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Meta-Analysis of the Effectiveness and Safety of Shugan Jieyu Capsules for the Treatment of Insomnia
Published on: February 17, 2023
Comparative effectiveness and predictors of cognitive behavioral therapy for insomnia and its components in older
Kathleen P O'Hora1, Allison B Morehouse1, Leah Freidman2
1Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California.
Study Objectives:
To determine the relative effectiveness and predictors of cognitive therapy (CT), behavioral therapy (BT), and cognitive behavioral therapy (CBT) for insomnia in older adults.
Methods:
In a registered clinical trial (NCT02117388), 128 older adults with insomnia disorder were randomly assigned to receive CBT, BT, or CT. Insomnia Severity Index (ISI) score was the primary outcome. Sleep diaries, fatigue, beliefs about sleep, cognitive arousal, and stress were secondary outcomes. Split-plot linear mixed models assessed within- and between-subject changes in outcomes among the treatments. As a secondary analysis, we used linear regression to test predictors of insomnia symptoms improvement, including sleep diary measures, cognitive arousal, stress, beliefs about sleep, baseline ISI score, and age. Benjamini-Hochberg correction was applied.
Results:
All groups exhibited insomnia symptom reduction at posttreatment (CT: d = -2.53, P < .001; BT: d = -2.39, P < .001; CBT: d = -2.90, P < .001) and at the 6-month follow-up (CT: d = -2.68, P < .001; BT: d = -2.85, P < .001; CBT: d = -3.14, P < .001). There were no group differences in the magnitude of ISI improvement (Padj = .63), response (Padj > .63), or remission (ISI < 8; Padj > .27). All groups exhibited significant improvements in secondary outcomes at posttreatment (Padj < .05) and at the 6-month follow-up (Padj < .05). At posttreatment, the CT and CBT groups showed greater reductions in beliefs about sleep than the BT group (FInteraction(2,185) = 5.99, Padj = .03), and the CBT group showed a greater time in bed reduction than the CT group (FInteraction(2,185) = 7.05, Padj = .01). Baseline ISI was the only treatment predictor (b = 1.95, Padj < .001).
Conclusions:
CBT for insomnia and its components each independently result in significant improvements in self-reported insomnia symptoms, beliefs about sleep, worry, and fatigue in older adults.
Clinical Trial Registration:
Registry: ClinicalTrials.gov; Name: Treatments for Insomnia: Mediators, Moderators and Quality of Life; URL: https://clinicaltrials.gov/study/NCT02117388; Identifier: NCT02117388.
Citation:
O'Hora KP, Morehouse AB, Freidman L, et al. Comparative effectiveness and predictors of cognitive behavioral therapy for insomnia and its components in older adults: main outcomes of a randomized dismantling trial. J Clin Sleep Med. 2025;21(10):1679-1695.
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