Sleep-specific outcomes attributable to digitally delivered cognitive behavioral therapy for insomnia in adults with insomnia and depressive symptoms.

OBJECTIVE: Randomized controlled trials (RCTs) of digitally delivered Cognitive Behavioral Therapy for insomnia (CBT-I) have demonstrated reductions in insomnia severity, depression symptoms, anxiety symptoms, and suicidal ideation. The present study aimed to evaluate the effectiveness of self-guided, digital CBT-I to improve sleep-specific outcomes. METHOD: An RCT of Australian adults with insomnia and depressive symptoms (N = 1149) compared SHUTi, a digital CBT-I intervention, with HealthWatch, an attention-matched control internet program, at baseline, posttest (9 weeks) and at 6-, 12-, and 18-month follow-ups. Online sleep diaries were used to derive measures of sleep-onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE), number of awakenings, sleep quality, and total sleep time (TST). RESULTS: Participants in the SHUTi condition had greater improvements at posttest compared with control for: SOL, WASO, SE, number of awakenings, and sleep quality. These improvements were sustained at every follow-up (p < .02 for all outcomes except TST, in which statistically significant increases were observed only at 12- and 18-months). CONCLUSIONS: Digitally delivered CBT-I produced lasting improvements in sleep outcomes among adults with insomnia and depressive symptoms. Findings provide further evidence of long-term improvements associated with a digital therapeutic for insomnia, compared to an attention-control condition.

mySmartCheck, a Digital Intervention to Promote Skin Self-examination Among Individuals Diagnosed With or at Risk for Melanoma: A Randomized Clinical Trial.

BACKGROUND: Regular skin self-examination (SSE) reduces melanoma mortality but is not often conducted. PURPOSE: To promote SSE performance in individuals at increased risk for melanoma. METHODS: One hundred sixteen individuals at heightened risk for development of melanoma (i.e., personal/family history of melanoma, high-risk mole phenotype) who did not conduct a thorough SSE during in the prior 3 months were randomly assigned to receive either an automated internet-based intervention (mySmartCheck) or usual care (UC). One hundred sixteen participants completed surveys before random assignment and 99 completed the follow-up survey 13-weeks afterward. The primary outcome was participant self-reported examination (SSE) of all 15 parts of the body in the last 3 months. Secondary outcomes were SSE of any part of the body in the last 3 months and number of body parts examined during the last SSE. RESULTS: More mySmartCheck participants examined all 15 body parts (32.6% vs. 7.1%, p = .001). More individuals in mySmartCheck reported conducting SSE on any body part than those in UC (81.4% vs. 62.5%, p = .04). Effect sizes were large (d = 1.19 all 15 body parts) to moderate (d = 0.55 for any body part). mySmartCheck participants examined more body areas than UC participants (12.7 vs. 10.3, p = 0.003) during the last SSE. Participants in mySmartCheck reported higher levels of knowledge of suspicious lesions, SSE benefits, SSE self-efficacy, and planning for SSE, and lower SSE barriers, than those assigned to UC. CONCLUSIONS: mySmartCheck had a significant positive impact on SSE performance and behaviors. Additional research with a larger sample size, a longer follow-up, and more varied clinical settings is needed. TRIAL REGISTRATION: ClinicalTrials.gov registration # NCT03725449 (https://clinicaltrials.gov/ct2/show/NCT03725449).

Do treatment effects of a web-based cognitive behavioral therapy for insomnia intervention differ for users with and without pain interference? A secondary data analysis.

Cognitive-behavioral therapy for insomnia (CBT-I) shows treatment benefits among individuals with pain interference; however, effects of Internet-delivered CBT-I for this population are unknown. This secondary analysis used randomized clinical trial data from adults assigned to Internet-delivered CBT-I to compare changes in sleep by pre-intervention pain interference. Participants (N = 151) completed the Insomnia Severity Index (ISI) and sleep diaries [sleep onset latency (SOL); wake after sleep onset (WASO)] at baseline, post-assessment, 6- and 12-month follow-ups. Linear mixed-effects models showed no differences between pain interference groups (no, some, moderate/severe) for changes from baseline to any follow-up timepoint for ISI (p = .72) or WASO (p = .88). There was a small difference in SOL between those reporting some versus no or moderate/severe pain interference (p = .04). Predominantly comparable and sustained treatment benefits for both those with and without pain interference suggest that Internet-delivered CBT-I is promising for delivering accessible care to individuals with comorbid pain and insomnia.

Developing a Process for the Analysis of User Journeys and the Prediction of Dropout in Digital Health Interventions: Machine Learning Approach.

BACKGROUND: User dropout is a widespread concern in the delivery and evaluation of digital (ie, web and mobile apps) health interventions. Researchers have yet to fully realize the potential of the large amount of data generated by these technology-based programs. Of particular interest is the ability to predict who will drop out of an intervention. This may be possible through the analysis of user journey data-self-reported as well as system-generated data-produced by the path (or journey) an individual takes to navigate through a digital health intervention. OBJECTIVE: The purpose of this study is to provide a step-by-step process for the analysis of user journey data and eventually to predict dropout in the context of digital health interventions. The process is applied to data from an internet-based intervention for insomnia as a way to illustrate its use. The completion of the program is contingent upon completing 7 sequential cores, which include an initial tutorial core. Dropout is defined as not completing the seventh core. METHODS: Steps of user journey analysis, including data transformation, feature engineering, and statistical model analysis and evaluation, are presented. Dropouts were predicted based on data from 151 participants from a fully automated web-based program (Sleep Healthy Using the Internet) that delivers cognitive behavioral therapy for insomnia. Logistic regression with L1 and L2 regularization, support vector machines, and boosted decision trees were used and evaluated based on their predictive performance. Relevant features from the data are reported that predict user dropout. RESULTS: Accuracy of predicting dropout (area under the curve [AUC] values) varied depending on the program core and the machine learning technique. After model evaluation, boosted decision trees achieved AUC values ranging between 0.6 and 0.9. Additional handcrafted features, including time to complete certain steps of the intervention, time to get out of bed, and days since the last interaction with the system, contributed to the prediction performance. CONCLUSIONS: The results support the feasibility and potential of analyzing user journey data to predict dropout. Theory-driven handcrafted features increased the prediction performance. The ability to predict dropout at an individual level could be used to enhance decision making for researchers and clinicians as well as inform dynamic intervention regimens.

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.

OBJECTIVE: 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.

Sleep disturbance in cancer patients and caregivers who contact telephone-based help services.

PURPOSE: Insomnia is highly prevalent in people who are affected by cancer. However, options available to receive support for insomnia are limited. Telephone-based help services, such as cancer helplines, may be ideally placed to meet unmet needs regarding insomnia after cancer. The present study describes the prevalence and predictors of insomnia in patients and caregivers who call cancer helplines seeking support. METHODS: Participants (N = 500 patients, N = 234 caregivers) were recruited through an Australian state-based telephone-delivered cancer helpline. In addition to routine screening with the Distress Thermometer, participants were administered the Insomnia Severity Index. RESULTS: Most participants were female, older than 50 years of age, and were three (caregivers) to four (patients) months post-diagnosis. Insomnia symptoms were reported by 59.4 % of patients and 62.9 % of caregivers, with moderate to severe levels of insomnia reported by 27 % of patients and 30 % of caregivers. Insomnia was predicted by distress level for both patients (ß = .31, p < .001) and caregivers (ß = .32, p < .001) and age for patients only (ß = -.13, p < .01). CONCLUSIONS: Insomnia symptoms are common in patients and caregivers who call cancer helplines and appear to be related to distress. Telephone-based helplines have the potential to act as the first line of support in a stepped care approach addressing insomnia.

The Sleep Or Mood Novel Adjunctive therapy (SOMNA) trial: a study protocol for a randomised controlled trial evaluating an internet-delivered cognitive behavioural therapy program for insomnia on outcomes of standard treatment for depression in men.

BACKGROUND: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse. Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care. We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes. METHODS/DESIGN: Male participants aged 50 years or more, meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms, will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program. The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period. During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments. The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited. The primary outcome is change in the severity of depressive symptoms from baseline to week 12. DISCUSSION: This study will provide evidence on whether a widely accessible, evidence-based, internet-delivered cognitive behavioural therapy for insomnia intervention can lead to greater improvements than standard treatment for depression alone, in a group who traditionally do not readily access psychotherapy. The study is designed to establish effect size, feasibility and processes associated with implementing e-health solutions alongside standard clinical care, to warrant undertaking a larger more definitive clinical trial. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12612000985886 .

Leveraging technology: creating and sustaining changes for health.

OBJECTIVE: The rapid growth and evolution of health-related technology capabilities are driving an established presence in the marketplace and are opening up tremendous potential to minimize and/or mitigate barriers associated with achieving optimal health, performance, and readiness. This article summarizes technology-based strategies that promote healthy habits related to physical activity, nutrition, and sleep. MATERIALS AND METHODS: The Telemedicine and Advanced Technology Research Center convened a workshop titled "Leveraging Technology: Creating & Sustaining Changes for Health" (May 29-30, 2013, Fort Detrick, MD). Participants included experts from academia (n=3), government (n=33), and industry (n=16). A modified Delphi method was used to establish expert consensus in six topic areas: (1) physical activity, (2) nutrition, (3) sleep, (4) incentives for behavior change, (5) usability/interoperability, and (6) mobile health/open platform. RESULTS: Overall, 162 technology features, constructs, and best practices were reviewed and prioritized for physical activity monitors (n=29), nutrition monitors (n=35), sleep monitors (n=24), incentives for change (n=36), usability and interoperability (n=25), and open data (n=13). CONCLUSIONS: Leading practices, gaps, and research needs for technology-based strategies were identified and prioritized. This information can be used to provide a research and development road map for (1) leveraging technology to minimize barriers to enhancing health and (2) facilitating evidence-based techniques to create and sustain healthy behaviors.

A randomized controlled trial of an internet intervention for adults with insomnia: effects on comorbid psychological and fatigue symptoms.

OBJECTIVE: Insomnia is frequently comorbid with other medical and psychological disorders. This secondary data analysis investigated whether an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention could also reduce comorbid psychological and fatigue symptoms. METHOD: Data from a pilot randomized controlled trial (RCT) testing the efficacy of Internet-delivered CBT-I relative to a waitlist control was used to examine changes in symptoms of depression, anxiety, mental health quality of life (QOL), and fatigue. RESULTS: Group by time interactions from repeated measures analyses revealed significant post intervention improvements in Internet participants (n = 22) relative to control participants (n = 22) on all psychological symptoms, mental health QOL, and fatigue. A small post hoc subsample of Internet participants with mild or moderate depression also showed large effect size changes in these constructs (depression, anxiety, mental health QOL, and fatigue). CONCLUSION: Internet-delivered CBT-I appears to not only improve sleep but also reduce comorbid psychological and fatigue symptoms.

Initial evaluation of an Internet intervention to improve the sleep of cancer survivors with insomnia.

OBJECTIVE: Insomnia is a common complaint among cancer survivors. Fortunately, cognitive-behavioral therapy for insomnia (CBT-I) has been shown to be an effective treatment in this population. However, it is rarely implemented given its limited availability. To address this barrier, we examined the ability of an easily accessible online CBT-I program to improve insomnia symptoms in cancer survivors. METHODS: Twenty-eight cancer survivors with insomnia were randomly assigned to either an Internet insomnia intervention (n = 14) or to a waitlist control group (n = 14). The online program, Sleep Healthy Using The Internet, delivers the primary components of CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention). Pre- and post-assessment data were collected via online questionnaires and daily sleep diaries. RESULTS: Participants in the Internet group showed significant improvements at post-assessment compared with those in the control group in overall insomnia severity (F(1,26) = 22.8; p<0.001), sleep efficiency (F(1,24) = 11.45; P = 0.002), sleep onset latency (F(1,24) = 5.18; P = 0.03), soundness of sleep (F(1,24) = 9.34; P = 0.005), restored feeling upon awakening (F(1,24) = 11.95; P = 0.002), and general fatigue (F(1,26) = 13.88; P = 0.001). Although other group × time interactions were not significant, overall adjusted effect sizes for all sleep variables as well as for fatigue, depression, anxiety, and quality of life ranged from small to large. CONCLUSIONS: CBT-I delivered through an interactive, individually tailored Internet intervention may be a viable treatment option for cancer survivors experiencing insomnia.

Using instructional design process to improve design and development of Internet interventions.

Given the wide reach and extensive capabilities of the Internet, it is increasingly being used to deliver comprehensive behavioral and mental health intervention and prevention programs. Their goals are to change user behavior, reduce unwanted complications or symptoms, and improve health status and health-related quality of life. Internet interventions have been found efficacious in addressing a wide range of behavioral and mental health problems, including insomnia, nicotine dependence, obesity, diabetes, depression, and anxiety. Despite the existence of many Internet-based interventions, there is little research to inform their design and development. A model for behavior change in Internet interventions has been published to help guide future Internet intervention development and to help predict and explain behavior changes and symptom improvement outcomes through the use of Internet interventions. An argument is made for grounding the development of Internet interventions within a scientific framework. To that end, the model highlights a multitude of design-related components, areas, and elements, including user characteristics, environment, intervention content, level of intervention support, and targeted outcomes. However, more discussion is needed regarding how the design of the program should be developed to address these issues. While there is little research on the design and development of Internet interventions, there is a rich, related literature in the field of instructional design (ID) that can be used to inform Internet intervention development. ID models are prescriptive models that describe a set of activities involved in the planning, implementation, and evaluation of instructional programs. Using ID process models has been shown to increase the effectiveness of learning programs in a broad range of contexts. ID models specify a systematic method for assessing the needs of learners (intervention users) to determine the gaps between current knowledge and behaviors, and desired outcomes. Through the ID process, designers focus on the needs of learners, taking into account their prior knowledge; set measurable learning objectives or performance requirements; assess learners' achievement of the targeted outcomes; and employ cycles of continuous formative evaluation to ensure that the intervention meets the needs of all stakeholders. The ID process offers a proven methodology for the design of instructional programs and should be considered an integral part of the creation of Internet interventions. By providing a framework for the design and development of Internet interventions and by purposefully focusing on these aspects, as well as the underlying theories supporting these practices, both the theories and the interventions themselves can continue to be refined and improved. By using the behavior change model for Internet interventions along with the best research available to guide design practice and inform development, developers of Internet interventions will increase their ability to achieve desired outcomes.

Changes in sleep following internet-delivered cognitive-behavioral therapy for insomnia in women treated for breast cancer: A 3-year follow-up assessment.

BACKGROUND: Sleep disturbances are common in women treated for breast cancer. We have previously shown that internet-delivered cognitive-behavioral therapy for insomnia (e-CBT-I) is an efficacious, low-cost treatment approach. Furthermore, research has shown that e-CBT-I can result in sustained improvements at 12 months post-treatment. However, given the complexity and long duration of post-treatment symptomatology in breast cancer patients, as well as the recommended use of antihormonal therapy for up to 10 years, it is relevant to investigate long-term (>12 months) changes in sleep following e-CBT-I in this population. In the present study, we report data from a 3-year long-term follow-up assessment after e-CBT-I. METHODS: Women treated for breast cancer with sleep disturbances (Pittsburg Sleep Quality Index [PSQI] global score >5) who had previously been enrolled in a randomized-controlled trial investigating the efficacy of e-CBT-I (n = 255), were invited to participate in a 3-year follow-up study. All women in the initial control group had also been granted access to e-CBT-I. Assessment included self-reported sleep quality (PSQI), insomnia severity (Insomnia Severity Index, ISI), cancer-related fatigue and symptoms of depression. Within-group changes in these outcomes from baseline to the 3-year long-term follow-up assessment were analyzed. RESULTS: A total of 131 women (51%) participated in the 3-year follow-up study of which 77 (59%) were from the initial intervention group and 54 (41%) from the initial control group. For the pooled sample, within-group improvements from baseline to the 3-year follow-up assessment corresponding to large effect sizes were observed in sleep quality (Cohen's d = 1.0 95% CI [0.78, 1.21]) and insomnia severity (Cohen's d = 1.36 CI 95% [1.12, 1.59]). Similar changes were observed in cancer-related fatigue (Cohen's d = 0.48 CI 95% [0.30, 0.66]) and symptoms of depression (Cohen's d = 0.80 CI 95%. [0.60, 0.99]). The proportion of patients with scores above established cut-offs on the PSQI and the ISI were 56.1% and 29.8%, respectively. Within the initial intervention group, 15.6% evidenced relapse at the 3-year assessment. CONCLUSION: Overall, these results indicate that long-term sleep quality and insomnia severity following the use of e-CBT-in women treated for breast cancer is significantly lower than the pre-treatment levels. However, a substantial proportion of participants still evidence sleep disturbances.

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

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.

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

BACKGROUND: There have been many research trials of various digital therapeutics, but few real world evaluations of their efficacy. This type of data, however, can provide a more rounded understanding of their impact, utility, reach, and adoption. Findings presented here focus on outcome and patient engagement data of SHUTi (Sleep Health Using the Internet), a digital therapeutic delivering Cognitive Behavioral Therapy for insomnia (CBT-I), in a large real-world dataset of adults with insomnia. METHODS: 7216 adults who purchased access to SHUTi between December 2015 and February 2019 are included in the analysis. The Insomnia Severity Index (ISI) was administered at the beginning of each of six treatment Cores of the intervention. Users entered sleep diaries between Cores to track changes in sleep over time and obtain tailored sleep recommendations. Number of Cores completed and sleep diaries entered indicate program usage. RESULTS: Users showed a reduction in mean ISI scores and a corresponding increase in effect size at the start of each subsequent Core (compared to Core 1) (range: d = 0.3-1.9). Effect sizes at the last Core relative to the first were moderate-to-large for diary-derived sleep onset latency and wake after sleep onset. A reduction in number of medicated nights was also found, with those with severe insomnia showing the largest reduction from last-to-first week of treatment (d = 0.3). At the last Core, 61% met criteria for meaningful treatment response (reduction of >7 points on ISI) and 40% met criteria for remission (ISI<8). Engagement was comparable to SHUTi research trials. CONCLUSION: Consistent with controlled trials, real-world data suggest that digital therapeutics can result in relatively high levels of engagement and clinically meaningful sleep improvements.

Validation of the insomnia severity index as a web-based measure.

Although the Insomnia Severity Index (ISI) is already administered online, this frequently used instrument has not been validated for Web delivery. This study compares online and paper-and-pencil ISI versions completed by participants in a randomized controlled trial testing an Internet-delivered intervention for insomnia. Forty-three adults with insomnia completed both ISI versions during pre- (Assessment 1) and post-intervention (Assessment 2). Correlations between total scores of both versions were significant (rs ≥ .98, ps < .001). For both ISI versions, internal consistency was acceptable (Assessment 1, α = .61; Assessment 2, α ≥ .88). Among participants not receiving the parent study intervention, correlations between 1 format at Assessment 1 and the alternative format at Assessment 2 were generally significant (rs = .26-.82). Together, findings suggest the ISI can be delivered online.

Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia.

Background: Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings and is challenging for people with insomnia to access because of uneven geographical distribution of behavioral sleep medicine providers. Prescription digital therapeutics can overcome these barriers. This study evaluates the effectiveness of a specific digital CBT-I therapeutic. Materials & methods:Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM) is a 9-week, open-label, decentralized clinical trial to collect real-world evidence for a digital therapeutic (Somryst™) delivering CBT-I to patients with chronic insomnia. The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350). Conclusion: This pragmatic study seeks to assess the potential benefits of treating insomnia with an asynchronous, mobile, tailored prescription digital therapeutic. Clinical trial registration: NCT04325464 (ClinicalTrials.gov).

Lay abstract Chronic insomnia is linked to a range of health problems, including heart disease, chronic pain, high blood pressure and depression. A behavioral treatment called cognitive behavioral therapy for insomnia (CBT-I) is considered the first choice for helping patients overcome insomnia and reduce their risks of insomnia-related problems. Although the benefits of CBT-I have been established, it can be difficult for patients to access trained CBT-I therapists. One possible solution is to use digital forms of CBT-I, which patients can access on mobile devices. Somryst™ is a prescription digital therapeutic, which means it is authorized by the US FDA and has been proven effective in carefully-controlled clinical trials. Less is known, however, about how well the prescription digital therapeutic works in real-world settings. The Digital Real-world Evidence trial for Adults with insomnia treated via Mobile study (DREAM) will explore this question by evaluating a range of symptoms and outcomes in at least 350 patients with chronic insomnia who will use Somryst and be followed for 1 year.

Randomized controlled trial of the mySmartSkin web-based intervention to promote skin self-examination and sun protection among individuals diagnosed with melanoma.

Adherence to regular, thorough skin self-examination (SSE) and consistent sun protection behaviors among melanoma survivors is relatively low. This study reports on the impact of an online intervention, called mySmartSkin (MSS), on engagement in SSE and sun protection behaviors among melanoma survivors, as well as the mediators of the intervention effects. The intervention was compared with usual care (UC), and primary outcomes were assessed at 24 and 48 weeks. Short-term outcomes were also evaluated at 8 weeks postbaseline. Results demonstrate a significant effect on SSE and sun protection. At all three follow-up assessments, the proportion of participants reporting conducting a thorough SSE in the time since the previous assessment was significantly greater in MSS than in UC. In addition, both multivariate and univariate analyses indicated that engagement in sun protection behaviors was significantly higher in MSS than UC at 24 weeks, but the effect on sun protection at 48 weeks was significant only in multivariate analyses. Beneficial effects of MSS were significantly mediated by knowledge about melanoma and characteristics of suspicious lesions, as well as self-efficacy. Participant engagement in MSS was satisfactory, with approximately two-thirds of participants completing at least two of the three core components. Content was rated as highly trusted, easy to understand, easy to navigate, and helpful. In conclusion, MSS illustrated significant and durable effects on SSE and mixed results on sun protection. Future studies should consider ways to further enhance treatment effects and engagement in MSS.

Effects of digital cognitive behavioural therapy for insomnia on insomnia severity: a large-scale randomised controlled trial.

BACKGROUND: Although several large-scale randomised controlled trials have shown the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I), there is a need to validate widespread dissemination of dCBT-I using recommended key outcomes for insomnia. We investigated the effect of a fully automated dCBT-I programme on insomnia severity, sleep-wake patterns, sleep medication use, and daytime impairment. METHODS: We did a parallel-group superiority randomised controlled trial comparing dCBT-I with online patient education about sleep. The interventions were available through a free-to-access website, publicised throughout Norway, which incorporated automated screening, informed consent, and randomisation procedures, as well as outcome assessments. Adults (age ≥18 years) who had regular internet access and scored 12 or higher on the Insomnia Severity Index (ISI) were eligible for inclusion, and were allocated (1:1) to receive dCBT-I (consisting of six core interactive sessions to be completed over 9 weeks) or patient education (control group). Participants were masked to group assignment and had no contact with researchers during the intervention period. The primary outcome was the change in ISI score from baseline to 9-week follow-up, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02558647) and is ongoing, with 2-year follow-up assessments planned. FINDINGS: Between Feb 26, 2016, and July 1, 2018, 5349 individuals commenced the online screening process, of which 1497 were ineligible or declined to participate, 2131 discontinued the screening process, and 1721 were randomly allocated (868 to receive dCBT-I and 853 to receive patient education). At 9-week follow-up, 584 (67%) participants in the dCBT-I group and 534 (63%) in the patient education group completed the ISI assessment. The latent growth model showed that participants in the dCBT-I group had a significantly greater reduction in ISI scores from baseline (mean score 19·2 [SD 3·9]) to 9-week follow-up (10·4 [6·2]) than those in the patient education group (from 19·6 [4·0] to 15·2 [5·3]; estimated mean difference -4·7 (95% CI -5·4 to -4·1; Cohen's d -1·21; p<0·001). Compared with patient education, the number needed to treat with dCBT-I was 2·7 (95% CI 2·4 to 3·2) for treatment response (ISI score reduction ≥8) and 3·2 (2·8 to 3·8) for insomnia remission (ISI score <8). No adverse events were reported to the trial team. INTERPRETATION: dCBT-I is effective in reducing the severity of symptoms associated with the insomnia disorder. These findings support the widespread dissemination of dCBT-I. Future research is needed to identify the moderators of response and to improve targeting. FUNDING: Norwegian Research Council; Liaison Committee for Education, Research and Innovation in Central Norway.

A behavior change model for internet interventions.

BACKGROUND: The Internet has become a major component to health care and has important implications for the future of the health care system. One of the most notable aspects of the Web is its ability to provide efficient, interactive, and tailored content to the user. Given the wide reach and extensive capabilities of the Internet, researchers in behavioral medicine have been using it to develop and deliver interactive and comprehensive treatment programs with the ultimate goal of impacting patient behavior and reducing unwanted symptoms. To date, however, many of these interventions have not been grounded in theory or developed from behavior change models, and no overarching model to explain behavior change in Internet interventions has yet been published. PURPOSE: The purpose of this article is to propose a model to help guide future Internet intervention development and predict and explain behavior changes and symptom improvement produced by Internet interventions. RESULTS: The model purports that effective Internet interventions produce (and maintain) behavior change and symptom improvement via nine nonlinear steps: the user, influenced by environmental factors, affects website use and adherence, which is influenced by support and website characteristics. Website use leads to behavior change and symptom improvement through various mechanisms of change. The improvements are sustained via treatment maintenance. CONCLUSION: By grounding Internet intervention research within a scientific framework, developers can plan feasible, informed, and testable Internet interventions, and this form of treatment will become more firmly established.

Exploring the relationship between parental worry about their children's health and usage of an internet intervention for pediatric encopresis.

OBJECTIVE: To investigate whether parental worry about their children's health predicts usage of a pediatric Internet intervention for encopresis. METHODS: Thirty-nine families with a child diagnosed with encopresis completed a national clinical trial of an Internet-based intervention for encopresis (www.ucanpooptoo.com). Parents rated worry about their children's health, encopresis severity, current parent treatment for depression, and parent comfort with the Internet. Usage indicators were collected while participants utilized the intervention. RESULTS: Regression analyses showed that parents who reported higher baseline levels of worry about their children's health showed greater subsequent intervention use (beta =.52, p =.002), even after accounting for other plausible predictors. Exploratory analyses indicated that this effect may be stronger for families with younger children. CONCLUSIONS: Characteristics of individuals using Internet-based treatment programs, such as parental worry about their children's health, can influence intervention usage, and should be considered by developers of Internet interventions.