Clinical trial NCT06658184: Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients
Official title: Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients With Prolonged Bed Rest and Maladaptive Sleep Patterns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Keywords: chronic insomnia
sleep restriction
stimulus control
sleep hygiene education
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients\&#39; sleep habits and maladaptive sleep behaviors.

Detailed description: The purpose of sleep restriction is to reduce the patient\&#39;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.

Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria for insomnia disorder as per DSM-5.
2. Pittsburgh Sleep Quality Index (PSQI) total score \> 5.
3. Age ≥ 18 years, at least a junior high school education level.
4. Assessment of sleep-wake behavior by sleep diary.
5. Assessment of "maladaptive sleep behavior" by self-designed 8-item questionnaire.
6. Voluntary participation in the study and signing an informed consent form.

Exclusion Criteria:

1. Presence of severe physical or severe mental illness, and suicide risk.
2. 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.
3. Pregnant or lactating women.
4. Currently undergoing any form of psychological therapy.

Primary outcomes:
measure: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: 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
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months.
measure: The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: 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
timeFrame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
measure: The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References: