This is the first study to create and investigate the effectiveness of a multi-component intervention protocol in students with sleep problems. The aim is that such an intervention, combining cognitive-behavioural therapy for insomnia, mindfulness,…
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be improvement in self-reported sleep parameters
(Insomnia Severity Index and sleep diary).
Secondary outcome
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.
Background summary
It is well established that students suffer from a variety of sleep problems
and are at an age group which has a high risk of developing psychological
disorders. Sleep problems also proceed full-blown manifestations of depression
and anxiety disorders.
Several protocols have been developed to improve sleep problems, from sleep
education to cognitive behavioral therapy for insomnia. No single prevention
protocol in students so far has integrated and addressed a range of problems
(e.g. sleep, mood, lifestyle, stress). Such factors are interrelated in the
daily lives of students and are likely to cause a vicious circle.
Study objective
This is the first study to create and investigate the effectiveness of a
multi-component intervention protocol in students with sleep problems. The aim
is that such an intervention, combining cognitive-behavioural therapy for
insomnia, mindfulness, stress, and lifestyle components will improve sleep
quality, mood and quality of life and prevent onset of sleep disorders but also
depression and anxiety disorders in the long run.
Study design
Randomized-controlled trial
Study burden and risks
No risks are expected and foreseen from participating in this research. The
only burden is time that participants spend on assessments and intervention.
Participants are free to withdraw at any point.
Wassenaarseweg 52
Leiden 2333AK
NL
Wassenaarseweg 52
Leiden 2333AK
NL
Listed location countries
Age
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.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64330.058.17 |
| OMON | NL-OMON24628 |