Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to validate the effect of cognitive correction and stimulus control on correcting sleep cognitive distortions and improving maladaptive sleep behaviors.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive correction and stimulus control | Experimental |
| |
| Sleep hygiene education | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The change of PSQI total scores from baseline to 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. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongxing Wang, MD & PhD | Contact | +86 13911127385 | wanghongxing@xwh.ccmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | 100053 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sleep hygiene education | Behavioral |
|
|
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. |
| 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. | Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency). | 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. | 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. | 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. | 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. | Baseline, 6 weeks, 3 months, 6 months, and 12 months |
| The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 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). | Baseline, 6 weeks, 3 months, 6 months, and 12 months. |
| The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 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. | Baseline, 6 weeks, 3 months, 6 months, and 12 months |
| The change of Beck Depression Inventory (BDI) total scores from baseline to 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. | Baseline, 6 weeks, 3 months, 6 months, and 12 months |
| The change of Beck Anxiety Inventory (BAI) total scores from baseline to 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. | Baseline, 6 weeks, 3 months, 6 months, and 12 months |
| The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 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. | Baseline, 6 weeks, 3 months, 6 months, and 12 months |
| 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. | 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. | Baseline, 6 weeks, 3 months, 6 months, and 12 months |
| The change of Life Events Scale (LES) total scores from baseline to 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. | Baseline, 6 weeks, 3 months, 6 months, and 12 months |
| D001523 |
| Mental Disorders |