Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients

NCT06658158 | Recruiting

• 1 other identifier: CC+SC-insomnia
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia

Keywords

chronic insomnia; cognitive correction; stimulus control; sleep hygiene education

Outcome Measures

Primary Outcomes (1)

• The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 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.

  Baseline, 6 weeks

Secondary Outcomes (12)

• The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months.

  Baseline, 3 months, 6 months, 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

Study Arms (2)

Cognitive correction and stimulus control

EXPERIMENTAL

Behavioral: Cognitive correction and stimulus control

Sleep hygiene education

ACTIVE COMPARATOR

Behavioral: Sleep hygiene education

Interventions

Cognitive correction and stimulus control 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.

Cognitive correction and stimulus control

Sleep hygiene education 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.

Sleep hygiene education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the diagnostic criteria for insomnia disorder according to DSM-5;
• PSQI total score \> 5;
• Age ≥ 18 years, with at least a junior high school education;
• Sleep cognitive distortions assessed using the DBAS-16;
• "Maladaptive Sleep Behavior Questionnaire - 8 items" used to assess "maladaptive sleep behaviors";
• Willing to participate in the study and sign an informed consent form.

You may not qualify if:

• Presence of severe physical illness or serious mental disorders, or at risk for suicide;
• Clinically diagnosed or suspected sleep-related breathing disorders, restless legs syndrome, and circadian rhythm sleep-wake disorders; shift workers;
• Pregnant or lactating women;
• Currently undergoing any form of psychological therapy.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+86 13911127385; wanghongxing@xwh.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: December 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)