Cognitive Behavioral Therapy For Insomnia Program Research Articles

Family cancer caregiver use of and benefit from an internet-delivered insomnia intervention: results from a single-group feasibility trial

Abstract Background: Cancer caregivers are more likely to report clinically significant symptoms of insomnia than patients with cancer and the general population, yet research has been limited regarding cognitive-behavioral therapy for insomnia (CBT-I) among this population. Methods: To better understand cancer caregivers' engagement with and benefit from CBT-I, cancer caregivers were enrolled in a nonrandomized pilot feasibility trial of an evidence-based Internet-delivered insomnia program. Thirteen caregivers completed mixed-methods assessments before receiving the insomnia program and after the nine-week intervention period. Results: Compared with the five caregivers who did not complete any intervention Cores, the eight caregivers who completed at least one of the intervention Cores tended to report more sleep impairment (insomnia symptom severity; minutes of sleep onset latency and wake after sleep onset), less physical and emotional strain from caregiving, and less maladaptive sleep beliefs at the baseline assessment. These caregivers who used the program also showed large improvements in their insomnia symptoms. Caregivers' qualitative feedback about their experience with the program identified potential areas that might be modified to improve caregivers' engagement with and benefit from Internet-delivered insomnia programs. Conclusions: Findings suggest that family cancer caregivers can use and benefit from a fully automated Internet-delivered CBT-I program, even without caregiving-specific tailoring. Further rigorous research is needed to better understand whether and how program modifications may allow more caregivers to initiate and engage with this program.

A retrospective cost-effectiveness analysis of different cognitive-behavioral therapy for insomnia intervention delivery approaches in adult cancer survivors.

Cognitive-behavioral therapy for insomnia (CBT-I) is considered the gold standard treatment for insomnia. Prior trials have delivered CBT-I across a range of treatment sessions. Understanding the economics of varying treatment approaches is essential for future implementation considerations. We conducted a retrospective cost-effectiveness analysis from the provider's perspective, comparing the implementation of a three-session CBT-I program for cancer survivors (CBT-I-CS) versus a stepped care treatment approach consisting of an initial single sleep education session followed by CBT-I-CS if elevated insomnia symptoms persisted. The effectiveness measure used was the percentage of participants whose insomnia had remitted by the end of each program. Stepped care delivery was more effective than CBT-I-CS alone, resulting in 35.4% more remitted patients by the end of the overall program. For a $480 willingness to pay threshold per percentage of remitted patients, stepped care CBT-I-CS reached a 98% probability of being cost-effective, while CBT-I-CS alone had only a 2% probability. Larger group sessions in the first step of a stepped care delivery model resulted in more favorable cost-effectiveness. A stepped care delivery model may be a more cost-effective approach if it can be implemented efficiently. These findings inform policies aimed at improving cancer survivors' access to much-needed insomnia treatment in settings where financial resources for CBT-I may be limited, and be an important barrier to treatment dissemination. These analyses were not registered.

Cognitive behavioral therapy for insomnia in a military traumatic brain injury clinic: a quality improvement project assessing the integration of a smartphone application with behavioral treatment

ObjectivesWhile the association between insomnia and traumatic brain injury (TBI) is well established, TBI rehabilitation programs that focus on sleep as a primary target are limited. Cognitive behavioral therapy for insomnia (CBTi) is an effective treatment for insomnia, however; its use within TBI clinics is relatively unknown. Therefore, our aim was to evaluate the implementation of CBTi, used in conjunction with a smartphone app for insomnia, within a US military TBI program to improve care within this setting.SettingA TBI clinic at a US military installation.MethodsMHS beneficiaries underwent 6 sessions of CBTi and a 1-month post-treatment follow up session. Data was collected at each treatment session as part of routine clinical care.ResultsA total of 69 US MHS beneficiaries seen at a TBI clinic with a diagnosis of insomnia began CBTi. Attrition rate at the end of the CBTi program and 1-month posttreatment session was 35% and 48%, respectively. Results demonstrated that sleep onset latency (SOL) and wake after sleep onset (WASO) decreased during treatment (p's < 0.001). Further, symptoms reported on the Insomnia Severity Index (ISI) improved during CBTi (p < 0.001).ConclusionFindings demonstrate how CBTi used in conjunction with a CBTi smartphone application can be used to effectively treat insomnia for MHS beneficiaries seeking care for TBIs. This evaluation provides the basis for further research on how CBTi may improve care within TBI programs.

Cognitive Behavioral Therapy for Insomnia in Patients With Schizophrenia Without Prior Psychotic Symptom Aggravation: A Prospective Single-Arm Trial

Objective: To determine the feasibility and efficacy of cognitive behavioral therapy for insomnia (CBT-I) in patients with schizophrenia without prior psychotic symptom aggravation.Methods: This prospective single-arm trial included 31 patients diagnosed with schizophrenia and insomnia who received CBT-I. We provided four weekly 60-min sessions of group or individual CBT-I. All patients completed several sleep-related scale assessments before and 2, 3, and 4 weeks after treatment: the Korean version of Pittsburgh Sleep Quality Index (PSQI-K), Insomnia Severity Index (ISI), Korean version of the Epworth Sleepiness Scale (K-ESS), Dysfunctional Beliefs and Attitudes about Sleep Scale-16 (DBAS-16), and sleep diary. The primary outcome was insomnia symptom changes over the treatment period, as indicated by the PSQI-K, ISI, sleep onset latency, and total sleep time from the sleep diary. The secondary outcome was improvement in maladaptive cognition associated with sleep, as indicated by the DBAS-16.Results: The total PSQI-K and ISI at each timepoint showed significant improvements over the CBT-I program period. The total K-ESS and DBAS-16 scores showed significant improvement over the treatment period. Sleep onset latency was significantly shortened; however, no significant changes were noted in the total sleep time and some PSQI-K subscales (sleep duration, use of sleep medication, and daytime dysfunction).Conclusion: Our findings suggest the efficacy of CBT-I in improving insomnia symptoms, dysfunctional beliefs, and attitudes toward sleep in patients with schizophrenia with relatively stable psychotic symptoms. Therefore, further large randomized controlled trials are warranted to provide precise estimates of the effects of CBT-I in this patient population.

Developing a culturally tailored digital health intervention for insomnia in Black women.

Insomnia disorder is highly prevalent among Black women. Cognitive-behavioral therapy for insomnia (CBT-I) is considered the optimal treatment, but very little efficacy research has been conducted in minority populations. Culturally tailoring intervention content may increase participant engagement and improve treatment outcomes. We culturally tailored an Internet-delivered CBT-I program (Sleep Healthy Using the Internet; SHUTi) for Black women. First, relevant stakeholders were identified. Semi-structured interviews were conducted after stakeholders completed each of the six SHUTi intervention sessions. Questions focused on improving program relatability and engagement for Black women. Key themes pertinent to peripheral, evidential, and sociocultural strategies for cultural adaptation were identified using thematic content analysis, and adaptation recommendations were developed. A total of 50 interviews, across 9 stakeholders, were conducted. Two overarching themes were identified: (i) there was limited visual African American representation, and (ii) there was a lack of diversity in the environments and lifestyles of the patient vignettes. Respondents provided peripheral, evidential, and sociocultural recommendations for program modifications, emphasizing the importance of race-concordant visual content and didactic content exploring the diverse cultural and social contexts in which insomnia occurs for Black women. As more diverse patients seek evidence-based insomnia treatment, digital health interventions must consider whether it is therapeutically important to address and tailor for cultural differences. Here, stakeholders made clear recommendations for taking cultural contexts into account to improve patient engagement with the program. Further research should work to understand the extent to which culturally tailored interventions are beneficial for health outcomes among minority populations.

0320 Improvements in Sleep & 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 & 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)

0404 Heart Failure Nurses’ Perceptions of Cognitive Behavioral Therapy for Insomnia and the Feasibility of Providing it to Patients

Abstract Introduction People with heart failure (HF) often report insomnia. Despite strong evidence to support treatment with Cognitive Behavioral Therapy for Insomnia (CBT-I), few with HF have access to CBT-I programs. Access may be improved if it is offered where HF patients receive their medical care, but little is known about the feasibility of doing so. The purpose of this focus group study was to explore HF Nurses’ perceptions of: the importance of insomnia and the value of CBT-I to their patients; the feasibility of making CBT-I available in clinic settings and its delivery by HF nurses; and preferences for alternative modes of delivery. Methods We used a descriptive qualitative study design. We recruited focus group participants via electronic invitation to members of the American Association of Heart Failure Nurses and through requests to local nurse collaborators to distribute within their networks. We conducted virtual focus groups. After providing a brief description of the components of CBT-I and its efficacy in the HF population, we elicited participant perceptions of the value of providing CBT-I for HF patients in the clinic setting, facilitators and barriers to implementation, and ways to increase access to CBT-I. We audio-recorded the focus group discussions and used a professional transcription service. Two researchers coded the data and performed thematic content analysis. Results We conducted four focus groups with registered nurses and advanced practice nurses employed in HF clinics (N=23). Nurses endorsed the importance of sleep to HF patients, their interest in addressing sleep, perceived benefits of CBT-I, and the need for increased resources to address sleep in the clinic setting. They favored multiple modes of CBT-I delivery extending beyond the clinic. All nurses believed they had a role to play in addressing sleep, but differed in their views about the possibility of becoming CBT-I interventionists and the training and support needed to do so. Conclusion HF nurses recognize the importance of insomnia and support the implementation of CBT-I. Implementation studies are needed to identify effective methods of increasing access to evidence based CBT-I in the HF clinic setting, including appropriate support and training for nurses with interest in CBT-I delivery. Support (if any) R01NR01691

0399 Examining Insomnia Treatment Adherence and Outcomes in Black Women Veterans

Abstract Introduction Black identified women and veterans consistently experience disproportionately higher rates of insomnia. Cognitive behavioral therapy for insomnia (CBT-I) improves sleep outcomes, although higher rates of attrition and sub-optimal adherence in these groups can limit symptom improvement. Few studies have examined CBT-I treatment adherence and outcomes in women veterans, particularly among those who identify as black. . The current study examined differences in adherence and treatment outcomes in Black identified women veterans compared to white identified women veterans who engaged in CBT-I. Methods As part of a larger clinical trial (NCT02076165), 26 black and 25 white women veterans with insomnia disorder completed a 5-session CBT-I program. Insomnia Severity Index (ISI) and sleep diaries were completed at baseline, post-treatment, and 3-month follow-up. Multiple and fractional regression models were used to evaluate the association between race and change in ISI, change in sleep diary sleep efficiency (SE), and adherence to bedtime and rise time during CBT-I. Results Mean change from baseline to 3-month follow-up in ISI score for black and white women were -7.31 and -7.97 and mean change in diary SE was +14.9% and +10.8%, respectively. Race did not impact change-scores for ISI or SE (1.09 < F < 1.8, p>.05); however, in the fractional regression model, (Χ2=6.9, p=.008; pseudo R2=.058) race was a significant predictor (OR=.27, p=.009) of adherence to prescribed bedtime in the second week of CBT-I, with black women less likely to adhere to prescribed bedtime than women. Race was not a significant predictor of wake time adherence. Conclusion Both black and white women veterans benefitted from CBT-I; however, early adherence to the recommended sleep schedule was lower in black women. Future research could expand on these findings by examining potential barriers in early adherence to recommendations, and how to improve early adherence to ensure that therapy meets the needs of all patients. Support (if any) VA/HSR&D IIR-HX002300 (PI: Martin), NIH/NHLBI K24HL143055 and VA HSR&D RCS 20-191. Dr. May supported by the VA Office of Academic Affiliations.

Effectiveness of one-week internet-delivered cognitive behavioral therapy for insomnia to prevent progression from acute to chronic insomnia: A two-arm, multi-center, randomized controlled trial

Acute insomnia is common and a substantial proportion of people with acute insomnia (i.e. 3 days to 3 months) transit into chronic insomnia (i.e. 3 months or longer). Therefore, early intervention for acute insomnia is vital to prevent chronicity. Previous trials with small sample sizes have shown that brief versions of both individual and group-based face-to-face cognitive behavioral therapy for insomnia (CBT-I) can improve insomnia symptoms among those with acute insomnia. However, it is unknown whether one-week internet-delivered cognitive behavioral therapy for insomnia (CBT-I) is effective in treating acute insomnia. This was a randomized controlled trial and 192 participants were randomly assigned to the CBT-I group (n = 95) or control group (n = 97). The primary outcome was the incidence of chronic insomnia, determined via a structured diagnostic questionnaire for insomnia disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Secondary outcomes were Insomnia Severity Index (ISI), Dysfunctional Beliefs and Attitudes about Sleep (DBAS), Epworth Sleepiness Scale (ESS), Pre-sleep Arousal Scale (PSAS), Ford Insomnia Response to Stress Test (FIRST), Sleep Hygiene and Practices Scale (SHPS), Hospital Anxiety and Depression Scale (HADS), and Short-Form 12-Item Health Survey version 2 (SF-12v2). At week 12, the incidence of chronic insomnia was significantly lower in the CBT-I group compared with control group (33.3% [27/81] vs. 65.8% [52/79]). Participants in the CBT-I group achieved significantly more improvements in ISI, ESS, PSAS, FIRST, SHPS, HADS-Depression, and the mental component summary and physical component summary of SF-12v2 than control group, but not DBAS and HADS-Anxiety. This one-week internet-delivered CBT-I program is an effective tool to prevent the chronicity of acute insomnia.

Treatment-related changes in insomnia, anticipatory pleasure, and depression symptoms: A proof-of-concept study with cancer survivors

Objective/BackgroundCancer survivors have elevated rates of insomnia and depression. Insomnia increases risk for depression onset, and the Integrated Sleep and Reward (ISR) Model suggests that impairments in reward responding (e.g., ability to anticipate and/or experience pleasure) plays a central role in this relationship. Cognitive behavioral therapy for insomnia (CBT-I) is efficacious for treating chronic insomnia and reducing depression in cancer survivor populations. The effects of CBT-I on anticipatory and consummatory pleasure are theoretically and clinically meaningful, yet remain unexamined. Patients/MethodsThis secondary analysis of a pilot RCT (N = 40 cancer survivors with insomnia) explicated changes in anticipatory and consummatory pleasure and depression symptoms following a 4-session, synchronous, virtual CBT-I program versus enhanced usual care (referral to a behavioral sleep medicine clinic + sleep hygiene handout). Linear mixed models examined changes in anticipatory and consummatory pleasure and depression symptoms as predictors of changes in insomnia severity from baseline to post-intervention and 1-month follow-up. ResultsCBT-I buffered against deterioration in anticipatory pleasure but not consummatory pleasure or depression symptoms. Across conditions, increased anticipatory pleasure was associated with insomnia reduction through 1-month follow-up, even after adjusting for changes in depression symptoms. ConclusionCBT-I may improve reward processing deficits in cancer survivors with insomnia. Findings provide support for the ISR Model and implicate pleasure as an important target for insomnia and depression.

The Role of Dysfunctional Sleep Beliefs in Mediating the Outcomes of Web-Based Cognitive Behavioral Therapy for Insomnia in Community-Dwelling Older Adults: Protocol for a Single-Group, Nonrandomized Trial

Sleeping well is an essential part of good health. Older adult populations report a high rate of sleep problems, with recent studies suggesting that cognitive processes as well as behavioral and hyperarousal-related mechanisms could be important factors in the development and maintenance of insomnia. Individuals who have an asynchronous or uncoupled sleep pattern and sleep appraisal-those who complain about their sleep but do not have poor sleep quality, and vice versa-might show differences in subjective sleep and sleep perceptions and other characteristics that could impact their treatment outcomes following cognitive behavioral therapy for insomnia (CBT-I). The purpose of this protocol is to describe the rationale and methods for a nonrandomized, single-arm trial assessing objective and subjective sleep quality in community-dwelling older adults aged 60-80 years with synchronous sleep patterns and sleep appraisal compared to those in older adults with asynchronous sleep patterns and sleep appraisal. The trial will further examine the role of cognitive, behavioral, and hyperarousal processes in mediating the treatment outcomes of web-based CBT-I. This trial aims to recruit a sample of 60 participants, who will be assigned to 1 of 4 sleep groups based on their sleep pattern and sleep appraisal status: complaining good sleepers, complaining poor sleepers, noncomplaining good sleepers, and noncomplaining poor sleepers, respectively. The trial will be completed in 2 phases: phase 1 will assess objective sleep (measured via wrist actigraphy) and subjective (self-reported) sleep. Phase 2 will investigate the impact of a web-based CBT-I program on the sleep outcomes of individuals with uncoupled sleep compared to that of individuals without uncoupled sleep, as well as the mediators of CBT-I. Recruitment began in March 2020, and the last participants were recruited by March 2021. A total of 65 participants completed phases 1 and 2. Data analysis for phase 1 was finished in December 2021, and data analysis for phase 2 was finalized in July 2022. The results for phase 1 were submitted for publication in March 2022, and those for phase 2 will be submitted by the end of December 2022. This trial will provide guidance on factors that contribute to the variability of sleep in older adults and their sleep outcomes following CBT-I. The outcomes of this study could be valuable for future research attempting to tailor CBT-I to individual needs. Australian New Zealand Clinical Trials Registry ACTRN12619001509156; https://tinyurl.com/69hhdu2w. DERR1-10.2196/32705.

Assessing Cognitive Behavioral Therapy for Insomnia to Improve Sleep Outcomes in Individuals With a Concussion: Protocol for a Delayed Randomized Controlled Trial.

BackgroundSleep disturbances post concussion have been associated with more frequent and severe concussion symptoms and may contribute to poorer recovery. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia; however, it remains unclear if this treatment method is effective in improving sleep outcomes and reducing concomitant postconcussion symptoms.ObjectiveThe hypotheses for this study are that (1) CBT-I will improve sleep outcomes and (2) CBT-I will improve concomitant postconcussion symptoms.MethodsIn total, 40 individuals who are within ≥4 weeks of postconcussion injury and have insomnia symptoms will be enrolled in this randomized controlled trial. Participants will be randomized into either a group that starts a 6-week CBT-I program immediately after baseline or a waitlist control group that starts CBT-I following a 6-week waiting period. All participants will be reassessed 6, 12, and 18 weeks after baseline. Standardized assessments measuring sleep outcomes, postconcussion symptoms, and mood will be used. Linear regression and t tests will be used for statistical analyses.ResultsEnrollment of 40 participants was completed July 2022, data collection will be completed in November 2022, and publication of main findings is anticipated in May 2023. It is anticipated that participants experience reduced insomnia symptoms and postconcussion symptoms following CBT-I and these improvements will be retained for at least 12 weeks. Additionally, we expect to observe a positive correlation between sleep and postconcussion symptom improvement.ConclusionsSuccessful completion of this pilot study will allow for a better understanding of the treatment of insomnia and postconcussion symptoms in individuals following a concussion.Trial RegistrationClinicalTrials.gov NCT04885205; https://clinicaltrials.gov/ct2/show/NCT04885205International Registered Report Identifier (IRRID)DERR1-10.2196/38608

Combining Cognitive-behavioral Therapy For Insomnia With Exercise Training In Adults With Insomnia And Short Sleep Duration: Impact On Sleep Outcomes

Cognitive-behavioral therapy for insomnia (CBT-I) is the first-line treatment for insomnia; however, there is mixed evidence as to whether CBT-I efficacy is blunted in adults with insomnia and short sleep duration. Exercise training may be a useful adjunct treatment to CBT-I for this population. PURPOSE: To explore changes in actigraphic- and polysomnographic-based sleep outcomes from a CBT-I intervention augmented by exercise training in a sample of adults with insomnia and short sleep duration. METHODS: Eight adults (50% female, 62.5% white) with insomnia disorder and short sleep duration (self-reported sleep duration <6 h) completed a 12-week single-arm trial. Participants were guided through the online “Sleep Healthy Using the Internet” (SHUT-I) CBT-I program while completing a supervised exercise program (EX; 150 min/wk of moderate-intensity aerobic exercise and 2 d/wk of resistance training). Prior to and following the intervention, participants completed 1 wk of home-based actigraphy monitoring and 1 night of laboratory-based polysomnography (PSG). Post-intervention PSG data were missing for 1 participant due to COVID lockdown restrictions. Differences between baseline and post-intervention sleep were analyzed using Cohen’s d effect size calculations and paired t-tests. RESULTS: At baseline, participants had actigraphy-assessed total sleep time (TST) of 6.9 ± 0.6 h and sleep efficiency (SE) of 86.6 ± 4.1%; PSG-based TST and SE were 6.9 ± 0.9 h and 87.6 ± 6.1%, respectively. At post-intervention, actigraphy-assessed TST decreased by 15.9 min (d = 0.40, p = .29) and SE increased by 1.4% (d = 0.92, p = .08) relative to baseline. For PSG-based outcomes, TST decreased by 27 min (d = -1.48, p = .08) and SE increased by 3.9% (d = 0.91, p = .05) at post-intervention. In addition, the proportion of time spent in non-REM (NREM) stage 1 sleep decreased by 2.0% (d = -1.05, p = .03) and the proportion of time spent in NREM stage 2 sleep increased by 3.0% (d = 0.82, p = .07) at post-intervention. CONCLUSIONS: These preliminary data suggest improvements in sleep continuity following the combination of CBT-I and exercise training, accompanied by small decreases in sleep duration. Future research should disentangle the independent effects of CBT-I and exercise on sleep outcomes in this population. Support: NIH K23 HL118318 (Kline)

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

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

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.

A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance.

This study examines the impact of cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) therapy for comorbid insomnia and sleep apnea on nocturnal sleep and daytime functioning. A partial factorial design was used to examine treatment pathways with CBT-I and PAP and the relative benefits of each treatment. One hundred eighteen individuals with comorbid insomnia and sleep apnea were randomized to receive CBT-I followed by PAP, self-monitoring followed by CBT-I concurrent with PAP, or self-monitoring followed by PAP only. Participants were assessed at baseline, PAP titration, and 30 and 90 days after PAP initiation. Outcome measures included sleep diary- and actigraphy-measured sleep, Flinders Fatigue Scale, Epworth Sleepiness Scale, Functional Outcome of Sleep Questionnaire, and cognitive emotional measures. A main effect of time was found on diary-measured sleep parameters (decreased sleep onset latency and wake after sleep onset; increased total sleep time and sleep efficiency) and actigraphy-measured sleep parameters (decreased wake after sleep onset; increased sleep efficiency) and daytime functioning (reduced Epworth Sleepiness Scale, Flinders Fatigue Scale; increased Functional Outcome of Sleep Questionnaire) across all arms (all P < .05). Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured sleep onset latency and wake after sleep onset and increasing sleep efficiency, as well as improving Functional Outcome of Sleep Questionnaire and Flinders Fatigue Scale compared to self-monitoring. Improvements in sleep and daytime functioning were found with PAP alone or concomitant with CBT-I. However, more rapid effects were observed on self-reported sleep and daytime performance when receiving CBT-I regardless of when it was initiated. Therefore, concomitant treatment appears to be a favorable approach to accelerate treatment outcomes. Registry: ClinicalTrials.gov; Name: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS); URL: https://clinicaltrials.gov/ct2/show/NCT01785303; Identifier: NCT01785303. Tu AY, Crawford MR, Dawson SC, etal. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance. J Clin Sleep Med. 2022;18(3):789-800.

Advanced Cognitive Behavioral Therapy for Insomnia (CBT-I) Based on Acceptance and Commitment Therapy Compared With CBT-I: A Pilot Study

Objectives: Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment for insomnia. However, many patients remain with sleep disturbances even after undergoing CBT-I, and those with short sleep durations have shown fewer gains. Acceptance and commitment therapy (ACT) is one of the third wave of behavioral therapies, and it is useful in helping patients get flexibility of mind. Therefore, we incorporated its components into CBT-I, came up with an advanced CBT-I program that involves cognitive behavior therapy based on ACT, and examined its efficacy in comparison to that of CBT-I. Methods: Patients with chronic primary insomnia were recruited at the memory center of CHA University Hospital from June to August 2020. To examine the efficacy of advanced CBT-I compared to that of CBT-I, the patients (n=16) were assigned to two groups (CBT-I: n=6; advanced CBT-I: n=10). The patients in each group were treated for 4 weeks (8 sessions). The quality of sleep, severity of insomnia, sleepiness, depression, anxiety, acceptance, efforts to sleep, and dysfunctional beliefs concerning sleep were assessed with self-report questionnaires. Results: The severity of insomnia, quality of sleep, depression, anxiety, acceptance, efforts to sleep, and dysfunctional beliefs concerning sleep improved after both CBT-I and advanced CBT-I treatment. Conclusions: This study examined the efficacy of advanced CBT-I in improving the severity of insomnia, sleep quality, and other symptoms related to sleep. The results suggest that components of ACT were useful for insomnia.

Anonymous online cognitive behavioral therapy for sleep disorders in shift workers\u2014a study protocol for a randomized controlled trial

BackgroundMany shift workers suffer from sleep issues, which negatively affect quality of life and performance. Scientifically evaluated, structured programs for prevention and treatment are scarce. We developed an anonymous online cognitive behavioral therapy for insomnia (CBT-I) program. After successful completion of a feasibility study, we now start this prospective, randomized, controlled superiority trial to compare outcomes of two parallel groups, namely an intervention group and a waiting-list control-group. Additionally, we will compare these outcomes to those of a face-to-face CBT-I outpatient sample.MethodsCollaborating companies will offer our anonymous online intervention to their shift-working employees. Company physicians and counseling services will screen those interested for inclusion and exclusion criteria. Participants will receive access to our online service, where they will complete psychometric assessment and receive random assignment to either the intervention group or the waiting-list control group. Participants and providers will be aware of the group assignment. We aim to allocate at least N = 60 participants to the trial. The intervention consists of psychoeducation, sleep restriction, stimulus control, relaxation techniques, and individual feedback delivered via four e-mail contacts. During the intervention, as well as during the waiting period, participants will fill out weekly sleep diaries. Immediately after completion of the program, the post-intervention assessment takes place. Participants in the control group will be able to participate in the program after all study assessments. To recruit an additional sample, collaborating outpatient sleep clinics will provide six sessions of standard face-to-face CBT-I to an ad hoc sample of shift working patients. We expect both the online and the face-to-face CBT-I interventions to have beneficial effects compared to the control group on the following primary outcomes: self-reported symptoms of depression and insomnia, sleep quality, and daytime sleepiness.ConclusionsThe online intervention allows shift workers to follow a CBT-I program independently of their working schedule and location. Forthcoming results might contribute to further improvement of prevention and therapy of sleep issues in shift workers.Trial registrationGerman Clinical Trials Register DRKS DRKS00017777. Registered on 14 January 2020—retrospectively registered.