Clinical trial NCT06963996: Efficacy of a Psychoeducational Intervention to Improve Sleep Health Among University Students
Official title: Psychosocial Determinants of Sleep Health Among University Students: Implementation of a Psychoeducational Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: RU-SATED
timeFrame: 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).
measure: Sleep satisfaction
timeFrame: 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).
measure: Sleep timing
timeFrame: 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).
measure: Sleep efficiency
timeFrame: 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).
measure: Sleep duration
timeFrame: 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).
measure: Sleep regularity
timeFrame: 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:
measure: Sleep hygiene beliefs
timeFrame: 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).
measure: Sleep Hygiene Practice Scale
timeFrame: 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).
measure: Self-efficacy
timeFrame: 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:
measure: Perceived stress
timeFrame: 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).
measure: Anxiety
timeFrame: 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).
measure: Depression
timeFrame: 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).
measure: Insomnia Severity Index
timeFrame: 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).
measure: Sociodemographic measures
timeFrame: Day 1 (T0)
Locations:
city: Québec
country: Canada
facility: Centre d'études des troubles du sommeil (CETS)
state: Quebec
Study officials:
References: