Hybrid Cognitive-Behavioral Therapy Intervention for Adolescents With Co-Occurring Migraine and Insomnia: A Single-Arm Pilot Trial.

This study aimed to evaluate feasibility and acceptability of a hybrid cognitive-behavioral therapy intervention for adolescents with co-occurring migraine and insomnia. Many youth with chronic migraine have co-occurring insomnia. Little research has been conducted to evaluate behavioral treatments for insomnia in youth with migraine. We conducted a single-arm pilot trial to evaluate the feasibility and acceptability of delivering cognitive-behavioral therapy for insomnia to 21 youth (mean age 15.5, standard deviation 1.6) with co-occurring chronic migraine and insomnia. Adolescents completed up to 6 individual treatment sessions over 6 to 12 weeks, and 1 booster session 1 month later. Assessments included a prospective 7-day headache and sleep diary, and self-report measures of insomnia, sleep quality, sleep habits, and activity limitations at pre-treatment, immediate post-treatment, and 3-month follow-up. Adolescents demonstrated good treatment adherence and families rated the intervention as highly acceptable. Preliminary analyses indicated improvements from pre-treatment to post-treatment in primary outcomes of headache days (M = 4.7, SD = 2.1 vs M = 2.8, SD = 2.7) and insomnia symptoms (M = 16.9, SD = 5.2 vs M = 9.5, SD = 6.2), which were maintained at 3-month follow-up (M = 2.7, SD = 2.8; M = 9.3, SD = 5.0, respectively). We also found improvements in secondary outcomes of pain-related activity limitations as well as sleep quality, sleep hygiene, and sleep patterns. These preliminary data indicate that hybrid cognitive-behavioral therapy is feasible and acceptable for youth with co-occurring chronic migraine and insomnia. Future randomized controlled trials are needed to test treatment efficacy on migraine, sleep, and functional outcomes. ClinicalTrials.gov Identifier: NCT03137147.

Law EF ，Wan Tham S ，Aaron RV ，Dudeney J ，Palermo TM ... -  《-》

A Single Arm Pilot Trial of Brief Cognitive Behavioral Therapy for Insomnia in Adolescents with Physical and Psychiatric Comorbidities.

The majority of adolescents with chronic insomnia have physical health or psychiatric comorbidities; insomnia is also associated with greater negative daytime symptoms (e.g., depressive symptoms) and reduced overall health-related quality of life (HRQOL). However, to date, there has been limited attention to treatment of insomnia in this population. The purpose of this study was to determine the preliminary efficacy of a brief cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep, psychological symptoms, and HRQOL outcomes in adolescents with insomnia and co-occurring physical or psychiatric comorbidities. We conducted a single arm pilot trial in which 40 youth (mean age = 14.93, standard deviation = 1.89) with insomnia and physical or psychiatric comorbidities (e.g., depression, chronic pain, anxiety, gastrointestinal problems) received CBT-I in four individual treatment sessions over 4 to 6 w. Adolescents completed 7 days of wrist actigraphy and self-report measures of insomnia, sleep quality and behaviors, psychological symptoms, and HRQOL outcomes at pretreatment, immediate posttreatment, and 3-mo follow-up. CBT-I was associated with improvements in self-reported measures of sleep including insomnia symptoms, sleep quality, sleep hygiene, pre-sleep arousal, and sleep onset latency. Psychological symptoms and HRQOL also improved. Effects were generally sustained at 3-mo follow-up. CBT-I may be efficacious for adolescents with co-occurring physical and mental health comorbidities; future randomized controlled trials are needed to test the effect of CBT-I on sleep, psychological symptoms, and HRQOL and to evaluate maintenance of treatment effects over longer time periods.

Palermo TM ，Beals-Erickson S ，Bromberg M ，Law E ，Chen M ... -  《-》

Randomized Controlled Pilot Trial of Behavioral Insomnia Treatment for Chronic Migraine With Comorbid Insomnia.

Migraine frequently co-occurs with and is triggered by sleep disturbance, particularly insomnia, and the large majority of patients with chronic migraine (CM) have comorbid insomnia. Limited evidence suggests that behavioral regulation of sleep may reduce migraine frequency, but studies to date have not assessed the viability of stimulus control and sleep restriction interventions or included objective measurement of sleep parameters. The aim of this study, thus, was to pilot-test the efficacy of a brief behavioral insomnia intervention for adults with CM and comorbid insomnia; headache diaries and actigraphy were included to assess outcomes throughout the trial. This randomized parallel-arm pilot trial recruited adults with both CM and comorbid insomnia. Participants were randomly assigned to three 30-minute biweekly sessions of cognitive-behavioral therapy for insomnia (CBTi) or control treatment. Participants were blinded to treatment and control conditions to control for outcome expectations. Each treatment condition involved training in and daily practice in 5 instructions/skills. The CBTi group learned and practiced skills pertaining to stimulus control and sleep restriction. The control intervention was the same as used by Calhoun and Ford (2007) and involved training in and daily practice of skills pertaining to keeping a consistent food/liquid intake, range of motion exercises, and acupressure. Participants provided outcome data via daily headache diaries, actigraphy, and self-report measures. The primary outcome was reduction in headache frequency at 2 weeks post-treatment and 6-week follow-up; secondary outcomes included other headache parameters, objective actigraphic and subjective changes in sleep, and treatment effect sizes and perceived credibility. Generalized estimating equations with a binomial logit link and inverse probability weights were used to assess the primary outcome among the intent-to-treat sample, and repeated measures generalized linear models were used to assess changes in secondary outcomes after controlling for baseline values. The intent-to-treat analyses included 31 adults (M age = 30.8 [12.9] years; 90.3% female; 80.6% white) with CM and comorbid insomnia. Both interventions yielded reductions in headache frequency at post-treatment (26.9% reduction for CBTi vs. 36.2% for control) and follow-up (48.9% for CBTi vs. 25.0% for control). At follow-up the odds of experiencing headache were 60% lower for CBTi than for control treatment, indicative of a large effect size that did not reach statistical significance after Bonferroni correction for assessing two primary endpoints (odds ratio: 0.40; 95% CI: 0.17, 0.91; P = .028). CBTi produced significantly larger increases than control treatment in total sleep time and sleep efficiency as quantified by actigraphy, as well as in self-reported insomnia severity. Adherence was high and treatments were perceived as credible without differences between groups, but the control group experienced a higher rate of dropouts. No adverse events were reported. Behavioral treatment of comorbid insomnia in individuals with CM produced large reductions in headache frequency, though some improvement in headache occurred with a behavioral intervention not focused on modifying sleep. Among the CBTi group only, both headache frequency and sleep parameters continued to improve after treatment, suggesting the presence of enduring effects over time. Directly treating insomnia using components of stimulus control and sleep restriction holds promise for reducing comorbid migraine. Development of and comparison to a truly inert pseudotherapy control presents unique challenges that future studies should address.

Smitherman TA ，Walters AB ，Davis RE ，Ambrose CE ，Roland M ，Houle TT ，Rains JC ... -  《-》

Intervention for Sleep and Pain in Youth (ISPY-RCT): protocol for a two-phase randomized controlled trial of sequenced cognitive-behavioral therapy for insomnia and pain management in adolescents with migraine.

Migraine is a major pediatric health problem impacting 10-12% of youth. About 1 in 3 youth with migraine are diagnosed with insomnia. Sleep and migraine share a cyclical relationship, and data indicate that insomnia symptoms increase migraine severity. CBT for insomnia (CBT-I) has demonstrated efficacy for improving insomnia in adults with migraine and other pain conditions; however, effects in youth have not been evaluated. Moreover, in adults, there is some indication that CBT-I may lead to changes in pain after there are sustained improvements in sleep, but this has never been empirically tested. Cognitive-behavioral therapy for pain management (CBT-Pain) is an established treatment approach for youth with migraine, leading to reductions in headache frequency and disability. In the proposed study, we will address these gaps in knowledge by using an innovative two-phase trial design to (1) test the efficacy of Internet-delivered CBT-I intervention for youth with migraine and comorbid insomnia compared to Internet-delivered sleep education for modifying sleep and (2) investigate how changes in sleep may modify the response to Internet-delivered CBT-Pain intervention. We will study a cohort of 180 adolescents, ages 11-17 years, with migraine (with or without aura, chronic migraine) and comorbid insomnia. In phase 1, youth will be randomly assigned to receive Internet-delivered CBT-I intervention or Internet sleep education control. In phase 2, all youth will receive Internet-delivered CBT-Pain intervention. Assessments will occur at baseline, immediately after phase 1 intervention, immediately after phase 2 intervention, and 6 months post-intervention. We will use a comprehensive multidimensional assessment of sleep and headache including self-report questionnaires, ambulatory actigraphy monitoring, and 14-day daily diaries. Given the high prevalence of insomnia in adolescents with migraine, an extension of CBT-I intervention to this population will address an important gap in clinical practice and in conceptual understanding of the relationship between sleep and migraine. By testing a separate CBT-I intervention, we will be able to apply this treatment in the future to other pediatric populations (e.g., cancer, arthritis) who commonly experience comorbid insomnia. ClinicalTrials.gov NCT04936321. Registered on June 23, 2021.

Law EF ，Ritterband L ，Zhou C ，Palermo TM ... -  《Trials》

Cognitive-Behavioral Therapy for Insomnia to Reduce Chronic Migraine: A Sequential Bayesian Analysis.

Insomnia is frequently comorbid with chronic migraine, and small trials suggest that cognitive-behavioral treatment of insomnia (CBTi) may reduce migraine frequency. This study endeavored to provide a quantitative synthesis of existing CBTi trials for adults with chronic migraine using Bayesian statistical methods, given their utility in combining prior knowledge with sequentially gathered data. Completer analyses of 2 randomized trials comparing CBTi to a sham control intervention (Calhoun and Ford, 2007; Smitherman et al, 2016) were used to quantify the effects of a brief course of treatment on headache frequency. Change in headache frequency from baseline to the primary endpoint (6-8 weeks posttreatment) was regressed on group status using a Gaussian linear model with each study specified in the order of completion. To estimate the combined effect, posterior distributions from the Calhoun and Ford study were used as informative priors for conditioning on the Smitherman et al data. In a combined analysis of these prior studies, monthly headache frequency of the treatment group decreased by 6.2 days (95%CrI: -9.7 to -2.7) more than the control group, supporting an interpretation that there is a 97.5% chance that the treatment intervention is at least 2.7 days better than the control intervention. The analysis supports the hypothesis that at least for those who complete treatment, there is high probability that individuals who receive CBTi experience greater headache reduction than those who receive a control intervention equated for therapist time and out-of-session skills practice. Cognitive-behavioral interventions for comorbid insomnia hold promise for reducing headache frequency among those with chronic migraine. These findings add to a small but growing body of literature that migraineurs with comorbid conditions often respond well to behavioral interventions, and that targeting comorbidities may improve migraine itself.

Smitherman TA ，Kuka AJ ，Calhoun AH ，Walters ABP ，Davis-Martin RE ，Ambrose CE ，Rains JC ，Houle TT ... -  《-》