No registrations found.
ID
Source
Brief title
Health condition
Sleep; mood; negative thoughts; slaap; stemming
Sponsors and support
Leiden Treatment and Expertise Center (Leiden Universitair Behandeling en Expertise Centrum)
Intervention
Outcome measures
Primary outcome
1. Insomnia Severity Index
2. Subjective sleep quality (as assessed with a sleep diary).
Secondary outcome
1. Objective sleep quality and quantity (as assessed with actigraphy); outcomes typically involve sleep efficiency, total sleep time, sleep onset latency and wake time after sleep onset.
2. Self-reported depressive symptoms (Beck Depression Inventory, BDI)
3. Self-reported anxiety symptoms (Hospital Anxiety and Depression scale – Anxiety Subscale, HADS-A)
4. Self-reported quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form, Q-LES-G-SF)
6.1.3 Other study parameters (if applicable)
Covariates: Demographic characteristics (age, gender), ethnicity, medication use, alcohol use, smoking, relationship status, children in household will be assessed at baseline via online questions.
Mediators: Ecological Momentary Assessments (positive /negative affect, alertness and fatigue). Online questionnaires: Dysfunctional Beliefs and Attitudes about Sleep (DBAS) and Pre-Sleep Arousal Scale (PSAS).
Background summary
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.
Study objective
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.
Study design
3 timepoints (pre-, post- and follow-up (6 months).
Intervention
Group therapy vs. waiting list
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
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7284 |
| NTR-old | NTR7516 |
| CCMO | NL64330.058.17 |
| OMON | NL-OMON46359 |