Effects of Relaxation Training 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 relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet the diagnostic criteria for insomnia disorder according to DSM-5.
Pittsburgh Sleep Quality Index (PSQI) total score > 5.
Age ≥ 18 years, with at least a middle school education level.
Anxiety symptoms meeting HAMA ≥ 14.
Disqualifiers
Individuals with severe physical illnesses or severe mental disorders, at risk of suicide.
Clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers.
Pregnant or lactating women.
Currently undergoing any psychological therapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Relaxation training and stimulus control
BehavioralRelaxation training: Progressive muscle relaxation; Breathing relaxation; Imagery training; Mindfulness relaxation. 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
Behavioral1. 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. 7. Avoid daytime napping.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Relaxation training 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
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Source ClinicalTrials.gov