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The SMILE study:Sleep Mood Intervention: Live Effectively a group intervention in students with sleep problems

The SMILE study:Sleep Mood Intervention: Live Effectively a group intervention in students with sleep problems - The SMILE study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46359
Enrollment
72
Registered
2018-09-18
Start date
2018-09-19
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

sleep problems

Interventions

None listed

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Self-reported sleep complaints (ISI score of >=10). 2. Currently enrolled as a student. 3. Aged 18-years or older. 4. Adequate proficiency in both written and spoken English. 5. Willingness to participate in a four-week group intervention program

Exclusion criteria

Exclusion criteria: 6. No self-reported severe sleep complaints (ISI score of

Design outcomes

Primary

MeasureTime frame
The primary outcome will be improvement in self-reported sleep parameters (Insomnia Severity Index and sleep diary).

Secondary

MeasureTime frame
Secondary outcomes will be: improvement in objective sleep measures (actigraphy) at posttest. Depression, Anxiety symptoms, as well as quality of life both at post-test and follow-up. Mediators: Cognitions about sleep and arousal; ecological momentary assessments will be analysed to examine which aspects (e.g. mood, fatigue) improved during the intervention.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 6, 2026