Sleep Restriction Treatment for Insomnia
- Conditions
- Insomnia
- Interventions
- Behavioral: sleep restriction treatmentBehavioral: sleep diary monitoring
- Registration Number
- NCT05548907
- Lead Sponsor
- VU University of Amsterdam
- Brief Summary
With a prevalence of about 10% chronic insomnia is a common problem. The standard treatment for insomnia is cognitive behavioral therapy. According to many, the core element within this treatment is sleep restriction. This element has been examined separately in a couple of studies and also appears to be effective in isolation. In the current study the aim is to get more information about the effectiveness of this core element of the treatment. For this reason, a randomized study is conducted to compare sleep restriction with a diary control condition.
The second aim in this study is to determine mechanisms behind treatments. Network intervention analysis will be used to determine which specific symptoms are associated with therapy success. This is the reason that throughout the study weekly and daily measures will be conducted.
The expectations are that:
* Participants in the sleep restriction condition will improve more on insomnia complaints than the sleep diary control condition (primary outcome)
* Participants in the sleep restriction condition will improve more on sleep diary outcomes and other secondary outcomes compared to the sleep diary control condition (secondary outcome)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- Insomnia Severity Index Score ≥ 10
- 18 years or older
- Self reported insomnia complaints: being awake ≥30 minutes per night, ≥3 nights per week, ≥ 3 months
- Daytime problems related to sleep complaints
- Sleep efficiency < 85%
- Dutch speaking
- (1) No acces to internet
- (2) Pregnant or breastfeeding
- (3) working in night shifts
- (4) currently in psychological treatment (started < 6 months) or on wait-list for treatment
- (5) cognitive behavioral treatment for insomnia in last 12 months
- (6) concrete suicidal ideation
- (7) schizophrenic or psychotic disorder
- (8) high level of depressive complaints (BDI-II > 28)
- (9) Instable medication use (medication should not be tampered in last 6 weeks) incidental sleep-medication use is allowed
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep restriction treatment sleep restriction treatment In this condition participants receive a behavioral sleep restriction intervention for six weeks Sleep monitoring sleep diary monitoring In this control condition people fill out a sleep diary for six weeks
- Primary Outcome Measures
Name Time Method Insomnia Severity Index Change from baseline to six weeks post-randomization The Insomnia Severity Index is a seven item-scale scored on a five-point Likert scale (Bastien et al. 2001). The total score ranges from 0 to 28. Higher scores indicate more insomnia.
- Secondary Outcome Measures
Name Time Method Cognitive arousal Change from baseline to six weeks post randomization cognitive arousal is measured daily with a visual analogue scale
Sleep diary: sleep onset latency Change from baseline to six-month follow-up (intervention only) Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).
Sleep diary: time in bed Change from baseline to six-month follow-up (intervention only) Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).
Current sleepiness Change from baseline to six weeks post randomization Sleepiness is measured daily with a visual analogue scale
Depression Change from baseline to six-month follow-up (intervention only) Depression is measured with the Dutch version of a nine-item depression scale, the Patient Health Questionnaire-9 (PHQ-9; range 0-27, Cronbach's α = 0.94; Spitzer et al., 1999). Higher scores indicating more depression.
Acceptance Change from baseline to six-month follow-up (intervention only) Acceptance is measured with 10-items of the 'flexibiliteits index test'. Items are scored on a 7-point Likert scale (0-6) and higher scores indicate more acceptance (range 0-60).
Sleep diary: wake after sleep onset Change from baseline to six-month follow-up (intervention only) Wake after sleep onset is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer wake after sleep onset )
Pre-sleep arousal Change from baseline to six-month follow-up (intervention only) Sleep-related arousal was measured with the Pre-sleep Arousal Scale (PSAS) (Nicassio et al. 1985). The PSAS consists of 16 items that range from 1 ('not at all') to 5 ('extremely'), higher scores indicating more arousal (range 16-80).
Dysfunctional beliefs Change from baseline to six-month follow-up (intervention only) Dysfunctional beliefs about sleep are measured using the 16-item Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16) (Morin et al. 2017). Items are scored on an 11-point Likert scale (0-10). Higher scores indicating more dysfunctional beliefs (range 0-160).
Rating coach Six-weeks post-randomization Coaches are rated with a single question 'how satisfied were you with your coach during the treatment'. This is rated on an 11-point Likert scale (0-10) with higher scores indicating more satisfaction
Sleep diary: terminal wakefulness Change from baseline to six-month follow-up (intervention only) Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).
Sleep diary: sleep efficiency Change from baseline to six-month follow-up (intervention only) Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Insomnia Severity Change from baseline to six-month follow-up (intervention only) The Insomnia Severity Index is a seven item-scale scored on a five-point Likert scale (Bastien et al. 2001). The total score ranges from 0 to 28. Higher scores indicate more insomnia.
Epworth Sleepiness Scale Change from baseline to six-month follow-up (intervention only) To assess daytime sleepiness the Epworth Sleepiness Scale (ESS) is used. The ESS consists of 8-items on a 4-point Likert scale (range 0-24) with higher scores indicating more sleepiness.
Anxiety Change from baseline to six-month follow-up (intervention only) Anxiety is measured with the Anxiety section of the Hospital Anxiety and Depression Scale (HADS-A; Cronbach's α = 0.84, seven items on a four-point Likert scale, scores ranging 0-21; Spinhoven et al., 1997). Higher scores indicating more anxiety.
Sleep diary: total sleep time Change from baseline to six-month follow-up (intervention only) Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).
Somatic arousal Change from baseline to six weeks post randomization Somatic arousal is measured daily with a visual analogue scale
Sleep-bed association Change from baseline to six-month follow-up (intervention only) Sleep-bed association is measured with a newly constructed scale of 5 items on a 7-point Likert scale (0-6). Higher scores indicating a stronger sleep-bed association (range 0-30)
Sleep safety Change from baseline to six-month follow-up (intervention only) Sleep safety behaviors are measured with the Dutch translation of the 32-item Sleep-Related Behaviors Questionnaire-SRBQ (Ree \& Harvey, 2004). The total score ranges from 0 (no safety behaviors) to 128 (severe safety behaviors).
Adverse events Six-weeks post-randomization Participants asked to report adverse events ("Did anything unpleasant happen to you that was related to your sleep or participation in the trial?"
Treatment quality Six-weeks post-randomization Treatment quality is rated with a single question 'how do you rate the treatment'. This is rated on an 11-point Likert scale (0-10) with higher scores indicating more satisfaction (intervention only)
Trial Locations
- Locations (1)
University of Amsterdam
🇳🇱Amsterdam, Noord Holland, Netherlands