The SMILE study:Sleep Mood Intervention: Live Effectively a group intervention in students with sleep problems
- Conditions
- sleep problems10040991
- Registration Number
- NL-OMON46359
- Lead Sponsor
- niversiteit Leiden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
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
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome will be improvement in self-reported sleep parameters<br /><br>(Insomnia Severity Index and sleep diary).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes will be: improvement in objective sleep measures<br /><br>(actigraphy) at posttest. Depression, Anxiety symptoms, as well as quality of<br /><br>life both at post-test and follow-up. Mediators: Cognitions about sleep and<br /><br>arousal; ecological momentary assessments will be analysed to examine which<br /><br>aspects (e.g. mood, fatigue) improved during the intervention. </p><br>