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

NCT06023693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2025-02-03

No results posted yet for this study

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

Interventions

BEHAVIORAL

i-Sleep & BioClock

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

BEHAVIORAL

Online Psychoeducation

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

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Niki Antypa, Dr. · Leiden University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-11-01
Completion
2025-01-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06023693 on ClinicalTrials.gov