Sleep Healthy Using The Internet Research Articles

Effects of a digital cognitive behavioral therapy for insomnia on sleep and alcohol consumption in heavy drinkers: A randomized pilot study.

Insomnia is a well-established, prospective risk factor for Alcohol Use Disorder. Thus, targeting sleep problems could serve as a novel and efficacious means of reducing problematic drinking. Here, we examined the potential utility of a well-validated, interactive, easy to use, self-paced digital cognitive behavioral therapy for insomnia program. In a randomized, single-blind pilot study, we examined the impact of treatment with Sleep Healthy Using the Internet (SHUTi) on drinking and sleep outcomes in a sample of heavy drinkers with insomnia. Heavy drinking men (n = 28) and women (n = 42) with insomnia were randomly assigned to complete either the SHUTi program or a control patient education program. Subjective measures of sleep and alcohol use were administered at baseline, immediately following completion of the intervention, 3 months post-intervention, and 6 months post-intervention. Sleep outcomes were assessed using the Insomnia Severity Index and Pittsburgh Sleep Quality Index. Drinking outcomes were assessed using the 30-Day Timeline Follow-Back calendar. We used linear mixed effects models to compare groups on both insomnia and drinking outcomes. Data from all 70 subjects (SHUTI: n = 40; control: n = 30) were analyzed. Linear mixed effects models showed that SHUTi significantly reduced insomnia symptoms (p = 0.01) and drinking outcomes (ps < 0.05) more than the control condition over time. Trend-level effects on sleep quality (p = 0.06) were also observed. No adverse events were reported. Improving sleep may be an effective treatment intervention for reducing hazardous drinking in at-risk individuals. Further, findings provide preliminary support for the implementation of an easily accessible health behavior intervention with significant public health impact in a high-risk population.

Online sleep diaries: considerations for system development and recommendations for data management.

To present development considerations for online sleep diary systems that result in robust, interpretable, and reliable data; furthermore, to describe data management procedures to address common data entry errors that occur despite those considerations. The online sleep diary capture component of the Sleep Healthy Using the Internet (SHUTi) intervention has been designed to promote data integrity. Features include diary entry restrictions to limit retrospective bias, reminder prompts and data visualizations to support user engagement, and data validation checks to reduce data entry errors. Despite these features, data entry errors still occur. Data management procedures relying largely on programming syntax to minimize researcher effort and maximize reliability and replicability. Presumed data entry errors are identified where users are believed to have incorrectly selected a date or AM versus PM on the 12-hour clock. Following these corrections, diaries are identified that have unresolvable errors, like negative total sleep time. Using the example of one of our fully-powered, U.S. national SHUTi randomized controlled trials, we demonstrate the application of these procedures: of 45,598 total submitted diaries, 487 diaries (0.01%) required modification due to date and/or AM/PM errors and 27 diaries (<0.001%) were eliminated due to unresolvable errors. To secure the most complete and valid data from online sleep diary systems, it is critical to consider the design of the data collection system and to develop replicable processes to manage data. Sleep Healthy Using The Internet for Older Adult Sufferers of Insomnia and Sleeplessness (SHUTiOASIS); https://clinicaltrials.gov/ct2/show/NCT03213132; ClinicalTrials.gov ID: NCT03213132.

0320 Improvements in Sleep &amp; Drinking Outcomes Among Heavy Drinkers Following a Digital CBT-I Program

Abstract Introduction Insomnia and Alcohol Use Disorder (AUD) and are highly comorbid, due in part to the use of alcohol as a sleep aid among individuals with insomnia. Initial studies have shown that cognitive behavioral therapy for insomnia (CBT-I), the first-line treatment for insomnia, is moderately successful at improving both sleep and drinking outcomes in heavy drinkers with insomnia. However, CBT-I is not widely available. Digital CBT-I could be a more accessible alternative. One digital CBT-I program, Sleep Healthy Using the Internet (SHUTi), is especially promising due to its high efficacy in treating insomnia and its individualized and interactive platform. Here we conducted a pilot study to examine the efficacy of SHUTi on improving sleep and drinking outcomes in a sample of heavy drinkers with insomnia. Methods Heavy drinking men and women with insomnia (n=53) were randomly assigned to complete the SHUTi program (n=26) or a nine-week patient education control program (n=27). Questionnaires examining sleep (Insomnia Severity Index and Pittsburgh Sleep Quality Index) and alcohol use (30-day Timeline Follow-Back) were completed pre-intervention, post-intervention, and 3-months post-intervention. Linear mixed effect models were used to examine the effects of SHUTi on sleep and alcohol consumption and whether any effects of SHUTi on drinking were mediated by the effects of SHUTi on sleep. Results SHUTi significantly improved sleep (ISI &amp; PSQI; ps ≤ .021) and drinking outcomes (past 30-day total drinks, drinking days, and binge episodes; ps ≤ .032) over time relative to the control condition. Additionally, the effects of SHUTi on drinking quantity, but not frequency, were mediated by SHUTi’s effects on sleep. Conclusion These results show that SHUTi is an effective intervention for improving sleep among heavy drinkers with insomnia. Further, they suggest that sleep may be an effective treatment target to slow the progression of AUD in at-risk individuals. Together, these findings provide preliminary support for the implementation of an inexpensive, easily accessible health behavior intervention with significant public health impact in a high-risk population. Support (if any)

Effect of Culturally Tailored, Internet-Delivered Cognitive Behavioral Therapy for Insomnia in Black Women

Black women are at risk for insomnia disorder. Despite interest in addressing sleep health disparities, there is limited research investigating the efficacy of criterion-standard treatment (cognitive behavioral therapy for insomnia [CBT-I]) among this racial minority population. To compare the efficacy of a standard version of an internet-delivered CBT-I program, a culturally tailored version, and a sleep education control at improving insomnia symptoms. In this single-blind, 3-arm randomized clinical trial, participants in a national, longitudinal cohort (Black Women's Health Study [BWHS]) were recruited between October 2019 and June 2020. BWHS participants with elevated insomnia symptoms were enrolled and randomized in the current study. Participants were randomized to receive (1) an automated internet-delivered treatment called Sleep Healthy Using the Internet (SHUTi); (2) a stakeholder-informed, tailored version of SHUTi for Black women (SHUTi-BWHS); or (3) patient education (PE) about sleep. The primary outcome was insomnia severity (Insomnia Severity Index [ISI]). Index score ranged from 0 to 28 points, with those scoring less than 8 points considered to not have clinically significant insomnia symptoms and a score of 15 points or higher suggesting insomnia disorder. An ISI score reduction of more than 7 points was considered a clinically significant improvement in insomnia symptoms. The SHUTi-BWHS program was hypothesized to be more effective at significantly decreasing insomnia severity compared with the SHUTi program and PE. A total of 333 Black women were included in this trial, and their mean (SD) age was 59.5 (8.0) years. Those randomized to receive either SHUTi or SHUTi-BWHS reported significantly greater reductions in ISI score at 6-month follow-up (SHUTi: -10.0 points; 95% CI, -11.2 to -8.7; SHUTi-BWHS: -9.3 points; 95% CI, -10.4 to -8.2) than those randomized to receive PE (-3.6 points; 95% CI, -4.5 to -2.1) (P < .001). Significantly more participants randomized to SHUTi-BWHS completed the intervention compared with those randomized to SHUTi (86 of 110 [78.2%] vs 70 of 108 [64.8%]; P = .008). Participants who completed either intervention showed greater reductions in insomnia severity compared with noncompleters (-10.4 points [95% CI, -11.4 to -9.4] vs -6.2 points [95% CI, -8.6 to -3.7]). In this randomized clinical trial, both the SHUTi and SHUTi-BWHS programs decreased insomnia severity and improved sleep outcomes more than PE. The culturally tailored SHUTi-BWHS program was more effective at engaging participants with the program, as a greater proportion completed the full intervention. Program completion was associated with greater improvements in sleep. ClinicalTrials.gov Identifier: NCT03613519.

Single-Group Trial of an Internet-Delivered Insomnia Intervention Among Higher-Intensity Family Caregivers: Rationale and Protocol for a Mixed Methods Study.

BackgroundFamily caregivers are more likely to experience insomnia relative to noncaregivers but have significant barriers to accessing gold standard cognitive behavioral therapy for insomnia treatment. Delivering interventions to caregivers through the internet may help increase access to care, particularly among higher-intensity caregivers who provide assistance with multiple care tasks over many hours per week. Although there are existing internet interventions that have been thoroughly studied and demonstrated as effective in the general population, the extent to which these interventions may be effective for caregivers without tailoring to address this population’s unique psychosocial needs has not been studied.ObjectiveThe goal of this trial is to determine what tailoring may be necessary for which caregivers to ensure they receive optimal benefit from an existing evidence-based, internet-delivered cognitive behavioral therapy for insomnia program named Sleep Healthy Using the Internet (SHUTi). Specifically, we will test the association between caregivers’ engagement with SHUTi and their caregiving context characteristics (ie, caregiving strain, self-efficacy, and guilt) and environment (ie, proximity to care recipient; functional status, cognitive status, and problem behavior of care recipient; and type of care provided). Among caregivers using the program, we will also test the associations between change in known treatment mechanisms (sleep beliefs and sleep locus of control) and caregiving context factors.MethodsA total of 100 higher-intensity caregivers with significant insomnia symptoms will be recruited from across the United States to receive access to SHUTi in an open-label trial with mixed methods preassessments and postassessments. At postassessment (9 weeks following preassessment completion), participants will be categorized according to their engagement with the program (nonusers, incomplete users, or complete users). Study analyses will address 3 specific aims: to examine the association between caregivers’ engagement with SHUTi and their caregiving context (aim 1a); to describe caregivers’ barriers to and motivations for SHUTi engagement from open-ended survey responses (aim 1b); and among caregivers using SHUTi, to determine whether cognitive mechanisms of change targeted by SHUTi are associated with differences in caregiving context (aim 2).ResultsInstitutional review board approvals have been received. Data collection is anticipated to begin in December 2021 and is expected to be completed in 2023.ConclusionsFindings will inform the next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers. Beyond implication to the SHUTi program, the findings will be translatable across intervention programs and will hold significant promise to reduce inefficiencies in developing digital health interventions for caregivers while also increasing their impact and reach for this underserved population.Trial RegistrationClinicalTrials.gov; NCT04986904; https://clinicaltrials.gov/ct2/show/NCT04986904?term=NCT04986904International Registered Report Identifier (IRRID)PRR1-10.2196/34792

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

ABSTRACT 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 first-generation 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.

Digital cognitive behavioural therapy for insomnia: the answer to a major public health issue?

Digital cognitive behavioural therapy for insomnia: the answer to a major public health issue?

0489 Initial Results from the Hypertension with Unsatisfactory Sleep Health (HUSH) Clinical Trial for Primary Care Patients with Insomnia and Comorbid Hypertension (INS-HTN)

Abstract Introduction Insomnia is commonly comorbid with, and may contribute to, hypertension. Cognitive-behavioral treatments improve insomnia, but their effects on hypertension are uncertain, and they are often unavailable in primary care practices, where most INS-HTN patients are treated. We evaluated the efficacy of Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi) compared to enhanced usual care (EUC) on insomnia and home blood pressure (HBP) in primary care patients with INS-HTN. Methods Patients were recruited via electronic health records from 67 primary care practices and randomized 2:2:1 to BBTI delivered via telephone/videoconferencing; SHUTi, an automated, web-based CBT-I program; or EUC including a patient education video. Assessments included self-report questionnaires, home sleep apnea testing, and one week of sleep diary and HBP, measured at Baseline and 9 weeks/ 6 months post-treatment. The primary outcome was the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance scale. Linear mixed models were fitted for continuous variables on the intent-to-treat sample (n=548), adjusting for age and sex. Chi-square tests were used for proportions. Results Patients were 61.8±11.3 years old, 67.2% female, and 55.9% were taking hypnotics. Insomnia Severity Index (ISI) was 15.4±4.4, Apnea-Hypopnea Index 9.8±11.4, and HBP 130±14/81±9. BBTI and SHUTi were significantly better than EUC (p≤.002) at 9 weeks and 6 months on PROMIS Sleep Disturbance and Sleep-Related Impairment scales, ISI, and diary sleep efficiency, but had inconsistent effects on PROMIS depression and anxiety scales (p=0.001-0.9). Greater proportions of BBTI and SHUTi vs. EUC-treated patients had 9-week and 6-month ISI scores &amp;lt;8 (p=.01, p=.04) and ISI changes scores ≥7 (p=.002, p=.003). HBP did not significantly differ by intervention group. Conclusion BBTI and SHUTi improved insomnia, but did not reduce HBP in patients with INS-HTN. These interventions appear suitable for dissemination and implementation in primary care, but may have limited effects on comorbid symptoms and conditions. Support NHLBI UH2/UH3 HL125103

Evaluating the Feasibility and Acceptability of Internet-Based Cognitive Behavioral Therapy for Insomnia in Rural Women.

Background: Insomnia, one of the most common sleep disorders among women in midlife, is associated with multiple negative health outcomes. Rural Appalachian women are disproportionately affected by insufficient sleep, but their barriers to care (e.g., health care shortages, cultural norms) may prevent intervention. This study assessed the feasibility and acceptability of Sleep Healthy Using the Internet (SHUTi) an Internet-based version of cognitive behavioral therapy for insomnia in Appalachian women ages 45+ years.Materials and Methods: We used mixed methods to assess feasibility (through summaries of recruitment and retention data) and acceptability (quantitatively through online survey scales and qualitatively through interviews). Subject-level responses for satisfaction, adherence, and helpfulness scales were averaged over the multiple response domains and reported as percentages. Interviews were transcribed and coded using a multistage coding process.Results: Forty-six women (average age 55 years) enrolled; 38 completed the SHUTi program (retention = 82.6%). The majority of participants (61%) indicated that SHUTi made things “somewhat better” or “a lot better.” Seventy-six percent reported that they followed the SHUTi protocol “most of the time” or “consistently.” Most participants (84%) ranked SHUTi as “moderately” or “very” helpful. Participants expressed enthusiasm about SHUTi and offered minor suggestions for improvement.Conclusions: This study was the first to asses SHUTi in the health disparity population of Appalachian women. Rich insights gained through quantitative and qualitative data suggest that SHUTi was feasible and acceptable for middle-aged Appalachian women. Given rural Appalachian women's documented barriers to utilizing technology, these results hold promise for SHUTi's utility in other rural populations. Future research should incorporate a randomized case–control design within a larger sample and consider participants' suggestions for improvement.

Internet-Based Cognitive Behavioral Therapy for Insomnia in Appalachian Women: A Pilot Study

ABSTRACT Objective/Background Appalachian women are disproportionately affected by insufficient sleep but live in a healthcare shortage area with prevalent prescription drug abuse. A self-administered, non-pharmacologic intervention such as Internet-based cognitive behavioral therapy for insomnia (CBT-I) may be ideal in this population, but psycho-social characteristics (e.g., high depression rates) and cultural norms (e.g., suspicion of technology) necessitate a pilot study. We evaluated the effectiveness of Sleep Healthy Using the Internet (SHUTi) on insomnia severity, sleep quality, perceived stress, depression symptoms, and sleep aid use in Appalachian women ages 45 +. Participants Forty-six women enrolled; 38 completed the six-week intervention in 2018 (mean age 55 years). Methods We employed a single group, pre/post-test, mixed-methods design. Participants completed an online survey and a qualitative interview pre- and post-intervention. Quantitative data were analyzed using one-way repeated measures ANOVA or generalized estimating equations. Interviews were qualitatively analyzed using a multi-stage coding process. Results Positive and statistically significant (p < .01) improvements were observed on mean scores for the Insomnia Severity Index (15.1 to 6.5), the Pittsburgh Sleep Quality Index (12.1 to 8.5), the Perceived Stress Scale (20 to 14.6), and the Center for Epidemiologic Studies Depression Scale Revised (9.8 to 5.2). The odds of reporting sleep medication use post-intervention were significantly lower than pre-intervention (OR 0.28 [95% CI 0.11–0.74]). Interviews highlighted most and least helpful intervention components and suggested that participants benefitted from SHUTi. Conclusions Internet-based CBT-I may be a useful, non-pharmacologic treatment that reduces insomnia severity, perceived stress, depression symptoms, and sleep aid use in middle-aged Appalachian women.

Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial

BackgroundChronic insomnia is associated with poor asthma control. Cognitive-behavioral treatment for insomnia (CBT-I) is an efficacious and durable treatment for comorbid insomnia in medical and psychiatric disorders. However, the efficacy and potential accompanying mechanisms of CBT-I have not been examined in asthma. The purpose of this study is to test the efficacy of a CBT-I intervention on sleep and asthma control in adults with insomnia and asthma. We will also explore airway inflammation (i.e., exhaled nitric oxide, blood eosinophils) as a potential biological mechanism linking improvements in sleep with improvements in asthma control. MethodsThe study is a single center, parallel group, randomized controlled trial. Two hundred and ten adults with insomnia and asthma that is not well-controlled will be randomized to either a 9-week Internet-based CBT-I program (Sleep Healthy Using the Internet (SHUTi)) or an enhanced usual care condition which utilizes an online educational video about insomnia. The primary sleep outcome is insomnia severity measured by the Insomnia Severity Index. Secondary sleep outcomes are sleep quality and wrist actigraph-recorded sleep parameters. Asthma control will be assessed by the Asthma Control Test, Asthma Quality of Life Questionnaire, pulmonary function testing, and self-report of asthma exacerbations and asthma-related healthcare utilization. Treatment outcomes will be measured at baseline, 9 weeks, and 6 months. DiscussionThis trial has the potential to identify a novel strategy for improving asthma control. Findings may advocate for the inclusion of treatment of comorbid insomnia into current asthma management practice guidelines.

Online cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia among individuals with alcohol use disorder: study protocol for a randomized controlled trial

Alcohol use disorder (AUD) is characterized by problematic drinking that becomes severe. Individuals with AUD often experience insomnia and other sleep disturbances at various phases of recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an efficacious non-pharmacological treatment for insomnia and is recommended as a first-line treatment for adults with chronic insomnia. Internet-based CBT-I could play a key role in the dissemination of this behavioral sleep intervention, given the paucity of trained clinicians able to provide CBT-I in person and other logistical/cost concerns. SHUTi (Sleep Healthy Using The Internet) is the most tested and empirically-sound Internet intervention for insomnia. Despite the promise of Internet-based CBT-I interventions, to date, no randomized controlled trials (RCTs) exist examining the feasibility/efficacy of an Internet-based CBT-I program among treatment-seeking individuals recovering from AUD. This is a two-phase RCT assessing feasibility/acceptability and efficacy of the SHUTi program among individuals with AUD in recovery with insomnia. Phase I will focus on assessing the feasibility and acceptability of program delivery and data collection (n = 10). Phase II will be an RCT powered to examine preliminary intervention efficacy (n = 30 per group). Participants for this study must meet criteria for “moderate to severe” insomnia. Individuals randomized to the intervention group will receive the SHUTi intervention (initiated while inpatient and completed while outpatient), and individuals randomized to the control group will receive an educational web-based program. The goals of the study are as follows: (1) assess the feasibility and acceptability of Internet-based CBT-I among individuals with AUD in recovery with insomnia (phase I), (2) compare the preliminary efficacy of CBT-I versus control group with respect to primary and secondary outcome variables (phase II), and (3) explore specific domains associated with improved outcomes, e.g., demographic, psychiatric, and drinking-related factors (phase II). Primary outcome measures include changes in insomnia severity over time and changes in actigraphy-recorded sleep efficiency over time.Trial registrationNCT#03493958; registered 1 June 2018.

Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study

ABSTRACTBackground/Objective: Insomnia is common among adults with asthma and is associated with worse asthma control. Cognitive-behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia with medical comorbidities, but it has not been tested in asthma. The purpose of this study was to assess the feasibility and acceptability of an Internet-based CBT-I intervention, called Sleep Healthy Using the Internet (SHUTi), among adults with asthma and comorbid insomnia, and to gather preliminary efficacy data on changes in insomnia severity, sleep quality, asthma control, and asthma-related quality of life. Methods: A single-group, pretest–posttest design was employed, where all participants completed the SHUTi program. Online questionnaires were completed pre- and postintervention. Individual telephone interviews were conducted after posttreatment data collection to obtain participants’ experiences with SHUTi and suggestions for improvement. Results: The sample (N = 23) comprised men and women aged 18–75 years with moderate to severe, not well-controlled asthma, and comorbid insomnia. Nineteen (83%) completed postintervention assessments. Improvements on the Insomnia Severity Index, Pittsburgh Sleep Quality Index, Asthma Control Test, and Asthma Quality of Life Questionnair–Marks were observed at postintervention. Data from the telephone interviews suggest that most participants had a positive experience with SHUTi. Participants suggested incorporating asthma-specific content into future versions of the intervention. Conclusions: Internet-based CBT-I is a potential treatment option for adults with asthma and comorbid insomnia.

Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression.

BackgroundInsomnia treatment using an internet-based cognitive–behavioural therapy for insomnia (CBT-I) program reduces depression symptoms, anxiety symptoms and suicidal ideation. However, the speed, longevity and consistency of these effects are unknown.AimsTo test the following: whether the efficacy of online CBT-I was sustained over 18 months; how rapidly the effects of CBT-I emerged; evidence for distinct trajectories of change in depressive symptoms; and predictors of these trajectories.MethodA randomised controlled trial compared the 6-week Sleep Healthy Using the Internet (SHUTi) CBT-I program to an attention control program. Adults (N=1149) with clinical insomnia and subclinical depression symptoms were recruited online from the Australian community.ResultsDepression, anxiety and insomnia decreased significantly by week 4 of the intervention period and remained significantly lower relative to control for >18 months (between-group Cohen’s d=0.63, 0.47, 0.55, respectively, at 18 months). Effects on suicidal ideation were only short term. Two depression trajectories were identified using growth mixture models: improving (95%) and stable/deteriorating (5%) symptoms. More severe baseline depression, younger age and limited comfort with the internet were associated with reduced odds of improvement.ConclusionsOnline CBT-I produced rapid and long-term symptom reduction in people with subclinical depressive symptoms, although the initial effect on suicidal ideation was not sustained.Declaration of interestP.J.B. has received grants from the National Health and Medical Research Council (NHMRC) during the conduct of the study. H.C. has received grants from the NHMRC and the Australian Research Council during the conduct of the study. L.M.R. receives research funding from the National Institutes of Health (NIH) that, in part, focuses on insomnia. F.P.T. and L.M.R. have equity ownership in BeHealth Solutions (Charlottesville, VA, USA), a company that develops and makes available products related to the research reported in this manuscript. BeHealth Solutions has licensed the SHUTi program and the software platform on which it was built from the University of Virginia. The terms of this arrangement have been reviewed and approved by the University of Virginia in accordance with its conflict of interest policy. N.G. has received grants from the NHMRC during the conduct of the study and personal fees from Lundbeck, Servier and Janssen outside the submitted work.Copyright and usage© The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) license.

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial

BackgroundInsomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC).Methods/DesignThe study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects.DiscussionThis randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions.Trial registrationClinicalTrials.gov (Identifier: NCT02508129; Date Registered: July 21, 2015).

The Short-Term Efficacy of an Unguided Internet-Based Cognitive-Behavioral Therapy for Insomnia: A Randomized Controlled Trial With a Six-Month Nonrandomized Follow-Up

ABSTRACTObjective: Insomnia is a major health problem, and the need for effective and accessible treatment is urgent. The aim of the current study was to evaluate the short-term efficacy of an unguided Internet-based cognitive-behavioral treatment program for insomnia (CBTi), called SHUTi (Sleep Healthy Using the Internet). Methods: This study used a parallel arm randomized controlled trial in Norway. Participants were randomly allocated to the SHUTi condition or a Web-based patient education condition. Both groups were assessed before and after the nine-week intervention period (online sleep diaries and questionnaires). The SHUTi participants were reassessed in a six-month nonrandomized follow-up. Primary outcome measures were the Insomnia Severity Index (ISI) and the Bergen Insomnia Scale (BIS). Results: A total of 181 participants were included in the study; SHUTi condition (n = 95), patient education condition (n = 86). Intention-to-treat mixed-model repeated-measures analysis revealed that the SHUTi group had better short-term outcomes compared with the patient education group on most sleep measures. The SHUTi group showed a significant decrease on the primary outcomes, the ISI (dbetween = –1.77, 95% CI = –2.23, –1.31) and the BIS (dbetween = –1.00, 95% CI = –1.32, –.68). Improvements were maintained among the completing SHUTi participants at the six-month nonrandomized follow-up. However, dropout attrition was high. Conclusion: Unguided Internet-based CBTi produced significant short-term improvements in sleep in patients with chronic insomnia. This highlights the benefits of making Internet-delivered CBTi programs available as a standard first-line treatment option in public health services. Nevertheless, the rate of dropout attrition (participants not completing post-assessment) in this trial limits the generalizability of the findings.

Online CBT for Insomnia Offers Long-Term Benefit

Online CBT for Insomnia Offers Long-Term Benefit

The GoodNight study--online CBT for insomnia for the indicated prevention of depression: study protocol for a randomised controlled trial.

BackgroundCognitive Behaviour Therapy for Insomnia (CBT-I) delivered through the Internet is effective as a treatment in reducing insomnia in individuals seeking help for insomnia. CBT-I also lowers levels of depression in this group. However, it is not known if targeting insomnia using CBT-I will lower depressive symptoms, and thus reduce the risk of major depressive episode onset, in those specifically at risk for depression. Therefore, this study aims to examine whether Internet delivery of fully automated self-help CBT-I designed to reduce insomnia will prevent depression.Method/designA sample of 1,600 community-dwelling adults (aged 18–64), who screen positive for both subclinical levels of depressive symptoms and insomnia, will be recruited via various media and randomised to either a 9-week online insomnia treatment programme, Sleep Healthy Using The internet (SHUTi), or an online attention-matched control group (HealthWatch). The primary outcome variable will be depression symptom levels at the 6-month post-intervention on the Patient Heath Questionnaire-9 (PHQ-9). A secondary outcome will be onset of major depressive episodes assessed at the 6-month post-intervention using ‘current’ and ‘time from intervention’ criteria from the Mini International Neuropsychiatric Interview.DiscussionThis trial is the first randomised controlled trial of an Internet-based insomnia intervention as an indicated preventative programme for depression. If effective, online provision of a depression prevention programme will facilitate dissemination.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR), Registration number: ACTRN12611000121965.

Co-morbid pain and sleep disturbance: sleep outcomes in a randomized controlled trial of internet-based cognitive-behavioral therapy for insomnia

Sleep disturbance is common among individuals with chronic pain, with over 50% reporting significant insomnia symptoms. However, little is known about the treatment of insomnia in this population. Secondary analyses of treatment outcome data were conducted to evaluate the efficacy of internet-based cognitive-behavioral therapy for insomnia (CBT-I) in a subgroup of adults with co-morbid insomnia and pain compared to adults without pain. Thirty-six adults (M = 48.19 years; 89% female) completed a CBT-I Internet intervention called Sleep Healthy Using The Internet (SHUTi).