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Completed

NCT Number: NCT05548907

Sleep Restriction Treatment for Insomnia

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)

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Amsterdam

Amsterdam, North Holland, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sleep restriction treatment

Behavioral

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

Behavioral

As an active control condition people monitor their sleep with a sleep diary (also included in the sleep restriction intervention)

Primary outcomes

  1. Insomnia Severity Index

    Time frame: 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 outcomes

  1. Sleep diary: sleep onset latency

    Time frame: Change from baseline to six-weeks post-randomization

    Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency).

  2. Sleep diary: sleep onset latency

    Time frame: 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).

  3. Sleep diary: wake after sleep onset

    Time frame: Change from baseline to six-weeks post-randomization

    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).

  4. Sleep diary: wake after sleep onset

    Time frame: 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 )

  5. Sleep diary: terminal wakefulness

    Time frame: Change from baseline to six-weeks post-randomization

    Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness).

  6. Sleep diary: terminal wakefulness

    Time frame: 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).

  7. Sleep diary: sleep efficiency

    Time frame: Change from baseline to six-weeks post-randomization

    Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).

  8. Sleep diary: sleep efficiency

    Time frame: 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).

  9. Sleep diary: total sleep time

    Time frame: Change from baseline to six-weeks post-randomization

    Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time).

  10. Sleep diary: total sleep time

    Time frame: 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).

  11. Sleep diary: time in bed

    Time frame: Change from baseline to six-weeks post-randomization

    Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed).

  12. Sleep diary: time in bed

    Time frame: 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).

  13. Cognitive arousal

    Time frame: Change from baseline to six weeks post randomization

    cognitive arousal is measured daily with a visual analogue scale

  14. Somatic arousal

    Time frame: Change from baseline to six weeks post randomization

    Somatic arousal is measured daily with a visual analogue scale

  15. Current sleepiness

    Time frame: Change from baseline to six weeks post randomization

    Sleepiness is measured daily with a visual analogue scale

  16. Insomnia Severity

    Time frame: 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.

  17. Sleep safety

    Time frame: Change from baseline to six weeks post-randomization

    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).

  18. Sleep safety

    Time frame: 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).

  19. Epworth Sleepiness Scale

    Time frame: Change from baseline to six weeks post-randomization

    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.

  20. Epworth Sleepiness Scale

    Time frame: 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.

  21. Pre-sleep arousal

    Time frame: Change from baseline to six weeks post-randomization

    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).

  22. Pre-sleep arousal

    Time frame: 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).

  23. Sleep-bed association

    Time frame: Change from baseline to six weeks post-randomization

    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)

  24. Sleep-bed association

    Time frame: 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)

  25. Dysfunctional beliefs

    Time frame: Change from baseline to six weeks post-randomization

    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).

  26. Dysfunctional beliefs

    Time frame: 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).

  27. Depression

    Time frame: Change from baseline to six weeks post-randomization

    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.

  28. Depression

    Time frame: 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.

  29. Anxiety

    Time frame: Change from baseline to six weeks post-randomization

    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.

  30. Anxiety

    Time frame: 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.

  31. Acceptance

    Time frame: Change from baseline to six weeks post-randomization

    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).

  32. Acceptance

    Time frame: 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).

  33. Adverse events

    Time frame: 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?"

  34. Treatment quality

    Time frame: 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)

  35. Rating coach

    Time frame: 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

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Official study title

Sleep Restriction Treatment for Insomnia: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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