Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients
ConditionChronic Insomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXuanwu Hospital, Beijing
About this trial
The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients\' sleep habits and maladaptive sleep behaviors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet the diagnostic criteria for insomnia disorder as per DSM-5.
Pittsburgh Sleep Quality Index (PSQI) total score > 5.
Age ≥ 18 years, at least a junior high school education level.
Assessment of sleep-wake behavior by sleep diary.
Disqualifiers
Presence of severe physical or severe mental illness, and suicide risk.
Clinical diagnosis or suspicion of sleep-breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as individuals working in rotating shifts or with shift work.
Pregnant or lactating women.
Currently undergoing any form of psychological therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
sleep restriction and stimulus control
BehavioralSleep restriction: a) Reduce bedtime to match actual sleep time, but ≥4.5 hours, and adjust bedtime according to sleep efficiency; b) Avoid daytime naps and maintain a regular wake-up time. Stimulus control: a) Reduce wakeful time in bed and rebuild a positive association between sleepiness and bed; b) Use the bed solely for sleeping and sexual activities; c) Only go to bed when feeling sleepy at night or at the designated sleep time; d) If unable to fall asleep within about 20 minutes of being in bed, leave the bedroom and engage in relaxation activities until feeling sleepy, then return to bed for sleep; if still unable to fall asleep within about 20 minutes, repeat the process; e) Wake up at the same time every morning, including weekends.
sleep hygiene education
BehavioralSleep hygiene education: 1. Sleep until feeling refreshed the next day. 2. Maintain regular exercise and eating habits, avoiding going to bed on an empty stomach. 3. Ensure a comfortable bedroom environment with suitable nighttime temperature, free from light and noise disturbances. 4. Avoid excessive consumption of beverages, alcohol, and smoking at night, and reduce caffeine intake. 5. Avoid bringing problems to bed and refrain from attempting to sleep. 6. Place the alarm clock under the bed or move it away from sight.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: sleep restriction and stimulus controlExperimental treatment 1 intervention
Group B: Sleep hygiene educationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
Time frame
Baseline, 6 weeksSecondary outcomes
1
The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months
The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
Time frame
baseline, 3 months, 6 months, and 12 months2
The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
The ISI reporting insomnia symptoms severity consists of 7-items on a 5-point Likert scale, and the total score ranges from 0 to 28 with higher scores indicating more severe insomnia.
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months3
The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency)
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months4
The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
The DBAS assessing sleep related cognitions in 16 items rated on a 10-point Likert scale, and the total score ranges from 0 to 160 with higher scores indicating more intensive dysfunctional beliefs.
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov