Clinical trial NCT05548907: Sleep Restriction Treatment for Insomnia
Official title: Sleep Restriction Treatment for Insomnia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: insomnia
behavioral treatment
randomized controlled trial
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial where participants are allocated to either a sleep restriction treatment condition or a sleep monitoring control condition. All participants keep a daily sleep diary and fill out weekly questionnaires
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Change from baseline to six weeks post-randomization
Secondary outcomes:
measure: Sleep diary: sleep onset latency
timeFrame: Change from baseline to six-weeks post-randomization
measure: Sleep diary: sleep onset latency
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Sleep diary: wake after sleep onset
timeFrame: Change from baseline to six-weeks post-randomization
measure: Sleep diary: wake after sleep onset
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Sleep diary: terminal wakefulness
timeFrame: Change from baseline to six-weeks post-randomization
measure: Sleep diary: terminal wakefulness
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Sleep diary: sleep efficiency
timeFrame: Change from baseline to six-weeks post-randomization
measure: Sleep diary: sleep efficiency
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Sleep diary: total sleep time
timeFrame: Change from baseline to six-weeks post-randomization
measure: Sleep diary: total sleep time
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Sleep diary: time in bed
timeFrame: Change from baseline to six-weeks post-randomization
measure: Sleep diary: time in bed
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Cognitive arousal
timeFrame: Change from baseline to six weeks post randomization
measure: Somatic arousal
timeFrame: Change from baseline to six weeks post randomization
measure: Current sleepiness
timeFrame: Change from baseline to six weeks post randomization
measure: Insomnia Severity
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Sleep safety
timeFrame: Change from baseline to six weeks post-randomization
measure: Sleep safety
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Epworth Sleepiness Scale
timeFrame: Change from baseline to six weeks post-randomization
measure: Epworth Sleepiness Scale
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Pre-sleep arousal
timeFrame: Change from baseline to six weeks post-randomization
measure: Pre-sleep arousal
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Sleep-bed association
timeFrame: Change from baseline to six weeks post-randomization
measure: Sleep-bed association
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Dysfunctional beliefs
timeFrame: Change from baseline to six weeks post-randomization
measure: Dysfunctional beliefs
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Depression
timeFrame: Change from baseline to six weeks post-randomization
measure: Depression
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Anxiety
timeFrame: Change from baseline to six weeks post-randomization
measure: Anxiety
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Acceptance
timeFrame: Change from baseline to six weeks post-randomization
measure: Acceptance
timeFrame: Change from baseline to six-month follow-up (intervention only)
measure: Adverse events
timeFrame: Six-weeks post-randomization
measure: Treatment quality
timeFrame: Six-weeks post-randomization
measure: Rating coach
timeFrame: Six-weeks post-randomization
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
state: Noord Holland
Study officials:
affiliation: University of Amsterdam
name: Jaap Lancee, PhD
role: PRINCIPAL_INVESTIGATOR
References: