NL-OMON46359CompletedNot Applicable
The SMILE study:Sleep Mood Intervention: Live Effectively a group intervention in students with sleep problems - The SMILE study
niversiteit Leiden0 sites72 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 72
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •6. No self-reported severe sleep complaints (ISI score of <10 ).
- •7. The presence of clinically significant psychopathology (as based on DSM IV criteria from the psychiatric interview); exclude current disorders: Major Depressive Disorder, Bipolar Disorder, Panic disorder, Social Anxiety Disorder, Post-traumatic Stress Disorder, Attention Deficit Hyperactivity Disorder, Eating disorders and Psychotic disorders.
- •8. The presence of a sleep disorder (incl. narcolepsy, sleep apnea).
- •9. The presence of an acute somatic (physical) illness that may interfere with the intervention.
Investigators
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