Abstract Introduction Use of telemedicine platforms for conducting CBTI has the potential to reach more patients than in person treatment alone. While CBTI has been shown to be effective in older adults, questions about proficiency with technology and preference for treatment modality have not been addressed. Methods Baseline data from participants in the RCT of the Effectiveness of Stepped-Care Sleep Therapy In General Practice (RESTING) study were used. Analyses compared CBTI treatment modality preference (in person, online [video platform], no preference) across the following variables: insomnia severity (Insomnia Severity Index; ISI), depression (Geriatric Depression Scale; GDS), cognitive functioning (telephone-based cognitive screen) and internet proficiency (IP; assessing comfort with and frequency of internet use). Data collected prior to the pandemic-shut down (March 2020) were utilized for the primary analysis of treatment preference; n=71, mean age = 62.5 (SD = 8.1); 64.8% female; treatment preferences: in person (33.8%), no preference (25.4%), online (40.8%). A secondary analysis compared IP data from participants with baseline data from pre-pandemic (Nov 2019-Feb 2020, n=71), early pandemic (March-June 2020, n=28), and late pandemic (the most recent four months of enrollment, July 2020-Nov 2020, n=40) periods. Results Pre-pandemic, age was not significantly associated with treatment modality preference, nor any baseline clinical characteristics or demographic variables (p’s >.01). Only ‘comfort’ and ‘comfort+frequency’ scores from the internet proficiency measure differed significantly between treatment preference groups (p’s<.002). Post-hoc analyses revealed the online group had significantly higher comfort and comfort+frequency scores than the in person group (p’s<. 003). Comparing data from pre-pandemic, early pandemic, and late pandemic, frequency of internet use and comfort+frequency with internet use differed across groups (p’s <.004). Post-hoc comparisons revealed frequency of internet use scores were higher in the late pandemic compared to pre-pandemic (p=.003). Conclusion These findings suggest that comfort using technology, but not age or clinical characteristics, is associated with treatment modality preference for patients with insomnia who are enrolled in a technology-based clinical trial of CBTI. As proficiency in use of technology increases, for example, during and following the pandemic, one can expect that telemedicine will be an increasingly viable approach to providing CBTI among older adults. Support (if any) 1R01AG057500
Abstract Introduction Prevalence of insomnia and prescription of sleep medications increases in older adults and is associated with heightened risk of falls, cognitive and psychomotor detriments, and exacerbation of pre-existing conditions. The present study aimed to characterize beliefs about sleep and sleep medications, hypnotic self-efficacy, and hypnotic dependence in a sample of older adults with insomnia disorder. Methods Adults 50 years and older (N = 141) who met DSM-5 criteria for insomnia disorder were enrolled in the RCT of the Effectiveness of Stepped-Care Sleep Therapy In General Practice (RESTING) study. At baseline, participants completed the Beliefs about Medications Questionnaire (BMQ; subscales assess the belief that hypnotics are necessary and concern regarding consequences of use), Insomnia Severity Index (ISI), Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS), Pre-Sleep Arousal Scale (PSAS), and the Patient Health Questionnaire-4 (PHQ-4). Participants taking prescription sleep medications (n = 54) also reported if they had sedative hypnotic reduction goals and completed the Sleep Medications Dependency Scale and Hypnotic Self-Efficacy Scale. Results Those taking prescription sleep medications reported greater belief in the necessity of sedative hypnotics (p < .001, d = 1.69) and greater anxiety and depression (p = .005, d = .57) than those not taking prescription medications; groups did not differ significantly on the BMQ concern subscale, ISI, DBAS, or PSAS. 70.4% of participants using prescription sleep medications endorsed decrease in sedative hypnotic use as a treatment goal. Dependency on sleep medications, but not hypnotic self-efficacy, was greater in those with this goal (p = .003, d = .94). Higher levels of hypnotic dependence were associated with both greater concern (r = .40, p = .003) and belief in the necessity of sleep medications (r = .48, p < .001). Conclusion Our findings indicate that many treatment-seeking older adults with insomnia disorder take prescription sleep medications. They tend to believe in the necessity of sleep medications for controlling sleep disruption, but also identify medication reduction as a treatment goal, even if endorsing dependence on hypnotics. This highlights the importance of disseminating non-medication treatments that address both insomnia and reduction of sedative hypnotic use. Support (if any) 1R01AG057500
Abstract Introduction Digital CBTI programs are effective at treating symptoms of insomnia. They also have the potential to increase treatment reach, convenience, and affordability for patients, and to reduce long wait times for behavioral sleep medicine providers. The COVID-19 pandemic has instigated an increased reliance on the use of technology for many. Thus, this study evaluates middle aged and older adults before and during the COVID-19 pandemic to assess: (1) differences in treatment modality preference (digital vs. therapist-led CBTI) and (2) sleep-related predictors of treatment modality preference. Methods Participants were older adults (N=229, 74% female, mean age=63.14) who were enrolled in the RCT of the Effectiveness of Stepped-Care Sleep Therapy in General Practice (RESTING) study. At baseline, participants rated if they would prefer to access CBTI digitally or with a CBTI therapist, either in person or via telemedicine. After March 2020, in person was no longer listed as an option. Participants completed the Insomnia Severity Index (ISI) and a two-week sleep diary that allowed for an assessment of total sleep time (TST), sleep onset latency (SOL), and wake after sleep onset (WASO). Analyses compared responses to these items from participants completing assessments before March 2020 (Pre-Covid; n=74, 65% female, mean age=62.52) and after March 2020 (During-Covid; n=155, 78% female, mean age=63.44). Results Pre-Covid, 26% of participants preferred digital treatment, 47% of participants preferred a therapist-led intervention, and 27% did not express a preference. During-Covid, 35% of participants preferred digital treatment, 32% of participants preferred a therapist-led intervention, and 32% did not express a preference. This difference was statistically significant (c2=4.24, p=0.04). Responses were not significantly different between the first six months and the most recent six months of the pandemic (p=0.60). None of the sleep measures (ISI, TST, SOL, WASO) were associated with treatment modality preference in the full sample, Pre-Covid, or During-Covid. Conclusion The COVID-19 pandemic was associated with increased preference for digital CBTI among patients who are 50 and older, regardless of insomnia severity. Findings suggest that digital CBTI may be an acceptable treatment to many individuals with insomnia, thus increasing its dissemination potential. Support (If Any) R01AG057500 and T32MH019938
Technology has the potential to increase access to evidence-based insomnia treatment. Patient preferences/perceptions of automated digital cognitive behavior therapy for insomnia (CBTI) and telehealth-delivered CBTI remain largely unexplored among middle-aged and older adults. Using a qualitative approach, the current study describes patients' reasons for participating in the clinical trial, preferences for digital CBTI (dCBTI) versus therapist-led CBTI, patient attitudes toward dCBTI, and patient attitudes toward telehealth-delivered therapist-led CBTI.
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
Abstract Introduction Interpersonal factors have implications for sleep quality. Research has begun to explore how such factors may play a role in cognitive behavioral therapy for insomnia (CBTI). This study investigated whether living alone predicts reductions in insomnia severity and sleep-related daytime impairment across the first two months of treatment in a trial of CBTI. Methods Participants were 224 middle-to-older-aged adults with insomnia (166 women, M age = 63.16) enrolled in the ongoing Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy (RESTING). All study participants received CBTI, delivered either via a therapist or a validated software program. At baseline, participants indicated whether they lived alone or with at least one other person. The Insomnia Severity Index (ISI) and PROMIS Sleep-Related Impairment (SRI) short form were administered at baseline and two months after starting treatment. Mixed effects models assessed whether living alone predicted reduction in symptoms across the first two months of CBTI. Results Across the total sample, ISI scores decreased from baseline to two months (β=-3.52, SE=0.35, p<.001, 95% CI=-4.20, -2.84). Living alone was not associated with baseline ISI scores nor change in ISI score. A reduction in PROMIS SRI score was also observed in the total sample from baseline to two months (β=-4.18, SE=0.50, p<.001, 95% CI=-5.15, -3.21). Living alone was not associated with baseline SRI score, but it did predict reduction in SRI score (β=-3.23, SE=0.88, p=.001, 95% CI=1.31, 5.15). Participants living alone displayed less reduction in SRI compared to those living with at least one other person. Conclusion Participants undergoing CBTI who live alone experienced reduction in insomnia severity over the course of treatment, but they displayed less improvement in daytime sequalae of poor sleep compared to those living with others. Future studies should further explore how living status contributes to insomnia treatment response across both nighttime and daytime sleep symptomology. Regular engagement with others living in the home may be important for insomnia treatment to translate into perceived functional improvements during the day. Support (If Any) 1R01AG057500
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.
Abstract Introduction Over 31% of patients who enter treatment for mental health problems experience insomnia symptoms, which can be effectively treated using cognitive behavior therapy for insomnia (CBTi). However, routine psychotherapy for mental health problems does not adequately address insomnia symptoms. Integrating CBTi into routine psychotherapy in a feasible and acceptable manner could both extend the reach of CBTi and enhance mental health outcomes. Digital CBTi (dCBTi) is a promising and scalable option for integration. Supported dCBTi programs have better engagement, adherence, and clinical outcomes compared to unsupported programs. Hence, integrating dCBTi into routine psychotherapy, whereby the therapist introduces and provides support for dCBTi among patients receiving general psychotherapy for other mental health problems, may improve adherence and engagement. This study aims to determine the initial feasibility and acceptability of integrated dCBTi to providers. Methods Six virtual focus groups were conducted with licensed therapists with a range of graduate training. Each focus groups included 6-11 participants and lasted one hour. Inductive thematic analysis was used to extract themes. Therapists also completed a zoom poll at the end of the focus group. Results The sample included 52 licensed therapists (81% female, 81% White). Therapists had a range of graduate training (21 PhD/PsyD, 11 LCSW, 10 MFT, 9 LPC, and 2 MD). 83% of therapists indicated that they want training in integrated dCBTi. Two participants (5%) had some previous training in CBTi; they were the only individuals who indicated no interest in receiving the training. Six participants (12%) were unclear. Two training focused themes arose: desire for receiving CEs and a need for advanced notice to reserve the time required for a workshop. 88% reported seeing the potential value of integrated dCBTi (unclear=12%). Two themes arose regarding content of training: the need to know the contents of dCBTi and the value of consultation. As a feasibility theme, therapist highlighted that they could find 5-10 minutes of session time to provide the support for dCBTi. Conclusion Preliminary analyses indicate that integrated dCBTi is a feasible approach. Therapists are willing to be trained and see its potential value. Support (if any) AASM Foundation 300-BS-23
Abstract Study Objectives Evaluate a triaged stepped-care strategy among adults 50 and older with insomnia disorder. Methods Participants (N = 245) were classified at baseline by a Triage Checklist. Those projected to do better if they start treatment with therapist versus digitally delivered CBT-I (tCBT-I vs dCBT-I) constituted the YES stratum (n = 137); the rest constituted the NO stratum (n = 108). Participants were randomized within stratum to a strategy that utilized only dCBT-I (ONLN) or to a strategy that prospectively allocated the first step of care to dCBT-I or tCBT-I based on the Triage Checklist and switched dCBT-I nonresponders at 2-months to tCBT-I (STEP). Co-primary outcomes were the insomnia severity index (ISI) and the average nightly amount of prescription hypnotic medications used (MEDS), assessed at 2, 4, 6, 9, and 12 months postrandomization. Results Mixed effects models revealed that, compared to ONLN, participants in STEP had greater reductions in ISI (p = .001; η2 = 0.01) and MEDS (p = .019, η2 = 0.01). Within the YES stratum, compared to ONLN, those in STEP had greater reductions in ISI (p = .0001, η2 = 0.023) and MEDS (p = .018, η2 = 0.01). Within the ONLN arm, compared to the YES stratum, those in the NO stratum had greater reductions in ISI (p = .015, η2 = 0.01) but not in MEDS. Results did not change with treatment-dose covariate adjustment. Conclusions Triaged-stepped care can help guide the allocation of limited CBT-I treatment resources to promote effective and safe treatment of chronic insomnia among middle-aged and older adults. Further refinement of the Triage Checklist and optimization of the timing and switching criteria may improve the balance between effectiveness and use of resources. Clinical Trial Information Name: The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy. Trial registration ID NCT03532282. URL: https://clinicaltrials.gov/study/NCT03532282
Abstract Introduction A shortage of trained providers limits access to cognitive behavioral therapy for insomnia (CBTI). Supplementing traditional in-person, therapist-led CBTI with telehealth delivery and fully automated digital CBTI (dCBTI) can improve accessibility. Characterizing perceived advantages and disadvantages of distinct delivery modalities among patients with insomnia can inform targeted resource allocation and clinical rollout of CBTI. Thus, the current study aims to describe patients’ pre-treatment preferences for therapist-led (in-person and telehealth-delivered) and automated dCBTI, as well as patient-identified advantages and disadvantages of these modalities. Methods Participants (N = 80) 50 years and older (M age = 64.2, SD = 7.9; female = 85.2%) were randomly selected from the RESTING Study, an RCT evaluating a triaged stepped-care model for treating insomnia disorder (DSM-5), to undergo a semi-structured interview at baseline, prior to study treatment assignment and exposure. Interviews were recorded, transcribed, and coded by three raters (inter-rater reliability: 85.0–93.0%). Response themes were identified inductively via qualitative thematic analysis. Results Approximately two-thirds of participants (n = 50, 62.5%) preferred therapist-led CBTI, delivered in-person or via telehealth, over automated dCBTI. The most common participant-identified advantage of dCBTI (n = 55; 68.8%) and telehealth-delivered CBTI (n = 65; 81.3%) was convenience. The most commonly reported disadvantages of dCBTI were limited customizability (n = 39, 38.75%) and lack of human connection (n = 40, 50.0%). However, some participants (n = 13, 16.30%) viewed lack of human connection as an advantage, citing the nonjudgmental nature of online programs and reduced social anxiety/fatigue. The main disadvantage identified for telehealth-delivered CBTi was loss of nonverbal communication (n = 20, 25%). Conclusion While participants identified advantages and disadvantages of both dCBTI and therapist-led CBTI, findings suggest a general preference for therapist-led treatment among middle-aged and older adults. This study is one of the first to examine participant preferences for and perceptions of CBTI delivery modalities prior to receiving study treatment(s). Findings can guide referring providers’ presentation of insomnia intervention options to patients and inform targeted discussions of perceived barriers to treatment. Moreover, results lay a foundation for future research examining the relationship between pre-treatment preferences/perceptions and longitudinal treatment adherence, engagement, and clinical outcomes. Support (if any) 1R01AG057500