Effectiveness of a Guided Self-help Intervention for Improving Sleep in University Students

NCT06023693 | Completed

• 1 other identifier: i-Sleep&BioClockRCT
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trials aims to assess the effectiveness of an online guided self-help intervention ('i-Sleep \& BioClock') based on CBTi principles for university students' sleep problems. The study will involve 192 students with subthreshold insomnia who will be randomized to the intervention or online psychoeducation. The intervention consists of 5 modules completed in about 5 weeks, supported by e-coaches. Outcomes include insomnia severity, mental health symptoms, functioning, quality of life, and academic performance, measured at baseline, post-treatment (6 weeks after baseline), and 18 weeks follow-up.

Conditions

Insomnia

Keywords

sleep; guided self-help; CBTi; e-health; university students

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index

  7-item self-report instrument to assess insomnia severity, scores 0-28, higher scores indicating more insomnia severity

  Baseline (T0), 3 weeks after baseline (T1), 6 weeks after baseline (T2), and 18 weeks after baseline (T3)

Secondary Outcomes (15)

• Sleep efficiency (in minutes)

  Change from week 1 to week 7

• Sleep onset latency (in minutes)

  Change from week 1 to week 7

• Wake after sleep onset (in minutes)

  Change from week 1 to week 7

• Early morning awakening (in minutes)

  Change from week 1 to week 7

• Total sleep time (in minutes)

  Change from week 1 to week 7

Other Outcomes (5)

• Adherence - Total number of completed modules

  Through study completion, an average of 18 weeks

• Adherence - Time spent in the platform (in minutes)

  Through study completion, an average of 18 weeks

• Adherence - Number of logins (total amount)

  Through study completion, an average of 18 weeks

Study Arms (2)

Guided online self-help intervention

EXPERIMENTAL

The intervention will be a guided e-health intervention based on CBTi principles (i-Sleep \& BioClock). It consists of 5 modules, to be completed in about 5 weeks, and is aimed at improving sleep in university students. The intervention will be entirely held online and will be supported by e-coaches. The topics covered will be sleep hygiene, psychoeducation on sleep and the biological clock, sleep restriction, stimulus control, worrying and relaxation, dysfunctional thoughts, and relapse prevention.

Behavioral: i-Sleep & BioClock

Online psychoeducation

ACTIVE COMPARATOR

The control group will receive access to the platform and to the sleep diary. Their intervention will consist of brief, unstructured online PE for insomnia based on recognized sleep hygiene advice, for example, recommendations about evening routines, and use of alcohol and caffeine. Students will be advised to monitor their sleep in the diary. In contrast to the intervention group, the control group will not receive support of an e-coach. Key differences to the CBTi group are that the online PE (1) does not provide individualized support by an e-coach; (2) includes less content, and (3) is not delivered in a step-by-step manner, but will be provided all at once.

Behavioral: Online Psychoeducation

Interventions

i-Sleep & BioClock BEHAVIORAL

Module 1 Psychoeducation about normal sleep and insomnia, Psychoeducation on the biological clock: the circadian rhythm, chronotypes, zeitgebers, importance of light behaviour Basic sleep hygiene: information about behaviours that are known to promote or impede sleep e.g. performing physical exercise or the use of caffeine Module 2 Sleep restriction and stimulus control: patients are taught to use the bedroom only to sleep and to restrict the time in bed to the average amount of night-time sleep Module 3 Worrying and relaxation: audio files with progressive muscle relaxation exercises are offered and techniques to stop worrying (e.g. thought blocking, evaluation and worry time) Module 4 Erroneous cognitions about sleep: the basics of cognitive behavioural therapy are explained and the most common erroneous ideas about insomnia are discussed Module 5 Summary and plan for the future

Guided online self-help intervention

Online Psychoeducation BEHAVIORAL

Online psychoeducation about sleep and the biological clock, basic sleep hygiene

Online psychoeducation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being fluent in Dutch and/or English
• Being enrolled as a student (Bachelor, Master or PhD) in one of the Caring Universities partner universities
• Being ≥ 16 years old
• Having self-reported sleep problems; Insomnia Severity Index ≥ 10

You may not qualify if:

• Regular night shifts (Not being able to comply to the intervention due to regular night shift, meaning work between 2AM and 6AM at least once a week)
• Current risk for suicidal behaviour

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden Univeristy

Leiden, 2333AK, Netherlands

Location

Related Publications (2)

• Pape LM, van Straten A, Struijs SY, Karch JD, Spinhoven P, Antypa N; Caring Universities Consortium. Effects of a Guided Digital Intervention on Sleep and Mental Health Outcomes in University Students - A Randomized Controlled Trial. Sleep. 2025 Nov 25:zsaf357. doi: 10.1093/sleep/zsaf357. Online ahead of print.

  PMID: 41288591 DERIVED

• Pape LM, van Straten A, Struijs SY, Spinhoven P, Antypa N. Effectiveness of a guided digital self-help intervention to improve sleep and the biological clock in university students - Study protocol for a randomized controlled trial. Internet Interv. 2024 Aug 2;37:100763. doi: 10.1016/j.invent.2024.100763. eCollection 2024 Sep.

  PMID: 39224668 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Niki Antypa, Dr.

  Leiden University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Philip Spinhoven

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: September 5, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)