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| ID | Type | Description | Link |
|---|---|---|---|
| HLSRG (Ministry of Health) |
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| Name | Class |
|---|---|
| Kochi University | OTHER |
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The purpose of this study is to examine the effectiveness of brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) in comparison with TAU alone for refractory insomnia among patients with major depression in partial remission.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) |
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| 2 | Active Comparator | Treatment as usual (TAU) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brief behavioral therapy for insomnia (bBT-I) | Behavioral | 4 50-minute individual sessions every week for 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment | at 8-week |
| Measure | Description | Time Frame |
|---|---|---|
| "No clinically significant insomnia" at the 8-week assessment, which is defined as 7 or less on the total ISI score | at 8-week | |
| "No clinically significant insomnia" at the 4-week assessment, which is defined as 7 or less on the total ISI score | at 4-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshiaki A Furukawa, MD, PhD | Nagoya City University Graduate School of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya City University Graduate School of Medical Sciences | Nagoya | Aichi-ken | 467-8601 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24733990 | Derived | Shimodera S, Watanabe N, Furukawa TA, Katsuki F, Fujita H, Sasaki M, Perlis ML. Change in quality of life after brief behavioral therapy for insomnia in concurrent depression: analysis of the effects of a randomized controlled trial. J Clin Sleep Med. 2014 Apr 15;10(4):433-9. doi: 10.5664/jcsm.3624. | |
| 21457679 | Derived |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual (TAU) | Other | The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy. |
|
| Changes in the total ISI score between the baseline and the 4-week assessment | at 4-week |
| Changes in the total score of the modified Pittsburgh Sleep Quality Index (PSQI) between the baseline and the 8-week assessment | at 8-week |
| Changes in the total score of the modified PSQI between the baseline and the 4-week assessment | at 4-week |
| Changes in the 17-item Hamilton Rating Scale for Depression (HAMD) between the baseline and the 8-week assessment | at 8-week |
| Changes in the 17- HAMD between the baseline and the 4-week assessment | at 4-week |
| Changes in the Short Form 36 (SF-36) scores between the baseline and the 8-week assessment | at 8-week |
| Changes in the SF-36 scores between the baseline and the 4-week assessment | at 4-week |
| Watanabe N, Furukawa TA, Shimodera S, Morokuma I, Katsuki F, Fujita H, Sasaki M, Kawamura C, Perlis ML. Brief behavioral therapy for refractory insomnia in residual depression: an assessor-blind, randomized controlled trial. J Clin Psychiatry. 2011 Dec;72(12):1651-8. doi: 10.4088/JCP.10m06130gry. Epub 2011 Mar 8. |