Effects of Relaxation Training and Stimulus Control in Chronic Insomnia Patients

NCT ID: NCT06658171

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-11-01

Brief Summary

The study aims to validate the effect of relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.

Detailed Description

Relaxation training typically includes techniques such as breathing exercises, muscle relaxation, and mindfulness meditation to help patients reduce levels of physical and psychological tension, promote relaxation, and create favorable conditions for sleep onset. Stimulus control aims to break the negative association between the bed and insomnia, and rebuild a positive association between the bed and sleep.

Conditions

Chronic Insomnia

Study Design

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

Study Groups

Relaxation training and stimulus control

Group Type: EXPERIMENTAL

Relaxation training and stimulus control

Intervention Type: BEHAVIORAL

Relaxation 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

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

Relaxation training and stimulus control

Relaxation 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.

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. Meet the diagnostic criteria for insomnia disorder according to DSM-5.

2. Pittsburgh Sleep Quality Index (PSQI) total score > 5.

3. Age ≥ 18 years, with at least a middle school education level.

4. Anxiety symptoms meeting HAMA ≥ 14.

5. "Self-developed 8-item questionnaire on maladaptive sleep behaviors" used to assess "maladaptive sleep behaviors."

6. Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria

1. Individuals with severe physical illnesses or severe mental disorders, at risk of suicide.

2. Clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers.

3. Pregnant or lactating women.

4. Currently undergoing any 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

RT-SC-insomnia

Identifier Type: -

Identifier Source: org_study_id