A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia

Effectiveness of cognitive behavioral therapy for pharmacotherapy-resistant chronic insomnia: a multi-center randomized controlled trial in Japan

Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve both sleep and depressive symptoms, but predictors of depression outcome following CBT-I have not been well examined. This study investigated how chronotype (i.e., morningness-eveningness trait) and changes in sleep efficiency (SE) were related to changes in depressive symptoms among recipients of CBT-I. Included were 419 adult insomnia outpatients from a sleep disorders clinic (43.20% males, age mean ± standard deviation = 48.14 ± 14.02). All participants completed the Composite Scale of Morningness and attended at least 4 sessions of a 6-session group CBT-I. SE was extracted from sleep diary; depressive symptoms were assessed using the Beck Depression Inventory (BDI) prior to (Baseline), and at the end (End) of intervention. Multilevel structural equation modeling revealed that from Baseline to End, SE increased and BDI decreased significantly. Controlling for age, sex, BDI, and SE at Baseline, stronger evening chronotype and less improvement in SE significantly and uniquely predicted less reduction in BDI from Baseline to End. Chronotype did not predict improvement in SE. In an insomnia outpatient sample, SE and depressive symptoms improved significantly after a CBT-I group intervention. All chronotypes benefited from sleep improvement, but those with greater eveningness and/or less sleep improvement experienced less reduction in depressive symptom severity. This suggests that evening preference and insomnia symptoms may have distinct relationships with mood, raising the possibility that the effect of CBT-I on depressive symptoms could be enhanced by assessing and addressing circadian factors.

BackgroundInsomnia and eveningness are common and often comorbid conditions in youths. While cognitive behavioural therapy for insomnia (CBT-I) has been suggested as a promising intervention, it remains unclear whether it is sufficient to also address circadian issues in youths. In addition, despite that light has been shown to be effective in phase-shifting one’s circadian rhythm, there has been limited data on the effects of bright light therapy and its combination with CBT-I on sleep and circadian outcomes in youths. The current protocol outlines a randomised controlled trial that examines the efficacy of CBT-I and CBT-I plus bright light therapy (BLT) in reducing insomnia severity, improving mood symptoms and daytime functioning (e.g. sleepiness, fatigue, cognitive function), and improving subjective and objective sleep and circadian measures compared to a waitlist control group.MethodsWe will carry out a randomised controlled trial (RCT) with 150 youths aged 12–24 who meet the criteria of insomnia and eveningness. Participants will be randomised into one of three groups: CBT-I with bright light therapy, CBT-I with placebo light, and waitlist control. Six sessions of CBT-I will be delivered in a group format, while participants will be currently asked to use a portable light device for 30 min daily immediately after awakening throughout the intervention period for bright light therapy. The CBT-I with light therapy group will receive bright constant green light (506 lx) while the CBT-I with placebo light group will receive the modified light device with the LEDs emitting less than 10 lx. All participants will be assessed at baseline and post-treatment, while the two active treatment groups will be additionally followed up at 1 month and 6 months post-intervention. The primary outcome will be insomnia severity, as measured by the Insomnia Severity Index. Secondary outcomes include self-reported mood, circadian, daytime functioning, and quality of life measures, as well as sleep parameters derived from actigraphy and sleep diary and neurocognitive assessments. Objective measures of the circadian phase using dim-light melatonin onset assessment and sleep parameters using polysomnography will also be included as the secondary outcomes.DiscussionThis study will be the first RCT to directly compare the effects of CBT-I and BLT in youths with insomnia and eveningness. Findings from the study will provide evidence to inform the clinical management of insomnia problems and eveningness in youths.Trial registrationClinicalTrials.gov NCT04256915. Registered on 5 February 2020.

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. 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). 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. 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. Registry: Clinicaltrials.gov; Name: Treatment for Insomnia During Pregnancy; URL: https://www.clinicaltrials.gov/ct2/show/NCT01846585; Identifier: NCT01846585. Manber R, Bei B, Suh S, etal. Randomized controlled trial of cognitive behavioral therapy for perinatal insomnia: postpartum outcomes. J Clin Sleep Med. 2023;19(8):1411-1419.

PurposeWhile studies indicate cognitive behavioral therapy for insomnia (CBT-I) improves self-report sleep outcomes from questionnaires in people with multiple sclerosis (MS), it is unclear if CBT-I improves outcomes from a sleep log or sleep assessed objectively via actigraphy in people with MS. This study aimed to determine if CBT-I improves sleep log and actigraphy outcomes in individuals with MS.Patients and MethodsTwenty-five participants (Mage= 53.04, SD= 10.90) were included in this secondary analysis of data from a pilot randomized control study to assess the feasibility and treatment effect of CBT-I in individuals with MS. Participants were asked to maintain a sleep log and wear an actigraph for a week at baseline and post-intervention. Participants were randomized into one of three groups (CBT-I, active control, or one-time brief education control group). One-way ANOVAs were used to assess for group differences and within group change in sleep latency, sleep efficiency (SE), time in bed, total sleep time (TST), wake after sleep onset, variability of SE, and variability of TST.ResultsCBT-I resulted in an increase in sleep efficiency (SE) and decrease in time in bed (TIB) and variability of SE from the sleep log. The CBT-I group also experienced a decrease in TIB and total sleep time (TST) from actigraphy. The active control group demonstrated an increase in variability of SE from actigraphy.ConclusionThis study indicates that individuals with MS may experience an improvement in sleep log and actigraphy sleep outcomes following CBT-I, but findings need to be replicated in a larger prospective study. The decrease in TST from actigraphy mirrors results from prior studies.

Objectives Insomnia often involves physiological hyperarousal, particularly autonomic dysregulation. Although Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective, some patients do not achieve complete remission. This preliminary study evaluated whether combining CBT-I with heart rate variability (HRV) biofeedback could enhance treatment effects by improving autonomic regulation. Methods Forty-four adults with insomnia were randomized to either a CBT-I group or a combined group that received HRV biofeedback (HRV-BF) and CBT-I (CBT-I+BF group). Both groups received seven weekly CBT-I sessions, with HRV-BF introduced in session four in the CBT-I+BF group. The primary outcome measure was the Insomnia Severity Index (ISI). Other outcome measures included the Pre-Sleep Arousal Scale (PSAS), sleep diaries, and HRV metrics. Assessments were conducted at baseline, post-treatment, and six-month follow-up. ISI and PSAS were also assessed at week 4 before the introduction of HRV-BF. Results Both groups significantly improved in insomnia severity, pre-sleep arousal, and some sleep diary variables.The CBT-I+BF group showed unique and significant improvement in subjective total sleep time. While overall autonomic balance only showed a trend-level improvement in the CBT-I+BF group, sensitivity analyses on participants with more severe objective sleep disturbance suggested greater autonomic balance improvement for the CBT-I+BF group. Conclusions Incorporating HRV-BF into CBT-I did not significantly enhance the benefits of CBT-I alone in this study. However, it offers additional advantages for individuals with more objective sleep disturbance, particularly in improving autonomic balance. Future research should identify optimal treatment intensity and explore the utility of HRV-BF in various insomnia sub-populations.

Effective, practical, nonpharmacologic therapies are needed to treat menopause-related insomnia symptoms in primary and women's specialty care settings. To evaluate the efficacy of telephone-based cognitive behavioral therapy for insomnia (CBT-I) vs menopause education control (MEC). A single-site, randomized clinical trial was conducted from September 1, 2013, to August 31, 2015, in western Washington State among 106 perimenopausal or postmenopausal women aged 40 to 65 years with moderate insomnia symptoms (Insomnia Severity Index [ISI] score, ≥12) and 2 or more daily hot flashes. Blinded assessments were conducted at baseline, 8, and 24 weeks postrandomization. An intent-to-treat analysis was conducted. Six CBT-I or MEC telephone sessions in 8 weeks. Participants submitted weekly electronic sleep diaries and received group-specific written educational materials. The CBT-I sessions included sleep restriction, stimulus control, sleep hygiene education, cognitive restructuring, and behavioral homework; MEC sessions provided information about menopause and women's health. Primary outcome was scores on the ISI (score range, 0-28; scores ≥15 indicate moderate to severe insomnia). Secondary outcome was scores on the Pittsburgh Sleep Quality Index (score range, 0-21; higher scores indicate worse sleep quality). Additional outcomes included sleep and hot flash diary variables and hot flash interference. At 8 weeks, ISI scores had decreased 9.9 points among 53 women receiving CBT-I (mean [SD] age, 55.0 [3.5] years) and 4.7 points among 53 women receiving MEC (age, 54.7 [4.7] years), a mean between-group difference of 5.2 points (95% CI, -6.1 to -3.3; P < .001). Pittsburgh Sleep Quality Index scores decreased 4.0 points in women receiving CBT-I and 1.4 points in women receiving MEC, a mean between-group difference of 2.7 points (95% CI, -3.9 to -1.5; P < .001). Significant group differences were sustained at 24 weeks. At 8 and 24 weeks, 33 of 47 women (70%) and 37 of 44 (84%) in the CBT-I group, respectively, had ISI scores in the no-insomnia range compared with 10 of 41 (24%) and 16 of 37 (43%) in the MEC group, respectively. The CBT-I group also had greater improvements in diary-reported sleep latency, wake time, and sleep efficiency. There were no between-group differences in frequency of daily hot flashes, but hot flash interference was significantly decreased at 8 weeks for the CBT-I group (-15.7; 95% CI, -20.4 to -11.0) compared with the MEC group (-7.1; 95% CI, -14.6 to 0.4) (P = .03), differences that were maintained at 24 weeks for the CBT-I group (-22.8; 95% CI, -28.6 to -16.9) and MEC group (-11.6; 95% CI, -19.4 to -3.8) (P = .003). Telephone-based CBT-I improved sleep in perimenopausal and postmenopausal women with insomnia and hot flashes. Results support further development and testing of centralized CBT-I programs for treating menopausal insomnia. clinicaltrials.gov Identifier: NCT01936441.

Introduction The long-term impact of addressing sleep-related cognitions, which is an important component of cognitive behavioral therapy for insomnia (CBTI), has not been established, particularly in older adults. We examined whether specific changes in sleep-related cognitions predicted long-term changes in sleep and other outcomes following CBTI in older adults. Methods We analyzed data from a randomized controlled trial testing CBTI in older veterans with insomnia (N=159, mean age 72 years). Sleep-related cognitions were assessed with the Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS, subscales: Consequences, Worry/Helplessness, Sleep Expectations, Medication). Outcome measures included the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), sleep diary variables, Flinders Fatigue Scale (FFS), and Short Form-12 health-related quality of life (QOL). Analyses completed slope of change in DBAS subscales (baseline to post-treatment: T1) between CBTI and control with respect to slope of change in sleep and other outcomes from post-treatment to 6-months (T2). Results Compared to controls, the CBTI group had significantly stronger associations between improvement (T1) in DBAS-Consequences and subsequent (T2) improvement in PSQI (difference in slopes [DIS]=0.9, 95%CI=[.29, 1.43], p=0.004), ISI (DIS=1.1, 95%CI=[.18, 2.0], p=0.019), ESS (DIS=0.6, 95%CI=[.10, 1.18], p=0.020), and FFS (DIS=1.9, 95%CI=[.76, 3.09], p=0.001). The CBTI group also had significantly stronger associations between improvement in DBAS-Worry/Helplessness and subsequent improvements in PSQI, ISI, and FFS; improvement in DBAS-Medication and PSQI and ISI; and improvement in DBAS-Sleep Expectations and improved FFS. Slopes were not different between groups for sleep diary variables or QOL. Conclusion Significant improvements in sleep-related cognitions with CBTI across DBAS subscales in older adults predicted improvement in several outcomes of nighttime sleep and daytime consequences. These findings suggest the importance of addressing dysfunctional sleep-related cognitions for sustained improvement with CBTI in older adults Support The study was supported by VA Health Services, Research and Development (Alessi, IIR 08-295), National Institute on Aging (K23AG055668, Song), National Heart, Lung, and Blood Institute (K24HL 143055, Martin) of the National Institutes of Health and VA Greater Los Angeles Healthcare System, Geriatric Research, Education and Clinical Center.

Insomnia is a distressing and often persisting consequence of cancer. Although cognitive behavioral therapy for insomnia (CBT-I) is the treatment of choice in the general population, the use of CBT-I in patients with cancer is complicated, because it can result in transient but substantial increases in daytime sleepiness. In this study, we evaluated whether CBT-I, in combination with the wakefulness-promoting agent armodafinil (A), results in better insomnia treatment outcomes in cancer survivors than CBT-I alone. We report on a randomized trial of 96 cancer survivors (mean age, 56 years; female, 87.5%; breast cancer, 68%). The primary analyses examined whether ≥ one of the 7-week intervention conditions (ie, CBT-I, A, or both), when compared with a placebo capsule (P) group, produced significantly greater clinical gains. Insomnia was assessed by the Insomnia Severity Index and sleep quality by the Pittsburgh Sleep Quality Inventory. All patients received sleep hygiene instructions. Analyses controlling for baseline differences showed that both the CBT-I plus A (P = .001) and CBT-I plus P (P = .010) groups had significantly greater reductions in insomnia severity postintervention than the P group, with effect sizes of 1.31 and 1.02, respectively. Similar improvements were seen for sleep quality. Gains on both measures persisted 3 months later. CBT-I plus A was not significantly different from CBT-I plus P (P = .421), and A alone was not significantly different from P alone (P = .584). CBT-I results in significant and durable improvements in insomnia and sleep quality. A did not significantly improve the efficacy of CBT-I or independently affect insomnia or sleep quality.

Older adults with insomnia have a high risk of incident and recurrent depression. Depression prevention is urgently needed, and such efforts have been neglected for older adults. To examine whether treatment of insomnia disorder with cognitive behavioral therapy for insomnia (CBT-I) compared with an active comparator condition, sleep education therapy (SET), prevents major depressive disorder in older adults. This assessor-blinded, parallel-group, single-site randomized clinical trial assessed a community-based sample of 431 people and enrolled 291 adults 60 years or older with insomnia disorder who had no major depression or major health events in past year. Study recruitment was performed from July 1, 2012, to April 30, 2015. The trial protocol was modified to extend follow-up from 24 to 36 months, with follow-up completion in July 2018. Data analysis was performed from March 1, 2019, to March 30, 2020. Participants were randomized to 2 months of CBT-I (n = 156) or SET (n = 135). The primary outcome was time to incident major depressive disorder as diagnosed by interview and Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria. Secondary outcome was sustained remission of insomnia disorder before depression event or duration of follow-up. Among 291 randomized participants (mean [SD] age, 70.1 [6.7] years; 168 [57.7%] female; 7 [2.4%] Asian, 32 [11.0%] Black, 3 [1.0%] Pacific Islander, 241 [82.8%] White, 6 [2.1%] multiracial, and 2 [0.7%] unknown), 156 were randomized to CBT-I and 135 to SET. A total of 140 participants (89.7%) completed CBT-I and 130 (96.3%) participants completed SET (χ2 = 4.9, P = .03), with 114 (73.1%) completing 24 months of follow-up in the CBT-I group and 117 (86.7%) in the SET group (χ2 = 8.4, P = .004). After protocol modification, 92 (59.0%) of the CBT-I participants and 86 (63.7%) of the SET participants agreed to extended follow-up (χ2 = 0.7, P = .41), with 81 (51.9%) of the CBT-I participants and 77 (57.0%) of the SET group completing 36 months of follow-up (χ2 = 0.8; P = .39). Incident or recurrent major depression occurred in 19 participants (12.2%) in the CBT-I group and in 35 participants (25.9%) in the SET group, with an overall benefit (hazard ratio, 0.51; 95%, CI 0.29-0.88; P = .02) consistent across subgroups. Remission of insomnia disorder continuously sustained before depression event or during follow-up was more likely in CBT-I participants (41 [26.3%]) compared with the SET participants (26 [19.3%], P = .03). Those in the CBT-I group with sustained remission of insomnia disorder had an 82.6% decreased likelihood of depression (hazard ratio, 0.17; 95%, CI 0.04-0.73; P = .02) compared with those in the SET group without sustained remission of insomnia disorder. The findings of this randomized clinical trial indicate that treatment of insomnia with CBT-I has an overall benefit in the prevention of incident and recurrent major depression in older adults with insomnia disorder. Community-level screening for insomnia concerns in older adults and wide delivery of CBT-I-based treatment for insomnia could substantially advance public health efforts to treat insomnia and prevent depression in this vulnerable older adult population. ClinicalTrials.gov Identifier: NCT01641263.

Objective To compare the effectiveness of protocols for acceptance and commitment therapy for insomnia (ACT-I) and cognitive behavioral therapy for insomnia (CBT-I) in adults. Method Participants were 37 adults (74.3% women; M = 43.7 years, SD = 10.7) with chronic insomnia who were randomized to 6 weekly group sessions consisting of ACT-I (n = 19) or CBT-I (n = 18). The primary outcome measures were based on the Insomnia Severity Index (ISI) total score, a measure of insomnia complaints, and included the proportions of treatment responders (defined as a change in score of 8 points or more) and remitters (defined as a final score below 8). Results Both treatment modalities significantly reduced insomnia severity. Post-treatment, the proportion of treatment responders was higher in the CBT-I than the ACT-I (64.7% vs. 50.0%, respectively) group and six months later, ACT-I made further improvements whereas CBT-I had a reduced treatment response (58.8% vs. 55.6%, respectively). CBT-I was associated with a higher proportion of insomnia remission at post treatment. Conclusions Both CBT-I and ACT-I are effective, with a higher proportion of insomnia remitters in CBT-I post-treatment. The different change trajectories for the two therapy groups provide insights into behavioral change via a cognitive versus contextual approach.

The purpose of this study was to compare the efficacy of individual and group cognitive behavioral therapy for insomnia (CBT-I) in outpatients with primary insomnia diagnosed by DSM-IV-TR. The participants were 20 individually treated (I-CBT-I) and 25 treated in a group therapy format (three to five patients per group) (G-CBT-I), which showed no significant difference regarding demographic variables between groups. The same components of CBT-I stimulus control therapy, sleep restriction therapy, cognitive therapy, and sleep hygiene education were applied on both groups. The short-term outcome (4 weeks after treatment) was measured by sleep logs, actigraphy, the Pittsburgh Sleep Quality Index (PSQI), and the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS), and was compared between I-CBT-I and G-CBT-I. The results indicated that CBT-I was effective in improving subjective and objective sleep parameters and subjective sleep evaluations for both individual and group treatment. However, I-CBT-I resulted in significantly better improvements over G-CBT-I, in (i) objective and subjective sleep onset latency time, (ii) objective sleep efficacy and moving time during sleeping, (iii) overall sleep quality and duration of actual sleep time in PSQI, (iv) consequences of insomnia, control and predictability of sleep, sleep requirement expectation, and sleep-promoting practices in DBAS. The present study suggested the superiority of I-CBT-I over G-CBT-I in clinical settings, and further evaluations are necessary.

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

12009 Background: Women on chemotherapy for breast cancer (BC) report high levels of insomnia and fatigue. This trial aimed to test the main effects of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Bright Light Therapy (BLT) on insomnia and fatigue symptoms. Methods: This multi-center, randomized, controlled, 2 x 2 factorial, superiority, trial enrolled 219 women receiving cytotoxic chemotherapy for any stage BC. Interventions were: (1) neither CBT-I nor BLT (sleep hygiene education; SHE), (2) BLT, (3) CBT-I, and (4) BLT+CBT-I. The 6-week interventions included one telehealth, 1:1 session followed by emails and a mid-treatment call. Assessments occurred at baseline, 3 and 6 weeks. Dual primary outcomes were the insomnia severity index (ISI) and PROMIS Fatigue. Intention-to-treat analyses were latent growth models. Effect sizes are standardized mean differences (SMDs). Results: Mean age was 50.7y and 24% had metastatic cancer. At baseline, average ISI was 13.24 (SD = 5.48; sub-threshold insomnia), and fatigue was 59.57 (SD = 7.91; moderate fatigue). 88% (n = 198) completed the telehealth session. 75% (n = 165) reported post-treatment outcomes. ISI and fatigue decreased in all conditions (see Table). CBT-I improved ISI (mean difference = -2.03; p = .001; SMD = -0.37), but BLT did not (mean difference = -1.09; p = .082; SMD = -0.20). Neither intervention affected fatigue (SMDs -0.06 to -0.07; p &gt; 0.60). There was no BLTxCBT-I interaction for ISI nor fatigue ( p &gt; 0.50). Conclusions: In patients receiving chemotherapy for BC, brief CBT-I can improve insomnia but not fatigue symptoms. BLT did not improve insomnia or fatigue. We found no evidence of an interaction between BLT and CBT-I. During chemotherapy, fatigue may not be responsive to brief sleep and circadian-oriented treatments. Clinical trial information: ACTRN12620001133921 . Between group (main effects) and within group (change). ISI [95% CI] P, SMD Fatigue [95% CI] P, SMD Main Effects BLT -1.09 [-2.31, 0.14] p = .082, SMD = -0.20 -0.49 [-2.87, 1.88] p = .68, SMD = -0.06 CBT-I -2.03 [-3.25, -0.81] p = .001, SMD = -0.37 -0.54 [-2.92, 1.83] p = .65, SMD = -0.07 Change: 0–6 weeks SHE -3.41 [-4.65, -2.17] p &lt; .001, SMD = -0.62 -3.75 [-6.16, -1.34] p = .002, SMD = -0.47 BLT -4.89 [-6.12, -3.66] p &lt; .001, SMD = -0.89 -3.75 [-6.13, -1.37] p = .002, SMD = -0.47 CBT-I -5.83 [-7.12, -4.54] p &lt; .001, SMD = -1.06 -3.80 [-6.30, -1.31] p = .003, SMD = -0.48 CBT-I+BLT -6.53 [-7.88, -5.18] p &lt; .001, SMD = -1.19 -4.79 [-7.44, -2.14] p &lt; .001, SMD = -0.61

Insomnia is a leading cause of disability in postmenopausal women. Multicomponent cognitive-behavioral therapy for insomnia (CBTI) is a first-line treatment for chronic insomnia, but support for its efficacy in treating menopause-related insomnia is scarce. The present study evaluated whether CBTI is an efficacious treatment for menopause-related chronic insomnia, and whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious compared with CBTI. In a single-site, randomized controlled trial, 150 postmenopausal women (56.44 ± 5.64 years) with chronic DSM-5 insomnia disorder related to menopause were randomized to three treatment conditions: sleep hygiene education (SHE), SRT, or CBTI. Blinded assessments were performed at baseline, posttreatment, and 6 months after treatment. The Insomnia Severity Index (ISI) and sleep diaries served as primary outcomes. From baseline to posttreatment, ISI decreased 7.70 points in the CBTI group (p < .001), 6.56 points in the SRT group (p < .001), and 1.12 in the SHE group (p = .01). Although average sleep duration increased in all groups by 6 month follow-up, CBTI patients obtained 40-43 more minutes of nightly sleep than those who received SHE or SRT. Remission rates in the CBTI (54%-84%) and SRT (38%-57%) groups were higher than SHE patients (4%-33%) at posttreatment and 6 month follow-up. CBTI patients were generally more likely to remit than SRT patients. CBTI and SRT effectively treat menopause-related insomnia disorder and are superior to SHE. Response to CBTI and SRT is similar, but CBTI outperforms SRT in improving sleep maintenance, which may increase likelihood of remission. Clinical Trial Name: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. Registration: NCT01933295.