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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
4 50-minute individual sessions every week for 4 weeks
The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.
Nagoya City University Graduate School of Medical Sciences
Nagoya, Aichi-ken, Japan
Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment
Time frame: at 8-week
"No clinically significant insomnia" at the 8-week assessment, which is defined as 7 or less on the total ISI score
Time frame: at 8-week
"No clinically significant insomnia" at the 4-week assessment, which is defined as 7 or less on the total ISI score
Time frame: at 4-week
Changes in the total ISI score between the baseline and the 4-week assessment
Time frame: at 4-week
Changes in the total score of the modified Pittsburgh Sleep Quality Index (PSQI) between the baseline and the 8-week assessment
Time frame: at 8-week
Changes in the total score of the modified PSQI between the baseline and the 4-week assessment
Time frame: at 4-week
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD) between the baseline and the 8-week assessment
Time frame: at 8-week
Changes in the 17- HAMD between the baseline and the 4-week assessment
Time frame: at 4-week
Changes in the Short Form 36 (SF-36) scores between the baseline and the 8-week assessment
Time frame: at 8-week
Changes in the SF-36 scores between the baseline and the 4-week assessment
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Time frame: at 4-week