3 weeks intervention), T2 week 16 (3 months post-intervention). Waitlist control group: T0 (day 1), T1 (3 weeks later T0), T2 week 8 (post 3 weeks intervention), T3 week 20 (3 months post-intervention).

• Depression

  Intervention group: T0 (day 1), T1 week 4 (post 3 weeks intervention), T2 week 16 (3 months post-intervention). Waitlist control group: T0 (day 1), T1 (3 weeks later T0), T2 week 8 (post 3 weeks intervention), T3 week 20 (3 months post-intervention).

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants assigned to the intervention group will receive first the intervention. They will complete various assessment at baseline (T0), post-intervention after the 3 weeks of intervention (T1), and 3 months after the end of the intervention (T2).

Behavioral: Sleep health education

Waitlist control group

EXPERIMENTAL

Participants assigned to the waitlist control group complete a baseline assessment (T0), a second assessment after 3 weeks of waiting (T1), and then receive the intervention. They are assessed again after the intervention (T2) and at 3-month follow-up (T3). This design allows for pre- and post-intervention comparisons while ensuring delayed access to the program.

Behavioral: Sleep health education

Interventions

Sleep health education BEHAVIORAL

The intervention consists of three structured sessions delivered over three weeks, with additional online follow-ups. Each session lasts 1.5 hours and takes place in the evening, with a one-week interval between sessions. Session 1 focuses on providing fundamental knowledge about sleep health. Session 2 introduces behavioral strategies to improve sleep health and asks participants to implement behavior change intentions. Session 3 reviews the implementation of the intention, the changes made or not, and addresses the relationship between stress and sleep, along with coping strategies.

Intervention group; Waitlist control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Students registered at Université Laval (either part-time or full-time)
• Aged between 18-30 years old
• With or without any sleep difficulties

You may not qualify if:

• Use of prescription sleep medication
• Diagnosed medical condition (diabetes, cancer, cardiovascular disease, chronic pain, etc.)
• Currently with a suicidal risk

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Centre d'études des troubles du sommeil (CETS)

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Sleep Hygiene; Health Education; Health Behavior

Condition Hierarchy (Ancestors)

Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: May 9, 2025
• Study Start: February 1, 2024
• Primary Completion: August 3, 2025
• Study Completion: August 3, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)