Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients

Not Applicable

Recruiting

• Conditions: Chronic Insomnia

• Registration Number: NCT06658184
• Lead Sponsor: Xuanwu Hospital, Beijing

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 Timeline

• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-26
• Study Start: 2024-12-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-09
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks	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 Outcome Measures

Name	Time	Method
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 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.
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 SHAPS assessing anhedonia consists of 14 items, and the total score ranges from 14 to 56 with higher scores indicating more serious the anhedonia.
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 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.
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 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.
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	Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency)
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 SF-36 quantifying the quality of life in relation to health status consists of 36-items with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The total score ranges from 0-100 (the worst possible to the most possible).
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 PHQ-4 comprises a 2-item depression scale and a 2-item anxiety scale. Each instrument can reach values from 0-6. Higher Scores are indicating higher distress.
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 BDI assessing the existence and severity of symptoms of depression consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe depressive symptoms.
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 BAI assessing the existence and severity of symptoms of anxiety consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe anxiety.
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 PHQ-15 measuring somatic distress consists of 15 items, and the total score ranges from 0 to 30 with higher scores indicating more severe somatic distress.
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 PDQ-D-5 assessing perceived cognitive deficits from the patient's perspective consists of 5 items, and the total score ranges from 0 to 20 with higher scores indicating greater perceived deficit.
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	The LES assessing the perceived stress and number of stressful life events experienced consists of 48 items which are classified into three dimensions: family life events (28 items), work and study events (13 items), and social events (7 items) with higher scores in LES perceived greater stressfulness.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China