Effects of Cognitive Correction and Stimulus Control in Chronic Insomnia Patients

Not Applicable

Recruiting

• Conditions: Chronic Insomnia

• Registration Number: NCT06658158
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

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. 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.

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 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, 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 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 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 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 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, 6 weeks, 3 months, 6 months, and 12 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