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Objective to explore whether cbt-i plus is more effective and feasible for patients with insomnia complicated with anxiety and depression than the traditional cognitive behavioral therapy for insomnia.
Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
The purpose of this study was to explore the treatment of cognitive behavioral enhancement of insomnia (cbt-i plus), which was randomly divided into cbt-i plus intervention group (Study Group) and cbt-i intervention group (control group). The study group used the unified cognitive behavioral therapy manual for insomnia (cbt-i plus) for one-to-one individual treatment intervention, once a week, 45-50 minutes each time, a total of 8 times; the control group used the unified cognitive behavioral therapy manual for insomnia (cbt-i) for one-on-one treatment intervention, once a week, 45-50 minutes each time, a total of 8 times. The related indexes were evaluated at baseline, 2 weeks, 4 weeks and 8 weeks after enrollment, and were followed up at 12 weeks and 24 weeks after enrollment. Hypothesis: cbt-i plus is superior to cbt-i in efficacy and feasibility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | The study group was treated with intensive cognitive behavioral therapy for insomnia. |
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| control group | Active Comparator | The control group was treated with traditional cognitive behavioral therapy for insomnia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plus Cognitive behavioral therapy of insomnia(CBT-I plus) | Behavioral | Cbt-i plus program is an enhanced version of cbt-i program, which increases the response to depression and anxiety symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of sleep efficiency | Sleep efficiency was measured by sleep diary Sleep efficiency was measured by sleep diary | Change from Baseline Sleep efficiency at 8 weeks |
| Change of depressive symptoms | The measurement tool is Hamilton Depression Scale-17 items,the minimum score of the scale was 0 and the maximum score was 52. The higher the score was, the more serious the depression was. | Change from Baseline Sleep efficiency at 8 weeks |
| Change of anxiety symptoms | The measurement tool is Hamilton Anxiety Scale, the minimum score of the scale was 0 and the maximum score was 56. The higher the score was, the more serious the anxiety was. | Change from Baseline Sleep efficiency at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengmei Yuan | Contact | 86-13818132592 | yuanchengmei@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Chengmei Yuan | Shanghai Mental Health Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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In this study, patients were randomly assigned to study group and control group by random number table.
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The blind method of this study is evaluator blindness, that is, the evaluator does not know the grouping of subjects.
| Cognitive behavioral therapy of insomnia(CBT-I) | Behavioral | Cognitive behavioral therapy of insomnia is mainly aimed at correcting the bad behaviors and beliefs among the maintenance factors of insomnia, which is considered as the first-line treatment program of insomnia disorder. Cognitive behavioral therapy of insomnia mainly includes five important components: sleep restriction, secondary control, cognitive therapy, relaxation therapy and sleep hygiene. |
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| D001523 |
| Mental Disorders |