Combination of Digital CBT and Traditional Medications Improves Insomnia, With Questions About Long-Term Sustainability

Zhengxing Huang, PhD

In a recently published retrospective cohort study assessing 3 therapeutic modes—digital cognitive behavioral therapy for insomnia (dCBT-I), medication therapy, and their combination—findings showed that dCBT-I was superior to medication therapy at 6-month follow-up, although results were found to be unstable.

Improvements in Pittsburgh Sleep Quality Index (PSQI) with dCBT-I and combination therapy were observed at the 6-month follow-up (dCBT-I: mean change from 13.51 [SD, 3.03] to 7.15 [SD, 3.25]; combination therapy: mean change from 12.92 [SD, 3.49] to 6.98 [SD, 3.43]), while pharmacological interventions (mean change from 12.85 [SD, 3.49] to 8.92 [SD, 4.03]) were less effective. At the conclusion of the analysis, investigators noted that further research is needed into the design, implementation, and delivery of dCBT-I in terms of engagement and stability.

"To our knowledge, this study is the first to systematically explore dCBT-I from multiple perspectives based on clinical data,” senior investigator Zhengxing Huang, PhD, a professor at the College of Biomedical Engineering and Instrument Science, Zhejiang University, and colleagues, wrote. "Overall, our main findings about effectiveness are consistent with previous findings that CBT-I can achieve better sleep health outcomes compared with medication therapy, combinations of CBT-I and medications had the potential to optimize outcomes."

Longitudinal data on 4052 patients with insomnia captured through the Good Sleep 365 mobile app from 2018 to 2022 were used for the analysis. Specifically, there were 418 (10.32%), 862 (21.27%), and 2772 (68.41%) in the dCBT-I, medication, and combination groups, respectively. Each of the therapeutic interventions was compared at month 1, 3, and 6, with Cohen d effect size, P value, and standardized mean difference (SMD) used to measure differences in treatment outcomes.

Overall, 77.30%, 81.97%, 76.19% of dCBT-I-treated participants were considered responders—at least a 3-point change in PSQI score—at 1-, 3, and 6-month follow-up. In contrast, 55.45%, 55.45%, and 54.08% of participants responded to medication therapy and 67.40%, 74.34%, and 76.31% of participants responded to combination therapy at the respective time points. Over the 6-month study, dCBT-I was found to be superior to medication therapy in terms of subjective sleep quality, sleep onset latency, sleep efficiency, and daytime dysfunction.

Secondary outcomes, which included the Epworth Sleepiness Scale, GAD-7, Patient Health Questionnaire (PHQ)-9, and PHQ-15, were all more greatly improved through dCBT-I. Throughout the study, the durability of the intervention was questioned. For example, treatment with dCBT-I produced a moderate effect on depression at month 1 (Cohen d, –0.63; 95% CI, –0.75 to –0.51; P <.001; SMD = 0.576), a moderate effect size at month 3 (Cohen d, –0.75; 95% CI, –0.87 to –0.63; P <.001; SMD = 0.667), and small effect size at month 6 (Cohen d, –0.40; 95% CI, –0.51 to –0.28; P = .004; SMD = 0.381).

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Over the 6-month study, symptoms of patients on combination therapy steadily improved, with sustainable changes on all outcomes. After 3 months of intervention, those on a combination approach showed gradual stability within a certain range on primary outcomes whereas outcomes for those on dCBT-I fluctuated. Combination therapy also had persistent and steady downward trends in improving secondary outcomes in comparison with dCBT-I, which had a rebound trend after 5 months, whereas medication monotherapy was slower to improve these comorbid disorders.

Within the first month of dCBT-I treatment, 56.02%, 80.03%, and 94.14% of participants completed sleep hygiene (SH), sleep restriction (SR), and relaxation training (RT), respectively, while only 8.78% and 8.93% participated in stimulus control (SC) and cognitive reconstruction (CR). Following that, investigators observed a downward trend in patients engaging in SH (from 56.03% to 8.56%), SR (80.03 to 42.66%), and RT (94.14% to 49.91%) while particiaptns in CR and SC increased gradually in the first 3 months.

"This observation is intuitive because in the dCBT-I program, the 5 sessions are organized in the order of SH, RT, SR, SC, and CR,” the study investigators wrote. “Overall, patient adherence during the dCBT-I program (the first 3 months) was significantly better than after the program."

REFERENCE
1. Lu M, Zhang Y, Zhang J, et al. Comparative effectiveness of digital cognitive behavioral therapy vs medication therapy among patients with insomnia. JAMA Netw Open. 2023;6(4):e237597