Therapy For Insomnia Research Articles

A Pilot Randomized-Controlled Trial of Sleep Scholar: A Brief, Internet-Based Insomnia Intervention for College Students

This randomized-controlled trial examined the efficacy of Sleep Scholar, a brief, internet-based insomnia intervention tailored to the needs of college students. College students commonly experience insomnia and various other mental health symptoms, including suicide ideation. Cognitive-Behavioral Therapy for Insomnia (CBT-I) is a promising suicide prevention effort for college students because insomnia is robust risk factor for suicide ideation and CBT-I reduces suicide ideation. Moreover, CBT-I can be brief, self-guided, and internet-based. CBT-I also may elicit less stigma than treatment specifically targeting suicide ideation. However, existing forms of brief CBT-I are neither self-guided nor internet-based, and existing forms of self-guided, internet-based CBT-I are not brief. In addition, previous iterations of CBT-I are not typically designed to address the unique sleep needs of college students. For this registered clinical trial, we recruited 61 college students with at least subclinical insomnia symptoms. Participants were randomized to either Sleep Scholar or a control condition, Building Healthy Habits. Participants completed pretreatment daily sleep diaries and surveys, a posttreatment assessment of acceptability and satisfaction, a 1-week and 1-month survey follow-up, and daily sleep diaries throughout the 1-month follow-up period. Results showed that Sleep Scholar was more acceptable and satisfactory compared to the control condition at posttreatment. However, Sleep Scholar was not more effective for improving sleep or mental health symptoms compared to the control condition. These findings suggest that modifications to Sleep Scholar are needed to improve its efficacy.

Pharmacological management of pediatric insomnia

Insomnia is the most commonly reported sleep disorder among children and adolescents, impacting their cognitive, emotional, behavioral, and physical development. The prevalence of insomnia generally increases with age, often persisting into adulthood if unaddressed. Insomnia is exceedingly common among those with developmental disabilities and is frequently comorbid with a great range of psychiatric diagnoses. The COVID-19 pandemic has only increased the prevalence of insomnia among children and adolescents. Health care providers are routinely called upon to treat insomnia in the pediatric population. Psychoeducation and behavioral interventions, especially cognitive behavioral therapy for insomnia (CBT-I), remain the first line treatments, given empirical evidence for their efficacy and success in relapse prevention. However, medications are frequently employed in clinical practice, despite the fact that no medications are approved by the Food and Drug Administration (FDA) for the treatment of pediatric insomnia. This review was designed to educate and support practitioners who are treating children and adolescents who struggle with insomnia. A thorough narrative review was completed to identify all published medication studies of pediatric insomnia; the identified studies are described and then graded into four categories according to the strength of the evidence supporting their use, side effect profiles, co-morbidities, and overall risk vs. benefit of each pharmacological treatment. This review will help practitioners in making clinical decisions for their pediatric patients who suffer with insomnia.

The effectiveness of cognitive behavioral therapy for insomnia on sleep outcomes in the context of pain among older adult veterans.

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.

Association between sleep state misperception and bedtime behavior in patients with chronic insomnia

Previous studies on sleep state misperception have objectively evaluated sleep status in special environments using polysomnography. There is a paucity of data from studies that evaluated habitual sleep status in home environments. The present study aimed to investigate sleep state misperception in the home environment of patients with chronic insomnia using a lumbar-worn actigraphy to identify sleep habits associated with sleep state misperception severity. Thirty-one patients and 42 healthy volunteers were included in the insomnia and non-insomnia group, respectively. Participants recorded subjective assessments in sleep diaries, objective assessments with an actigraphy worn for 14 days, and self-assessments using questionnaires. Both groups had similar objective sleep ratings; however, insomnia group had significantly worse subjective ratings (total sleep time, wake after sleep onset, and sleep onset latency). A significant correlation was found between subjective and objective total sleep time scores in non-insomnia group but not in insomnia group. Insomnia group had earlier bedtimes, significantly longer bedtimes, and impaired daytime functioning (Sheehan Disability Scale score); additionally, they underestimated their total sleep time, particularly with earlier bedtimes and longer laying durations. Monitoring the sleep status and habits of individuals in home environments could be instrumental in identifying key points for targeted interventions on sleep hygiene and cognitive behavioral therapy for insomnia.

Treatment strategies for insomnia in Japanese primary care physicians’ practice: A Web-based questionnaire survey

BackgroundIt is unclear how primary care physicians manage insomnia after the introduction of novel hypnotics such as orexin receptor antagonists and melatonin receptor agonists. This Web-based questionnaire survey aimed to examine treatment strategies for insomnia in Japanese primary care practice.MethodsOne-hundred-and-seventeen primary care physicians were surveyed on the familiarity of each management option for insomnia on a binary response scale (0 = “unfamiliar”; 1 = “familiar”) and how they managed insomnia using a nine-point Likert scale (1 = “I never prescribe/perform it”; 9 = “I often prescribe/perform it”). Physicians who were unfamiliar with a management option were deemed to have never prescribed or performed it.ResultsRegarding medication, most physicians were familiar with novel hypnotics. Suvorexant was the most used hypnotic, followed by lemborexant and ramelteon. These novel hypnotics averaged 4.8–5.4 points and 4.0–4.7 points for sleep onset and sleep maintenance insomnia, respectively. By contrast, most benzodiazepines were seldom used below two points. Regarding psychotherapy, only approximately 40% of the physicians were familiar with cognitive behavioral therapy for insomnia (CBT-I) and they rarely implemented it, at an average of 1.5–1.6 points. More physicians were familiar with single-component psychotherapies (i.e., relaxation, sleep restriction therapy, and stimulus control) compared to CBT-I, and 48–74% of them implemented it slightly more often, with scores ranging from 2.6 to 3.4 points.ConclusionThis study suggests that Japanese primary care physicians seldom use CBT-I to treat insomnia. In addition, they use novel sleep medications more frequently than benzodiazepines in terms of pharmacotherapy. The use and availability of CBT-I in Japanese primary care might be facilitated by: educating primary care physicians, implementing brief or digital CBT-I, and/or developing collaborations between primary care physicians and CBT-I specialists.

Cognitive behavioural therapy for insomnia (CBT-I) in schizophrenia and schizoaffective disorder: protocol for a randomised controlled trial

IntroductionInsomnia is a common symptom among patients with schizophrenia and schizoaffective disorder, negatively impacting symptom severity, functioning and well-being; however, it is rarely the direct focus of treatment. The main...

Impact of an internet-based insomnia intervention on suicidal ideation and associated correlates in veterans at elevated suicide risk.

Improving public health approaches to suicide prevention requires scalable evidence-based interventions that can be easily disseminated. Given empirical data supporting the association between insomnia and suicide risk, internet-delivered insomnia interventions are promising candidates to meet this need. The purpose of this study was to examine whether an unguided internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) improved insomnia severity, suicidal ideation (SI), and suicide risk correlates (depression, post-traumatic stress disorder, anxiety, hostility, belongingness, hopelessness, agitation, irritability, concentration) in a sample of veterans. Secondary data analysis of Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn veterans (n = 50) with clinically significant insomnia and elevated SI drawn from a larger randomized controlled trial (RCT) of an iCBT-I, Sleep Healthy Using the Internet (SHUTi). Two-sample t-tests or Wilcoxon rank sum tests were used to evaluate between-group differences (SHUTi vs. Insomnia Education Website control) in symptom improvement from baseline to post-intervention. SHUTi participants experienced a significant improvement in insomnia severity (P < .001; d = -1.08) and a non-significant with small (subthreshold medium) effect size reduction of SI (P = .17, d = 0.40), compared to control participants. Significant improvement in hopelessness was observed (medium effect size), with non-significant small to medium effect size reductions in most remaining suicide risk correlates. Self-administered iCBT-I was associated with improvements in insomnia severity in veterans at elevated risk for suicide. These preliminary findings suggest that SI and suicide risk correlates may improve following an iCBT-I intervention, demonstrating the need for future well-powered iCBT-I RCTs targeted for populations at elevated suicide risk.

Sleep Symptoms in Migraine.

To review replicated and highlight novel studies of sleep in children and adults with episodic and chronic migraine. Attack-related sleep symptoms are most common in the prodrome and may represent early activation of the hypothalamus rather than migraine triggers. Interictally, patients with migraine report poor sleep quality and high rates of insomnia symptoms. Cognitive behavioral therapy for insomnia in adults and adolescents with chronic migraine and comorbid insomnia results in significant improvement on their headache burden. Thus far, objective studies report that migraine per se is a not associated with sleep apnea. At the present time, there is minimal evidence that migraine is under circadian influence. The current body of evidence suggests that the insomnia symptoms and poor sleep quality commonly reported by patients with migraine are not attack-related but occur interictally and are a marker of worsening disease. The development of clinical guidelines to approach sleep symptoms and expansion of CBT-I trials in those with episodic migraine would be clinically valuable.

Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well)

BackgroundInsomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined.MethodsThis study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment).DiscussionThe widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I.Trial registrationTrial registration number in the German Clinical Trials Register: DRKS00028153 (https://drks.de/search/de/trial/DRKS00028153). Registered on 16th May 2023.

Feasibility and Acceptability of Mindfulness-based Stress Reduction and Prenatal Sleep Classes for Poor Prenatal Sleep Quality: Pilot Randomized Controlled Trial

ABSTRACT Objectives The main objectives of the current paper were to examine the feasibility, acceptability, and adherence of a remotely delivered intervention consisting of mindfulness-based stress reduction plus prenatal sleep classes (MBSR+PS) compared with treatment as usual (TAU). Method In this pilot randomized controlled trial, 52 pregnant women with poor sleep quality were randomized to MBSR+PS or TAU. MBSR was delivered through eight weekly 2.5-hour sessions, and PS was delivered through eight weekly 30-minute sessions. PS content drew material from cognitive behavioral therapy for insomnia tailored for the perinatal period and from a mindfulness- and acceptance-based lens. Participants completed endpoint measures 10–12 weeks after randomization. Results We surpassed all acceptability targets, including the percentage of eligible participants willing to be randomized (96%), percentage of participants who initiated treatment (88%), and satisfaction scores (Client Satisfaction Questionnaire-8 score M = 28.04, SD = 3.6). We surpassed all feasibility targets, including our enrollment target, retention rate (92%), and measure completion (96%). Finally, we surpassed adherence targets, including MBSR and PS session attendance (≥80%). Though sleep outcomes were exploratory, increases in sleep efficiency were greater in the MBSR+PS group relative to TAU (SMD=.68). Conclusions Patient-reported poor sleep quality during pregnancy has high public health significance because it is common, consequential, and under-treated. The current feasibility and acceptability data for using remotely delivered MBSR and PS to improve prenatal sleep quality are encouraging and warranting future research that is sufficiently powered and designed to provide efficacy data. In addition, exploratory sleep outcomes offer preliminary evidence that this sleep program may improve sleep efficiency during pregnancy.

Towards a personalized prediction, prevention and therapy of insomnia: gut microbiota profile can discriminate between paradoxical and objective insomnia in post-menopausal women

BackgroundInsomnia persists as a prevalent sleep disorder among middle-aged and older adults, significantly impacting quality of life and increasing susceptibility to age-related diseases. It is classified into objective insomnia (O-IN) and paradoxical insomnia (P-IN), where subjective and objective sleep assessments diverge. Current treatment regimens for both patient groups yield unsatisfactory outcomes. Consequently, investigating the neurophysiological distinctions between P-IN and O-IN is imperative for devising novel precision interventions aligned with primary prediction, targeted prevention, and personalized medicine (PPPM) principles.Working hypothesis and methodology.Given the emerging influence of gut microbiota (GM) on sleep physiology via the gut-brain axis, our study focused on characterizing the GM profiles of a well-characterized cohort of 96 Italian postmenopausal women, comprising 54 insomniac patients (18 O-IN and 36 P-IN) and 42 controls, through 16S rRNA amplicon sequencing. Associations were explored with general and clinical history, sleep patterns, stress, hematobiochemical parameters, and nutritional patterns.ResultsDistinctive GM profiles were unveiled between O-IN and P-IN patients. O-IN patients exhibited prominence in the Coriobacteriaceae family, including Collinsella and Adlercreutzia, along with Erysipelotrichaceae, Clostridium, and Pediococcus. Conversely, P-IN patients were mainly discriminated by Bacteroides, Staphylococcus, Carnobacterium, Pseudomonas, and respective families, along with Odoribacter.ConclusionsThese findings provide valuable insights into the microbiota-mediated mechanism of O-IN versus P-IN onset. GM profiling may thus serve as a tailored stratification criterion, enabling the identification of women at risk for specific insomnia subtypes and facilitating the development of integrated microbiota-based predictive diagnostics, targeted prevention, and personalized therapies, ultimately enhancing clinical effectiveness.

Acceptance and commitment therapy versus cognitive behavioral therapy for insomnia: A randomized controlled trial.

To compare the effectiveness of an acceptance and commitment therapy (ACT)-based protocol and cognitive behavior therapy (CBT) for insomnia in adults. The participants comprised 227 adults with insomnia. They were randomized to six weekly group sessions consisting of acceptance and commitment therapy for insomnia (n = 76), cognitive behavioral therapy for insomnia (n = 76), or waitlist (WL; n = 75). Both treatment modalities significantly reduced insomnia severity with large effect sizes in the posttreatment phase. These results were maintained during the follow-up period with large effect sizes. CBT was superior to ACT in reducing the Insomnia Severity Index at posttreatment and follow-up, with a small effect size. ACT was superior to WL at posttreatment and at follow-up, with a moderate effect size. The treatment response and remission ratios were higher with CBT at posttreatment and similar at 6-month follow-up for both therapies, as ACT made further gains in response and remission. ACT had a significantly higher proportion of response and remission than WL in both periods (posttreatment and follow-up). Both therapies improved daytime functioning at both posttreatment and follow-up, with few differential changes across the groups. Both cognitive behavior therapy and acceptance and commitment therapy are effective, with CBT showing superiority and ACT showing delayed improvement. ACT has proven to be an effective therapy, especially in the long term, even in the absence of behavioral techniques such as stimulus control and sleep restriction, and it is a viable option for those who have difficulties adhering to behavioral techniques. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

The adherence and response of a combined approach of online self-help cognitive behavioral therapy and phone-based psychological guidance among French patients with cancer with insomnia.

12100 Background: Insomnia affects 30–60% of patients with cancer. Cognitive behavioral therapy for insomnia (CBT- I) is the gold-standard treatment for insomnia. However, the uptake of CBT-I in routine care remains low. Technology can be leveraged to facilitate the access and delivery of CBT-I. Nevertheless, adherence rates to online self-help interventions seem low (50-60%), and is associated with reduced intervention efficacy. The Sleep-4-All-2.0 is a prospective multicentric single arm study that evaluated an approach that combined a validated online self-help CBT-I program (Insomnet, 6 modules) to a phone-based guidance with a psychologist (3 orientation meetings). This study assessed: 1) how this combined approach performed in terms of adherence, behavior change and insomnia remission rates compared to prior literature investigating self-help CBT-I, and 2) the patients’ characteristics that are associated with a better or a poorer response. Methods: Data were collected with online questionnaires to compare outcomes: adherence (5 to 6 modules completed), behavior change (ad hoc questionnaire), insomnia remission (Insomnia Severity Index, ISI &lt; 8), sleep perception (ad hoc questionnaire), response to the program (changes in ISI score) at post intervention (week 6, 12 and 24). A descriptive analysis of patient characteristics at each time point was performed. Then, multivariate analyses were conducted: mixed models with a random effect at patient level (repeated measures) and fixed effects for the other variables. The following variables at baseline were used in the adjusted models: socio-demographic and clinical variables, ISI score, symptoms (ESAS), digital skills, barriers to change, motivation, social support and the referring professional. Results: Among the 348 patients included: 79% were women, 59% had breast cancer and 68% were undergoing treatment. A total of 310 patients (89%) initiated Insomnet. The adherence rate was 74% and 79% have changed their behavior. Insomnia remission rates were 34%, 46% and 50% at week 6, 12 and 24, respectively. Insomnia was no longer a problem for 48%, 63% and 66% at week 6, 12 and 24, respectively. Female gender (β=-1.22; p=0.05) and unemployed patients (β=-1.77; p&lt;0.01) were associated with a decrease in ISI scores. Sleep medication (β=1.58; p&lt;0.01), patients with a high sleepiness score (ESAS) (β=0.25; p=0.02) and patients with less digital skills (β=1.85; p&lt;0.01) were associated with an increase in ISI scores. Conclusions: A combination of online self-help CBT-I with phone-based guidance showed satisfactory rates of program adherence, change behavior and insomnia remission. However, some patient profiles such as the ones with lower digital skills and severe insomnia at baseline seemed to benefit less from this approach, and may require further care intensification. Clinical trial information: CONVENTION DE RECHERCHE no. 2020-1-PL SHS-03-IGR-1.

What Is the Evidence for Cognitive Behavioural Therapy for Insomnia (CBTI) in Improving Sleep in People With Mild Cognitive Impairment or Dementia?

What Is the Evidence for Cognitive Behavioural Therapy for Insomnia (CBTI) in Improving Sleep in People With Mild Cognitive Impairment or Dementia?

Improving sleep outcomes in patients with cancer with chronic insomnia using cognitive behavioral therapy: A retrospective study.

e13555 Background: Cancer patients experience a threefold higher rate of insomnia (23-54%) than the general population. Cognitive behavioral therapy for Insomnia (CBT- i) is the gold standard treatment of chronic insomnia. Few studies, however, have demonstrated CBT- i efficacy for chronic insomnia in cancer patients. To address the needs of cancer patients with insomnia, a psycho-oncology physician trained to provide CBT- i therapy established an insomnia clinic in an ambulatory oncology center tailored for oncology patients. The objective of this study is to assess the efficacy of CBT- i for chronic insomnia among cancer patients. Methods: A retrospective review of electronic medical records was performed on consecutive referrals to an insomnia clinic in an ambulatory oncology center. All patients with ICD-10 confirmed chronic insomnia diagnosis who received at least 2 sessions up to a maximum of 7 sessions of CBT- i were included in the analysis. Demographic variables, cancer-related disease and treatment variables, and sleep parameters at initial session (T1) and last session (T2) were collected. Sleep parameters included sleep efficiency, total sleep time, sleep onset latency, number of nightly awakenings, and sleep quality. Semi-structured psychiatric clinical interviews, past medical and sleep history, and patient-rated Pittsburgh Sleep Quality Index (PSQI) scores at T1 were collected. Data analysis utilized SPSS descriptive statistics and T-test to compare differences between the baseline (T1) and post-CBT- i treatment (T2) sleep variable outcome measures. Results: The sample included 18 cancer patients (mean age 59 years; 12 Hispanics, 6 non-Hispanics; 16 females, 2 males) with ICD-10-confirmed chronic insomnia treated with CBT- i. Cancer-related variables among the sample included a mean duration of 18 months since cancer diagnosis, disease staging ranging from 0-IV, and 16 patients completed curative treatment. The sample included 13 breast cancer patients. Mean duration of insomnia was 6 years. PSQI score was 14 (PSQI score ranges from 0 to 21, scores above 5 are indicative of poor sleep quality). The mean number of sessions delivered was 5. Sleep parameters at T2 showed a significant improvement compared to those at T1 (Table). The number of nightly awakenings decreased from 3 at T1 to 2 at T2 (p=0.01), and 78% (14/18) of patients reported an improvement in their sleep quality at T2. Conclusions: Cognitive Behavioral Therapy for Insomnia demonstrates efficacy in the treatment of chronic insomnia in cancer patients and is easily administered within an ambulatory oncology center. [Table: see text]

Sleep health primary care clinical resource.

Obstructive sleep apnoea (OSA) and insomnia are the two most common sleep disorders and are frequent reasons for presentation in Australian general practice. This article describes the development, content and suggested uses of the online sleep health primary care clinical resource, which provides general practitioners and other primary healthcare professionals with evidence-based information on the aetiology, assessment, management, referral and ongoing care for OSA and chronic insomnia. The Royal Australian College of General Practitioners-accepted clinical resource for the management of OSA and chronic insomnia in primary care was developed by the Australian National Centre for Sleep Health Services Research. The resource is designed to be used during consultations (eg following the steps in assessment and management and the use of online questionnaires for the assessment of OSA [Epworth Sleepiness Scale/OSA50/STOP-Bang] and insomnia [Sleep Condition Indicator/and Insomnia Severity Index]) and as an education/training tool (eg evidence on the role of continuous positive airway pressure/mandibular advancement splints for management of OSA and brief behavioural therapy for insomnia/cognitive behavioural therapy for insomnia for the management of insomnia).

A Pilot Randomized Trial of Combined Cognitive-Behavioral Therapy and Exercise Training Versus Exercise Training Alone for the Management of Chronic Insomnia in Obstructive Sleep Apnea.

Insomnia treatment among individuals with comorbid insomnia and obstructive sleep apnea is suboptimal. In a pilot randomized controlled trial, 19 individuals with comorbid insomnia and obstructive sleep apnea were allocated to one of two arms: EX + EX, consisting of two 8-week phases of exercise training (EX), or RE + CBTiEX, encompassing 8weeks of relaxation training (RE) followed by 8weeks of combined cognitive-behavioral therapy and exercise(CBTiEX). Outcomes included Insomnia Severity Index (ISI), polysomnography, and cardiorespiratory fitness measures. A mixed-model analysis of variance revealed a Group × Time interaction on peak oxygen consumption change, F(1, 14) = 10.1, p = .007, and EX increased peak oxygen consumption (p = .03, g' = -0.41) and reduced ISI (p = .001, g' = 0.82) compared with RE (p = .49, g = 0.16) post-8weeks. Post-16weeks, there was a significant Group × Time interaction (p = .014) driven by RE + CBTiEX yielding a larger improvement in ISI (p = .023, g' = 1.48) than EX + EX (p = .88, g' < 0.1). Objective sleep was unchanged. This study showed promising effects of regular EX alone and combined with cognitive-behavioral therapy for insomnia on ISI in comorbid insomnia and obstructive sleep apnea.

The influence of yoga and cognitive behavioral therapy on mediational relationships between insomnia and cancer-related fatigue: A URCC NCORP RCT in 550 cancer survivors.

12015 Background: Cancer-related fatigue (CRF) often co-occurs with insomnia and both are incapacitating adverse toxicities of cancer and its treatment which may persist months and years after the completion of treatment. Yoga and Cognitive Behavioral Therapy for Insomnia (CBT-I) are promising behavioral approaches for improving CRF and insomnia among cancer survivors. However, the influence of changes in insomnia resulting from participating in yoga or CBT-I on the subsequent changes in CRF is not fully understood. Methods: We conducted mediation analyses on data collected from a multicenter phase III RCT among cancer survivors who were randomized to receive 1) Yoga for Cancer Survivors (YOCAS, 75-min./session, 2x/wk. for 4 wks.), 2) CBT-I (90-min./session, 1x/wk. for 8 wks.), or 3) a behavioral placebo (ASCO recommended Survivorship Education, 75-min/session, 2x/wk. for 4 wks.). Brief Fatigue Inventory and Insomnia Severity Index were used to assess CRF and insomnia, respectively, at pre-, mid-, and post-intervention. Causal mediation analyses were conducted to estimate the influence of changes in insomnia at mid-intervention resulting from participating in YOCAS, CBT-I, or behavioral placebo on subsequent changes in CRF at post-intervention. Results: 550 survivors (93% female; mean age 57 years; 75% were breast cancer survivors) completed baseline and post-intervention assessments. YOCAS, compared to placebo, significantly improved CRF and insomnia at mid-intervention (CRF: -0.38±0.16, p = 0.01; Insomnia: -1.15±0.35, p &lt; 0.01) and post-intervention (CRF: -0.35±0.17, p = 0.03; Insomnia: -1.43±0.41, p &lt; 0.01). Among YOCAS participants, improvement in insomnia at mid-intervention significantly influenced the subsequent reduction in CRF (-0.14±0.06, p = 0.01) and accounted for 37% (95% CI: 0% - 78%) of the total reduction in CRF at post-intervention. CBT-I, compared to placebo, also significantly improved CRF and insomnia at mid- (CRF: -0.32±0.18, p = 0.06; Insomnia: -2.64±0.40, p &lt; 0.01) and post-intervention (CRF: -0.59±0.18, p &lt; 0.01; Insomnia: -4.95±0.46, p &lt; 0.01). Among CBT-I participants, the improvement in insomnia at mid-intervention significantly influenced the subsequent reduction in CRF (-0.40±0.09, p &lt; 0.01) and accounted for 60% (95% CI: 21% - 99%) of the total reduction in CRF at post-intervention. Conclusions: Both YOCAS and CBT-I effectively improve CRF and insomnia among survivors. 37%-60% of the reduction in CRF resulting from participating in YOCAS or CBT-I is due to improvement in insomnia. Clinicians should consider prescribing YOCAS yoga or CBT-I for survivors who experience CRF and insomnia. Clinical trial information: NCT02613364 .

Cognitive behavioural therapy for insomnia (CBT-I) in patients with coronary heart disease: a protocol for a randomized controlled trial with six months follow-up

Cognitive behavioural therapy for insomnia (CBT-I) in patients with coronary heart disease: a protocol for a randomized controlled trial with six months follow-up

Effect of melatonin on insomnia and daytime sleepiness, in patients with obstructive sleep apnea and insomnia (COMISA): A randomized double-blinded placebo-controlled trial

BackgroundCOMISA is a common disorder that results in nighttime awakenings ,daytime sleepiness and PAP intolerance. Cognitive behavioral therapy for insomnia is used to improve PAP adherence and no medication has been evaluated in such population yet. Melatonin with its chronobiotic and antioxidant effects may have potential benefits on COMISA consequences at the appropriate dose and time. This study aimed to evaluate the effect of melatonin on sleep quality, daytime sleepiness and PAP Compliance in patients with COMISA.MethodsThis double-blind placebo trial randomly assigned eligible OSA patients who suffered from insomnia despite using PAP for over a month to receive either melatonin 10 mg or placebo. The primary outcomes were measured by changes in the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire (FOSQ-10) over one month. Adherence to PAP was measured by the results of the PAP device reports on the average length of time and number of nights that the device was used.ResultsThirty patients were enrolled in the study after randomization. The melatonin arm showed significant improvement in all four primary outcomes compared to the placebo arm. The PSQI score was 3.836±1.839 in the melatonin arm versus 10.522±3.626 in the placebo arm (Pvalue<0.001). The ISI score was 8.476±3.568 in the melatonin arm versus 14.47±4.50 in the placebo arm (Pvalue<0.001). The ESS score was 6.854±4.334 in the melatonin arm versus 13.298±5.119 in the placebo arm (Pvalue<0.001). The FOSQ-10 score was 24.93±5.02 in the melatonin arm versus 19.87±4.24 in the placebo arm (Pvalue= 0.006). Additionally, nighttime consequences such as sleep latency and awakenings showed significant improvement in the melatonin arm. PAP devices results revealed improvement in duration of PAP use overnight. ConclusionsAdministering melatonin has been shown to improve self-reported sleep quality and PAP adherence in patients with COMISA.Trial registrationRegistration number IRCT20220105053635N1 was issued by the Iranian Registry of Clinical Trials (IRCT).