Feasibility Trial i-Sleep & BioClock Intervention

NCT05363995 | Completed

• 1 other identifier: BioClockWP1.4
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to prevent the development or exacerbation of mental health problems. The investigators will assess the feasibility, usability and acceptability of the intervention in this pilot trial.

Conditions

Insomnia

Keywords

sleep; biological clock; CBTi; e-health intervention; 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

  Change from baseline (T0) to 7 weeks after baseline (T1)

Secondary Outcomes (6)

• Sleep and light exposure diary

  Change from week 0 (7 days prior to intervention period) to week 8 (7 days after T1)

• Munich Chronotype Questionnaire (MCTQ)

  Change from baseline (T0) to 7 weeks after baseline (T1)

• Patient Health Questionnaire (PHQ-9)

  Change from baseline (T0) to 7 weeks after baseline (T1)

• Generalised Anxiety Disorder scale (GAD-7)

  Change from baseline (T0) to 7 weeks after baseline (T1)

• Work and Social Adjustment Scale (WSAS)

  Change from baseline (T0) to 7 weeks after baseline (T1)

Other Outcomes (5)

• Client Satisfaction Questionnaire (CSQ-8)

  7 weeks after baseline (T1)

• System Usability Scale (SUS-10)

  7 weeks after baseline (T1)

• Working Alliance Inventory for guided Internet interventions (WAI-I)

  7 weeks after baseline (T1)

Study Arms (1)

Experimental

EXPERIMENTAL

Blended e-health intervention

Behavioral: i-Sleep & BioClock Intervention

Interventions

i-Sleep & BioClock Intervention BEHAVIORAL

The 'i-Sleep \& BioClock' intervention aims at improving sleep and the biological clock among university students. It is incorporates evidence-based techniques such as cognitive behavioural therapy for insomnia (CBTi). The intervention has a duration of 5 weeks and consists of five modules: 1. psychoeducation on insomnia, sleep hygiene and the biological clock, 2. stimulus control and sleep restriction therapy, 3. worrying and relaxation exercises, 4. cognitive therapy to change dysfunctional thoughts about sleep, and 5. summary module, relapse prevention, and plan for the future. The intervention is supported by e-coaches who give personalized written feedback. Students will fill in a sleep \& light exposure diary daily.

Experimental

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• 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 seven participating universities (Leiden University, Vrije Universiteit Amsterdam, Utrecht University, Maastricht University, Erasmus University Rotterdam, University of Amsterdam, Inholland University of Applied Sciences)
• Being ≥ 16 years old
• Having self-reported sleep problems; Insomnia Severity Index ≥ 8 (at least subthreshold insomnia)

You may not qualify if:

• Current risk for suicidal behaviour

Sponsors & Collaborators

• Leiden University: lead

Study Sites (1)

Leiden Univeristy

Leiden, North Holland, 2333AK, Netherlands

Location

Related Publications (1)

• Pape LM, Antypa N, Spinhoven P, van Straten A, Struijs SY; Caring Universities Consortium. Open pilot study of a guided digital self-help intervention targeting sleep and the biological clock in university students using a pre-test post-test design. Sci Rep. 2025 Jul 1;15(1):21837. doi: 10.1038/s41598-025-04891-8.

  PMID: 40593043 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, PhD

  Leiden University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Philip Spinhoven

Model Details: Single arm open feasibility study

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 6, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)