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Randomized controlled trial on the effects of a combined sleep hygiene education and behavioral approach program on sleep quality in workers with insomnia
Kaku A, Nishinoue N, Takano T, Eto R, Kato N, Ono Y, Tanaka K
Industrial Health 2012;50(1):52-59
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

To evaluate the effects of a combined sleep hygiene education and behavioral approach program on sleep quality in workers with insomnia, we conducted a randomized controlled trial at a design engineering unit in Japan. Employees evaluated for insomnia by the Athens Insomnia Scale (>= 6 points) were divided into an intervention and control group. The intervention group received a short-term intervention (30 min) program that included sleep hygiene education and behavioral approaches (relaxation training, stimulus control, and sleep restriction) performed by occupational health professionals. We calculated differences in change in Pittsburgh Sleep Quality Index (PSQI) scores between the two groups from baseline to three months after the start of intervention after adjusting for gender, age, job title, job category, average number of hours of overtime during the study period, marital status, smoking habit, average number of days of alcohol consumption per week, exercise habits, K6 score, and baseline PSQI score. Results showed that the average PSQI score decreased by 1.0 in the intervention group but increased by 0.9 in the control group. Additionally, the difference in variation between the two groups was 1.9 (95% confidence interval: 0.6 to 3.4), which was significant. Taken together, these results indicate that the intervention program significantly improved the sleep quality of workers with insomnia.

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