The aim is that the SMILE 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 depression, anxiety in the long run.
ID
Bron
Verkorte titel
Aandoening
Sleep; mood; negative thoughts; slaap; stemming
Ondersteuning
Leiden Treatment and Expertise Center (Leiden Universitair Behandeling en Expertise Centrum)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Insomnia Severity Index<br>
2. Subjective sleep quality (as assessed with a sleep diary).
Achtergrond van het onderzoek
We created a multi-component intervention which combines different therapeutic elements in order to improve the sleep quality and mood of students. The intervention includes four 2-hour sessions (in groups of 6 participants). During the sessions we target a range of issues including: sleep hygiene, negative thoughts, worrying, stress and arousal, relaxation techniques, as well as perfectionistic tendencies, time planning and burnout. The aim is to give students ‘a bag of psychological tools’ to improve their sleep habits, mood and quality of life. The study design is a randomized-controlled trial, where participants are randomized to either the intervention group or to a waiting-list control group that receives the intervention at a later time point. Assessments include online questionnaires, but also ecological momentary assessments (mobile phone app questions that participants can answer in real time about their mood, energy levels, etc.) Participants will also wear a watch that measures activity and sleep quality before and after the intervention/waiting list.
Doel van het onderzoek
The aim is that the SMILE 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 depression, anxiety in the long run.
Onderzoeksopzet
3 timepoints (pre-, post- and follow-up (6 months).
Onderzoeksproduct en/of interventie
Group therapy vs. waiting list
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
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.
10. Current use of medication known to influence sleep (hypnotics, anxiolytics, recent onset of antidepressants, stimulants). When treatment with an antidepressant has started more than 3 months prior to study entry and dosage remains stable participants can be included.
11. Current substance use dependence.
12. Concurrent psychotherapy (CBT, including past CBT for sleep or depression).
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7284 |
| NTR-old | NTR7516 |
| CCMO | NL64330.058.17 |
| OMON | NL-OMON46359 |