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A study on the effectiveness of a guided e-health sleep and biological clock intervention in university students (i-Sleep & BioClock)

A study on the effectiveness of a guided e-health sleep and biological clock intervention in university students (i-Sleep & BioClock) - i-Sleep & BioClock for students

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53645
Enrollment
192
Registered
2023-07-17
Start date
2023-10-01
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, slaapstoornissen Sleeping problems

Interventions

The *i-Sleep & BioClock* intervention for students is based on the i-Sleep intervention which was developed by Prof. Annemieke van Straten and Dr. Jaap Lancee. The intervention was developed based o

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - Presence of current suicidal ideation - Not being able to adhere to the intervention guideline due to regular night shifts (at least once per week)

Design outcomes

Primary

MeasureTime frame
The primary outcome will be insomnia severity (Insomnia Severity Index).

Secondary

MeasureTime frame
Secondary outcomes will be depression (PHQ-9), anxiety (GAD-7), daily functioning (WSAS), quality of life (MHQoL), and sleep & light exposure diary outcomes. Outcomes will be measured at baseline, at post-treatment (6 weeks after baseline), and at 4.5 months follow-up. Mediators such as shift in chronotype and light exposure will be examined at baseline, mid-treatment and post-treatment.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 16, 2026