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Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education.

ABSTRACT: STUDY OBJECTIVES:Insomnia is a chief complaint among postmenopausal women, and insomnia impairs daytime functioning and reduces quality of life. Recent evidence supports the efficacy of cognitive behavioral therapy for insomnia (CBTI) for menopausal insomnia, but it remains unclear whether treating insomnia improves daytime function in this population. This study evaluated whether CBTI improves daytime fatigue, energy, self-reported sleepiness, work productivity, and quality of life in postmenopausal women with insomnia, and whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious. METHODS:Single-site, randomized control trial. One hundred fifty postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset or exacerbation of chronic insomnia were randomized to 3 treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI. Blinded assessments were performed at pretreatment, posttreatment, and 6-month follow-up. RESULTS:CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later. The CBTI group reported better quality of life as indicated by substantial improvements in emotional wellbeing and resiliency to physical and emotional problems, whereas the SRT and SHE groups only showed improvements in resiliency to physical problems. Pain complaints decreased as sleep improved but were not associated with specific treatment conditions. Similarly, insomnia remitters reported fewer daytime and nighttime hot flashes, although reductions were not associated with any specific treatment. CONCLUSIONS:CBTI and SRT are efficacious options for postmenopausal women with chronic insomnia. Both interventions improve daytime function, quality of life, and work performance, although CBTI produces superior results including the added benefit of improved emotional health. CLINICAL TRIAL REGISTRATION:Registry: ClinicalTrials.gov; Title: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295; URL: https://clinicaltrials.gov/ct2/show/record/NCT01933295.

SUBMITTER: Kalmbach DA

PROVIDER: S-EPMC6622507 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education.

Kalmbach David A DA Cheng Philip P Arnedt J Todd JT Cuamatzi-Castelan Andrea A Atkinson Rachel L RL Fellman-Couture Cynthia C Roehrs Timothy T Drake Christopher L CL

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine 20190715 7

<h4>Study objectives</h4>Insomnia is a chief complaint among postmenopausal women, and insomnia impairs daytime functioning and reduces quality of life. Recent evidence supports the efficacy of cognitive behavioral therapy for insomnia (CBTI) for menopausal insomnia, but it remains unclear whether treating insomnia improves daytime function in this population. This study evaluated whether CBTI improves daytime fatigue, energy, self-reported sleepiness, work productivity, and quality of life in p ...[more]

PMID: 31383238

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Project description:IntroductionDepression increases during menopause, and subclinical depressive symptoms increase risk for major depression. Insomnia is common among postmenopausal women and increases depression-risk in this already-vulnerable population. Recent evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBTI) to treat menopausal insomnia, but it remains unclear whether treating insomnia also alleviates co-occurring depressive symptoms and depressogenic features. This trial tested whether CBTI improves depressive symptoms, maladaptive thinking, and somatic hyperarousal in postmenopausal women with insomnia; as well as whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious.Materials and methodsSingle-site, randomized controlled trial. 117 postmenopausal women (56.34 ± 5.41 years) with peri-or-postmenopausal onset of chronic insomnia were randomized to three treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI. Blinded assessments were performed at baseline, posttreatment, and six-month follow-up.ResultsCBTI produced moderate-to-large reductions in depressive symptoms, whereas SRT produced moderate reductions but not until six months posttreatment. Treatment effects on maladaptive thinking were mixed. CBTI and SRT both produced large improvements in dysfunctional beliefs about sleep, but weaker influences on presleep cognitive arousal, rumination, and worry. Presleep somatic arousal greatly improved in the CBTI group and moderately improved in the SRT group. Improvements in depression, maladaptive thinking, and hyperarousal were linked to improved sleep. SHE produced no durable treatment effects.ConclusionsCBTI and SRT reduce depressive symptoms, dysfunctional beliefs about sleep, and presleep somatic hyperarousal in postmenopausal women, with CBTI producing superior results. Despite its cognitive emphasis, cognitive arousal did not respond strongly or durably to CBTI. NAME: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov.RegistrationNCT01933295.

Project description:INTRODUCTION:Insomnia is a prevalent sleep disorder that negatively affects quality of life. Multicomponent cognitive-behavioural therapy (CBT) is the recommended treatment but access remains limited, particularly in primary care. Sleep restriction therapy (SRT) is one of the principal active components of CBT and could be delivered by generalist staff in primary care. The aim of this randomised controlled trial is to establish whether nurse-delivered SRT for insomnia disorder is clinically and cost-effective compared with sleep hygiene advice. METHODS AND ANALYSIS:In the HABIT (Health-professional Administered Brief Insomnia Therapy) trial, 588 participants meeting criteria for insomnia disorder will be recruited from primary care in England and randomised (1:1) to either nurse-delivered SRT (plus sleep hygiene booklet) or sleep hygiene booklet on its own. SRT will be delivered over 4?weekly sessions; total therapy time is approximately 1?hour. Outcomes will be collected at baseline, 3, 6 and 12 months post-randomisation. The primary outcome is self-reported insomnia severity using the Insomnia Severity Index at 6?months. Secondary outcomes include health-related and sleep-related quality of life, depressive symptoms, use of prescribed sleep medication, diary and actigraphy-recorded sleep parameters, and work productivity. Analyses will be intention-to-treat. Moderation and mediation analyses will be conducted and a cost-utility analysis and process evaluation will be performed. ETHICS AND DISSEMINATION:Ethical approval was granted by the Yorkshire and the Humber - Bradford Leeds Research Ethics Committee (reference: 18/YH/0153). We will publish our primary findings in high-impact, peer-reviewed journals. There will be further outputs in relation to process evaluation and secondary analyses focussed on moderation and mediation. Trial results could make the case for the introduction of nurse-delivered sleep therapy in primary care, increasing access to evidence-based treatment for people with insomnia disorder. TRIAL REGISTRATION NUMBER:ISRCTN42499563.

Project description:Study objectivesThis 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.MethodsA 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.ResultsA 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.ConclusionsImprovements 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.Clinical trial registrationRegistry: ClinicalTrials.gov; Name: Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS); URL: https://clinicaltrials.gov/ct2/show/NCT01785303; Identifier: NCT01785303.CitationTu AY, Crawford MR, Dawson SC, et al. 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.

Project description:Study objectivesThis study involves the analysis of a secondary outcome of a trial examining whether cognitive behavior therapy for insomnia (CBT-I), a wake-promoting medication (armodafinil), or both results in greater improvement in prospectively assessed sleep continuity and daytime sleepiness than a placebo-alone group among a heterogeneous group of cancer survivors. Whether or not armodafinil alone, and/or when combined with CBT-I, affected adherence with CBT-I was evaluated.DesignThis study is a randomized, placebo-controlled, clinical trial.SettingThis study was conducted at two northeastern academic medical centers.ParticipantsEighty-eight cancer survivors with chronic insomnia were recruited between October 2008 and November 2012. Participants were assigned to one of four conditions: 1) CBT-I and placebo (CBT-I+P); 2) CBT-I and armodafinil (CBT-I + A); 2) armodafinil alone (ARM); or 4) placebo alone (PLA).InterventionsCBT-I was delivered in seven weekly individual therapy sessions (three in person, four via telephone). The armodafinil dosage was 50 mg BID.Measurements and resultsSleep continuity was measured with daily sleep diaries assessing sleep latency (SL), wake after sleep onset (WASO), and total sleep time (TST). The Epworth Sleepiness Scale (ESS) measured daytime sleepiness. Compared to the PLA group, the CBT-I+P and CBT-I+A groups reported a significant reduction in SL with effect sizes of 0.67 and 0.58, respectively. A significant reduction was observed in WASO in the CBT-I+A group with an effect size of 0.64. An increasing trend of TST was observed in the CBT-I+P, CBT-I+A, and PLA groups, but not in the ARM group. No statistically significant reductions in daytime sleepiness (ESS) were observed for any of the groups.ConclusionCBT-I alone and in combination with armodafinil caused significant improvement in sleep continuity. The addition of armodafinil did not appear to improve daytime sleepiness or enhance adherence to CBT-I.

Project description:Study objectivesInsomnia symptoms are common during the perinatal period and are linked to adverse outcomes. This single-blind three-arm randomized-controlled trial examined whether two interventions targeting different mechanisms prevent postpartum insomnia.MethodsParticipants were nulliparous females 26-32 weeks gestation with Insomnia Severity Index (ISI) scores ≥ 8, recruited in Australia and randomized 1:1:1 to: (1) a responsive bassinet (RB) designed to support infant sleep and reduce maternal sleep disruption until 6 months postpartum, (2) therapist-assisted cognitive behavioral therapy for insomnia (CBT-I) delivered during pregnancy and postpartum, or (3) a sleep hygiene booklet (control; CTRL). Outcomes were assessed at baseline (T1), 35-36 weeks gestation (T2), and 2, 6, and 12 months postpartum (T3-T5). The primary outcome was ISI scores averaged T3-T5. Primary analyses were regressions controlling for baseline outcomes.ResultsOne hundred and twenty-seven participants (age M ± SD = 32.62 ± 3.49) were randomized (RB = 44, CBT-I = 42, CTRL = 41). Both interventions were feasible and well-accepted, with few related adverse events reported. Compared to CTRL, the average ISI across T3-T5 was lower for CBT-I (p = .014, effect size [ES] = 0.56, medium) but not RB (p = .270, ES = 0.25, small). Exploratory findings on maternal insomnia diagnosis, sleep disturbance, sleep-related impairment, beliefs and attitudes about sleep, depression, anxiety, as well as infant sleep outcomes were also presented.ConclusionsCBT-I but not RB reduced prenatal insomnia (very large effect) and prevented postpartum insomnia (medium effect). Further research is needed to examine the effects of both CBT-I and RB on other outcomes such as sleep-related well-being, postpartum depression, and maternal postpartum sleep duration.Clinical trial registrationThe Study for Mother-Infant Sleep (The SMILE Project): reducing postpartum insomnia using an infant sleep intervention and a maternal sleep intervention in first-time mothers. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377927, Australian New Zealand Clinical Trials Registry: ACTRN12619001166167.

Project description:Study objectivesSleep restriction therapy (SRT) has been shown to be comparably effective relative to cognitive behavioral therapy for insomnia (CBT-I), but with lower requirements for patient contact. As such, SRT appears to be a viable alternate treatment for those who cannot complete a full course of CBT-I. However, it is unclear whether SRT-a treatment solely focusing on restricting time in bed-increases risk for sleepiness comparably to CBT-I. The current study tested objective sleepiness as an outcome in a randomized controlled trial comparing SRT, CBT-I, and attention control in a sample of postmenopausal women in whom insomnia was diagnosed according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.MethodsSingle-site, randomized controlled trial. A total of 150 postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition insomnia disorder were randomized to 3 treatment conditions: sleep education control (6 sessions); SRT (2 sessions with interim phone contact); and CBT-I (6 sessions). Blinded assessments were performed at pretreatment and posttreatment. Risk of excessive sleepiness was evaluated using a symmetry analysis of sleepiness measured through the Multiple Sleep Latency Test (MSLT).ResultsThe odds ratios (ORs) of being excessively sleepy versus nonsleepy were not different than 1.0 for both SRT (OR = 0.94, 95% confidence interval [0.13-6.96]) and CBT-I (OR = 0.62, 95% confidence interval [0.09-4.46]), indicating that the odds of becoming excessively sleepy following treatment was not different from the odds of being nonsleepy. This suggests that excessive sleepiness is not of unique concern following SRT relative to CBT-I or sleep education.ConclusionsSRT appears to have a comparable risk profile for excessive sleepiness as CBT-I, and thus may be considered a safe alternative to CBT-I. Future research should characterize objective measures of excessive sleepiness immediately following sleep restriction.Clinical trail registrationRegistry: ClinicalTrials.gov; Name: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295.

Dataset Information

Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education.

Publications

Improving Daytime Functioning, Work Performance, and Quality of Life in Postmenopausal Women With Insomnia: Comparing Cognitive Behavioral Therapy for Insomnia, Sleep Restriction Therapy, and Sleep Hygiene Education.

Similar Datasets

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