Sleep Restriction Treatment for Insomnia

Insomnia Clinical Trial

Official title:

Sleep Restriction Treatment for Insomnia: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05548907
• Other study ID #: 2022-CP-15342
• Status: Completed
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: November 11, 2023

Study information

• Verified date: December 2023
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: November 11, 2023
• Est. primary completion date: November 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• (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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• sleep restriction treatment
Treatment consists of sleep restriction treatment for insomnia. In this treatment, participants limit their bedtimes to the time they actually sleep. If they sleep most of the time in bed again then bedtimes are slowly built up again. This treatment technique has already been studied in several trials and found to be effective. Mode of delivery is an online booklet, online exercises and weekly telephone support
• sleep diary monitoring
As an active control condition people monitor their sleep with a sleep diary (also included in the sleep restriction intervention)

Locations

Country	Name	City	State
Netherlands	University of Amsterdam	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index	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.	Change from baseline to six weeks post-randomization
Secondary	Sleep diary: sleep onset latency	Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).	Change from baseline to six-weeks post-randomization
Secondary	Sleep diary: sleep onset latency	Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).	Change from baseline to six-month follow-up (intervention only)
Secondary	Sleep diary: wake after sleep onset	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).	Change from baseline to six-weeks post-randomization
Secondary	Sleep diary: wake after sleep onset	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 )	Change from baseline to six-month follow-up (intervention only)
Secondary	Sleep diary: terminal wakefulness	Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).	Change from baseline to six-weeks post-randomization
Secondary	Sleep diary: terminal wakefulness	Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).	Change from baseline to six-month follow-up (intervention only)
Secondary	Sleep diary: sleep efficiency	Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).	Change from baseline to six-weeks post-randomization
Secondary	Sleep diary: sleep efficiency	Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).	Change from baseline to six-month follow-up (intervention only)
Secondary	Sleep diary: total sleep time	Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).	Change from baseline to six-weeks post-randomization
Secondary	Sleep diary: total sleep time	Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).	Change from baseline to six-month follow-up (intervention only)
Secondary	Sleep diary: time in bed	Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).	Change from baseline to six-weeks post-randomization
Secondary	Sleep diary: time in bed	Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).	Change from baseline to six-month follow-up (intervention only)
Secondary	Cognitive arousal	cognitive arousal is measured daily with a visual analogue scale	Change from baseline to six weeks post randomization
Secondary	Somatic arousal	Somatic arousal is measured daily with a visual analogue scale	Change from baseline to six weeks post randomization
Secondary	Current sleepiness	Sleepiness is measured daily with a visual analogue scale	Change from baseline to six weeks post randomization
Secondary	Insomnia Severity	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.	Change from baseline to six-month follow-up (intervention only)
Secondary	Sleep safety	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).	Change from baseline to six weeks post-randomization
Secondary	Sleep safety	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).	Change from baseline to six-month follow-up (intervention only)
Secondary	Epworth Sleepiness Scale	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.	Change from baseline to six weeks post-randomization
Secondary	Epworth Sleepiness Scale	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.	Change from baseline to six-month follow-up (intervention only)
Secondary	Pre-sleep arousal	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).	Change from baseline to six weeks post-randomization
Secondary	Pre-sleep arousal	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).	Change from baseline to six-month follow-up (intervention only)
Secondary	Sleep-bed association	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)	Change from baseline to six weeks post-randomization
Secondary	Sleep-bed association	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)	Change from baseline to six-month follow-up (intervention only)
Secondary	Dysfunctional beliefs	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).	Change from baseline to six weeks post-randomization
Secondary	Dysfunctional beliefs	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).	Change from baseline to six-month follow-up (intervention only)
Secondary	Depression	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 a = 0.94; Spitzer et al., 1999). Higher scores indicating more depression.	Change from baseline to six weeks post-randomization
Secondary	Depression	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 a = 0.94; Spitzer et al., 1999). Higher scores indicating more depression.	Change from baseline to six-month follow-up (intervention only)
Secondary	Anxiety	Anxiety is measured with the Anxiety section of the Hospital Anxiety and Depression Scale (HADS-A; Cronbach's a = 0.84, seven items on a four-point Likert scale, scores ranging 0-21; Spinhoven et al., 1997). Higher scores indicating more anxiety.	Change from baseline to six weeks post-randomization
Secondary	Anxiety	Anxiety is measured with the Anxiety section of the Hospital Anxiety and Depression Scale (HADS-A; Cronbach's a = 0.84, seven items on a four-point Likert scale, scores ranging 0-21; Spinhoven et al., 1997). Higher scores indicating more anxiety.	Change from baseline to six-month follow-up (intervention only)
Secondary	Acceptance	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).	Change from baseline to six weeks post-randomization
Secondary	Acceptance	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).	Change from baseline to six-month follow-up (intervention only)
Secondary	Adverse events	Participants asked to report adverse events ("Did anything unpleasant happen to you that was related to your sleep or participation in the trial?"	Six-weeks post-randomization
Secondary	Treatment quality	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)	Six-weeks post-randomization
Secondary	Rating coach	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	Six-weeks post-randomization