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PsychoeducationalNCT06963996

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

A study testing Sleep health education in people with Psychoeducational and Psychoeducational Waitlist Control, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
What is being tested?
Sleep health education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteCanada
Study dates
1 Feb 2024to 3 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre d'études des troubles du sommeil (CETS)

    Québec, Quebec, G1V 0A6

Other trials in Canada

About this study

Official title: Psychosocial Determinants of Sleep Health Among University Students: Implementation of a Psychoeducational Intervention

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.

Read more

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.

Read the 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.

Being tested
Sleep health education
Keywords
psychoeducation, sleep, sleep hygiene, randomized controlled trial, waiting lists, control groups, sleep health, health education, intention, behavioral intention, health behavior, self-management
Medical subject headings
Sleep Hygiene, Health Education, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep health educationBehavioural

    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.

Study groups in NCT06963996
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants 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).
Receives: Behavioral: Sleep health education
Waitlist control groupExperimentalParticipants 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.
Receives: Behavioral: Sleep health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

  2. 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.

    Measured: 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).

  3. 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.

    Measured: 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).

  4. Sleep efficiency

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

    Measured: 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).

  5. Sleep duration

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

    Measured: 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).

  6. 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.

    Measured: 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)
  1. Sleep hygiene beliefs

    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.

    Measured: 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).

  2. Sleep Hygiene Practice Scale

    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.

    Measured: 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).

  3. Self-efficacy

    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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start1 Feb 2024
  3. Primary completion3 Aug 2025
  4. Study completion3 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06963996
Sponsor's protocol ID
2023-092
Status last verified
Aug 2025
First submitted
18 Mar 2025
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sleep health education in people with Psychoeducational and Psychoeducational Waitlist Control, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RU-SATED (time frame: 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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.

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