NCT06658184RecruitingNot Applicable
Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients With Prolonged Bed Rest and Maladaptive Sleep Patterns
Xuanwu Hospital, Beijing1 site in 1 country88 target enrollmentStarted: December 1, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
Study Overview
Brief Summary
The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients' sleep habits and maladaptive sleep behaviors.
Detailed Description
The purpose of sleep restriction is to reduce the patient's time in bed, bringing it closer to their actual sleep time, thereby improving sleep efficiency and quality. Stimulus control, on the other hand, aims to associate the bed with a rapid sense of falling asleep, reducing the negative association between the bed and insomnia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meet the diagnostic criteria for insomnia disorder as per DSM-
- •Pittsburgh Sleep Quality Index (PSQI) total score >
- •Age ≥ 18 years, at least a junior high school education level.
- •Assessment of sleep-wake behavior by sleep diary.
- •Assessment of "maladaptive sleep behavior" by self-designed 8-item questionnaire.
- •Voluntary participation in the study and signing an informed consent form.
Exclusion Criteria
- •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.
Arms & Interventions
Sleep hygiene education
Active Comparator
Intervention: sleep hygiene education (Behavioral)
sleep restriction and stimulus control
Experimental
Intervention: sleep restriction and stimulus control (Behavioral)
Outcomes
Primary Outcomes
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
Time Frame: Baseline, 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.
Secondary Outcomes
- The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months(baseline, 3 months, 6 months, and 12 months)
- The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- 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(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months.)
- The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months(Baseline, 6 weeks, 3 months, 6 months, and 12 months)
- The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
Investigators
Study Sites (1)
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