Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients

NCT ID: NCT06658158

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-01

Brief Summary

This study aims to validate the effect of cognitive correction and stimulus control on correcting sleep cognitive distortions and improving maladaptive sleep behaviors.

Detailed Description

Cognitive correction aims to identify and change patients' erroneous beliefs and attitudes about sleep, which may include exaggerated sleep needs, excessive worry about the consequences of insomnia, and unrealistic expectations about bedtime. Stimulus control, on the other hand, focuses on modifying patients' behaviors in bed, linking the bed with a rapid onset of sleep, and reducing the negative association between the bed and insomnia.

Conditions

Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cognitive correction and stimulus control

Group Type: EXPERIMENTAL

Cognitive correction and stimulus control

Intervention Type: BEHAVIORAL

Cognitive correction:

a) correcting unrealistic sleep expectations; b) maintaining a natural sleep onset; c) avoiding worry about losing control oversleep; d) not associating nocturnal dreaming with adverse daytime consequences; e) avoiding feelings of frustration due to one night of poor sleep; f) developing tolerance to the impact of insomnia and avoiding compensatory behaviors.

Stimulus control:

1. Minimize wakefulness during time in bed and establish a positive association between sleepiness and the bed.

2. Use the bed only for sleep and sexual activities.

3. Go to bed only when feeling sleepy at night or at the designated sleep time.

4. If unable to fall asleep within approximately 20 minutes of being in bed, leave the bedroom, engage in relaxing activities, and return to bed when feeling sleepy. Repeat this process if unable to fall asleep within approximately 20 minutes.

5. Wake up at the same time every morning, including weekends.

Sleep hygiene education

Group Type: ACTIVE_COMPARATOR

Sleep hygiene education

Intervention Type: BEHAVIORAL

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.

7. Avoid daytime napping.

Interventions

Cognitive correction and stimulus control

Cognitive correction:

a) correcting unrealistic sleep expectations; b) maintaining a natural sleep onset; c) avoiding worry about losing control oversleep; d) not associating nocturnal dreaming with adverse daytime consequences; e) avoiding feelings of frustration due to one night of poor sleep; f) developing tolerance to the impact of insomnia and avoiding compensatory behaviors.

Stimulus control:

1. Minimize wakefulness during time in bed and establish a positive association between sleepiness and the bed.

2. Use the bed only for sleep and sexual activities.

3. Go to bed only when feeling sleepy at night or at the designated sleep time.

4. If unable to fall asleep within approximately 20 minutes of being in bed, leave the bedroom, engage in relaxing activities, and return to bed when feeling sleepy. Repeat this process if unable to fall asleep within approximately 20 minutes.

5. Wake up at the same time every morning, including weekends.

Intervention Type: BEHAVIORAL

Sleep 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.

7. Avoid daytime napping.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Meets the diagnostic criteria for insomnia disorder according to DSM-5;

2. PSQI total score > 5;

3. Age ≥ 18 years, with at least a junior high school education;

4. Sleep cognitive distortions assessed using the DBAS-16;

5. "Maladaptive Sleep Behavior Questionnaire - 8 items" used to assess "maladaptive sleep behaviors";

6. Willing to participate in the study and sign an informed consent form.

Exclusion Criteria

1. Presence of severe physical illness or serious mental disorders, or at risk for suicide;

2. Clinically diagnosed or suspected sleep-related breathing disorders, restless legs syndrome, and circadian rhythm sleep-wake disorders; shift workers;

3. Pregnant or lactating women;

4. Currently undergoing any form of psychological therapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongxing Wang, MD & PhD

Role: CONTACT

wanghongxing@xwh.ccmu.edu.cn

+86 13911127385

Other Identifiers

CC+SC-insomnia

Identifier Type: -

Identifier Source: org_study_id