Efficacy of a Psychoeducational Intervention to Improve Sleep Health Among University Students
- Conditions
- PsychoeducationalPsychoeducational Waitlist Control
- Registration Number
- NCT06963996
- Lead Sponsor
- Laval University
- Brief Summary
This study aims to evaluate the effectiveness 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.
- Detailed Description
A process evaluation will be conducted immediately after the 3 weeks intervention to assess participants' comprehension, adherence to the intervention, as well as the accessibility and relevance of intervention content. Moreover, in terms of logistics, this involves evaluating the premises used, the facilitator, the size of the group, the number and length of sessions, the face-to-face offer, and the use of teaching aids such as manuals during the sessions. These data are collected to inform potential improvements in future iterations of the intervention and are not included as outcome measures.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Students registered at Université Laval (either part-time or full-time)
- Aged between 18-30 years old
- With or without any sleep difficulties
- Use of prescription sleep medication
- Diagnosed medical condition (diabetes, cancer, cardiovascular disease, chronic pain, etc.)
- Currently with a suicidal risk
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method RU-SATED 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). 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.Sleep satisfaction 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 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.
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). 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.
Sleep timing 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). 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.
Sleep efficiency 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). Calculated from self-reported sleep diary entries as the ratio of total sleep time to time in bed, expressed as a percentage.
Sleep duration 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). Self-reported total sleep time calculated daily using sleep onset and wake-up time entries in the sleep diary.
- Secondary Outcome Measures
Name Time Method 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). This outcome is assessed students' beliefs about sleep hygiene using the Theory of Planned Behavior (TPB). Since no standardized tools exist, items were developed based on prior research and theoretical guidelines. Validity was confirmed through factor analysis and internal consistency testing.
The instrument includes 7-point Likert scales measuring:
Attitudes (6 items) - Perceptions of sleep hygiene. Higher scores indicate more favorable attitudes (score range of 6 to 42).
Subjective norms (4 items) - Perceived social expectations. Higher scores reflect stronger norms (score range of 4 to 28).
Motivation to comply (4 items) - Importance given to others' opinions (score range of 4 to 28).
Perceived control (4 items) - Confidence in maintaining good sleep habits (score range of 4 to 28).
Intention (3 items) - Readiness to adopt healthy sleep behaviors (score range of 3 to 21).
This structured approach ensures a comprehensive assessment of beliefs and behavioral influences.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). Sleep hygiene is measured by the Sleep hygiene practice scale (SHPS), which is an instrument that measures sleep hygiene including 4 domains: (1) factors related to the sleep-wake cycle (e.g. irregular bedtime/rising time, lack of exposure to outside light), (2) factors related to activation and activating behaviours (e.g. falling asleep watching television or listening to music, intense exercise in the 2 hours before going to sleep), (3) factors related to consumption and diet (e.g.going to bed hungry, drinking alcohol close to bedtime), and (4) factors related to the sleep environment (e.g. sleeping environment too noisy, too bright, too hot). The total score is distributed between 30 and 180, where the higher the score, the higher the frequency of poor sleep hygiene practices.
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). This study evaluates self-efficacy in adopting, maintaining, and recovering sleep habits. Inspired by prior research, the instrument includes:
Adoption efficacy (2 items) - Confidence in changing sleep habits despite difficulties.
Maintenance efficacy (4 items) - Ability to sustain new sleep routines over time.
Recovery efficacy (3 items) - Capacity to resume habits after interruption. Each item is rated on a 4-point Likert scale (1 = "Completely false," 4 = "Completely true").
The range of scores is 2 to 8, 4 to 16 and 3 to 12 respectively. Higher scores indicate stronger self-efficacy in each domain.
Trial Locations
- Locations (1)
Centre d'études des troubles du sommeil (CETS)
🇨🇦Québec, Quebec, Canada