Sleep Restriction Treatment for Insomnia

VU University of Amsterdam

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: sleep restriction treatment; Behavioral: sleep diary monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05548907

2022-CP-15342

Details and patient eligibility

About

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)

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups, including a placebo group

Sleep restriction treatment

Experimental group

Description:

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

Treatment:

Behavioral: sleep restriction treatment

Sleep monitoring

Placebo Comparator group

Description:

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

Treatment:

Behavioral: sleep diary monitoring