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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Cbt-i plus program is an enhanced version of cbt-i program, which increases the response to depression and anxiety symptoms.
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.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
RECRUITINGChange of sleep efficiency
Sleep efficiency was measured by sleep diary Sleep efficiency was measured by sleep diary
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline Sleep efficiency at 8 weeks
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