Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia

Chow, Philip I.; Ingersoll, Karen S.; Thorndike, Frances P.; Lord, Holly; Gönder-Frederick, Linda; Morin, Charles M.; Ritterband, Lee M.

doi:10.1016/j.sleep.2017.11.1140

Cited by 42 publications

(30 citation statements)

References 39 publications

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“…A further limitation of our study is that the follow-up period is rather short, given that the persistence of iCBT-I treatment effect remains questionable. A study of Sleep Healthy Using the Internet (SHUTi) CBT-I program proved maintenance of the treatment effect after an 18-month follow-up period ( 80 , 81 ). Another study reports that the effects of iCBT-I were maintained for 36 months; however, insomnia severity in iCBT-I did not differ statistically from the control group at the end of the follow-up ( 82 ).…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and Cost-Effectiveness of Internet-Based Cognitive Behavioral Therapy for Insomnia in Clinical Settings

et al. 2020

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Background: Internet-delivered cognitive-behavior treatment for insomnia (iCBT-I) has the potential to fill the gap created by the discrepancy between insomnia cases and number of trained professionals. Although the effectiveness of this method was proven in multiple studies conducted in research settings, its feasibility in routine care is still unclear. Predictors, mediators, and moderators of treatment effect remain uncertain since previous studies often give contradictory results. The present study aims to investigate clinical effectiveness and cost-effectiveness of an internet-based CBT-I program Sleepsy in comparison with care as usual (CAU) among patients with CI recruited from clinical settings. Baseline data will be further analyzed to find predictors of treatment outcome. Methods/Design: The proposed study is a parallel-group randomized controlled trial comparing CAU plus iCBT-I with CAU in a clinical setting. One hundred ten participants will be referred from the medical doctors in Moscow. Both groups will have access to CAU, which corresponds to the treatment prescribed by the referring doctor. Patients of the first group will additionally get access to the iCBT-I program with the opportunity to contact a specialist (guidance on request) in a secured environment. The primary outcome is insomnia severity change from pre-to post-treatment. Secondary outcomes include change of subjective sleep characteristics, life quality, fatigue, daytime sleepiness, comorbid affective disorders, dysfunctional beliefs about sleep, sleep hygiene, healthcare consumption, productivity losses, and longer term outcomes at 3 months follow-up. Predictor analysis will include baseline scores of the aforementioned outcomes along with treatment expectancies and personality traits. Discussion: The proposed study is one of the first studies evaluating whether iCBT-I also works in routine care. We expect that recruitment of the participants let us determine the target group more precisely and exclude health problems interfering with treatment. Using CAU as control condition may result in a loss of power to detect a meaningful difference.

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Section: Discussionmentioning

confidence: 99%

Effectiveness and Cost-Effectiveness of Internet-Based Cognitive Behavioral Therapy for Insomnia in Clinical Settings

et al. 2020

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“…The insomnia and sleep outcomes from 2 pivotal clinical trials that supported FDA-clearance of Somryst are discussed below for the purposes of this review; however, additional outcomes based on secondary analyses of each study have also been published [45,47,52,53].…”

Section: Data From Pre-fda Clearance Studiesmentioning

confidence: 99%

Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy

Morin

2020

Expert Review of Medical Devices

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Introduction: Prescription digital therapeutics (PDTs) represent a new class of software-based medical devices authorized by the Food and Drug Administration (FDA) to treat disease. Somryst ™ , the first PDT for treating chronic insomnia, delivers cognitive behavioral therapy for insomnia (CBT-I) via a mobile application. CBT-I is the guideline-recommended, first-line treatment for chronic insomnia, but availability of CBT-I therapists is limited. Somryst addresses this need by providing asynchronous access to CBT-I treatment. As a contactless therapeutic medium, Somryst is also an ideal option when face-to-face therapy is not available or recommended for safety reasons (e.g. because of possible exposure to the SARS-CoV-2 virus). Areas covered: This review summarizes the mechanisms of action and technical features of Somryst, and describes safety and effectiveness data from the randomized trials on which FDA clearance was based. Expert opinion: Somryst demonstrates robust clinical efficacy with a favorable benefit-to-risk profile for treating adults with chronic insomnia. FDA clearance was based on data from 2 clinical trials of the firstgeneration web-based CBT-I platform Sleep Healthy Using the Internet (SHUTi). Somryst, and PDTs in general, are promising devices to address the need for greater accessibility to effective therapies.

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“…Several cognitive processes have been hypothesized to mediate insomnia improvement. In the past 5 years, the evidence for a role of dysfunctional beliefs about sleep as a mediating factor in the improvement of insomnia after dCBT has grown substantially [ 30 , 51 , 58 ]. Additionally, knowledge, locus of control, sleep-related worry, and pre-sleep arousal have been suggested to mediate improvement in sleep [ 51 , 58 ].…”

Section: Evidence For Dcbt For Insomniamentioning

confidence: 99%

“…This can also further improve treatment and reduce attrition. Although several studies have increased our understanding [ 30 , 47 , 51 , 52 •, 55 , 58 , 75 , 76 ], we still have a limited understanding of why people drop out and why some do not respond. This is also true for in-person CBT; we still do not know why a third of patients do not respond to CBT for insomnia [ 84 ].…”

Section: The Future Of Digital Treatments For Insomniamentioning

confidence: 99%

Digital Delivery of Cognitive Behavioral Therapy for Insomnia

Luik

Zweerde

Straten

et al. 2019

Curr Psychiatry Rep

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Purpose of Review Digital cognitive behavioral therapy (dCBT) has been available for over a decade. We reviewed the evidence that accumulated over the past 5 years and discuss the implications for introducing dCBT into standard healthcare. Recent Findings Studies have consistently supported the use of dCBT to treat insomnia. Evidence is now demonstrating large short-term effects and smaller long-term effects up to 1.5 years after treatment across populations with various co-occurring health problems. The effects also extend into a range of psychological well-being factors. Mediators and moderators have been studied to understand mechanisms and create new opportunities to enhance effectiveness and reduce dropout. Incorporating personalized guidance in dCBT may further enhance effectiveness. Summary The evidence for dCBT for insomnia is strong and suggests that dCBT is ready for application in standard healthcare. Further research, digital innovation, and development of effective implementation methods are required to ensure dCBT fulfills its potential.

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Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia

Abstract: Online CBT-I may reduce the enormous public health burden of insomnia by changing underlying cognitive variables that lead to long-term changes in sleep outcomes.

Cited by 42 publications

References 39 publications

Effectiveness and Cost-Effectiveness of Internet-Based Cognitive Behavioral Therapy for Insomnia in Clinical Settings

Effectiveness and Cost-Effectiveness of Internet-Based Cognitive Behavioral Therapy for Insomnia in Clinical Settings

Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy

Digital Delivery of Cognitive Behavioral Therapy for Insomnia

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