Outcomes from a combined cognitive behavioral therapy for insomnia (CBT-I) and sleep-related medication and substance use reduction treatment.

TMS and CBT-I for comorbid depression and insomnia. Exploring feasibility and tolerability of transcranial magnetic stimulation (TMS) and cognitive behavioral therapy for insomnia (CBT-I) for comorbid major depressive disorder and insomnia during the COVID-19 pandemic

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.

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.

Cognitive behavioral therapy for insomnia (CBT-I) is the gold-standard treatment for insomnia disorder in adults. Compared to young adults, older adults have increased risk for the development of conditions associated with chronic pain, which may impact the efficacy of CBT-I in improving insomnia symptoms in older adults. This study evaluated the effect of participant-rated pain on sleep-related outcomes of a supervised, non-clinician administered CBT-I program in older adult patients with chronic insomnia disorder. Secondary analysis was conducted using data from a randomized controlled trial among 106 community-dwelling older adult veterans (N = 106; mean age 72.1 years, 96% male, 78.3% White, 6.6% Hispanic, 5.7% African American) with chronic (≥3 months) insomnia disorder. Participants engaged in five sessions of manual-based CBT-I in individual or group format within one Department of Veterans Affairs healthcare system, provided by non-clinician "sleep coaches" who had weekly telephone supervision by behavioral sleep medicine specialists. Insomnia symptoms (Insomnia Severity Index), perceived sleep quality (Pittsburgh Sleep Quality Index), fatigue (Flinder's Fatigue Scale), daytime sleepiness (Epworth Sleepiness Scale), and perceived pain severity (items from the Geriatric Pain Measure) were assessed at 4 time points: baseline, one-week posttreatment, 6-month follow-up, and 12-month follow-up. Mixed effects models with time invariant and time varying predictors were employed for analyses. CBT-I improved insomnia symptoms, perceived sleep quality, fatigue, and daytime sleepiness among older veterans with chronic insomnia. Participant-reported pain was associated with greater improvements in insomnia symptoms following CBT-I. Pain did not affect improvements in other sleep-related outcomes (-0.38 ≤ b ≤ 0.07, p > 0.05). Between-subjects differences in pain, but not within-subject changes in pain over time, appeared to play a central role in insomnia symptom improvement at posttreatment, with individuals with higher-than-average pain showing greater insomnia symptom improvement (ISI score reduction; -0.32 ≤ b ≤ -0.28, p ≤ 0.005). Pain did not meaningfully hinder the effects of CBT-I on sleep outcomes. Among older veterans with chronic insomnia disorder, individuals with higher pain exhibited slightly greater improvement in insomnia than those with lower levels of pain. These findings suggest that experiencing pain does not impair treatment response and should not preclude older adults with insomnia from being offered CBT-I.

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

Introduction Mild cognitive impairment (MCI) is an important public health concern for aging Veterans as it is a known risk factor for progression to dementia. Insomnia is common in MCI occurring in up to 60% of patients. Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended treatment for insomnia, however, cognitive impairments experienced by individuals with MCI may limit the ability of some individuals to adequately understand and actively participate in CBT-I. In this study a modified CBT-I treatment Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy) was developed and pilot tested with Veteran input. Sleep-SMART incorporates supportive cognitive strategies into a CBT-I protocol to enhance CBT-I learning and adherence. Methods 14 Veterans completed the 6-week Sleep-SMART intervention. Each participant was assessed on the Insomnia Severity Index (ISI) and the Pittsburgh Quality Sleep Index (PSQI) at pre- and post-treatment (Weeks 0 and 6 respectively). Veterans also completed weekly sleep diaries for the duration of the 6-weeks of treatment. Independent t-tests were performed comparing pre and post-treatment scores for the ISI, PSQI, and sleep diary variables (sleep efficiency [SE], total sleep time [TST], sleep latency [SL], wake after sleep onset [WASO], and early morning awakening [EMA]). Treatment acceptability was examined using the average rating on the Acceptability of Intervention Measure (AIM; 1–5-point Likert type scale, with higher scores indicating greater acceptability). Results Participants (11M/3F, age=71.8+/-6.9yrs) showed significant symptom improvement on both ISI (pre=18.25/post=10.83,p&amp;lt;.001) and PSQI (pre=11/post=8.73,p=.034) total scores. This improvement was further illustrated in the sleep diary measures which showed significant improvement across all metrics: SE (pre=70%/post=89%,p&amp;lt;.001), TST (pre=5.40hrs/post=6.49hrs,p=.007), WASO (pre=50.53mins/post=20.73mins,p&amp;lt;.001), and EMA (pre=61.29mins/post=15.16mins,p=.003). Importantly, the Sleep-SMART treatment protocol was viewed as acceptable to Veterans (AIM; M=4.46,SD= 0.62). Conclusion The Sleep-SMART intervention was viewed as acceptable and produced significant improvements in insomnia symptoms. These findings suggest that Sleep-SMART has the potential to be an effective modified form of CBT-I treatment that is uniquely tailored to aging Veterans with cognitive challenges. Future randomized controlled trials are warranted to investigate the efficacy of Sleep-SMART more broadly. Support (if any) This research supported by SPiRE Award 1 I21 RX003721-01A1 (D3721-P) from Department of Veterans Affairs Rehabilitation Research and Development Service.

Apport de la pleine conscience dans les thérapies cognitives et comportementales de l’insomnie

Efficacy of cognitive behavioral therapy for insomnia in geriatric primary care patients.

Introduction Sex disparities in both insomnia and perceived pain have been demonstrated, where female patients tend to report greater insomnia symptoms, pain sensitivity and higher prevalence to insomnia disorder and chronic pain conditions compared to male patients. The present trial examined the sex differences in response to cognitive behavioral therapy for insomnia (CBT-I) in patients with insomnia disorder undergoing hip or knee joint arthroplasty. Methods Participants (N=69; 68% Female; Mean age=67.3 years) were randomly assigned to receive CBT-I (n=23 female; n=11 male) or Health Education Control (HEC; n=24 female, n=11 Male). The Insomnia Severity Index (ISI), PROMIS Pain, and Hip/Knee Osteoarthritis Outcome Score (HOOS/KOOS) were administered at baseline and post-intervention. Generalized linear models were performed to detect sex and treatment group differences and sub-group analysis by sex. Results There were no significant differences between male versus female participants for pre-post intervention changes in ISI, PROMIS pain intensity or pain interference. In female participants, change in ISI from baseline to post-treatment was significantly lower in the CBTI group than the HEC group (-8.5±6.4 vs -2.1±7.6; P=0.02), but not in male participants (P=0.21). In female participants, there was a significant correlation in pre-post change in ISI with pre-post change in PROMIS pain intensity (r=0.5, P=0.03), pain interference (r=0.6, P=0.01), HOOS/KOOS activities of daily living (r=-0.4, P=0.04) and quality of life (r=-0.5, P=0.01). No significant associations between insomnia and pain were observed in male participants. Conclusion Among individuals with insomnia recovering from hip or knee joint arthroplasty, there was a greater decrease in insomnia severity following CBT-I compared to HEC in female participants but not male participants. Pain outcomes improved across both treatment conditions for male and female participants and no significant group differences were found. Regardless of treatment group of the female participants, improvements in insomnia severity were associated with improvements in pain intensity, pain interference, activities of daily living, and quality of life. Support (if any) This work is supported by NIH Grant #s R01NR018342 (PI Nowakowski) and IQUEST Center (CIN 13-413).

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 and anxiety are highly prevalent and frequently co-occur. Given limited therapeutic resources and time constraints, the aim of this study was to compare which treatment-internet cognitive behavioral therapy (CBT) for insomnia or internet CBT for anxiety-leads to the best outcomes in individuals with comorbid insomnia and anxiety. 120 participants with comorbid insomnia and clinical anxiety (as defined by scores above the clinical cutoff on the insomnia severity index (ISI) and the generalized anxiety disorder 7-item scale (GAD-7)) were randomized to receive internet-based cognitive behavioral therapy (iCBT) for insomnia or iCBT for anxiety. The primary outcome measures were the ISI and the generalized anxiety disorder 7-item scale. Primary outcome measures were assessed before treatment, at mid-treatment, at post-treatment, and 3 months after treatment. Secondary outcome measures assessed depression symptoms, distress, and sleep diary parameters. Participants in both groups experienced large reductions in symptoms of insomnia, anxiety, depression, and distress, as well as improvements in sleep efficiency and total sleep time. Improvements were maintained at follow-up. Crucially, at the end of treatment, the insomnia treatment was more effective in reducing symptoms of insomnia than the anxiety treatment, and equally effective in reducing symptoms of anxiety. Treatment gains were maintained at 3-month follow-up, however, there were no differences between groups at that time point. These results suggest that in the common case of a patient presenting with comorbid insomnia and anxiety, treatment for insomnia may be the most efficient treatment strategy. The trial was registered with the Australian and New Zealand Clinical Trials Registry, https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001141235. Trial ID: ACTRN12618001141235. Trial name: a comparison of internet-based CBT for insomnia versus internet-based CBT for anxiety in a comorbid sample.

The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network conducted three randomized clinical trials (RCTs) testing six interventions treating vasomotor symptoms (VMS), and also collected self-reported sleep outcomes. A fourth RCT assessed an intervention for insomnia symptoms among women with VMS. We describe these seven interventions' effects relative to control in women with comparably severe insomnia symptoms and VMS. We analyzed pooled individual-level data from 546 peri- and postmenopausal women with Insomnia Severity Index (ISI) ≥ 12, and ≥14 bothersome VMS/week across the four RCTs. Interventions included the following: escitalopram 10-20 mg/day; yoga; aerobic exercise; 1.8 g/day omega-3 fatty acids; oral 17-beta-estradiol 0.5-mg/day; venlafaxine XR 75-mg/day; and cognitive behavioral therapy for insomnia (CBT-I). Outcome measures were ISI and Pittsburgh Sleep Quality Index (PSQI) over 8-12 weeks of treatment. CBT-I produced the greatest reduction in ISI from baseline relative to control at -5.2 points (95% CI -7.0 to -3.4). Effects on ISI were similar for exercise at -2.1 and venlafaxine at -2.3 points. Comparably small decreases in ISI were observed with escitalopram, yoga, and estradiol. The largest reduction in PSQI from baseline was with CBT-I at -2.7 points (-3.9 to -1.5), although PSQI decreases of 1.2 to 1.6 points were significantly better than control with escitalopram, exercise, yoga, estradiol, and venlafaxine. Omega-3 supplements did not improve insomnia symptoms. This study's findings support current recommendations for CBT-I as a first line treatment in healthy midlife women with insomnia symptoms and moderately bothersome VMS.

The endophenotype of insomnia disorder is complex and the treatment is not targeted. The data-driven typing method might provide some bases for precise treatment. The present study was based on a post hoc analysis, aiming to explore the association between subtypes of insomnia disorder and the efficacy of cognitive-behavioral therapy for insomnia (CBT-I). The present study was conducted on data of 118 patients with chronic insomnia disorder combined mild anxiety or/and depressive symptoms, who had completed an 8-week randomized controlled trial of CBT-I vs CBT-I plus (CBT-I combined with modules targeting anxiety and depressive symptoms). The silhouette coefficient determined the optimal number of clusters, and a K-means clustering analysis was performed. T-tests were conducted to assess baseline differences at eight weeks, and the changes in self-reported total sleep time (sTST), Pittsburgh Sleep Quality Index (PSQI), Hamilton Depression Rating Scale (HRSD-17), and Hamilton Anxiety Rating Scale (HAMA) scores in order to explore the impact of subtypes and treatment approaches (CBT-I and CBT-I plus) on insomnia and emotional symptoms. The analysis revealed no significant demographic differences between the two clusters. Subtype 2 was characterized by significantly poorer baseline sleep quality (PSQI: 16.59 vs 12.74, t = -9.90, p < 0.01), higher depressive (HRSD: 18.47 vs 13.21, t = -8.37, p < 0.01), and anxiety levels (HAMA: 17.47 vs 13.46, t = -6.23, p < 0.01), and shorter sTST (4.67 vs 6.09 h, t = 8.31, p < 0.01) compared to Subtype 1. Post-treatment analyses showed significant improvements in both subtypes, with Subtype 2 experiencing a larger increase in sleep duration (csTST: 0.58 vs 1.77 h, t = -7.18, p < 0.01) and more pronounced improvements in sleep quality (cPSQI: 6.92 vs 8.88, t = -3.57, p < 0.001), depression (cHRSD: 8.07 vs 10.59, t = -2.71, p = 0.008), and anxiety (cHAMA: 9.28 vs 11.22, t = -2.56, p = 0.012). Despite these improvements, Subtype 1 maintained significantly better outcomes in sleep quality (PSQI: 5.81 vs 7.71, p < 0.01), depression (HRSD: 5.14 vs 7.89, p < 0.01), and anxiety (HAMA: 4.18 vs 6.25, p < 0.01) at 8 weeks. No significant differences in baseline characteristics were found between treatment groups within subtypes, indicating homogeneity. Within Cluster 1, CBT-I plus was more effective in reducing depressive symptoms (cHRSD: t = -2.48, p = 0.016), whereas CBT-I was superior in enhancing sTST in Cluster 2 (t = 2.01, p = 0.049), with no significant differences in other measures. The study underscores the heterogeneity within ID subtypes and the differential response of sleep quality and depressive symptoms to CBT-I and CBT-I plus, highlighting the importance of personalized treatment strategies based on insomnia subtypes.

The aim of this randomised controlled assessor-blinded trial was to examine the effect of cognitive behavioural therapy for insomnia on sleep variables and depressive symptomatology in outpatients with comorbid insomnia and moderate to severe depression. Forty-seven participants were randomized to receive one weekly session in 6 weeks of cognitive behavioural therapy for insomnia or treatment as usual. The intervention was a hybrid between individual and group treatment. Sleep scheduling could be especially challenging in a group format as patients with depression may need more support to adhere to the treatment recommendations. The primary outcome measure was the Insomnia Severity Index. Secondary measures were sleep diary data, the Dysfunctional Beliefs and Attitudes about Sleep Questionnaire, the Hamilton Depression Rating Scale, and the World Health Organization Questionnaire for Quality of Life and polysomnography. Compared to treatment as usual, cognitive behavioural therapy significantly reduced the insomnia severity index (mean ISI 20.6 to 12.1, p = 0.001) and wake after sleep onset (mean 54.7 min to 19.0 min, p = 0.003) and increased sleep efficiency (mean SE 71.6 to 83.4, p = 0.006). Total sleep time and sleep onset latency were not significantly changed. The results were supported by analyses of the other rating scales and symptom dimensions. In conclusion, cognitive behavioural therapy for insomnia as add-on to treatment as usual was effective for treating insomnia and depressive symptoms in a small sample of outpatients with insomnia and major depression. ClinicalTrials.gov Identifier: NCT02678702.