Digital Cognitive Behavioural Therapy For Insomnia Research Articles

Cognitive Behavioral Therapy for Insomnia Self-Management Mobile Apps: A Review of Efficacy and Quality.

Cognitive behavioral therapy for insomnia (CBT-I) is the recommended treatment for insomnia, yet multiple barriers limit utilization. Digital CBT-I may present a solution, though related reviews have focused on Internet-based delivery rather than app use. The high utilization of health apps and prevalence of sleep apps indicate the need to equip clinicians with app-specific research. Toward this end, we reviewed efficacy and quality data on self-management CBT-I smartphone apps, revealing efficacy research on eleven apps, five of which were publicly available. While preliminary, these efficacy studies showed consistent positive findings. When examining quantitative quality indicators for the five publicly available apps, two had consistent data. Overall, two apps, CBTi Coach and Insomnia Coach, had positive, empirical findings across all efficacy and quality assessment approaches. We provide recommendations to guide clinician decision making regarding CBT-I self-management apps based on the literature and publicly available methods of app evaluations.

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

ABSTRACT 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.

The Intersection of Insomnia Disorder and Major Depressive Disorder: A Clinical Perspective

Major depressive disorder (MDD) is associated with profound sleep architectural alterations including reduced slow wave activity, increased delta sleep ratio, REM sleep disinhibition, shortened REM onset latency, and increased REM density. Antidepressants, though mitigating depressive symptoms, often disrupt sleep patterns, highlighting the delicate balance between treatment benefits and sleep-related impacts. Comprehensive assessment and management of insomnia is pivotal due to its significant implications for effective clinical management and treatment outcomes in MDD. Nonpharmacological treatments, notably cognitive-behavioral therapy for insomnia (CBTi), and digital CBTi (dCBTi) should be considered. CBTi unravels maladaptive sleep beliefs and behaviors, yielding improvements in both insomnia and MDD symptoms. Digital CBTi platforms extend accessibility, offering potential relief to a broader demographic. Sedating antidepressants, nonbenzodiazepine hypnotics, and atypical antipsychotics address insomnia within MDD, with cautious consideration for side effects. A combination of pharmacotherapy with CBTi might yield augmented outcomes in patients with MDD and comorbid insomnia. Ketamine, electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), vagal nerve stimulation (VNS), and deep brain stimulation (DBS) explore novel dimensions in treating treatment-resistant depression, potentially influencing sleep disruptions. [ Psychiatr Ann . 2023;53(11):502–507.]

O035 Digital CBT-i versus digital sleep education control in an Australian community-based cohort: A randomised controlled trail.

Abstract Background Insomnia is a prevalent and debilitating condition in Australia. Cognitive behavioural therapy for insomnia (CBT-i) is the recommended first-line treatment, but is accessed by very few people with insomnia. We aimed to develop and test an interactive self-guided digital CBT-i program in an Australian community-based sample. Methods A randomised controlled trial was used to investigate the effect of digital CBT-i, versus digital sleep education control, on changes in insomnia (ISI), depression (PHQ-9) and anxiety symptoms (GAD-7) by 8-week follow-up in people with insomnia symptoms (ISI≥15). Intention-to-treat linear mixed models and complete-case chi-square analyses were used. Results Participants included 62 adults with insomnia symptoms (82% female, Age M [sd] = 52.5 [16.3]). There were no between-group differences in baseline characteristics, or rates of missing data at 8-weeks. CBT-i was associated with significantly greater improvements in the ISI (M [95%CI] reduction = 9.7 [7.8-11.6], d = 3.5) and PHQ-9 (M reduction = 4.8 [3.1-6.6], d = 1.0), but not GAD-7, compared to control (M ISI reduction = 1.6 [-0.2-3.4]; M PHQ-9 reduction = 1.0 [-0.7-2.6]; both interaction p &amp;lt; 0.001). Compared to control, CBT-i resulted in greater rates of insomnia improvement (ISI reduction ≥6; 7%, vs 75%), insomnia remission (ISI&amp;lt;8; 0%, vs 42%), and lower rates of clinically significant insomnia by 8-weeks (ISI≥15; 61%, vs 12%, all p &amp;lt; 0.001). Conclusion This digital CBT-i program leads to large improvements in insomnia and depression symptoms adults with insomnia. Implementation programs are required to increase access to digital CBT-i in Australia.

P055 Maintaining effectiveness and mitigating sleepiness: A tailored digital CBT-i approach.

Abstract Background Bedtime restriction therapy, a core component of cognitive behavioural therapy for insomnia (CBT-i), often leads to an acute increase in daytime sleepiness. To mitigate the effect of bedtime restriction on accident-risk, we aimed to develop and test a 5-session self-guided digital CBT-i program that incorporates self-reported sleepiness into personalised treatment algorithms. Methods We recruited people with insomnia symptoms (ISI≥15) reporting no excessive daytime sleepiness (ESS&amp;lt;16) to a clinical trial. We assessed weekly self-reported sleepiness (ESS), nocturnal insomnia severity (Range: 0 [no symptoms] to 12 [worst symptoms]), and self-reported sleep/wake parameters during each digital CBT-i session. Intention-to-treat mixed models were used to investigate changes in weekly symptoms. Results Peri-treatment data from 52 people were used (Age M [sd] = 54.2 [15.7]; 81% female). Average ESS scores did not change from session one (M [±95%CI] = 5.9 [1.1]) to sessions two (6.2 [1.1]), three (6.2 [1.2]), four (5.4 [1.2]), or five (5.2 [1.2]). Improvements from sessions one to five were observed in; nocturnal insomnia severity (M [±95%CI] reduction = 4.0 [1.1], d = 2.3), and self-reported sleep onset latency (M reduction = 26.1 minutes [16.5], d = 0.6), wake after sleep onset (M reduction = 73.6 minutes [29.2], d = 1.0), sleep duration (M increase = 36.2 minutes [31.0], d = 0.5), and sleep efficiency (M increase = 17.9% [6.6], d = 1.2). Conclusion This digital CBT-i program improved insomnia symptoms without increasing average daytime sleepiness during any session. Further research is required in people commencing treatment with excessive daytime sleepiness.

Development and Initial Evaluation of Web-Based Cognitive Behavioral Therapy for Insomnia in Rural Family Caregivers of People With Dementia (NiteCAPP): Mixed Methods Study.

Informal caregivers of people with dementia frequently experience chronic insomnia, contributing to stress and poor health outcomes. Rural caregivers are particularly vulnerable but have limited access to cognitive behavioral therapy for insomnia (CBT-I), a recommended frontline treatment for chronic insomnia. Web-based delivery promises to improve insomnia, particularly for rural caregivers who have limited access to traditional in-person treatments. Our team translated an efficacious 4-session standard CBT-I content protocol into digital format to create NiteCAPP. This study aimed to (1) adapt NiteCAPP for dementia caregivers to create NiteCAPP CARES, a tailored digital format with standard CBT-I content plus caregiver-focused modifications; (2) conduct usability testing and evaluate acceptability of NiteCAPP CARES' content and features; and (3) pilot-test the adapted intervention to evaluate feasibility and preliminary effects on sleep and related health outcomes. We followed Medical Research Council recommendations for evaluating complex medical interventions to explore user needs and adapt and validate content using a stepwise approach: (1) a rural dementia caregiver (n=5) and primary care provider (n=5) advisory panel gave feedback that was used to adapt NiteCAPP; (2) caregiver (n=5) and primary care provider (n=7) focus groups reviewed the newly adapted NiteCAPP CARES and provided feedback that guided further adaptations; and (3) NiteCAPP CARES was pilot-tested in caregivers (n=5) for feasibility and to establish preliminary effects. Self-report usability measures were collected following intervention. Before and after treatment, 14 daily electronic sleep diaries and questionnaires were collected to evaluate arousal, health, mood, burden, subjective cognition, and interpersonal processes. The stepped approach provided user and expert feedback on satisfaction, usefulness, and content, resulting in a new digital CBT-I tailored for rural dementia caregivers: NiteCAPP CARES. The advisory panel recommended streamlining content, eliminating jargon, and including caregiver-focused content. Focus groups gave NiteCAPP CARES high usefulness ratings (mean score 4.4, SD 0.79, scored from 1=least to 5=most favorable; score range 4.2-4.8). Multiple features were evaluated positively, including the intervention's comprehensive and engaging information, caregiver focus, good layout, easy-to-access intervention material, and easy-to-understand sleep graphs. Suggestions for improvement included the provision of day and night viewing options, collapsible text, font size options, tabbed access to videos, and a glossary of terms. Pilot-test users rated usefulness (mean score 4.3, SD 0.83; range 4.1-4.5) and satisfaction (mean score 8.4, SD 1.41, scored from 1=least to 10=most satisfied; range 7.4-9.0) highly. Preliminary effects on caregiver sleep, arousal, health, mood, burden, cognition, and interpersonal processes (all P<.05) were promising. Adaptations made to standard digital CBT-I created a feasible, tailored digital intervention for rural dementia caregivers. Important next steps include further examination of feasibility and efficacy in a randomized controlled trial with an active control condition, a multisite effectiveness trial, and eventual broad dissemination. ClinicalTrials.gov NCT04632628; https://clinicaltrials.gov/ct2/show/NCT04632628.

Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial.

Chronic insomnia is one of the most common health problems among veterans and negatively impacts their health, function, and quality of life. Although cognitive behavioral therapy for insomnia (CBT-I) is the first-line recommended treatment, sedative-hypnotic medications remain the most common. Sedative-hypnotics, however, have mixed effectiveness, are frequently prescribed longer than recommended, and are associated with numerous risks and adverse effects that negatively impact veteran function. Meeting the treatment needs of veterans impacted by insomnia requires delivering gold standard behavioral care, like CBT-I, and the reduction of sedative-hypnotics through innovative methods. The objective of this feasibility clinical trial is to test a digital CBT-I approach combined with deprescribing to improve the success of sedative-hypnotic reduction among veterans. The intervention combines Noctem Health Clinician Operated Assistive Sleep Technology (COAST), an effective and efficient, scalable, and adaptable digital platform to deliver CBT-I, with clinical pharmacy practitioner (CPP)-led deprescribing of sedative-hypnotic medications. In this nonrandomized single-group clinical trial, 50 veterans will be recruited and enrolled to receive CBT-I delivered via Noctem COAST and CPP-led deprescribing for up to 12 weeks. Assessments will occur at baseline, posttreatment, and 3-month follow-up. The aims are to (1) assess the feasibility of recruiting veterans with chronic sedative-hypnotic use to participate in the combined intervention, (2) evaluate veterans' acceptability and usability of the COAST platform, and (3) measure changes in veterans' sleep, sedative-hypnotic use, and function at baseline, posttreatment, and 3-month follow-up. The institutional review board approved the study in October 2021 and the trial was initiated in May 2022. Recruitment and data collection began in September 2022 and is anticipated to be completed in April 2024. Aim 1 will be measured by tracking the response to a mail-centric recruitment approach using electronic medical records to identify potentially eligible veterans based on sedative-hypnotic use. Aim 2 will be measured using the Post-Study System Usability Questionnaire, assessing overall usability as well as system usefulness, information quality, and interface quality. Aim 3 will use the Insomnia Severity Index and sleep diaries to measure change in insomnia outcomes, the Patient-Reported Outcome Measurement Information System Profile to measure change in physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles, pain, cognitive function, and self-reported sedative-hypnotic use to measure change in dose and frequency of use. Findings will inform the utility of a combined digital CBT-I and CPP-led deprescribing intervention and the development of an adequately powered clinical trial to test the effectiveness in a diverse sample of veterans. Further, findings will help inform potential new approaches to deliver care and improve access to care for veterans with insomnia, many of whom use sedative-hypnotics that may be ineffective and increase the risk for negative outcomes. ClinicalTrials.gov NCT05027438; https://classic.clinicaltrials.gov/ct2/show/NCT05027438. DERR1-10.2196/47636.

Effectiveness of digital cognitive-behavioral therapy for insomnia alone or combined with sleep medication: A real-world evidence study

Insomnia is a highly prevalent sleep disorder, but its first line of treatment (Cognitive Behavioral Therapy for Insomnia - CBTi) is not widely available and affordable. Digital therapy has been an alternative to these limitations and its combination with pharmacological treatment may improve patients' clinical outcomes and therapy adherence. This was a real-world evidence study aimed to evaluate the efficacy of a CBTi smartphone app combined or not with sleep medication, based on a sample of users of a CBTi smartphone app (SleepUp®) registered between June 2020 and June 2022. Individuals were categorized into two groups (“dCBTi alone” and “dCBTi combined”) according to their self-reported use of sleep medication on the first day of treatment. Assessments were made based on the self-report of sleep logs (sleep quality and efficiency) and on insomnia severity (Insomnia Severity Index). Comparisons were made considering the first entry (baseline) and the mean of the last three days in which sleep logs were filled out (final). The final samples comprised 143 individuals: 73 (51%) reported using sleep medication at baseline, while 70 (49%) did not. In both groups, there was an improvement in sleep quality, (p<0.001), sleep efficiency (p<0.001), and insomnia severity (p<0.001). The magnitude of effects on sleep efficiency and insomnia severity was greater in the dCTBi combined group. This result indicates that dCBTi can be useful as an adjuvant treatment for insomnia.

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)

0325 Reducing nocturnal cognitive arousal and rumination mediate treatment effects of digital cognitive behavioral therapy for insomnia

Abstract Introduction High cognitive arousal—i.e., heightened cognitive activity often in the form of perseverative thinking—is a central feature insomnia. Emerging evidence from randomized controlled trials (RCTs) support alleviating cognitive arousal as a mechanism by which cognitive behavioral therapy for insomnia (CBTI) reduces symptoms of insomnia and depression. However, few RCTs have published CBTI data on cognitive arousal outcomes. The present study tested whether CBTI alleviates cognitive arousal symptoms, and whether reducing cognitive arousal symptoms mediate CBTI effects on insomnia and depression. Methods 434 patients with clinical insomnia symptoms (Insomnia Severity Index [ISI] ≥ 15) were randomized to digital CBTI or digital sleep education control. Study outcomes included insomnia (ISI), depression (quick inventory of depressive symptomatology self-report 16-item survey, QIDS-SR16), and two indices of cognitive arousal (pre-sleep arousal scale’s cognitive factor [PSASC] and daytime insomnia symptoms response scale [DISRS]). Treatment effects and mediation analyses were conducted using multivariate linear regression. Results While controlling for baseline symptoms, CBTI patients, relative to controls, reported lower levels of insomnia (b=-2.45, p&amp;lt;.001), depression (b=-1.13, p&amp;lt;.001), nocturnal cognitive arousal (b=-2.37, p&amp;lt;.001) and insomnia-focused rumination (b=-3.43, p&amp;lt;.001) after treatment. Posthoc independent samples t-tests showed that CBTI produced small-medium effects on nocturnal cognitive arousal (Cohen’s d=.40) and insomnia-focused rumination (Cohen’s d=.31). Mediation analyses showed that reducing nocturnal cognitive arousal (PSASCT2-T1) mediated 29.0% of CBTI effects on insomnia (αβ=-.709, 95%CI=-1.09, -0.38), and 35.1% of CBTI effects on depression (αβ=-.397, 95%CI=-0.65, -0.19). Mediation analyses showed that reducing insomnia-focused rumination (DISRST2-T1) mediated 10.6% of CBTI on insomnia (αβ=-.261, 95%CI=-0.50, -0.08), but did not mediate antidepressant effects (αβ=-.300, 95%CI=-1.46, 0.72). Conclusion Digital CBTI effectively alleviated nocturnal cognitive arousal and insomnia-focused rumination. Moreover, alleviating nocturnal cognitive arousal was a mechanism by which CBTI reduced symptoms of insomnia and depression. By comparison, reducing insomnia-focused rumination mediated a small proportion of CBTI effects on insomnia and was uninvolved in depression effects. Although reducing cognitive arousal facilitated insomnia and depression outcomes, CBTI is likely limited by its modest effects on cognitive arousal symptoms. Improving insomnia therapy benefits for cognitive arousal may enhance patient outcomes. Support (if any) This RCT (NCT03322774) was supported by NIMH R01-MH122636.

0331 Effects of Cognitive Behavioral Therapy for Insomnia (CBTI) on Daytime Cognitive Functioning: A Report from the AIR Trial

Abstract Introduction Prior studies have shown that CBTI improves patient reported outcomes including daytime fatigue, mood status and quality of life, yet there are limited data concerning the effects of therapy on objective measures of daytime function. The current study tested the effects of CBTI on measures derived from the psychomotor vigilance test (PVT) in a sample of patients with comorbid insomnia disorder and sleep apnea. Methods Patients with insomnia and comorbid OSA, who were prescribed PAP therapy (N =155; Mage= 56.8±12.5 yrs.; 58.1% women) were randomized to digital CBTI (dCBTI) or Sleep Hygiene (CTRL). They completed PVT at baseline and after 8 weeks of treatment. Patients in the dCBTI arm who reached remission were offered no additional insomnia treatment, whereas those who did not were randomly assigned to 8 weeks of continued access to dCBTI or to a therapist delivered CBTI. Patients again completed the PVT after this second 8-week treatment phase. PVT outcome measures included mean reaction time, attentional lapses and efficiency scores. Linear mixed models were used to compare the PVT measures of patients receiving either of the CBTI treatment sequences with those assigned to the CTRL. Results Analyses showed significant group x time interactions for PVT attentional lapses (F = 3.04; p &amp;lt; .05) and for efficiency scores (F= 4.06; p&amp;lt; .025). Those who received either of the CBTI treatment sequences showed a greater reduction in attentional lapses and greater improvement in their efficiency scores from baseline to the post-treatment assessments than did those assigned the CTRL. Conclusion Findings indicate that CBTI improves objective indices of daytime cognitive functioning among those with comorbid apnea and insomnia disorder. Further tests of CBTI’s effects on these and other measures of cognitive functioning are warranted in other samples of insomnia patients who do and do not have medical, psychiatric and sleep disorder comorbidities. Support (if any) Funding support from the National Heart, Lung and Blood Institute, Grant # 1R01HL130559-01A1.

Subjective versus objective sleep outcomes in older adults with and without uncoupled sleep following online cognitive behavioural therapy for insomnia

Uncoupled sleep is a phenomenon characterised by a disconnect between sleep pattern and sleep complaint. This study examined the impact of uncoupled sleep on dysfunctional sleep beliefs and objective and subjective sleep outcomes in community-dwelling older adults following digitally delivered Cognitive Behavioural Therapy for Insomnia (CBT-I) to assess how these groups respond to CBT-I. Objective sleep was measured using wrist actigraphy, subjective sleep quality via sleep diaries and the Pittsburgh Sleep Quality Index (PSQI). Dysfunctional sleep beliefs were assessed by the Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16). All measurements were taken prior to and following a 4-week online CBT-I program. Linear mixed model and generalised linear mixed model analyses were conducted to examine objective and subjective sleep onset latency, total sleep time, wake after sleep onset and number of awakenings as well as PSQI and DBAS-16 scores, respectively. Out of 80 enrolled participants, 62 participants (55 females, 89%; 16 complaining good sleepers, 26 complaining poor sleepers, 11 non-complaining good sleepers, and nine non-complaining poor sleepers) completed the study. CBT-I reduced dysfunctional sleep beliefs across all sleeper classifications. Objective and self-reported changes in sleep parameters were demonstrated in complaining poor sleepers without uncoupled sleep. Complaining good sleepers with uncoupled sleep only reported a decrease in the number of subjective sleep awakenings. There were no changes in sleep outcomes in non-complaining good and non-complaining poor sleepers. Online CBT-I was effective in improving the sleep outcomes of individuals who had both subjective and objective poor sleep. However, as the online CBT-I reduced dysfunctional sleep beliefs in all sleep groups, further examination of dysfunctional sleep beliefs and whether they mediate the outcomes of digital CBT-I in older adults will need to be conducted.

Exploring digital cognitive behavioural therapy for insomnia in an early intervention in psychosis service - A study protocol for an initial feasibility study with process evaluation.

Early psychosis may be a critical time at which clinical trajectories are still evolving, and sleep interventions hold promise to improve outcomes at this stage. Although cognitive behavioural therapy (CBT) for insomnia shows promise in psychosis, there has been limited evaluation of delivery within current care. This study aims to evaluate the feasibility and acceptability of providing fully-automated digital CBT for insomnia (CBT-I) within an early intervention in psychosis service. We will conduct a single-arm feasibility trial within an early psychosis intervention service, and up to 40 individuals experiencing a first episode of psychosis and with evidence of insomnia can be enrolled (May 2021 - August 2022). Additional service user inclusion criteria are capacity to consent and access to a suitable technological device to access digital CBT. Participants will be offered access to a fully-automated digital CBT-I program (Sleepio) delivered using web and/or mobile app. The study comprises pre- and post- intervention questionnaire assessments and interviews with service users and staff to provide initial outcome signals. Quantitative questionnaire data will be analysed descriptively, alongside rates of eligibility, consent, uptake and completion. Qualitative data will be analysed using thematic analysis. Results will be used to develop a logic model describing feasibility and implementation. From this study, we hope to better understand how to deliver digital CBT for insomnia within an early intervention in psychosis service. This study will help inform further research, including how best to support staff in using Sleepio, and inform the design of subsequent trials in this area.

Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression

BackgroundPrevention of major depressive disorder (MDD) is a public health priority. Strategies targeting individuals at elevated risk for MDD may guide effective preventive care. Insomnia is a reliable precursor to depression, preceding half of all incident and relapse cases. Thus, insomnia may serve as a useful entry point for preventing MDD. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for insomnia, but widespread implementation is limited by a shortage of trained specialists. Innovative stepped-care approaches rooted in primary care can increase access to CBT-I and reduce rates of MDD.Methods/designWe propose a large-scale stepped-care clinical trial in the primary care setting that utilizes a sequential, multiple assignment, randomized trial (SMART) design to determine the effectiveness of dCBT-I alone and in combination with clinician-led CBT-I for insomnia and the prevention of MDD incidence and relapse. Specifically, our care model uses digital CBT-I (dCBT-I) as a first-line intervention to increase care access and reduce the need for specialist resources. Our proposal also adds clinician-led CBT-I for patients who do not remit with first-line intervention and need a more personalized approach from specialty care. We will evaluate negative repetitive thinking as a potential treatment mechanism by which dCBT-I and CBT-I benefit insomnia and depression outcomes.DiscussionThis project will test a highly scalable model of sleep care in a large primary care system to determine the potential for wide dissemination and implementation to address the high volume of population need for safe and effective insomnia treatment and associated prevention of depression.Trial registrationClinicalTrials.gov NCT03322774. Registered on October 26, 2017

Racial disparities in treatment engagement and outcomes in digital cognitive behavioral therapy for insomnia among pregnant women

ObjectivesIn the United States, Black women are disproportionately afflicted with prenatal insomnia. Although cognitive-behavioral therapy for insomnia (CBTI) may represent a strategy to reduce disparities in insomnia, racial minorities attend fewer healthcare appointments and have poorer outcomes from prenatal care and mental health treatment relative to white patients. The present study examined differences in treatment engagement and patient-reported outcomes in non-Hispanic Black and white pregnant women receiving digital CBTI. MethodsSecondary analysis of 39 pregnant women with clinical insomnia who received digital CBTI. Treatment engagement was operationalized as the number of sessions completed (≥4 considered an adequate dose). Treatment outcomes were assessed using the Insomnia Severity Index (ISI; insomnia) and Pittsburgh Sleep Quality Index (PSQI; global sleep disturbance). ResultsBlack women were 4 times more likely than white women to discontinue CBTI before receiving an adequate dose (8.3% vs. 33.3%). Regarding treatment outcomes, white women reported a mean reduction of 5.75 points on the ISI and a reduction of 3.33 points on the PSQI (Cohen's dz = 1.10-1.19). By comparison, Black women reported reductions of 2.13 points on the ISI and 1.53 points on the PSQI, which were statistically non-significant. Differences in treatment engagement did not account for the disparities in patient-reported outcomes. ConclusionsDuring pregnancy, Black women completed fewer CBTI sessions and experienced poorer treatment outcomes in response to digital CBTI relative to white women. Enhancements to insomnia therapy and its digital delivery may improve adherence and outcomes in Black pregnant women.

Efficacy of a digital cognitive behavioral therapy for insomnia in people with low back pain: a feasibility randomized co-twin and singleton-controlled trial

BackgroundDigital cognitive behavioral therapy for insomnia (CBT-i) in people with low back pain (LBP) may be efficacious in improving both sleep and pain; and twin trial designs provide greater precision of treatment effects by accounting for genetic and early environmental factors. We aimed to determine the feasibility of a trial investigating the efficacy of a digital CBT-i program in people with comorbid symptoms of insomnia and LBP, in twins and people from the general community (singletons).MethodsThirty-two twins (16 pairs) and 66 singletons with comorbid symptoms of insomnia and LBP (> 6 weeks duration) were randomized to digital CBT-i (intervention) or educational program (control) for 6 weeks. The digital CBT-I, Sleepio (developed by Big Health Inc.), was an online interactive, automated, personalized course comprising of six sessions, once a week. The education program was six emails with general sleep information, once a week. Participants were blinded to their group allocation and offered the alternative intervention at the completion of the study. Feasibility outcomes included recruitment and follow-up rates, data collection and outcome measure completion, contamination (communication about trial interventions), acceptability (adherence), credibility, and participants’ experience of the intervention.ResultsSixteen out of 722 contacted twin pairs were recruited (recruitment rate = 2.2%). Twins were recruited between September 2015 and August 2018 (35 months) and singletons between October 2017 and Aug 2018 (10 months). Follow-up rates for post-intervention and 3-month follow-up were 81% and 72% for twins and 82% and 78% for singletons respectively. Adherence rates (percentage of sessions completed out of six) for the digital CBT-i were 63% for twins and 55% for singletons. Contamination (speaking about the study to each other) was present in two twin pairs (13%). Written or verbal feedback (n = 21) regarding the digital CBT-i intervention from participants were positive (n = 11), neutral (n = 5), or negative (n = 6).ConclusionsOnline CBT-i was received favorably with people with comorbid symptoms of insomnia and LBP. While the online data collection was successful, strategies need to be implemented to improve adherence, follow-up, control group credibility (for digital CBT-i), and twin recruitment rates (for twin trials).Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12615000672550). Registered 29 June 2015

0682 Cognitive-behavioral therapy for insomnia alleviates and prevents suicidal ideation

Abstract Introduction Patients with insomnia disorder are at increased risk for suicidal thoughts and behaviors. Early evidence suggests that insomnia therapeutics may reduce suicidal ideation (SI). However, the role of digital insomnia therapeutics in both the alleviation and prevention of SI remains unclear. Methods A total of 658 community adults with DSM-5 insomnia disorder enrolled into a single-site RCT evaluating the efficacy of digital cognitive behavioral therapy for insomnia (CBTI) relative to attention control. Before treatment, 126 patients endorsed SI, whereas 532 patients denied SI. First, we tested whether CBTI can reduce SI in patients with baseline SI. Second, we tested whether CBTI reduces risk for SI development in those without baseline SI. Results Among those with baseline SI, just 30.0% of CBTI patients reported SI after treatment, which was lower than the 54.5% of controls with posttreatment SI (OR=2.81, p=.006). Among those without baseline SI, CBTI did not reduce risk for developing SI after treatment (p=.681). However, a multivariate logit model regression odds for SI onto condition (p=.140) and posttreatment remission status (OR=5.68, p=.007) indicated that patients who remitted from insomnia exhibited a reduction in SI risk. Importantly, CBTI was associated with a 6.29 odds increase of insomnia remission relative to control. PRODCLIN estimation of the indirect effect indicated that CBTI prevents SI, but that the effect is fully mediated by the extent to which CBTI produces insomnia remission (αβ=-3.13=5, 95% CI=-5.28, -0.96). Conclusion Digital CBTI reduces risk for SI development in insomnia patients without pretreatment SI. These data support a role for digital insomnia therapeutics in SI prevention in this high-risk patient population. Moreover, digital CBTI reduces SI in insomnia patients with SI. These data indicate that digital CBTI can alleviate SI, but it possible that adjunct treatment directly targeting SI may enhance suicide risk reduction. Support (If Any) Robert Wood Johnson Foundation

0459 The First Step of a Triaged Stepped-Care Delivery of CBTI: A Preliminary Report from the RESTING Study

Abstract Introduction Both online and therapist-led cognitive behavioral therapy for insomnia (CBTI) are effective. However, little is known about the optimal combination and sequence to maximize both access and effectiveness. The RESTING study is a randomized controlled trial assessing the effectiveness of a triaged stepped care approach (STEPPPED-CARE) to delivering CBTI that utilizes a simple five-item Checklist to determine which patients should start treatment with online versus therapist-led CBTI. Methods Adults 50 years and older (N=222; age = 63.1 (SD=8.2); 74% female) with insomnia disorder who met the study’s broad eligibility criteria were randomized to STEPPED-CARE (N=112) or to ONLINE-ONLY CBTI (N=110). Participants in the STEPPED-CARE arm who responded yes to any Checklist item (Checklist Yes) received therapist-led CBTI (N=61); the rest (Checklist NO) received the online CBTI program Sleepio (N=62). All participants in the ONLINE-ONLY arm received Sleepio. Randomization was stratified by Checklist (Yes/No). We used mixed effects models with an Arm by Checklist by Time interaction to determine the effect of STEPPED-CARE on insomnia severity two months after randomization, using the Insomnia Severity Index (ISI). Results A mixed effects model revealed an Arm by Checklist by Time interaction (p=0.013). Post-hoc analyses within stratum revealed that within the Checklist Yes stratum, participants assigned to STEPPED-CARE (all received therapist-led treatment) experienced significantly greater reduction in ISI (from 16.2 (SD=1.2) to 11.6 (SD=2.1)) than those assigned to ONLINE-ONLY (from 16.2 (SD=1.2) to 13.7 (SD=1.4); p=0.007, d=0.22). Among those in the Checklist No stratum, there was no Arm difference in ISI change. The combined mean ISI in the Checklist No group was 14.8 (0.8) at baseline and 11.2 (0.8) at 2 months. Overall, remission of insomnia (ISI&amp;lt;8) was attained by 23% of those in STEPPED-CARE and 15% of those assigned to ONLINE-ONLY. Conclusion Results support the efficacy of the first step of a triaged stepped care approach to CBTI among middle age and older adults with insomnia disorder. Given minimal exclusion criteria, results from the current trial are generalizable to individuals with comorbidities and those who use hypnotics, offering a way to triage patients to digital or therapist-led CBTI effectively and efficiently. Support (If Any) R01AG057500

0447 Racial disparities in patient outcomes and treatment engagement in cognitive behavioral therapy for insomnia among pregnant women

Abstract Introduction Insomnia affects over half of pregnant women, and epidemiological data suggest that insomnia rates are twice as high among black women relative to white women in pregnancy. Recently, cognitive behavioral therapy for insomnia (CBTI) has been supported as an efficacious intervention for prenatal insomnia. However, it remains unclear whether CBTI is equally efficacious across racial groups, which is necessary to help reduce race-related disparities in prenatal insomnia. Methods This study is a secondary analysis of a single-site trial. Thirty-nine women who self-identified as white (n=24) and black (n=15) completed CBTI during pregnancy. Insomnia was measured using the Insomnia Severity Index (ISI). Before CBTI, patients reported sociodemographics. Treatment outcomes were collected a week after completing treatment during pregnancy. Results Although racial groups did not differ in ISI before treatment, white patients reported significantly larger decreases in ISI relative to black patients after CBTI (-5.75 vs -2.13, p=.046). Notably, black women were less engaged in treatment than white women based on mean number of sessions attended (4.20 vs 5.54 sessions, p=.013). Even so, multivariate linear regression showed that posttreatment ISI was 4 points higher for black women than white women (b=4.10, p=.049) when controlling for baseline ISI (p=.001), obesity (p=.072), poverty (p=.091), sessions attended (p=.155), and short sleep (p=.406). Notably, 41.7% of white CBTI patients remitted relative to 26.7% of black CBTI patients, suggesting that white women are 56% more likely to remit from CBTI than black women. Conclusion Our data suggest that black pregnant women exhibit poorer response to digital CBTI than white pregnant women. Moreover, racial disparities in CBTI response during pregnancy were not attributable to differences in session attendance. We must identify barriers to treatment response in black women, thereby guiding refinement to CBTI to provide better care for black women during pregnancy. Support (If Any) Ameriican Academy of Sleep Medicine

RCT of the effectiveness of stepped-care sleep therapy in general practice: The RESTING study protocol

Cognitive behavioral therapy for insomnia (CBT-I) is an effective, non-pharmacological intervention, designated by the American College of Physicians as the first-line treatment of insomnia disorder. The current randomized controlled study uses a Hybrid-Type-1 design to compare the effectiveness and implementation potential of two approaches to delivering CBT-I in primary care. One approach offers therapy to all patients through an automated, digital CBT-I program (ONLINE-ONLY). The other is a triaged STEPPED-CARE approach that uses a simple Decision Checklist to start patients in either digital or therapist-led treatment; patients making insufficient progress with digital treatment at 2 months are switched to therapist-led treatment. We will randomize 240 individuals (age 50 or older) with insomnia disorder to ONLINE-ONLY or STEPPED-CARE arms. The primary outcomes are insomnia severity and hypnotic medication use, assessed at baseline and at months 2, 4, 6, 9, and 12 after randomization. We hypothesize that STEPPED-CARE will be superior to ONLINE-ONLY in reducing insomnia severity and hypnotic use. We also aim to validate the Decision Checklist and explore moderators of outcome. Additionally, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, we will use mixed methods to obtain data on the potential for future dissemination and implementation of each approach. This triaged stepped-care approach has the potential to improve sleep, reduce use of hypnotic medications, promote safety, offer convenient access to treatment, and support dissemination of CBT-I to a large number of patients currently facing barriers to accessing treatment.Clinical trial registration:NCT03532282