Cognitive behavioural therapy for insomnia reduces actigraphy and diary measured sleep discrepancy for individuals with comorbid insomnia and major depressive disorder: A report from the TRIAD study.

OBJECTIVE/BACKGROUND: Discrepancies between sleep diaries and actigraphy occur among individuals with insomnia. Cognitive behavioural therapy for insomnia (CBT-I) improves insomnia but the impact on discrepancy is unclear. This study examined CBT-I's effects on actigraphy-diary discrepancy and explored sleep-related beliefs and attitudes as a mediator. PATIENTS/METHODS: Participants were 108 (age M±SD = 47.23 ± 12.42, 67.60 % female) adults with insomnia and major depressive disorder from the Treatment of Insomnia and Depression study. They were randomized to 7 sessions of CBT-I or sham Quasi-Desensitization Therapy for Insomnia (DTI), plus 16 weeks of antidepressants. Two weeks of actigraphy and sleep diary were collected at baseline, mid-treatment, end-treatment. Differences between sleep diary and actigraphy total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency (SE) were calculated. Participants completed Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) at baseline and mid-treatment. RESULTS: At baseline, diary (versus actigraphy) TST was shorter (1.1 ± 1.41h), whilst SOL (21.64 ± 41.25min) and WASO (17.45 ± 61.99min) were longer. Mixed effects models using daily data showed that after adjusting for age and sex, participants in the CBT-I group (versus DTI) showed greater reduction in all actigraphy-diary discrepancy domains (all p-values<.01), reductions evident from mid-treatment. Group differences on actigraphy-diary discrepancy reductions in TST, SOL, and SE (not WASO) were mediated by changes in DBAS from baseline to mid-treatment (all p-values<.05). Changes in discrepancy did not mediate insomnia symptom changes (p-values>.39). CONCLUSIONS: CBT-I reduced actigraphy-diary discrepancy in individuals with comorbid insomnia and depression; this reduction was associated with improved sleep-related attitudes, a therapeutic target of CBT-I. CLINICAL TRIAL REGISTRATION: TRIAD (Treatment of Insomnia and Depression): Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants. Prospectively registered with Clinical Trials (NCT00767624). SUPPORT (IF ANY): MH078924, MH078961, MH079256.

Patient Engagement and Provider Effectiveness of a Novel Sleep Telehealth Platform and Remote Monitoring Assessment in the US Military: Pilot Study Providing Evidence-Based Sleep Treatment Recommendations.

BACKGROUND: Sleep problems are common and costly in the US military. Yet, within the military health system, there is a gross shortage of trained specialist providers to address sleep problems. As a result, demand for sleep medicine care far exceeds the available supply. Telehealth including telemedicine, mobile health, and wearables represents promising approaches to increase access to high-quality and cost-effective care. OBJECTIVE: The purpose of this study was to evaluate patient engagement and provider perceived effectiveness of a novel sleep telehealth platform and remote monitoring assessment in the US military. The platform includes a desktop web portal, native mobile app, and integrated wearable sensors (ie, a commercial off-the-shelf sleep tracker [Fitbit]). The goal of the remote monitoring assessment was to provide evidence-based sleep treatment recommendations to patients and providers. METHODS: Patients with sleep problems were recruited from the Internal Medicine clinic at Walter Reed National Military Medical Center. Patients completed intensive remote monitoring assessments over 10 days (including a baseline intake questionnaire, daily sleep diaries, and 2 daily symptom surveys), and wore a Fitbit sleep tracker. Following the remote monitoring period, patients received assessment results and personalized sleep education in the mobile app. In parallel, providers received a provisional patient assessment report in an editable electronic document format. Patient engagement was assessed via behavioral adherence metrics that were determined a priori. Patients also completed a brief survey regarding ease of completion. Provider effectiveness was assessed via an anonymous survey. RESULTS: In total, 35 patients with sleep problems participated in the study. There were no dropouts. Results indicated a high level of engagement with the sleep telehealth platform, with all participants having completed the baseline remote assessment, reviewed their personalized sleep assessment report, and completed the satisfaction survey. Patients completed 95.1% of sleep diaries and 95.3% of symptom surveys over 10 days. Patients reported high levels of satisfaction with most aspects of the remote monitoring assessment. In total, 24 primary care providers also participated and completed the anonymous survey. The results indicate high levels of perceived effectiveness and identified important potential benefits from adopting a sleep telehealth approach throughout the US military health care system. CONCLUSIONS: Military patients with sleep problems and military primary care providers demonstrated high levels of engagement and satisfaction with a novel sleep telehealth platform and remote monitoring assessment. Sleep telehealth approaches represent a potential pathway to increase access to evidence-based sleep medicine care in the US military. Further evaluation is warranted.

Perspectives on increasing the impact and reach of CBT-I.

Cognitive behavioral therapy for insomnia is now recognized as the front-line treatment for chronic insomnia, yet many challenges remain in improving its impact and reach. This manuscript describes our perspective on some of these challenges. Based on the literature that maladaptive cognitions predict low adherence and that high levels of cognitive-emotional hyperarousal may be associated with poor outcomes, we propose added focus on cognitive therapy strategies in CBT-I. Specifically, we propose broadening the range of traditional cognitive therapy strategies, utilizing acceptance-based strategies, and fuller integration of the broadened range of cognitive strategies into CBT-I throughout the course of treatment. We also highlight a few other promising emerging approaches to enhance the impact of CBT-I. These include involving partners to promote adherence with CBT-I treatment recommendations, using culturally relevant treatment adaptations to increase retention of patients in treatment, and using strategies for timely identification of barriers to engagement. We propose broadening the public health impact of CBT-I by integrating support for reduction in long-term use of hypnotic sleep medications, which is in line with current medical guidelines. We advocate for a case conceptualization-based approach for implementing CBT-I in a patient-centered manner, flexibly, yet with fidelity, to enhance its impact by addressing the factors above. For increasing the reach of CBT-I, we discuss the need to train more clinicians and ways to combine therapist and digital deliveries of CBT-I, highlighting stepped care strategies.

The Role of Emotion Regulation, Affect, and Sleep in Individuals With Sleep Bruxism and Those Without: Protocol for a Remote Longitudinal Observational Study.

BACKGROUND: Sleep bruxism (SB) is an oral behavior characterized by high levels of repetitive jaw muscle activity during sleep, leading to teeth grinding and clenching, and may develop into a disorder. Despite its prevalence and negative outcomes on oral health and quality of life, there is currently no cure for SB. The etiology of SB remains poorly understood, but recent research suggests a potential role of negative emotions and maladaptive emotion regulation (ER). OBJECTIVE: This study's primary aim investigates whether ER is impaired in individuals with SB, while controlling for affective and sleep disturbances. The secondary aim tests for the presence of cross-sectional and longitudinal mediation pathways in the bidirectional relationships among SB, ER, affect, and sleep. METHODS: The study used a nonrandomized repeated-measures observational design and was conducted remotely. Participants aged 18-49 years underwent a 14-day ambulatory assessment. Data collection was carried out using electronic platforms. We assessed trait and state SB and ER alongside affect and sleep variables. We measured SB using self-reported trait questionnaires, ecological momentary assessment (EMA) for real-time reports of SB behavior, and portable electromyography for multinight assessment of rhythmic masticatory muscle activity. We assessed ER through self-reported trait questionnaires, EMA for real-time reports of ER strategies, and heart rate variability derived from an electrocardiography wireless physiological sensor as an objective physiological measure. Participants' trait affect and real-time emotional experiences were obtained using self-reported trait questionnaires and EMA. Sleep patterns and quality were evaluated using self-reported trait questionnaires and sleep diaries, as well as actigraphy as a physiological measure. For the primary objective, analyses will test for maladaptive ER in terms of strategy use frequency and effectiveness as a function of SB using targeted contrasts in the general linear model. Control analyses will be conducted to examine the persistence of the SB-ER relationship after adjusting for affective and sleep measures, as well as demographic variables. For the secondary objective, cross-sectional and longitudinal mediation analyses will test various competing models of directional effects among self-reported and physiological measures of SB, ER, affect, and sleep. RESULTS: This research received funding in April 2017. Data collection took place from August 2020 to March 2022. In all, 237 participants were eligible and completed the study. Data analysis has not yet started. CONCLUSIONS: We hope that the effort to thoroughly measure SB and ER using gold standard methods and cutting-edge technology will advance the knowledge of SB. The findings of this study may contribute to a better understanding of the relationship among SB, ER, affect, and sleep disturbances. By identifying the role of ER in SB, the results may pave the way for the development of targeted interventions for SB management to alleviate the pain and distress of those affected. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41719.

Sleep-wake timing and chronotype in perinatal periods: longitudinal changes and associations with insomnia symptoms, sleep-related impairment, and mood from pregnancy to 2 years postpartum.

Across the perinatal transition, existing research focuses mainly on significant changes in sleep duration and quality, neglecting sleep timing. This study investigated change trajectories of sleep timing and chronotype from late pregnancy to 2 years postpartum and examined longitudinal associations of chronotype with symptoms of insomnia, daytime sleep-related impairment, and mood. Data were from a two-arm randomised controlled trial testing parent-focused wellbeing interventions. Participants were a community sample of nullipara without severe sleep/mental health conditions. Participants self-reported bedtime, rise-time, chronotype, insomnia symptoms, sleep-related impairment, depression, and anxiety at seven time points: gestation Weeks 30 and 35, and postpartum Months 1.5, 3, 6, 12 and 24. Trajectories were estimated using mixed-effects models with continuous time, quadratic splines, and a knot at childbirth, controlling for age and group allocation. A total of 163 participants (mean [SD] age 33.35 [3.42] years) took part. Bedtime and rise-times delayed during late pregnancy (~8 and ~20 min, respectively) but became progressively earlier (~20 and ~60 min, respectively) over the 2 postpartum years. Chronotype became more eveningness in late pregnancy, and more morningness after childbirth, however changes were small. Controlling for sleep duration and efficiency, greater morningness was associated with significantly less symptoms of insomnia and sleep-related impairment over time (all p < 0.001); longitudinal associations between chronotype and symptoms of depression and anxiety were non-significant (all p > 0.65). Sleep-wake timing and chronotype became progressively earlier from pregnancy to 2 years postpartum. Morningness chronotype may be sleep-protective during the transition from pregnancy to parenthood. Mechanisms underlying these associations require further research.

Daytime affect and sleep EEG activity: A data-driven exploration.

It has long been thought that links between affect and sleep are bidirectional. However, few studies have directly assessed the relationships between: (1) pre-sleep affect and sleep electroencephalogram (EEG) activity; and (2) sleep EEG activity and post-sleep affect. This study aims to systematically explore the correlations between pre-/post-sleep affect and EEG activity during sleep. In a community sample of adults (n = 51), we measured participants' positive and negative affect in the evening before sleep and in the next morning after sleep. Participants slept at their residence for 1 night of EEG recording. Using Fourier transforms, the EEG power at each channel was estimated during rapid eye movement sleep and non-rapid eye movement sleep for the full range of sleep EEG frequencies. We first present heatmaps of the raw correlations between pre-/post-sleep affect and EEG power during rapid eye movement and non-rapid eye movement sleep. We then thresholded the raw correlations with a medium effect size |r| ≥ 0.3. Using a cluster-based permutation test, we identified a significant cluster indicating a negative correlation between pre-sleep positive affect and EEG power in the alpha frequency range during rapid eye movement sleep. This result suggests that more positive affect during the daytime may be associated with less fragmented rapid eye movement sleep that night. Overall, our exploratory results lay the foundation for confirmatory research on the relationship between daytime affect and sleep EEG activity.

Randomized controlled trial of cognitive behavioral therapy for perinatal insomnia: postpartum outcomes.

STUDY OBJECTIVES: This study aimed to assess the effectiveness of cognitive behavioral therapy for insomnia (CBTI) during the postpartum period as part of a larger randomized controlled trial of CBTI on perinatal insomnia. METHODS: A total of 179 women of 18-30 gestational weeks with insomnia disorder were randomly assigned to CBTI or an active control (CTRL) therapy. Participants were assessed between 18 and 32 weeks of pregnancy at baseline, after the intervention during pregnancy, and at 8, 18, and 30 weeks postpartum. The primary outcomes were Insomnia Severity Index (ISI) scores and total awake time, defined as minutes awake during the sleep opportunity period, assessed with actigraphy and sleep diaries. Included in the analyses were women who provided data for at least 1 of 3 postpartum assessments (68 in CBTI; 61 in CTRL). RESULTS: Piecewise mixed-effects models revealed a main effect reflecting reduction in ISI scores from 8-18 weeks postpartum (P = .036) and a nonsignificant increase from 18-30 weeks; significant effects for group allocation were present only in week 30 (P = .042). CTRL participants reported significantly longer time awake, excluding time spent caring for the infant, at each postpartum assessment; time awake at night caring for the infant did not differ between groups. There was no significant group difference in the postpartum trajectory of actigraphy-measured total awake time, the two diary measures of time awake (P values > .05). CBTI participants with at least 50% reduction in ISI during pregnancy had consistently stable ISI scores (mean < 6) during the postpartum period; those in the CTRL group had variable ISI scores over time with large individual differences. CONCLUSIONS: For women with insomnia disorder during pregnancy, CBTI initiated during pregnancy conferred postpartum benefits in terms of wakefulness after sleep onset (excluding time spent caring for the infant) and insomnia severity, though the latter emerged only later in the postpartum period. These findings underscore the importance of treating insomnia during pregnancy, a conclusion that is further supported by our finding that pregnant women who responded to insomnia treatment during pregnancy experienced better sleep in the postpartum period. CLINICAL TRIAL REGISTRATION: Registry: Clinicaltrials.gov; Name: Treatment for Insomnia During Pregnancy; URL: https://www.clinicaltrials.gov/ct2/show/NCT01846585; Identifier: NCT01846585. CITATION: Manber R, Bei B, Suh S, et al. Randomized controlled trial of cognitive behavioral therapy for perinatal insomnia: postpartum outcomes. J Clin Sleep Med. 2023;19(8):1411-1419.

Beliefs about prescription sleep medications and interest in reducing hypnotic use: an examination of middle-aged and older adults with insomnia disorder.

STUDY OBJECTIVES: To examine beliefs about prescription sleep medications (hypnotics) among individuals with insomnia disorder seeking cognitive behavioral therapy for insomnia and predictors of wishing to reduce use. METHODS: Baseline data was collected from 245 adults 50 years and older enrolled in the "RCT of the Effectiveness of Stepped-Care Sleep Therapy in General Practice" study. T-tests compared characteristics of prescription sleep medication users with those of nonusers. Linear regression assessed predictors of patients' beliefs about sleep medication necessity and hypnotic-related concerns. Among users, we examined predictors of wishing to reduce sleep medications, including perceived hypnotic dependence, beliefs about medications, and demographic characteristics. RESULTS: Users endorsed stronger beliefs about the necessity of sleep medications and less concern about potential harms than nonusers (P < .01). Stronger dysfunctional sleep-related cognitions predicted greater beliefs about necessity and concern about use (P < .01). Patients wishing to reduce sleep medications reported greater perceived hypnotic dependence than those disinterested in reduction (P < .001). Self-reported dependence severity was the strongest predictor of wishing to reduce use (P = .002). CONCLUSIONS: Despite expressing strong beliefs about necessity, and comparatively less concern about taking sleep medications, three-quarters of users wished to reduce prescription hypnotics. Results may not generalize to individuals with insomnia not seeking nonpharmacological treatments. Upon completion, the "RCT of the Effectiveness of Stepped-Care Sleep Therapy in General Practice" study will provide information about the extent to which therapist-led and digital cognitive behavioral therapy for insomnia contribute to prescription hypnotic reduction. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy (RESTING); URL: https://clinicaltrials.gov/ct2/show/NCT03532282; Identifier: NCT03532282. CITATION: Tully IA, Kim JP, Simpson N, et al. Beliefs about prescription sleep medications and interest in reducing hypnotic use: an examination of middle-aged and older adults with insomnia disorder. J Clin Sleep Med. 2023;19(7):1247-1257.

Objective sleep duration and response to combined pharmacotherapy and cognitive behavioral insomnia therapy among patients with comorbid depression and insomnia: a report from the TRIAD study.

STUDY OBJECTIVES: Several studies have shown that patients with short sleep duration show a poor response to cognitive behavioral therapy for insomnia (CBT-I), but such studies have not included patients with comorbid conditions. The current study was conducted to determine whether pretreatment sleep duration moderates the response of patients with major depression and insomnia disorders to a combined CBT-I and antidepressant medication treatment. METHODS: This study comprised a secondary analysis of a larger randomized trial that tested combined CBT-I/antidepressant medication treatment of patients with major depression and insomnia. Participants (n = 99; 70 women; Mage = 47.712.4 years) completed pretreatment polysomnography and then were randomly assigned to a 12-week treatment with antidepressant medication combined with CBT-I or a sham therapy. Short and longer sleepers were defined using total sleep time cutoffs of < 5, < 6, and < 7 hours for short sleep. Insomnia and depression remission ascertained respectively from the Insomnia Severity Index and Hamilton Rating Scale for Depression were used to compare treatment responses of short and longer sleepers defined by the cutoffs mentioned. RESULTS: Logistic regression analyses showed that statistically significant results were obtained only when the cutoff of < 5 hours of sleep was used to define "short sleep." Both the CBT-I recipients with < 5 hours of sleep (odds ratio = 0.053; 95% confidence interval = 0.006-0.499) and the sham-therapy group with ≥ 5 hours of sleep (odds ratio = 0.149; 95% confidence interval = 0.045-0.493) were significantly less likely to achieve insomnia remission than were CBT-I recipients with ≥ 5 hours of sleep. The shorter sleeping CBT-I group (odds ratio = 0.118; 95% confidence interval = 0.020-0.714) and longer sleeping sham-therapy group (odds ratio = 0.321; 95% confidence interval = 0.105-0.983) were also less likely to achieve insomnia and/or depression remission than was the longer sleeping CBT-I group with ≥ 5 hours of sleep. CONCLUSIONS: Sleeping < 5 hours may dispose comorbid major depression/insomnia patients to a poor response to combined CBT-I/medication treatments for their insomnia and depression. Future studies to replicate these findings and explore mechanisms of treatment response seem warranted. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Treatment of Insomnia and Depression (TRIAD); URL: https://clinicaltrials.gov/ct2/show/results/NCT00767624; Identifier: NCT00767624. CITATION: Edinger JD, Smith ED, Buysse DJ, et al. Objective sleep duration and response to combined pharmacotherapy and cognitive behavioral insomnia therapy among patients with comorbid depression and insomnia: a report from the TRIAD study. J Clin Sleep Med. 2023;19(6):1111-1120.

Pre-sleep affect predicts subsequent REM frontal theta in nonlinear fashion.

Pre-sleep affect is thought to influence sleep, but associations with both sleep architecture and the electroencephalographic (EEG) power spectrum are mixed. In this pre-registered study, we assessed negative valence and arousal 1 h pre-sleep in 52 adults drawn from the community, then recorded one night of polysomnography (PSG) in participants' own homes. Pre-sleep affect was not associated with nonrapid eye movement (NREM) or rapid eye movement (REM) sleep architecture parameters, but we did observe inverted U-shaped relationships between both negative valence and arousal and REM frontal theta power, such that theta power was highest at moderate negative valence and arousal, and lowest at either affective extreme. When entered into a model together, both valence and arousal accounted for independent variance. Secondary analyses revealed a similar quadratic association with pre-sleep positive valence, suggesting a nonspecific effect of pre-sleep valence on REM frontal theta. Robustness checks confirmed that effects were not explained by homeostatic sleep pressure or sleep timing. Our results suggest that mixed findings in the literature may reflect different ends of a quadratic function, underscoring the importance of assessing how different components of pre-sleep affect relate to sleep.

Objective and subjective sleep health in adolescence: Associations with puberty and affect.

Sleep health tends to worsen during adolescence, partially due to pubertal-related changes that, in combination with social and psychological factors, can lead to long-lasting impairments in sleep health and affective functioning. Discrepant findings between subjective and objective measures of sleep in relation to affect have been reported in studies of adults; however, few investigations have assessed both subjective and objective sleep quality in a single sample, and fewer have examined this in the context of pubertal development. We aimed to (1) characterise pubertal associations with subjective sleep satisfaction, objective sleep efficiency, and objective and subjective sleep duration in adolescents; (2) examine the longitudinal association between daily affect and sleep metrics; and (3) test whether pubertal stage moderated this association. Eighty-nine participants (64% female, ages 13-20) completed an ecological momentary assessment (EMA) and actigraphy protocol. Independent of age, advanced pubertal stage was associated with lower subjective sleep satisfaction but not with objective sleep indices. Subjective sleep satisfaction was associated with within-person trajectories of negative affect, but not with positive affect. Pubertal stage and sleep satisfaction did not interact to predict within-day negative or positive affect. These findings are consistent with previous reports showing that objective and subjective sleep health are associated differently with puberty, and that subjective sleep health is associated with daily affect. Pubertal stage may be a more important indicator of subjective sleep quality in adolescence than is chronological age, most likely due to hormonal changes and psychological adjustment to the physical changes associated with the pubertal transition.

Daytime napping and nighttime sleep in pregnant individuals with insomnia disorder.

STUDY OBJECTIVES: Examine bidirectional associations between daytime napping and nighttime sleep among pregnant individuals with insomnia disorder. METHODS: We used baseline data from a randomized controlled trial of insomnia treatment during pregnancy (n = 116). Participants in their second or third trimester of pregnancy self-reported daytime napping and nighttime sleep parameters using a sleep diary and wore an Actiwatch-2 during the same 7-day period. Linear regression models, accounting for intraindividual correlation, were used to estimate associations between daytime napping and nighttime sleep parameters (duration, efficiency, quality, awakenings). Models were also stratified by trimester of pregnancy. RESULTS: Sixty-three percent of participants reported napping on at least 1 day. Among participants in the second trimester (65%), napping 15-59 minutes was associated with 6.3% greater self-reported sleep efficiency (95% confidence interval: 2.3, 10.2) and 0.5 units greater self-reported sleep quality (95% confidence interval: 0.0, 0.9) that night; napping 60+ minutes was associated with 0.6 hours shorter actigraphy-measured sleep duration (95% confidence interval: -1.0, -0.2). Napping was not associated with nighttime sleep overall or during the third trimester. Nighttime sleep parameters were not associated with napping duration the following day. CONCLUSIONS: Among pregnant individuals with insomnia in the second trimester, short napping duration was associated with higher self-reported sleep efficiency and quality; long napping duration was associated with shorter actigraphy-measured sleep duration. Additional research is needed to examine the interaction between nap duration and nap timing. In the future, these results may lead to more nuanced recommendations for daytime napping among pregnant individuals with insomnia disorder. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Treatment for Insomnia during Pregnancy; URL: https://clinicaltrials.gov/ct2/show/NCT01846585; Identifier: NCT01846585. CITATION: Badon SE, Dietch R, Simpson N, Lyell DJ, Manber R. Daytime napping and nighttime sleep in pregnant individuals with insomnia disorder. J Clin Sleep Med. 2023;19(2):371-377.

Intensity of Chronic Low Back Pain and Activity Interference: A Daily Diary Study of the Moderating Role of Cognitive Pain Coping Strategies.

OBJECTIVE: Chronic low back pain (CLBP) has a significant negative impact on daily functioning, particularly for those with challenges coping adaptively with ongoing pain. However, the dynamics of pain coping in daily life remain understudied. Therefore, we examined the extent to which pain intensity interferes with daily activities, and assessed whether pain coping strategies (as assessed using daily diaries) moderated this link. METHOD: We analyzed diary data from a sample of 84 participants with CLBP who completed daily diaries for up to 30 days rating pain intensity, pain interference with daily activities, and their use of pain coping strategies, including pain rumination (i.e., repetitive thinking about the pain and its causes), reappraisal (i.e., evaluating one's pain less negatively or more positively), and distraction (i.e., diverting attention from the pain). We hypothesized that these coping strategies would moderate the associations between pain and pain interference with daily activities, although in different directions. RESULTS: Results suggest that pain rumination strengthens the association between pain intensity and pain interference both on the person and day level, while pain reappraisal and distraction weaken this association, at the day and person levels, respectively. CONCLUSION: Our findings suggest that those who are more preoccupied with their pain and those who are less likely to reappraise their pain have more pain interference with daily activities. These findings build on prior work on pain coping by using daily diaries and highlight two pain coping strategies that have particular relevance for reducing the impact of CLBP in daily life.

Integrating technology to increase the reach of CBT-I: state of the science and challenges ahead.

In this Round Table Discussion, an international panel of experts discuss issues related to the use of technology in the delivery of cognitive behavioral therapy for insomnia (CBT-I), in order to increase its reach. Panelists were, in alphabetical order, Carmela Alcántara, PhD, an Associate Professor at Columbia University School of Social Work in New York, USA, Bei Bei, PhD., an Associate Professor at Monash University in Melbourne, Australia, Charles M. Morin, PhD., a Professor of Psychology at Laval University in Quebec City, Canada, and Annemieke A. van Straten, PhD., a Professor of Clinical Psychology at the Vrije Universiteit in Amsterdam, the Netherlands. The session was chaired by Rachel Manber, PhD., a Professor of Psychiatry and Behavioral Sciences at Stanford University, in Palo Alto, California, USA. In their introductions each panelist discussed the use of technology in their respective country. All indicated that the most common way technology is used in the treatment of insomnia is through the use of video calls (telemedicine) to deliver individual CBT-I, and that this is mostly covered by publicly funded health insurance programs such as Medicare, especially since the COVID-19 pandemic. There are also some fully automated insomnia treatment programs, but they're often not covered by Medicare or other health insurance programs.

Improving perinatal sleep via a scalable cognitive behavioural intervention: findings from a randomised controlled trial from pregnancy to 2 years postpartum.

BACKGROUND: Sleep disturbance is common in gestational parents during pregnancy and postpartum periods. This study evaluated the feasibility and efficacy of a scalable cognitive behavioural therapy (CBT) sleep intervention tailored for these periods. METHODS: This is a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Nulliparous females without severe medical/psychiatric conditions were randomised 1:1 to CBT or attention- and time-matched control. All participants received a 1 h telephone session and automated multimedia emails from the third trimester until 6 months postpartum. Outcomes were assessed with validated instruments at gestation weeks 30 (baseline) and 35 (pregnancy endpoint), and postpartum months 1.5, 3, 6 (postpartum endpoint), 12 and 24. RESULTS: In total, 163 eligible participants (age M ± s.d. = 33.35 ± 3.42) were randomised. The CBT intervention was well accepted, with no reported adverse effect. Intention-to-treat analyses showed that compared to control, receiving CBT was associated with lower insomnia severity and sleep disturbance (two primary outcomes), and lower sleep-related impairment at the pregnancy endpoint (p values ⩽ 0.001), as well as at 24 months postpartum (p ranges 0.012-0.052). Group differences across the first postpartum year were non-significant. Participants with elevated insomnia symptoms at baseline benefitted substantially more from CBT (v. control), including having significantly lower insomnia symptoms throughout the first postpartum year. Group differences in symptoms of depression or anxiety were non-significant. CONCLUSIONS: A scalable CBT sleep intervention is efficacious in buffering against sleep disturbance during pregnancy and benefitted sleep at 2-year postpartum, especially for individuals with insomnia symptoms during pregnancy. The intervention holds promise for implementation into routine perinatal care.

Stepped care management of insomnia co-occurring with sleep apnea: the AIR study protocol.

BACKGROUND: Obstructive sleep apnea (OSA) and insomnia are commonly co-occurring conditions that amplify morbidity and complicates the management of affected patients. Unfortunately, previous research provides limited guidance as to what constitutes the best and most practical management approach for this comorbid patient group. Some preliminary studies show that when cognitive behavioral insomnia therapy (CBT-I) is combined with standard OSA therapies for these patients, outcomes are improved. However, the dearth of trained providers capable of delivering CBT-I has long served as a pragmatic barrier to the widespread use of this therapy in clinical practice. The emergence of sophisticated online CBT-I (OCBT-I) programs could improve access, showing promising reductions in insomnia severity. Given its putative scalability and apparent efficacy, some have argued OCBT-I should represent a 1st-stage intervention in a broader stepped care model that allocates more intensive and less assessable therapist-delivered CBT-I (TCBT-I) only to those who show an inadequate response to lower intensity OCBT-I. However, the efficacy of OCBT-I as a 1st-stage therapy within a broader stepped care management strategy for insomnia comorbid with OSA has yet to be tested with comorbid OSA/insomnia patients. METHODS/DESIGN: This dual-site randomized clinical trial will use a Sequential Multiple Assignment Randomized Trial (SMART) design to test a stepped care model relative to standard positive airway pressure (PAP) therapy and determine if (1) augmentation of PAP therapy with OCBT-I improves short-term outcomes of comorbid OSA/insomnia and (2) providing a higher intensity 2nd-stage CBT-I to patients who show sub-optimal short-term outcomes with OCBT-I+PAP improves short and longer-term outcomes. After completing baseline assessment, the comorbid OSA/insomnia patients enrolled will be randomized to a 1st-stage therapy that includes usual care PAP + OCBT-I or UC (usual care PAP + sleep hygiene education). Insomnia will be reassessed after 8 weeks. OCBT-I recipients who meet "remission" criteria (defined as an Insomnia Severity Index score < 10) will continue PAP but will not be offered any additional insomnia intervention and will complete study outcome measures again after an additional 8 weeks and at 3 and 6 month follow-ups. OCBT-I recipients classified as "unremitted" after 8 weeks of treatment will be re-randomized to a 2nd-stage treatment consisting of continued, extended access to OCBT-I or a switch to TCBT-I. Those receiving the 2nd-stage intervention as well as the UC group will be reassessed after another 8 weeks and at 3- and 6-month follow-up time points. The primary outcome will be insomnia remission. Secondary outcomes will include subjective and objective sleep data, including sleep time, sleep efficiency, fatigue ratings, PAP adherence, sleepiness ratings, sleep/wake functioning ratings, and objective daytime alertness. DISCUSSION: This study will provide new information about optimal interventions for patients with comorbid OSA and insomnia to inform future clinical decision-making processes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03109210 , registered on April 12, 2017, prospectively registered.

Sleep and affect: A conceptual review.

Everyday experience suggests that sleep and affect are closely linked, with daytime affect influencing how we sleep, and sleep influencing subsequent affect. Yet empirical evidence for this bidirectional relationship between sleep and affect in non-clinical adult samples remains mixed, which may be due to heterogeneity in both construct definitions and measurement. This conceptual review proposes a granular framework that deconstructs sleep and affect findings according to three subordinate dimensions, namely domains (which are distinct for sleep and affect), methods (i.e., self-report vs. behavioral/physiological measures), and timescale (i.e., shorter vs. longer). We illustrate the value of our granular framework through a systematic review of empirical studies published in PubMed (N = 80 articles). We found that in some cases, particularly for sleep disturbances and sleep duration, our framework identified robust evidence for associations with affect that are separable by domain, method, and timescale. However, in most other cases, evidence was either inconclusive or too sparse, resulting in no clear patterns. Our review did not find support for granular bidirectionality between sleep and affect. We suggest a roadmap for future studies based on gaps identified by our review and discuss advantages and disadvantages of our granular dimensional framework.

Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials.

BACKGROUND: Nonpharmacologic mind-body therapies have demonstrated efficacy in low back pain. However, the mechanisms underlying these therapies remain to be fully elucidated. OBJECTIVE: In response to these knowledge gaps, the Stanford Center for Low Back Pain-a collaborative, National Institutes of Health P01-funded, multidisciplinary research center-was established to investigate the common and distinct biobehavioral mechanisms of three mind-body therapies for chronic low back pain: cognitive behavioral therapy (CBT) that is used to treat pain, mindfulness-based stress reduction (MBSR), and electroacupuncture. Here, we describe the design and implementation of the center structure and the associated randomized controlled trials for characterizing the mechanisms of chronic low back pain treatments. METHODS: The multidisciplinary center is running two randomized controlled trials that share common resources for recruitment, enrollment, study execution, and data acquisition. We expect to recruit over 300 chronic low back pain participants across two projects and across different treatment arms within each project. The first project will examine pain-CBT compared with MBSR and a wait-list control group. The second project will examine real versus sham electroacupuncture. We will use behavioral, psychophysical, physical measure, and neuroimaging techniques to characterize the central pain modulatory and emotion regulatory systems in chronic low back pain at baseline and longitudinally. We will characterize how these interventions impact these systems, characterize the longitudinal treatment effects, and identify predictors of treatment efficacy. RESULTS: Participant recruitment began on March 17, 2015, and will end in March 2023. Recruitment was halted in March 2020 due to COVID-19 and resumed in December 2021. CONCLUSIONS: This center uses a comprehensive approach to study chronic low back pain. Findings are expected to significantly advance our understanding in (1) the baseline and longitudinal mechanisms of chronic low back pain, (2) the common and distinctive mechanisms of three mind-body therapies, and (3) predictors of treatment response, thereby informing future delivery of nonpharmacologic chronic low back pain treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT02503475; https://clinicaltrials.gov/ct2/show/NCT02503475. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37823.

Examining Experiences of Poor Sleep During Pregnancy: A Qualitative Study to Inform the Development of a Prenatal Sleep Intervention.

Background: Poor sleep is common during pregnancy and is associated with increased risk of negative health outcomes. Research indicates that physical discomfort and having an active mind are primary factors for prenatal sleep disturbances. Mindfulness-based interventions have the potential for addressing these factors, but have yet to be optimized for this purpose in this population. Objective: The objective of this study was to gather input from pregnant and postpartum individuals about the value of a mindfulness-based program for improving prenatal sleep and their preferred content and delivery format. Methods: We conducted 2 focus groups with 12 pregnant people experiencing poor sleep quality and 3 individual interviews with postpartum people. Interviews were thematically analyzed. Results: The majority of participants expressed strong interest in a mindfulness program for improving prenatal sleep. Participants reported that pregnancy-specific physical discomfort and worry (both general and pregnancy-specific) affected their sleep. Participants wanted sleep education, and strategies for calming the mind, reducing physical discomfort, reducing impact of bedtime partners on sleep, and tips for improving sleep schedule and quality. Participants recognized the convenience of an online intervention and the social benefits of an in-person intervention and favored a hybrid delivery model. Conclusion: Addressing prenatal sleep problems is an unmet need. Given the challenges and discomfort women face during pregnancy, and the importance of adequate sleep for promoting mental and physical health during pregnancy, sleep difficulties are critical to address. A mindfulness-based intervention for improving prenatal sleep was deemed of high interest to this perinatal population.

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.