Randomized Noninferiority Trial of Telehealth Delivery of Cognitive Behavioral Treatment of Insomnia Compared to In-Person Care.

Objective: Insomnia is prevalent and is associated with a range of negative sequelae. Cognitive behavioral treatment for insomnia (CBT-I) is the recommended intervention, but availability is limited. Telehealth provides increased access, but its efficacy is not certain. The objective of this study was to compare the efficacy of CBT-I delivered by telehealth to in-person treatment and to a waitlist control.Methods: Individuals with DSM-5 insomnia disorder (n = 60) were randomized to telehealth CBT-I, in-person CBT-I, or 8-week waitlist control. CBT-I was delivered over 6-8 weekly sessions by video telehealth or in-person in an outpatient clinic. Follow-up assessments were at 2 weeks and 3 months posttreatment. The Insomnia Severity Index (ISI) was the primary outcome. Change in ISI score was compared between the CBT-I group in an intent-to-treat, noninferiority analysis using an a priori margin of -3.0 points. All analyses were conducted using mixed-effects models. Data collection occurred from November 2017-July 2020.Results: The mean (SD) change in ISI score from baseline to 3-month follow-up was -7.8 (6.1) points for in-person CBT-I, -7.5 (6.9) points for telehealth, and -1.6 (2.1) for waitlist, and the difference between the CBT-I groups was not statistically significant (t28 = -0.98, P = .33). The lower confidence limit of this between-group difference in the mean ISI changes was greater than the a priori margin of -3.0 points, indicating that telehealth treatment was not inferior to in-person treatment. There were significant improvements on most secondary outcome measures but no group differences.Conclusions: Telehealth CBT-I may produce clinically significant improvements in insomnia severity that are noninferior to in-person treatment. CBT-I is also associated with significant gains across a range of domains of functioning. Telehealth is a promising option for increasing access to treatment without loss of clinical gains.Trial Registration: ClinicalTrials.gov identifier: NCT03328585.

Cognitive Behavioral Therapy for Insomnia in Alcohol-Dependent Veterans: A Randomized, Controlled Pilot Study.

BACKGROUND: Insomnia is highly prevalent in individuals recovering from alcohol dependence (AD) and increases their risk of relapse. Two studies evaluating cognitive behavior therapy for insomnia (CBT-I) have demonstrated its efficacy in non-Veterans recovering from AD. The aim of this study was to extend these findings in an 8-week trial of CBT-I in Veterans. METHODS: Veterans recovering from AD were randomly assigned to 8 weeks of treatment with CBT-I (N = 11) or a Monitor-Only (MO; N = 11) condition and were evaluated 3 (N = 21/22) and 6 months posttreatment (N = 18/22). The primary outcome measure was the Insomnia Severity Index (ISI) score. Secondary outcome measures were sleep diary measures, percent days abstinent (PDA), and scores on the Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS), Sleep Hygiene Index (SHI), Penn Alcohol Craving Scale (PACS), Quick Inventory of Depressive Symptoms (QIDS), State-Trait Anxiety Inventory-Trait (STAI-T) scale, and Short Form 12-item (SF-12). Mixed-effects regression models, adjusted for race, evaluated differences in outcomes between the groups over a 6-month period (clinicaltrials.gov identifier = NCT01603381). RESULTS: Subjects were male, aged 54.5 (SD = 6.9) years, and had 26.4 (SD = 26.3) days of abstinence before their baseline evaluation. CBT-I produced a significantly greater improvement in model-based estimates than MO (mean change at 6 months compared to their baseline) for ISI, sleep latency from a daily sleep diary, DBAS mean score, and SHI total score. PDA and QIDS improved over time, but there was no difference between the groups. PACS, STAI-T, or SF-12 scale did not show any improvement from their baseline scores. CONCLUSIONS: CBT-I treatment demonstrated substantial efficacy in reducing insomnia, associated negative cognitions, and improving sleep hygiene in Veterans during early recovery, though it did not reduce drinking behavior.

Cognitive behavioral therapy for insomnia in Parkinson's disease: a case series.

Chronic insomnia is common in patients with Parkinson's disease. There are limited data to guide its treatment in this patient population, especially in regards to non-pharmacologic interventions, some of which are highly effective in the non-Parkinson's disease population. The aim of this study is to describe a series of Parkinson's disease patients who underwent cognitive behavioral therapy for insomnia (CBTi). Parkinson's disease patients who had undergone a baseline and at least one follow-up CBTi session were identified. Electronic medical records and pre-treatment and post-treatment patient sleep diaries were reviewed. Sleep measures of interest included wake time after sleep onset, sleep efficiency, sleep onset latency, and total sleep time. Pre-treatment and post-treatment values were compared within subjects using paired t-test. Five patients were included. Patients attended an average of eight sessions of CBTi (range 5-12). Significant increases in sleep efficiency (p = 0.02) and decreases in number of awakenings per night (p = 0.02) were found. Our data provide preliminary evidence that cognitive behavioral therapy is an effective treatment for insomnia in Parkinson's disease, and is well tolerated and well received by patients. Given the limited data supporting use of medications to treat chronic insomnia in Parkinson's disease, combined with their risks, randomized trials to demonstrate the efficacy of CBTi in Parkinson's disease are warranted.

Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors.

STUDY OBJECTIVES: This 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. DESIGN: This study is a randomized, placebo-controlled, clinical trial. SETTING: This study was conducted at two northeastern academic medical centers. PARTICIPANTS: Eighty-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). INTERVENTIONS: CBT-I was delivered in seven weekly individual therapy sessions (three in person, four via telephone). The armodafinil dosage was 50 mg BID. MEASUREMENTS AND RESULTS: Sleep 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. CONCLUSION: CBT-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.

Sleep Duration and Insomnia Symptoms as Risk Factors for Suicidal Ideation in a Nationally Representative Sample.

OBJECTIVE: Suicidal behavior (suicidal ideation, suicide attempts, and suicide completion) has been increasingly linked with difficulty initiating sleep, maintaining sleep, and early morning awakenings. However, the relationship between suicidal behavior and sleep duration abnormalities is unclear, especially at the population level. The present study used a nationally representative sample to examine the association of suicidal ideation with extreme sleep durations and insomnia symptoms. METHOD: Cross-sectional data from adult respondents (≥ 18 years of age, N = 6,228) were extracted from the 2007-2008 wave of the National Health and Nutritional Examination Survey. Ordinal logistic regression analyses were used to evaluate the relationship of suicidal ideation with sleep duration, global insomnia, and individual insomnia symptoms in models adjusted for sociodemographic, socioeconomic, and health-related covariates. RESULTS: Suicidal ideation was associated with abnormalities of sleep duration. This relationship ceased to exist once the model was adjusted for depressive symptoms. As expected, an increased level of suicidal ideation was consistently associated with insomnia. Of the insomnia symptoms, difficulty maintaining sleep was found to be the most predictive of suicidal ideation, followed by difficulty initiating sleep (P< .05). CONCLUSIONS: Abnormalities of sleep duration and continuity should prompt a clinical assessment for suicide risk.

Short and long sleep duration and risk of drowsy driving and the role of subjective sleep insufficiency.

Experimental sleep restriction increases sleepiness and impairs driving performance. However, it is unclear whether short sleep duration in the general population is associated with drowsy driving. The goal of the present study was to evaluate whether individuals in the general population who obtained sleep of 6h or less are more likely to report drowsy driving, and evaluate the role of perceived sleep sufficiency. Data exploring whether subgroups of short sleepers (those who report the most or least unmet sleep need) show different risk profiles for drowsy driving are limited. From the 2009 Behavioral Risk Factor Surveillance System (N=31,522), we obtained the following self-reported data: (1) sleep duration (≤5, 6, 7, 8, 9, or ≥10 h/night); (2) number of days/week of perceived insufficient sleep; (3) among drivers, yes/no response to: "During the past 30 days, have you ever nodded off or fallen asleep, even just for a brief moment, while driving?" (4) demographics, physical/mental health. Using 7 h/night as reference, logistic regression analyses evaluated whether self-reported sleep duration was associated with drowsy driving. Overall, 3.6% reported drowsy driving. Self-identified short-sleepers reported drowsy driving more often, and long sleepers, less often. Among those who perceived sleep as always insufficient, drowsy driving was reported more often when sleep duration was ≤5 h, 6 h, or ≥10 h. Among those who perceived sleep as always sufficient, drowsy driving was reported more often among ≤5 h and 6h sleepers. Overall, drowsy driving was common, particularly in self-identified short-sleepers as a whole, as well as subgroups based on sleep insufficiency.