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Secondary outcomes of a behavioral sleep intervention: A randomized clinical trial.

ABSTRACT: OBJECTIVE:Nearly 80% of cancer patients struggle with insomnia, which is associated with decreased heart rate variability (HRV) and quality of life (QOL). The aim of this secondary analysis was to evaluate the possible effects of Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI), delivered during chemotherapy visits, on QOL and HRV in patients with breast cancer (BC). METHOD:QOL and HRV data were obtained during a pilot clinical trial assessing the feasibility and effects of BBT-CI on insomnia. A total of 71 BC patients (mean age = 52.5 years) were randomly assigned to either BBT-CI or a healthy-eating control intervention (HEAL). BBT-CI and HEAL were delivered over 6 weeks (2 face-to-face sessions plus 4 phone calls) by trained staff at 4 National Cancer Institute-funded Community Oncology Research Program clinics. QOL was measured with the Functional Assessment of Cancer Therapy (FACT-G) and HRV with the Firstbeat device at baseline and after intervention. RESULTS:There were significant improvements in QOL after intervention for BBT-CI (FACT-G, p = .009; FACT-B, p = .016; ANCOVA) and 5-min supine HRV measures (SDNN, p = .005; rMSSD, p = .004; HF, p = .009; ANCOVA) compared with HEAL. CONCLUSIONS:Patients randomized to BBT-CI showed improvements in QOL and HRV, providing support for BBT-CI's possible benefit when delivered in the community oncology setting by trained staff. A more definitive efficacy trial of BBT-CI is currently being planned with sufficient statistical power to evaluate the intervention's clinical utility. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

SUBMITTER: Palesh O

PROVIDER: S-EPMC6892630 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Secondary outcomes of a behavioral sleep intervention: A randomized clinical trial.

Palesh Oxana O Scheiber Caroline C Kesler Shelli S Gevirtz Richard R Heckler Charles C Guido Joseph J JJ Janelsins Michelle M Cases Mallory G MG Tong Bingjie B Miller Jessica M JM Chrysson Nick G NG Mustian Karen K

Health psychology : official journal of the Division of Health Psychology, American Psychological Association 20190301 3

<h4>Objective</h4>Nearly 80% of cancer patients struggle with insomnia, which is associated with decreased heart rate variability (HRV) and quality of life (QOL). The aim of this secondary analysis was to evaluate the possible effects of Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI), delivered during chemotherapy visits, on QOL and HRV in patients with breast cancer (BC).<h4>Method</h4>QOL and HRV data were obtained during a pilot clinical trial assessing the feasibility and effe ...[more]

PMID: 30762399

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Project description:BackgroundBreast cancer survivors often have persisting headache. In a secondary analysis of the Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) clinical trial (ClinicalTrials.gov identifier NCT02165839), the authors examined the effects of BBT-CI on headache outcomes in patients with breast cancer.MethodsPatients with breast cancer who were receiving chemotherapy were randomly assigned to receive either the BBT-CI intervention or the Healthy EAting Education Learning for healthy sleep (HEAL) control intervention, and both were delivered over 6 weeks by trained staff. Headache outcomes and heart rate variability (HRV) were measured at baseline, 6 weeks, 6 months, and 12 months. Mixed-effects models were used to examine longitudinal headache outcomes in the groups according to the intention to treat. Principal component analysis and agglomerative hierarchical clustering were conducted to reduce 16 variables for data-driven phenotyping.ResultsPatients in the BBT-CI arm (n = 73) exhibited a significant reduction in headache burden over time (P = .02; effect size [Cohen d] = 0.43), whereas the reduction was not significant among those in the HEAL arm (n = 66). The first principal component was positively loaded by headache, sleep, fatigue, and nausea/vomiting and was negatively loaded by cognitive, physical, and emotional functioning. Agglomerative hierarchical clustering revealed 3 natural clusters. Cluster I (n = 58) featured the highest burden of headache, insomnia, and nausea/vomiting; cluster II (n = 50) featured the lowest HRV despite a low burden of headache and insomnia; and cluster III (n = 31) showed an inverse relation between HRV and headache-insomnia, signifying autonomic dysfunction.ConclusionsBBT-CI is efficacious in reducing headache burden in breast cancer survivors. Patient phenotyping demonstrates a headache type featuring sleep disturbance, nausea/vomiting, and low physical functioning-revealing similarities to migraine.Lay summaryBreast cancer survivors often have persisting headache symptoms. In patients with cancer, treatment of chronic headache disorders using daily medications may be challenging because of drug interactions with chemotherapy and other cancer therapies as well as patients' reluctance to add more drugs to their medicine list. Headache and sleep disorders are closely related to each other. This study demonstrates that a sleep behavioral therapy reduced headache burden in breast cancer survivors. In addition, the majority of headache sufferers had a headache type with similarities to migraine-featuring sleep disturbance, nausea/vomiting, and low physical functioning.

Project description:BackgroundInfant behavioral sleep problems are common, with potential negative consequences. We conducted a randomized controlled trial to assess effects of a sleep intervention comprising a two-hour group teaching session and four support calls over 2 weeks. Our primary outcomes were reduced numbers of nightly wakes or parent report of sleep problem severity. Secondary outcomes included improvement in parental depression, fatigue, sleep, and parent cognitions about infant sleep.MethodsTwo hundred thirty five families of six-to-eight month-old infants were randomly allocated to intervention (n = 117) or to control teaching sessions (n = 118) where parents received instruction on infant safety. Outcome measures were observed at baseline and at 6 weeks post intervention. Nightly observation was based on actigraphy and sleep diaries over six days. Secondary outcomes were derived from the Multidimensional Assessment of Fatigue Scale, Center for Epidemiologic Studies Depression Measure, Pittsburgh Sleep Quality Index, and Maternal (parental) Cognitions about Infant Sleep Questionnaire.ResultsOne hundred eight intervention and 107 control families provided six-week follow-up information with complete actigraphy data for 96 in each group: 96.9% of intervention and 97.9% of control infants had an average of 2 or more nightly wakes, a risk difference of -0.2% (95% CI: -1.32, 0.91). 4% of intervention and 14% of control infants had parent-assessed severe sleep problems: relative risk 0.3, a risk difference of -10% (CI: 0.11, 0.84-16.8 to -2.2). Relative to controls, intervention parents reported improved baseline-adjusted parental depression (CI: -3.7 to -0.4), fatigue (CI: -5.74 to -1.68), sleep quality (CI: -1.5 to -0.2), and sleep cognitions: doubts (CI: -2.0 to -0.6), feeding (CI: - 2.1 to - 0.7), anger (CI: - 1.8 to - 0.4) and setting limits (CI: -3.5 to -1.5).ConclusionsThe intervention improved caregivers' assessments of infant sleep problem severity and parental depression, fatigue, sleep, and sleep cognitions compared with controls.Trial registrationISRCTN42169337 , NCT00877162.

Project description:ImportanceAdenotonsillectomy (AT) is associated with improved behavior in children with obstructive sleep apnea (OSA). However, it is unknown whether polysomnographic parameters are superior to the parent-reported severity of sleep-disordered breathing (SDB) in predicting behavioral changes after AT.ObjectiveTo ascertain whether polysomnographic parameters vs parent-reported severity of SDB are better predictors of treatment-related behavioral changes in children with OSA.Design, setting, and participantsThis ad hoc secondary analysis of the Childhood Adenotonsillectomy Trial (CHAT) downloaded and analyzed data from January 1 to January 31, 2020. Children aged 5 to 9 years with a polysomnographic diagnosis of OSA were enrolled in the CHAT and subsequently randomized to undergo either early AT or watchful waiting with supportive care. All outcome measures were obtained at baseline and at follow-up (7 months after randomization).InterventionsEarly AT vs watchful waiting with supportive care.Main outcomes and measuresPostrandomization changes between the baseline and follow-up periods were derived from (1) T scores in 4 validated behavioral assessments (Conners Global Index parent and teacher versions, Behavior Rating Inventory of Executive Function metacognition index, and Child Behavior Checklist of total, internalizing, and externalizing behavior subscales); (2) 8 aggregated polysomnographic parameters representing the severity of obstruction, hypoxemia, sleep quality, and structure; and (3) the parent-reported severity of SDB measured by the Pediatric Sleep Questionnaire-Sleep-Related Breathing Disorder (PSQ-SRBD) scale. The treatment-related changes in each of the behavioral outcomes attributable to changes in SDB severity (represented by the subjective PSQ-SRBD score and objective polysomnographic parameters) were measured and compared using mediation analysis.ResultsA total of 453 children were assessed at baseline, of whom 234 were girls (52%) and the mean (SD) age was 6.6 (1.4) years. The postrandomization changes in 7 of 8 behavioral outcome measures between the baseline and follow-up periods were partially mediated by the changes in PSQ-SRBD scores (range of nonzero causally mediated effects, 2.4-3.5), without contribution from any of the polysomnographic parameters.Conclusions and relevanceThis secondary analysis of a national randomized clinical trial found that most treatment-related behavioral changes in children with OSA were mediated by the changes in parent-reported SDB severity alone. These findings suggest that polysomnographic parameters provide clinicians with limited means to predict the improvement in neurobehavioral morbidity in OSA.Trial registrationClinicalTrials.gov Identifier: NCT00560859.

Project description:ImportanceBlack individuals in the US experience sleep disparities beginning in infancy and continuing throughout the lifespan, suggesting early interventions are needed to improve sleep.ObjectiveTo investigate whether a responsive parenting (RP) intervention for Black mothers improves infant sleep and increases responsive sleep parenting practices.Design, setting, and participantsThis is a post hoc secondary analysis of the Sleep SAAF (Strong African American Families) study, a randomized clinical trial comparing an RP intervention with a safety control condition over the first 16 weeks post partum. Data were collected between spring 2018 and summer 2021. Families were recruited from the mother-infant nursery at Augusta University Medical Center, Augusta, Georgia, and completed home visits at 1, 3, 8, and 16 weeks post partum. Primiparous Black mother-infant dyads were screened for eligibility using medical records. Results were analyzed on an intention-to-treat model. Data were analyzed from March 2022 to January 2023.InterventionsThe RP intervention curriculum focused on infant sleep, soothing and crying, and feeding. The control group received a safety intervention. Community research associates delivered the interventions during home visits at 3 and 8 weeks post partum.Main outcomes and measuresThe primary end point was infant sleep duration at 16 weeks. Mothers reported on bedtime routine and sleep behaviors, infant sleep duration, and nighttime waking and feeding at 8 and 16 weeks post partum using questionnaires.ResultsA total of 212 Black mothers (mean [SD] age, 22.7 [4.5] years) were randomized, including 208 mothers (98.6%) who identified as non-Hispanic and 3 mothers (1.4%) who identified as Hispanic; 108 mothers were randomized to the RP group and 104 mothers were randomized to the control group. At 16 weeks post partum, infants in the RP group had longer reported nighttime sleep duration (mean difference, 40 [95% CI, 3 to 77] minutes), longer total sleep duration (mean difference, 73 [95% CI, 14 to 131] minutes), fewer nighttime wakings (mean difference, -0.4 [95% CI, -0.6 to -0.1] wakings), and greater likelihood of meeting guidelines of at least 12 hours of total sleep per day (risk ratio [RR], 1.4 [95% CI, 95% CI, 1.1 to 1.8]) than controls. Relative to controls, mothers in the RP group more frequently reported engaging in some RP practices, including giving the baby a few minutes to fall back asleep on their own (RR, 1.6 [95% CI, 1.0 to 2.6]) and being less likely to feed their baby as the last activity before bed (RR, 0.5 [95% CI, 0.3 to 0.8]).Conclusions and relevanceThis secondary analysis of a randomized clinical trial found that an RP intervention for Black families improved infant sleep and increased some responsive sleep parenting practices.Trial registrationClinicalTrials.gov Identifier: NCT03505203.

Project description:IntroductionThis study evaluated the secondary effectiveness outcomes for Quit Genius, a digital clinician-assisted cognitive behavioral therapy (CBT) intervention for smoking cessation.MethodsAdult smokers (N = 556) were randomly assigned to Quit Genius (n = 277), a digital, clinician-assisted CBT intervention or very brief advice (VBA) to stop smoking, an evidence-based, 30-s intervention designed to facilitate quit attempts, coupled with referral to a cessation service (n = 279). Participants were offered combination nicotine replacement therapy (patches and gum) tailored to individual nicotine dependence. Analyses (n = 530), by intention-to-treat, compared Quit Genius and VBA at 4, 26, and 52 weeks post-quit date (QD). The primary outcome was self-reported 7-day point prevalence abstinence (PPA) at 4 weeks post-QD. Consecutive 7-day point-prevalence abstinence, defined as abstinent at two or more consecutive timepoints, was examined at weeks 26 and 52 to indicate long-term effectiveness. Abstinence was verified using a random sample of participants with carbon monoxide breath testing of <5 parts per million (n = 280).ResultsSelf-reported consecutive 7-day PPA at weeks 26 and 52 for Quit Genius was 27.2% and 22.6%, respectively, compared with VBA which was 16.6% and 13.2% (RR = 1.70, 95% CI, 1.22-2.37; p = .003, 26 weeks; RR = 1.71, 95% CI, 1.17-2.50; P = .005, 52 weeks). Biochemically verified abstinence was significantly different at 26- (p = .03) but not 52 weeks (p = .16). Quit Genius participants were more likely to remain abstinent than those who received VBA (RR = 1.71, 95% CI 1.17-2.50; p = .005).ConclusionsThis study provides secondary evidence for the long-term effectiveness of Quit Genius in comparison with VBA. Future trials of digital interventions without clinician support and comparisons with active treatment are needed.ImplicationsThe long-term effectiveness of clinician-assisted digital smoking cessation interventions has not been well studied. This study established the long-term effectiveness of an extended CBT-based intervention; results may inform implementation of scalable approaches to smoking cessation in the health system.

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Secondary outcomes of a behavioral sleep intervention: A randomized clinical trial.

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Secondary outcomes of a behavioral sleep intervention: A randomized clinical trial.

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