Real-world evidence from users of a behavioral digital therapeutic for chronic insomnia

Ritterband, Lee M.; Thorndike, Frances P.; Morin, Charles M.; Gerwien, Robert; Enman, Nicole M.; Xiong, Xiaorui; Luderer, Hilary F.; Edington, Samantha; Braun, Stephen; Maricich, Yuri

doi:10.1016/j.brat.2022.104084

Cited by 27 publications

(23 citation statements)

References 39 publications

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“…Dr. Morin has also conducted extensive research on cognitive behavioral therapy for insomnia and its comorbidities ( 110 , 111 ). His team’s current efforts continue to focus on evaluating the efficacy of cognitive behavioral therapy and optimizing the procedural approach ( 112 , 113 ).…”

Section: Discussionmentioning

confidence: 99%

The top 100 most cited papers in insomnia: A bibliometric analysis

Wan

Wang

et al. 2023

Front. Psychiatry

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ObjectiveThe number of citations to a paper represents the weight of that work in a particular area of interest. Several highly cited papers are listed in the bibliometric analysis. This study aimed to identify and analyze the 100 most cited papers in insomnia research that might appeal to researchers and clinicians.MethodsWe reviewed the Web of Science (WOS) Core Collection database to identify articles from 1985 to 24 March 2022. The R bibliometric package was used to further analyze citation counts, authors, year of publication, source journal, geographical origin, subject, article type, and level of evidence. Word co-occurrence in 100 articles was visualized using VOS viewer software.ResultsA total of 44,654 manuscripts were searched on the Web of Science. Between 2001 and 2021, the top 100 influential manuscripts were published, with a total citation frequency of 38,463. The top countries and institutions contributing to the field were the U.S. and Duke University. Morin C.M. was the most productive author, ranking first in citations. Sleep had the highest number of manuscripts published in the top 100 (n = 31), followed by Sleep Medicine Reviews (n = 9). The most cited manuscript (Bastien et al., Sleep Medicine, 2001; 3,384 citations) reported clinical validation of the Insomnia Severity Index (ISI) as a brief screening indicator for insomnia and as an outcome indicator for treatment studies. Co-occurrence analyses suggest that psychiatric disorders combined with insomnia and cognitive behavioral therapy remain future research trends.ConclusionThis study provides a detailed list of the most cited articles on insomnia. The analysis provides researchers and clinicians with a detailed overview of the most cited papers on insomnia over the past two decades. Notably, COVID-19, anxiety, depression, CBT, and sleep microstructure are potential areas of focus for future research.

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Section: Discussionmentioning

confidence: 99%

The top 100 most cited papers in insomnia: A bibliometric analysis

Wan

Wang

et al. 2023

Front. Psychiatry

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“…Numerous RCTs, studies, and real-world evaluations 35 have convincingly demonstrated the effectiveness of digitally-delivered, CBT-I, but an evaluation of Somryst/SHUTi on HCRU outcomes has not previously been reported. The analyses presented in this paper demonstrate that use of the digital therapeutic was associated with long-term reductions in HCRU as well as reductions in per-patient health care costs.…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

“…Notably, these changes in ISI are consistent with previous clinical trials as well as real-world data where the persistent durability of the ISI response was observed at eighteen months after a single treatment with the digital therapeutic. 30,31,35 Given the heavy financial burden that chronic insomnia places on payers, employers, and state and federal healthcare programs, the clinical improvements and cost reductions demonstrated in these analyses are highly relevant and encouraging. Mental Health inequity is a major issue 43 and chronic insomnia patients have high rates of co-occurring depressive symptoms and anxiety symptoms.…”

Section: Dovepressmentioning

confidence: 99%

“…One of the most extensively studied digital therapeutics, Somryst/SHUTi has been evaluated in over 40 randomized clinical trials and studies. [30][31][32][33][34][35] The Somryst therapeutic delivers digital CBT-I and also allows for periodic assessment of key clinical variables such as insomnia severity index (ISI) score, sleep onset latency, and wake after sleep onset as well as symptoms of depression and anxiety. 36 Meta-analyses of randomized controlled trials (RCTs) have found that digitally delivered CBT-I is effective and can reduce insomnia severity.…”

Section: Introductionmentioning

confidence: 99%

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Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia

Forma¹,

Knight²,

Thorndike³

et al. 2022

CEOR

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Background and Objectives This analysis evaluated insomnia severity and long-term impact on healthcare resource utilization (HCRU) and costs after treatment with Somryst ® (previously called SHUTi), a digital therapeutic delivering cognitive behavioral therapy for insomnia (CBT-I). Methods Change from baseline in insomnia severity index (ISI) score was assessed using last observed ISI score. A pre/post analysis of claims data was conducted, comparing HCRU in patients with self-identified sleep problems who successfully initiated the therapeutic (index date) between June 1, 2016 and December 31, 2018. Results A total of 248 patients were analyzed (median age 56.5 years, 57.3% female, mean ISI score 19.13, 52.4% treated with sleep aid medications pre-index). After 9 weeks, mean ISI score declined by 37.2% from baseline (19.1 vs 12.0), 58.8% of patients achieved ISI responder status (ISI score improved by =>7; NNT: 1.7), and 26.6% of patients achieved insomnia remission (ISI score <8; NNT for remission: 3.8). After two-year follow-up, post-index events were reduced (compared to 2 years pre-index) for emergency department visits (−53%; IRR: 0.47; 95% CI 0.27, 0.82; P =0.008), hospiatizations (-21%; IRR: 0.79; 95% CI 0.46, 1.35; P =0.389) and hospital outpatient visits (−13%; IRR: 0.87; 95% CI 0.66, 1.14; P =0.315). Slightly increased rates were observed for ambulatory surgical center visits (2%; IRR: 1.02; 95% CI 0.73, 1.44; P =0.903) and office visits (2%; IRR: 1.02; 95% CI 0.92, 1.14; P =0.672). The number of patients treated with sleep aid medications dropped 18.5% (52.4% pre-index vs 42.7% post-index). Average number of prescriptions decreased from 3.98 pre-index to 3.73 post-index ( P = 0.552). Total two-year cost reduction post-index vs pre-index was $510,678, or -$2059 per patient. Conclusion In a real-world cohort of patients with chronic insomnia, treatment with a digital therapeutic delivering CBT-I was associated with reductions in insomnia severity, emergency department visits, and net costs.

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Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia

Zhang

et al. 2023

JAMA Netw Open

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ImportanceAlthough digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in many randomized clinical trials and is recommended as a first-line treatment option, few studies have systematically examined its effectiveness, engagement, durability, and adaptability in clinical settings.ObjectiveTo evaluate the clinical effectiveness, engagement, durability, and adaptability of dCBT-I.Design, Setting, and ParticipantsThis retrospective cohort study was conducted using longitudinal data collected via a mobile app named Good Sleep 365 between November 14, 2018, and February 28, 2022. Three therapeutic modes (ie, dCBT-I, medication, and their combination) were compared at month 1, month 3, and month 6 (primary). Inverse probability of treatment weighting (IPTW) using propensity scores was applied to enable homogeneous comparisons between the 3 groups.ExposuresTreatment with dCBT-I, medication therapy, or combination therapy according to prescriptions.Main Outcomes and MeasuresThe Pittsburgh Sleep Quality Index (PSQI) score and its essential subitems were used as the primary outcomes. Effectiveness on comorbid somnolence, anxiety, depression, and somatic symptoms were used as secondary outcomes. Cohen d effect size, P value, and standardized mean difference (SMD) were used to measure differences in treatment outcomes. Changes in outcomes and response rates (≥3 points change in PSQI score) were also reported.ResultsA total of 4052 patients (mean [SD] age, 44.29 [12.01] years; 3028 [74.7%] female participants) were selected for dCBT-I (n = 418), medication (n = 862), and their combination (n = 2772). Compared with the change in PSQI score at 6 months for participants receiving medication alone (from a mean [SD] of 12.85 [3.49] to 8.92 [4.03]), both dCBT-I (from a mean [SD] of 13.51 [3.03] to 7.15 [3.25]; Cohen d, −0.50; 95% CI, −0.62 to −0.38; P &lt; .001; SMD = 0.484) and combination therapy (from a mean [SD] of 12.92 [3.49] to 6.98 [3.43]; Cohen d, 0.50; 95% CI, 0.42 to 0.58; P &lt; .001; SMD = 0.518) were associated with significant reductions; dCBT-I had a comparable effect as combination therapy (Cohen d, 0.05; 95% CI, −0.05 to 0.15; P = .66; SMD = 0.05), but showed unstable durability. Outcomes of dCBT-I improved steadily and rapidly during the first 3 months, and then fluctuated. The response rates with dCBT-I and combination therapy were higher than with medication. Changes in secondary outcomes indicated statistically significant benefits from dCBT-I and combination therapy. The results of subgroup analysis were consistent with the main findings, demonstrating the superiority of dCBT-I vs medication therapy in various subpopulations.Conclusions and RelevanceIn this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits for insomnia. Future studies are needed to analyze its clinical effectiveness and reliability in distinct subpopulations.

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Real-world evidence from users of a behavioral digital therapeutic for chronic insomnia

Cited by 27 publications

References 39 publications

The top 100 most cited papers in insomnia: A bibliometric analysis

The top 100 most cited papers in insomnia: A bibliometric analysis

Real-World Evaluation of Clinical Response and Long-Term Healthcare Resource Utilization Patterns Following Treatment with a Digital Therapeutic for Chronic Insomnia

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia

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