A two-phase, prescriptive comparative effectiveness study to optimize the treatment of co-occurring insomnia and depression with digital interventions

Insomnia and depression are highly co-morbid conditions that share a complex, bi-directional relationship. By reviewing the literature examining the links between insomnia and depression, it becomes apparent that insomnia symptoms need to be directly targeted alongside depression symptoms when co-morbidities exist for optimal outcomes. The most common treatment in Australia for co-morbid insomnia and depression is currently antidepressant medication. Because a large percentage of individuals given antidepressants fail to remit from their depression and insomnia symptoms, an effective adjunct treatment to antidepressants for co-morbid insomnia and depression is required. Cognitive behavioural therapy for insomnia (CBT-I) is an empirically validated treatment for insomnia, and is efficacious in improving insomnia that is co-morbid with depression. Recent evidence also suggests that CBT-I produces significant improvements in depression severity. The main aim of the thesis was therefore to develop a cost-effective CBT-I intervention that could be easily administered, distributed and implemented on a wide-scale basis, both on its own for insomnia, and primarily as an adjunct therapy for co-morbid insomnia and depression. A therapist manual of CBT-I, based on the latest empirical findings, was specifically developed to increase consistency and ease of treatment administration by therapists wanting to deliver CBT-I treatment. A resource booklet was also developed to give to all individuals undergoing CBT-I treatment, to ensure that they were provided with the latest information about sleep and how to reduce their insomnia severity. A randomised controlled trial was then developed to investigate the efficacy of this CBT-I intervention in individuals with co-morbid insomnia and depression whose symptoms have failed to remit through antidepressant treatment. Forty-one participants (aged 18-64 years) were randomized to receive four sessions of either CBT-I or sleep education (self-help therapy) over an 8-week period (one session every two weeks). Participants had been treated with antidepressants for at least six weeks prior to screening, but were otherwise healthy. The Insomnia Severity Index and the Beck Depression Inventory were assessed at baseline, following each session, and at 3-month follow-up. Secondary outcomes were sleep quality and duration (actigraphy and self-report), anxiety, fatigue, and daytime sleepiness. Results indicated that CBT-I, compared to sleep education, produced significantly reduced depression and insomnia severity, and improved anxiety, fatigue, sleep quality and sleep efficiency. It is the first randomised controlled trial of CBT-I for co-morbid insomnia and depression, with an active control treatment, to show significant reductions in both insomnia and depression severity at post-treatment and follow-up. Large effect sizes were found for both insomnia and depression at post-treatment, and these effect sizes increased further by three month follow-up. At follow-up, ten times more CBT-I participants were in remission from both insomnia and depression than sleep education participants. This demonstrates that CBT-I is an efficacious treatment for co-morbid insomnia and depression, and should be considered an important adjunct therapy in individuals whose symptoms have not remitted through antidepressant treatment. Following the positive results of the randomised controlled trial, the proposed mediators of CBT-I were examined to determine which aspects of the intervention had the largest influence on reductions in insomnia and depression severity at post-treatment and 3-month follow-up. Changes in time-in-bed, bedtime variability, rise-time variability, sleep hygiene practices, dysfunctional beliefs about sleep and stress levels were assessed as potential mediators. Post-treatment results indicated that the significantly reduced depression severity through CBT-I was primarily via reduced stress levels, improved sleep hygiene practices, and other therapeutic effects of CBT-I, whereas reduced insomnia severity was primarily via reduced dysfunctional beliefs about sleep. By follow-up, the significantly reduced depression severity in the CBT-I group was primarily via reduced stress levels and reduced dysfunctional beliefs about sleep, whereas reduced dysfunctional beliefs about sleep and other therapeutic effects of CBT-I explained the significantly reduced insomnia severity. These results indicate that reducing stress levels through CBT-I treatment is required for optimal depression outcomes, whereas reducing dysfunctional beliefs about sleep is essential for optimal insomnia outcomes. Improving sleeping practices behaviourally is important for initial depression improvements, but reducing dysfunctional beliefs about sleep becomes more important for longer-term remission of depression symptoms. Other non-factual therapeutic elements of CBT-I treatment appear to be important, and may lead to a greater willingness to engage in the CBT-I strategies, which can improve depression in the short-term and insomnia in the longer-term. These mediators of CBT-I treatment had not been specifically examined in individuals with co-morbid insomnia and depression before this study. Their identification suggests that relaxation and behavioural sleep interventions should be prioritized initially through CBT-I for co-morbid insomnia and depression, followed by cognitive interventions to target unhelpful beliefs about sleep. By increasing the efficiency of CBT-I, optimal treatment outcomes can be achieved for individuals with co-morbid insomnia and depression, and the risk of future relapse can be minimized.

BackgroundInsomnia is common in people with long-term medical conditions and is related to increased mortality and morbidity. Cognitive behavioral therapy for insomnia (CBT-I) is first choice treatment and effective for people with insomnia and comorbid long-term medical conditions. However, CBT-I has some limitations as it might not always be available or appeal to patients with medical conditions. Furthermore, a small proportion of patients do not respond to CBT-I. Preliminary evidence and clinical experience suggest that low-dose amitriptyline (AM) might be an effective alternative to treat insomnia in patients with medical comorbidity. In this randomized controlled trial, we will determine whether AM is non-inferior to the first choice treatment for insomnia, CBT-I.Methods/designThis study will test if treatment with low-dose amitriptyline for insomnia in patients with medical comorbidity is non-inferior to CBT-I in a multicenter randomized controlled non-inferiority trial. Participants will be 190 adults with a long-term medical condition and insomnia. Participants will be randomly allocated to one of two intervention arms: 12 weeks AM (starting with 10 mg per day, and if ineffective at 3 weeks, doubling this dose) or 12 weeks of CBT-I consisting of 6 weekly sessions and a follow-up session 6 weeks later. The primary outcome is subjective insomnia severity, measured with the Insomnia Severity Index (ISI). The primary endpoint is at 12 weeks. Secondary outcomes include sleep quality (e.g., sleep efficiency), questionnaires on daytime functioning (physical functioning and impairment of functioning), and symptoms (e.g., fatigue, pain, anxiety) at 12 weeks and 12 months post treatment and relapse of insomnia until 12 months after treatment.DiscussionIrrespective of the outcome, this study will be a much-needed contribution to evidence based clinical guidelines on the treatment of insomnia in patients with medical comorbidity.Trial registrationDutch Trial Register NTR NL7971. Registered on 18 August 2019

Individuals enrolling in the Veterans Health Administration frequently report symptoms consistent with insomnia disorder. Cognitive behavioral therapy for insomnia (CBT-I) is a gold standard treatment for insomnia disorder. While the Veterans Health Administration has successfully implemented a large dissemination effort to train providers in CBT-I, the limited number of trained CBT-I providers continues to restrict the number of individuals who can receive CBT-I. Digital mental health intervention adaptations of CBT-I have been found to have similar efficacy as traditional CBT-I. To help address the unmet need for insomnia disorder treatment, the VA commissioned the creation of a freely available, internet-delivered digital mental health intervention adaptation of CBT-I known as Path to Better Sleep (PTBS). We aimed to describe the use of evaluation panels composed of veterans and spouses of veterans during the development of PTBS. Specifically, we report on the methods used to conduct the panels, the feedback they provided on elements of the course relevant to user engagement, and how their feedback influenced the design and content of PTBS. A communications firm was contracted to recruit 3 veteran (n=27) and 2 spouse of veteran (n=18) panels and convene them for three 1-hour meetings. Members of the VA team identified key questions for the panels, and the communications firm prepared facilitator guides to elicit feedback on these key questions. The guides provided a script for facilitators to follow while convening the panels. The panels were telephonically conducted, with visual content displayed via remote presentation software. The communications firm prepared reports summarizing the panelists' feedback during each panel meeting. The qualitative feedback described in these reports served as the raw material for this study. The panel members provided markedly consistent feedback on several elements of PTBS, including recommendations to emphasize the efficacy of CBT-I techniques; clarify and simplify written content as much as possible; and ensure that content is consistent with the lived experiences of veterans. Their feedback was congruent with previous studies on the factors influencing user engagement with digital mental health interventions. Panelist feedback influenced multiple course design decisions, including reducing the effort required to use the course's sleep diary function, making written content more concise, and selecting veteran testimonial videos that emphasized the benefits of treating chronic insomnia symptoms. The veteran and spouse evaluation panels provided useful feedback during the design of PTBS. This feedback was used to make concrete revisions and design decisions consistent with existing research on improving user engagement with digital mental health interventions. We believe that many of the key feedback messages provided by these evaluation panels could prove useful to other digital mental health intervention designers.

BackgroundInsomnia affects up to one-third of US adults and is a significant health challenge with an estimated economic burden of up to $100 billion annually. Cognitive behavioral therapy (CBT) for insomnia (CBT-I) is the recommended first-line treatment, but access is limited due to a shortage of trained therapists. Digital CBT-I offers an effective alternative that may enhance accessibility and reduce higher healthcare costs associated with insomnia.ObjectiveTo evaluate the US healthcare cost-savings of digital CBT-I compared with standard-of-care control.MethodsA retrospective difference-in-differences analysis compared 1-year preinitiation and post-initiation healthcare costs for 11 027 individuals receiving SleepioRx (FDA-cleared digital CBT treatment for insomnia disorder) compared with 1:1 exact matched controls with insomnia receiving standard care (n = 10 770). Commercial and Medicare claims were adjusted for comorbidities, index year, and baseline utilization.ResultsDigital CBT-I was associated with statistically significant mean annual total cost savings of 2083(951508-$2657, P < .001) per person, equating to a 42% reduction in costs with SleepioRx relative to matched controls who received standard of care (medications for insomnia).DiscussionDigital CBT-I was associated with substantial cost savings for payers. The integration of guideline-concordant treatment through digital delivery into standard care pathways offers a promising strategy to address the clinical and economic challenges of insomnia, supporting more efficient resource allocation.ConclusionsFindings suggest that implementing digital CBT-I at scale may lead to decreased costs for healthcare payers, relative to the current standard of care, while improving access to effective insomnia treatment.

Special Considerations in the Adaptation of Cognitive Behavioral Therapy for Insomnia With Active-Duty U.S. Army Personnel

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

To evaluate the effectiveness of small-group nurse-administered cognitive behavioural therapy for insomnia (CBTI) as an early intervention of mood disorders with comorbid insomnia. A total of 200 patients with first-episode depressive or bipolar disorders and comorbid insomnia were randomized in a ratio of 1:1 to receiving 4-session CBTI or not in a routine psychiatric care setting. Primary outcome was Insomnia Severity Index. Secondary outcomes included response and remission status; daytime symptomatology and quality of life; medication burden; sleep-related cognitions and behaviours; and the credibility, satisfaction, adherence and adverse events of CBTI. Assessments were conducted at baseline, 3, 6, and 12-month. Only a significant time-effect but no group-by-time interaction was found in the primary outcome. Several secondary outcomes had significantly greater improvements in CBTI group, including higher depression remission at 12-month (59.7% vs. 37.9%, χ2 = 6.57, p = .01), lower anxiolytic use at 3-month (18.1% vs. 33.3%, χ2 = 4.72, p = .03) and 12-month (12.5% vs. 25.8%, χ2 = 3.26, p = .047), and lesser sleep-related dysfunctional cognitions at 3 and 6-month (mixed-effects model, F = 5.12, p = .001 and .03, respectively). Depression remission rate was 28.6%, 40.3%, and 59.7% at 3, 6, and 12-month, respectively in CBTI group and 28.4%, 31.1%, and 37.9%, respectively in no CBTI group. CBTI may be a useful early intervention to enhance depression remission and reduce medication burden in patients with first-episode depressive disorder and comorbid insomnia.

Investigating the antidepressant effects of CBT-I in those with major depressive and insomnia disorders

Introduction Acceptance and Behavioral Changes to Treat Insomnia (ABC-I) is a promising acceptance- and behavioral-based intervention for the treatment of chronic insomnia disorder, with previously demonstrated non-inferiority to Cognitive Behavioral Therapy for Insomnia (CBT-I) for symptom reduction and superior adherence to behavioral treatment recommendations among women veterans. Comorbid posttraumatic stress disorder (PTSD) is a common clinical presentation that can hinder insomnia treatment engagement and outcomes. This analysis sought to determine whether ABC-I led to greater PTSD symptom improvement, compared to CBT-I, in women veterans. Methods We analyzed data from a subset of participants in a randomized comparative effectiveness trial of ABC-I vs CBT-I in women veterans with probable PTSD (NCT02076165). Analysis 1 included 30 participants who received ABC-I. Analysis 2 also included 23 participants who received CBT-I. PTSD symptoms were measured via PTSD Checklist (PCL-5) total and cluster scores (i.e., B: intrusion, C: avoidance, D: negative cognitions/mood, E: hyperarousal). Probable PTSD was defined by PCL-5 total score ≥ 33. For analysis 1 we used paired-groups t-tests, and for analysis 2 we used independent groups t-tests (comparing improvement for the ABC-I vs. CBT-I group). Effect sizes were computed for both analyses (Cohen’s d). We employed 1-tailed testing and alpha =.20 as the a-priori threshold given the exploratory nature of these analyses. Results In Analysis 1, veterans who received ABC-I demonstrated a significant reduction in PCL-5 total and cluster (B-E) scores at both post-treatment and 3-month follow-up (ds = -0.71—1.50, ps &amp;lt; 0.01). In Analysis 2, ABC-I demonstrated greater PTSD symptom reductions (i.e., change-scores) than CBT-I at the 3-month follow-up (but not post-treatment) for PCL-5 total (Δd = -6.8, p = 0.08) and cluster C and D scores (Δd = -1.1, p = 0.10, Δd = -4.2, p = 0.03). Conclusion ABC-I holds promise for addressing insomnia and PTSD symptoms in trauma-exposed individuals, a population that has historically demonstrated sub-optimal responses to CBT-I. Further work should explore potential mechanisms by which ABC-I may confer ancillary treatment benefits. Support (if any) VA/HSR IIR-HX002300; VA/HSR RCS20-191; NIH/NHLBI K24HL143055; VA/HSR CDA 20-227; NIH/NHLBI K23HL157754

Cognitive behavioral therapy for insomnia (CBT-I) is effective for not only primary insomnia (PI) but also comorbid insomnia (CI; insomnia associated with psychiatric/physical diseases or other types of sleep disorders). This study aimed to compare the outcomes of CBT-I implemented in the same manner between patients with PI and CI. In total, 41 adult patients who had completed CBT-I were enrolled in this retrospective analysis and divided into a PI group and a CI group. The authors then examined and compared the significance of changes after therapy between the two groups. The magnitude of improvement on the Japanese version of the Insomnia Severity Index (ISI-J) was analyzed as the primary endpoint. In the PI group (n = 24), both the ISI-J score and the dose of hypnotics decreased significantly following CBT-I. On the other hand, in the CI group (n = 17), only the dose of hypnotics decreased significantly; no statistically significant improvement was seen in the ISI-J score. Sleep onset latency and sleep quality rating in recorded sleep diaries were significantly correlated with improved ISI-J scores in the CI group only. CBT-I was shown to be effective for CI, but its efficacy for CI was inferior to that for PI in terms of impact on sleep and mental condition. These results suggest that in addition to the basic components of CBT-I, treatment for CI, especially when accompanied by severe insomnia symptoms, should include approaches targeting the comorbid disease.

Insomnia is a prevalent condition in Australia that increases the risk of depression and anxiety symptoms. Cognitive behaviour therapy for insomnia (CBT-i) is the recommended 'first line' treatment but is accessed by a minority of people with insomnia. To improve CBT-i access in Australia, we aimed to develop and test a self-guided interactive digital CBT-i program. An online randomised controlled trial was conducted from August 2022 to August 2023 to investigate the effect of digital CBT-i, versus digital sleep education control, on symptoms of insomnia (ISI), depression (PHQ-9), anxiety (GAD-7), fatigue, sleepiness and maladaptive beliefs about sleep at 8-week follow-up. The control group accessed the intervention after the 8-week follow-up. Questionnaires were additionally administered at 16 and 24 weeks. Intent-to-treat mixed models and complete-case chi-squared analyses were used. Participants included 62 adults with insomnia symptoms (age M (SD) = 52.5 (16.3), 82% female, ISI = 18.6 (2.9)). There were no between-group differences in baseline characteristics or missing 8-week data (14.5%). After adjusting for baseline scores, CBT-i was associated with lower insomnia (Diffadj (95% CI) = 7.32 (5.0-9.6), P < 0.001, d = 1.64), depression (3.36 (1.3-5.4), p = 0.002, d = 0.84), fatigue (5.2 (2.5-7.9), P < 0.001, d = 1.00) and maladaptive beliefs about sleep (11.0 (4.1-18.0), P = 0.002, d = 0.82), but not anxiety symptoms at 8 weeks (1.84 (-0.1 to 3.8), p = 0.060, d = 0.50). Compared to control, CBT-i was associated with greater rates of insomnia remission (ISI <8; 0.0%, vs 40.0%, P < 0.001) and response at 8 weeks (ISI reduction ≥6; 7.1% vs 72.0%, P < 0.001). Improvements in insomnia and depression were maintained at 24 weeks in the CBT-i group. This interactive digital CBT-i program resulted in large and sustained improvements in symptoms of insomnia, depression, fatigue and maladaptive beliefs about sleep in Australian adults with insomnia symptoms. Implementation programs are required to increase digital CBT-i access and uptake.

Insomnia is common in primary care. Cognitive behavioural therapy for insomnia (CBT-I) is effective but requires more time than is available in the general practice consultation. Sleep restriction is one behavioural component of CBT-I. To assess whether simplified sleep restriction (SSR) can be effective in improving sleep in primary insomnia. Randomised controlled trial of patients in urban general practice settings in Auckland, New Zealand. Adults with persistent primary insomnia and no mental health or significant comorbidity were eligible. Intervention patients received SSR instructions and sleep hygiene advice. Control patients received sleep hygiene advice alone. Primary outcomes included change in sleep quality at 6 months measured by the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and sleep efficiency (SE%). The proportion of participants reaching a predefined 'insomnia remission' treatment response was calculated. Ninety-seven patients were randomised and 94 (97%) completed the study. At 6-month follow-up, SSR participants had improved PSQI scores (6.2 versus 8.4, P<0.001), ISI scores (8.6 versus 11.1, P = 0.001), actigraphy-assessed SE% (difference 2.2%, P = 0.006), and reduced fatigue (difference -2.3 units, P = 0.04), compared with controls. SSR produced higher rates of treatment response (67% [28 out of 42] versus 41% [20 out of 49]); number needed to treat = 4 (95% CI = 2.0 to 19.0). Controlling for age, sex, and severity of insomnia, the adjusted odds ratio for insomnia remission was 2.7 (95% CI = 1.1 to 6.5). There were no significant differences in other outcomes or adverse effects. SSR is an effective brief intervention in adults with primary insomnia and no comorbidities, suitable for use in general practice.

Insomnia is prevalent in multiple sclerosis (MS) and may negatively affect quality of life and brain health. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment, but access is limited due to a shortage of trained therapists. Fully automated digital CBT-I (dCBT-I) has been developed to expand availability. Its effectiveness in MS, and whether improvements in insomnia severity lead to benefits in fatigue, mental health, and cognitive function, remains unknown. This randomized controlled trial will examine the effectiveness of dCBT-I compared with patient education about insomnia (PE) in people with MS. We plan to invite all individuals in the Norwegian MS registry (>90% of people diagnosed with MS in Norway) to the trial with the aim of including 550 participants. Participants will be randomly allocated 1:1 to dCBT-I or PE. Outcomes will be assessed at baseline, 9 weeks, 6 months, and 12 months, with additional health registry data collected 5 years after randomization. The between-group difference in self-reported insomnia severity at 9-weeks is the primary endpoint (intention to treat). Secondary outcomes include between-group differences in fatigue, mental health, cognitive function, sleep and daytime activity with actigraphy, medication use, pain, alcohol use, quality of life, social and work functioning, and resource utilization and whether changes in fatigue, mental health and cognitive function are mediated by changes in insomnia severity. The study protocol is approved by the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (Ref: 623308) and is preregistered at ClinicalTrials.gov (ref: NCT06113666).A Digital Therapeutic to Improve Insomnia in Multiple Sclerosis: A Randomized Controlled Trial. (NorseMS) Sponsor: St.Olavs Hospital, Postboks 3250 Torgården, 7006 Trondheim.Statement of SignificanceInsomnia is common in multiple sclerosis (MS), and has a significant impact on daytime functioning. Fully automated digital Cognitive Behavioral Therapy for Insomnia offers a scalable option that could be deployed in routine MS care. This pragmatic randomized trial is designed to detect effects on insomnia severity in a heterogeneous sample of people with MS and self-reported insomnia, and to test whether improving insomnia leads to benefits in fatigue, mental health, and cognitive function. Data on pain, alcohol use, quality of life, social and work functioning, national registry data, and actigraphy recordings for 90 days during the intervention phase will also be collected. Findings will directly inform clinical implementation pathways and provide new knowledge about the role of insomnia in MS.

Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for insomnia disorder. The goal of this study was to evaluate clinical benefits of CBT-I to veterans with insomnia disorder during the early months of the COVID-19 pandemic using an uncontrolled observational design. A cohort of 63 Veterans Affairs (VA) mental health providers delivered CBT-I to 180 veterans as part of an evidence-based psychotherapy training program and captured de-identified treatment outcome data through a data portal. The main patient outcomes were change in the Insomnia Severity Index (ISI) total score from the initial clinical assessment session to the last treatment session, response rate (% with ISI change > 7 from assessment to last session), and remission rate (% with ISI < 8 at the last session). We tested the noninferiority of telehealth only compared with at least 1 in-person session. Fifty-six percent of veterans seen for an evaluation completed CBT-I treatment during the structured training program phase and completed an initial and final ISI. Among these veterans, ISI scores decreased by an average of 9.9 points from before to after treatment (P < .001), 66% experienced a clinically meaningful treatment response, and 43% experienced insomnia symptom remission. Benefits were similar whether the veteran received some in-person care or received CBT-I entirely via telehealth. Findings suggest, regardless of treatment modality, CBT-I remained highly effective during the early months of the pandemic, which was a challenging time for both clinical providers and veterans in need of insomnia treatment. Martin JL, DeViva J, McCarthy E, etal. In-person and telehealth treatment of veterans with insomnia disorder using cognitive behavioral therapy for insomnia during the COVID-19 pandemic. J Clin Sleep Med. 2023;19(7):1211-1217.

Many military service members and veterans report insomnia after sustaining traumatic brain injury (TBI). Limitations of first-line treatment, cognitive-behavioral therapy for insomnia (CBT-I), include availability of qualified clinicians, low completion rates, and cost. To investigate the feasibility and efficacy of internet-guided CBT-I (eCBT-I) in military service members and veterans with insomnia and a history of TBI. This randomized clinical trial of fully remote internet-based interventions and evaluations was conducted from September 1, 2020, to June 30, 2021, with 3 months of follow-up. Participants included a volunteer sample of military service members and veterans aged 18 to 64 years with a history of mild TBI/concussion and at least moderately severe insomnia defined as an insomnia severity index (ISI) score of greater than 14 and Pittsburgh Sleep Quality Index of greater than 4. Self-reported race, ethnicity, and educational level were generally representative of the US military. Data were analyzed from October 21, 2021, to April 29, 2024. Internet-based CBT-I delivered over 6 weekly lesson modules with assigned homework activities. The prespecified primary outcome measure was change in ISI score over time. Prespecified secondary outcome measures included self-reported measures of depression symptoms, posttraumatic stress disorder (PTSD) symptoms, sleep quality, migraine impact, and fatigue. Of 204 people screened, 125 were randomized 3:1 to eCBT-I vs online sleep education, and 106 completed baseline evaluations (83 men [78.3%]; mean [SD] age, 42 [12] years). Of these, 22 participants (20.8%) were Hispanic or Latino and 78 (73.6%) were White. Fifty participants completed postintervention evaluations, and 41 completed the 3-month follow-up. Baseline mean (SD) ISI scores were 19.7 (4.0) in those randomized to eCBT-I and 18.9 (5.0) in those randomized to sleep education. After intervention, mean (SD) ISI scores were 13.7 (5.6) in those randomized to eCBT-I and 16.6 (5.7) in those randomized to sleep education. The difference in the extent of reduction in ISI scores between groups was 3.5 (95% CI,-6.5 to -0.4 [P = .03]; Cohen d, -0.32 [95% CI, -0.70 to -0.04]). In the eCBT-I group, the extent of insomnia improvement correlated with the extent of depressive symptom improvement (Spearman ρ = 0.68 [P < .001]), PTSD symptoms (ρ = 0.36 [P = .04]), sleep quality (ρ = 0.54 [P = .001]), and fatigue impact (ρ = -0.58 [P < .001]) but not migraine-related disability. The findings of this randomized clinical trial suggest that fully remote eCBT-I was moderately feasible and effective for self-reported insomnia and depression symptoms in military service members and veterans with a history of TBI. There is great potential benefit for eCBT-I due to low availability and cost of qualified CBT-I clinicians, although optimization of completion rates remains a challenge. Future studies may use home-based objective sleep assessments and should increase study retention. ClinicalTrials.gov Identifier: NCT04377009.