Sleep Restriction Treatment for Insomnia

NCT05548907 | Completed

• 1 other identifier: 2022-CP-15342
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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)

Conditions

Insomnia

Keywords

insomnia; behavioral treatment; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (35)

• Sleep diary: sleep onset latency

  Change from baseline to six-weeks post-randomization

• Sleep diary: sleep onset latency

  Change from baseline to six-month follow-up (intervention only)

• Sleep diary: wake after sleep onset

  Change from baseline to six-weeks post-randomization

• Sleep diary: wake after sleep onset

  Change from baseline to six-month follow-up (intervention only)

• Sleep diary: terminal wakefulness

  Change from baseline to six-weeks post-randomization

Study Arms (2)

Sleep restriction treatment

EXPERIMENTAL

In this condition participants receive a behavioral sleep restriction intervention for six weeks

Behavioral: sleep restriction treatment

Sleep monitoring

PLACEBO COMPARATOR

In this control condition people fill out a sleep diary for six weeks

Behavioral: sleep diary monitoring

Interventions

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 restriction treatment

sleep diary monitoring BEHAVIORAL

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

Sleep monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Insomnia Severity Index Score ≥ 10
• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• VU University of Amsterdam: lead

Study Sites (1)

University of Amsterdam

Amsterdam, North Holland, Netherlands

Location

Related Publications (1)

• Looman MI, Blanken TF, Schoenmakers TM, Reesen JE, Effting M, Linnebank FE, van Straten A, Kamphuis JH, Lancee J. Telephone-Guided Sleep Restriction for Insomnia: A Randomized Sleep Diary-Controlled Trial. Psychother Psychosom. 2025;94(3):147-161. doi: 10.1159/000545138. Epub 2025 Mar 21.

  PMID: 40122034 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jaap Lancee, PhD

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 22, 2022
• Study Start: September 20, 2022
• Primary Completion: November 11, 2023
• Study Completion: November 11, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)