Digital Cognitive Behavioural Therapy For Insomnia Research Articles

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 < .05) and for efficiency scores (F= 4.06; p< .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<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

A qualitative examination of the usability of a digital cognitive behavioral therapy for insomnia program after stroke

ABSTRACT Objective Sleep is commonly impaired after stroke. Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line recommended treatment for sleep difficulty. “Sleepio” is a digital CBT-I program, allowing delivery of this treatment at scale. However, Sleepio has not yet been tested specifically in people with stroke. Before doing so, we wanted to explore the experience of people with stroke using the program, and potential barriers to completion. Method Community dwelling survivors of stroke (n = 11, 41–78 years of age, 6 male) were given access to Sleepio. Participants discussed their experiences with the program during a semi-structured interview, which was analyzed using thematic analysis. Results We found four common themes: (1) positive and negative experiences impacted engagement with the program, (2) motivation to follow the program was proportional to perceived severity of sleep problem, (3) impractical advice for people with stroke, (4) difficulty operating the program. Conclusion Sleepio can be used by some people at the chronic stage of stroke. However, some barriers to completion were highlighted, and not all suggestions were deemed practical for everyone. We therefore suggest possible adaptations which may make the program more easily usable and engaging for survivors of stroke with varying impairments.

Treating Insomnia with High Risk of Depression Using Therapist-Guided Digital Cognitive, Behavioral, and Circadian Rhythm Support Interventions to Prevent Worsening of Depressive Symptoms: A Randomized Controlled Trial

Introduction: The global disease burden of major depressive disorder urgently requires prevention in high-risk individuals, such as recently discovered insomnia subtypes. Previous studies targeting insomnia with fully automated eHealth interventions to prevent depression are inconclusive: dropout was high and likely biased, and depressive symptoms in untreated participants on average improved rather than worsened. Objective: This randomized controlled trial aimed to efficiently prevent the worsening of depressive symptoms by selecting insomnia subtypes at high risk of depression for internet-based circadian rhythm support (CRS), cognitive behavioral therapy for insomnia (CBT-I), or their combination (CBT-I+CRS), with online therapist guidance to promote adherence. Methods: Participants with an insomnia disorder subtype conveying an increased risk of depression (n = 132) were randomized to no treatment (NT), CRS, CBT-I, or CBT-I+CRS. The Inventory of Depressive Symptomatology – Self Report (IDS-SR) was self-administered at baseline and at four follow-ups spanning 1 year. Results: Without treatment, depressive symptoms indeed worsened (d = 0.28, p = 0.041) in high-risk insomnia, but not in a reference group with low-risk insomnia. Therapist-guided CBT-I and CBT-I+CRS reduced IDS-SR ratings across all follow-up assessments (respectively, d = –0.80, p = 0.001; d = –0.95, p < 0.001). Only CBT-I+CRS reduced the 1-year incidence of clinically meaningful worsening (p = 0.002). Dropout during therapist-guided interventions was very low (8%) compared to previous automated interventions (57–62%). Conclusions: The findings tentatively suggest that the efficiency of population-wide preventive strategies could benefit from the possibility to select insomnia subtypes at high risk of developing depression for therapist-guided digital CBT-I+CRS. This treatment may provide effective long-term prevention of worsening of depressive symptoms. Trial registration: the Netherlands Trial Register (NL7359).

P093 A Systematic Review of Adherence to Cognitive Behavioural Therapy for Insomnia (CBT-I) - Key Findings

Abstract Introduction Research into factors influencing adherence to CBT-I and how adherence impacts treatment outcomes remains scarce. Through a systematic review, we aimed to determine how adherence is assessed; which factors predict adherence; and which treatment outcomes are predicted by adherence. Methods Included publications met the following criteria: adults with insomnia; an intervention of CBT-I, including sleep restriction (SRT) and/or stimulus control (SCT); a reported measure of adherence; and written in English. Results Final n=103 papers. Measures assessed either global adherence or adherence to specific components of CBT-I via questionnaires, sleep diaries, interviews, or actigraphy. Most common measures were sleep diary-derived CBT-I components for therapist-led studies, and module completion for digital studies. Twenty-eight papers (27.2% of total) examined predictors of adherence. Depression, pre- and post-session sleep, psychosocial support, and dysfunctional beliefs about sleep predicted adherence. Demographic variables, other psychological comorbidities, insomnia severity, and sleep questionnaires did not predict adherence. Twenty-eight papers (27.2%) examined whether adherence predicted treatment outcomes. Neither global adherence nor adherence to any specific component of therapist-led CBT-I reliably predicted sleep outcomes. For digital CBT-I, completion of treatment modules was linked to improvements in ISI, however there were only five studies. Conclusion There was a high degree of heterogeneity in how adherence was measured, and in predictors and outcome variables assessed. This heterogeneity likely explains why adherence does not appear to predict treatment outcome. The field needs to develop a standardised method for assessing each specific adherence construct to fully understand the role of adherence in CBT-I.

Implementation of a digital cognitive behavioral therapy for insomnia pathway in primary care

BackgroundInsomnia is a prevalent and debilitating disorder commonly managed by family physicians. Insomnia guidelines recommend cognitive behavioral therapy for insomnia (CBTi) as the ‘first-line’ treatment. However, family physicians report limited time, knowledge, access, support, and referral options to manage patients with CBTi. Consequently, many patients with insomnia are prescribed potentially harmful and addictive sedative-hypnotic medicines (e.g. benzodiazepines). Family physicians require an insomnia management pathway that is specifically tailored to the guideline-recommendations, time demands, and capacity of family practice.MethodsThis mixed-methods implementation trial will test the feasibility, acceptability and effectiveness of a comprehensive digital insomnia management pathway in family practice. This novel pathway includes digital recruitment of family physicians, automatic identification of patients whose electronic medical records contain recent sedative-hypnotic prescriptions using a software management pathway and real-time notifications prompting physicians to refer patients to a well-established digital CBTi program. At least 10 family physicians and 375 patients with insomnia will be recruited. Physicians will be provided with an eBook to guide gradual sedative-hypnotic withdrawal. Feasibility and acceptability will be assessed from the perspective of patients and physicians. Effectiveness will be determined by co-primary outcomes: cessation of sedative-hypnotic use, and improvement in self-reported insomnia symptoms from baseline to 12-month follow-up. Analysis of trends in costs, cost-effectiveness and cost-utility analyses will be conducted from a societal perspective.Results and discussionThis implementation trial will pave the way for future scaling-up of this insomnia management pathway to improve access to CBTi and reduce reliance on sedative-hypnotic medicines in family practice.Trial Registration: This trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001539123).

Examining Patient Feedback and the Role of Cognitive Arousal in Treatment Non-response to Digital Cognitive-behavioral Therapy for Insomnia during Pregnancy

ABSTRACT Objective Insomnia affects over half of pregnant and postpartum women. Early evidence indicates that cognitive-behavioral therapy for insomnia (CBTI) improves maternal sleep and mood. However, standard CBTI may be less efficacious in perinatal women than the broader insomnia population. This study sought to identify patient characteristics in a perinatal sample associated with poor response to CBTI, and characterize patient feedback to identify areas of insomnia therapy to tailor for the perinatal experience. Participants Secondary analysis of 46 pregnant women with insomnia symptoms who were treated with digital CBTI in a randomized controlled trial. Methods We assessed insomnia, cognitive arousal, and depression before and after prenatal treatment, then 6 weeks postpartum. Patients provided feedback on digital CBTI. Results Residual cognitive arousal after treatment was the most robust factor associated with treatment non-response. Critically, CBTI responders and non-responders differed on no other sociodemographic or pretreatment metrics. After childbirth, short sleep (<6 hrs/night) was associated with maternal reports of poor infant sleep quality. Patient feedback indicated that most patients preferred online treatment to in-person treatment. Although women described digital CBTI as convenient and helpful, many patients indicated that insomnia therapy would be improved if it addressed sleep challenges unique to pregnancy and postpartum. Patients requested education on maternal and infant sleep, flexibility in behavioral sleep strategies, and guidance to manage infant sleep. Conclusions Modifying insomnia therapy to better alleviate refractory cognitive arousal and address the changing needs of women as they progress through pregnancy and early parenting may increase efficacy for perinatal insomnia. Name: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression URL: clinicaltrials.gov Registration: NCT03596879

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 therapeuticscan 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).

Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic.

Study ObjectivesStressful life events contribute to insomnia, psychosocial functioning, and illness. Though individuals with a history of insomnia may be especially vulnerable during stressful life events, risk may be mitigated by prior intervention. This study evaluated the effect of prior digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic.MethodsCOVID impact, insomnia, general- and COVID-related stress, depression, and global health were assessed in April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus sleep education control (n = 106) in 2016–2017. Regression analyses were used to evaluate the effect of intervention conditions on subsequent stress and health during the pandemic.ResultsInsomnia symptoms were significantly associated with COVID-19 related disruptions, and those who previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education. Moreover, the odds for resurgent insomnia was 51% lower in the dCBT-I versus control condition. Similarly, odds of moderate to severe depression during COVID-19 was 57% lower in the dCBT-I condition.ConclusionsThose who received dCBT-I had increased health resilience during the COVID-19 pandemic in adults with a history of insomnia and ongoing mild to moderate mental health symptoms. These data provide evidence that dCBT-I is a powerful tool to promote mental and physical health during stressors, including the COVID-19 pandemic.Clinical Trial RegistrationNCT02988375

Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials

ObjectivesAlthough cognitive behavioural therapy for insomnia (CBT-I) has been recommended the initial therapy for insomnia, its clinical usage remains limited due to the lack of therapists. Digital CBT-I (dCBT-I) can potentially circumvent this problem. This meta-analysis aims to evaluate the short-term and long-term efficacy of dCBT-I for adults with insomnia. MethodsSystematic search of PubMed, EMBASE, PsycINFO, and CENTRAL from inception till 5 March 2020 was conducted. Randomised controlled trials (RCTs) comparing dCBT-I with controls (wait-list/treatment-as-usual/online education) in adults with insomnia were eligible. The primary outcome was insomnia severity index (ISI) at post-intervention, short-term follow-up (ranging 4 weeks to 6 months) and 1-year follow-up. Mean differences were pooled using the random-effects model. Results94 articles were assessed full-text independently by two team members and 33 studies were included in this meta-analysis. 4719 and 4645 participants were randomised to dCBT-I and control respectively. dCBT-I significantly reduces ISI at post-intervention with mean difference −5.00 (95% CI −5.68 to −4.33, p < 0.0001) (I2 = 79%) compared to control. The improvements were sustained at short-term follow-up, −3.99 (95% CI −4.82 to −3.16, p < 0.0001) and 1-year follow-up, −3.48 (95% CI −4.21 to −2.76, p < 0.0001). Compared to dCBT-I, face-to-face CBT-I produced greater improvement in ISI, 3.07 (95% CI 1.18 to 4.95, p = 0.001). However, this was within the non-inferiority interval of 4 points on ISI. ConclusionThis meta-analysis provides strong support for the effectiveness of dCBT-I in treating insomnia. dCBT-I has potential to revolutionise the delivery of CBT-I, improving the accessibility and availability of CBT-I content for insomnia patients worldwide.

0536 Motivation at Pretreatment and its Correlates in a Trial of Digital CBT For Insomnia: Preliminary Findings

Abstract Introduction Pretreatment motivation is a critical variable in any intervention seeking to modify behaviors. Lack of motivation may hamper the effects of cognitive-behavioral therapy for insomnia (CBT-I), especially when delivered online. This study aims to investigate baseline correlates of pretreatment motivation and its influence on treatment outcomes in the context of digitalized CBT-I. Methods This is a secondary analysis of an ongoing pragmatic trial conducted in primary care clinics of Québec City, Canada. The trial was designed to assess the efficacy of a stepped-care intervention for chronic insomnia in which participants received a digital CBT-I (SHUTi), alone or in addition to sleep medication they were already using. Pre-treatment motivation was measured using two items based on the perceived importance of improving sleep and readiness to change behaviors to improve sleep (Score range: 0 to 20; cronbach’s alpha 0.79). Baseline questionnaires included an extended version of Insomnia Severity Index (ISI), Fatigue Severity Scale (FFS), Generalized Anxiety Disorder (GAD-7) and Patient Health Questionnaire (PHQ-9). Treatment outcome was measured by a change in ISI scores (i.e. ISI post - ISI pre). Results A total of 28 participants were included in the analysis. All participants preferentially selected ISI either as monotherapy (n=13)or in combination with their usual sleep medication (n=15). Participants’ motivation before treatment was high (Mean: 18.04; SD: 1.93). We did not find any associations between motivation and ISI score change or incidence of dropout. However, baseline fatigue was positively correlated with pretreatment motivation (r = 0.51, p = 0.005) and more severe insomnia symptoms were also associated with higher motivation (r=0.43, p=0.03). Specifically, perceived importance was associated with both nighttime and daytime insomnia symptoms while readiness for behavioral change was only associated with daytime impairments on energy, mood and social activities (all p = 0.01). Baseline anxiety and depressive symptoms were not correlated with motivation. Conclusion Insomnia-related daytime impairments and elevated fatigue levels appear to be linked to pretreatment motivation, especially for behavioral changes. Further study with greater statistic power is warranted to understand the relationship between participants’ motivation and treatment adherence or outcomes. Support CIHR0083000212

0470 A Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia in Pregnant Women

Abstract Introduction Over half of pregnant women experience clinical insomnia, which is linked to perinatal depression and cognitive-emotional dysregulation. Despite high rates of prenatal insomnia and known maternal consequences, efficacious insomnia treatment options for this population are woefully scant. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy digital CBTI via mobile health app in pregnant women with insomnia. Methods Single-site RCT. Ninety-one pregnant women (29.03±4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. Blinded assessments were performed before treatment, after treatment (during pregnancy), and 6 weeks after childbirth. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale’s Cognitive factor (PSAS-C) served as study outcomes. Results From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p&amp;lt;.001) and PSQI (-2.98 points, p&amp;lt;.001) and increases in nightly sleep duration by 32 minutes. Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 minutes per night (p=.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed. Conclusion Digital CBTI improves sleep quality and increases sleep duration during pregnancy and after childbirth. Digitally delivered interventions have potential to improve the health of new and expectant mothers, but CBTI likely needs to be tailored for perinatal patients to optimize outcomes. Support This study was funded by the American Academy of Sleep Medicine (198-FP-18, PI: Kalmbach).