[Expert consensus on diagnosis and treatment of insomnia disorder in primary medical institutions].

Insomnia disorder is the most common sleep disorder. It not only increases the risk of multiple somatic and mental disorders, but also carries a heavy social health economic burden. Currently, there is a lack of diagnosis and treatment standards for insomnia disorder in primary medical institutions at home and abroad. To this end, the Chinese Sleep Research Society organized domestic sleep medical experts in sleep medicine to develop this consensus based on the latest research on insomnia disorder. The current consensus elaborates on the pathophysiological mechanism, epidemiology, diagnosis, screening assessment, prevention and control measures and basic management, and has established a total of 15 recommendations. These recommendations aim to provide comprehensive and standardized references and guidelines for the diagnosis and treatment of insomnia disorder.

Advancements in the physiopathological study of acupuncture treatment for insomnia: A review.

Insomnia is a common sleep disorder that significantly impacts an individual's psychological and physical health, characterized by persistent difficulties in falling asleep, decreased sleep quality, and impaired daytime functioning. Traditional treatment approaches primarily rely on pharmacotherapy and behavioral therapy, yet not all patients benefit from these methods, and they often come with certain side effects. Thus, identifying safe and effective alternative or adjunctive treatments is of paramount importance. The purpose of this paper is to review the research progress on acupuncture in the treatment of insomnia and to explore the mechanisms by which acupuncture may treat insomnia through regulating neurotransmitters and nervous system, anti-inflammatory actions, and improving neuroplasticity, providing evidence to support the broad application of acupuncture in clinical practice.

Complementary and Integrative Medicine in Treating Headaches, Cognitive Dysfunction, Mental Fatigue, Insomnia, and Mood Disorders Following Traumatic Brain Injury: A Comprehensive Review.

Traumatic brain injury (TBI) is a complex condition associated with a range of persistent symptoms including headaches, cognitive dysfunction, mental fatigue, insomnia, and mood disorders. Conventional treatments for TBI-related symptoms can be insufficient, leading to interest in complementary and integrative medicine (CIM) approaches. This comprehensive article examines the existing literature on CIM modalities, including mind-body interventions, acupuncture/acupressure, herbal remedies, nutritional supplements, biofeedback, yoga, and tai chi in the context of managing secondary complications following TBI. The article highlights potential benefits and limitations of CIM modalities, while acknowledging the need for further research to better establish efficacy and safety in this specific population.

Enhancing sleep quality for adult patients: Interventions and insights.

ABSTRACT: Sleep is critical to a person's physiological and psychological functioning. Approximately 30% to 40% of the general population experiences insomnia, and among patients with mental health conditions, the prevalence of insomnia and other sleep disturbances rises to about 70%. Insomnia is associated with many adverse health issues, including lower immunity, weight gain, elevated BP, and increased mortality, and it is often undiagnosed and either untreated or self-treated. Providers can work together with patients to enact measures-such as implementation of enhanced sleep hygiene, engagement in cognitive behavioral therapy, and treatment of any underlying causes-that can markedly improve patient sleep quality. This article provides an overview of evidence-based best practices and whole-person strategies that NPs can adopt to address poor sleep quality in adult patients, and it serves as a primer for primary care NPs on common presentations of several sleep disorders.

[Pharmacological treatment of posttraumatic stress disorder]. / Pharmakologische Behandlung der Posttraumatischen Belastungsstörung.

In addition to trauma-focussed psychotherapy, pharmacological treatment is often unavoidable, especially in patients with severe posttraumatic stress disorder (PTSD). As long as comorbid disorders do not dictate the pharmacotherapy approach, sertraline and paroxetine, along with other off-label prescribable substances approved in Germany, can be used for the treatment of PTSD. Venlafaxine, in particular, has shown good effectiveness in studies, whereas risperidone has shown lower effectiveness in augmentation. Overall, only a small to medium effect size is to be expected for all substances. Psychopharmacotherapy plays an important role in addressing sleep disorders, which are highly prevalent in PTSD. Treatment of trauma-related nightmares can be attempted with doxazosin or clonidine. In contrast, there are limited empirical data available for sleep disorders associated with PTSD, but the pharmacological treatment of insomnia can provide some guidance.

Comorbid Insomnia and Sleep Apnea: COMISA.

The term "comorbid insomnia and sleep apnea" (COMISA) has been used to categorize the co-occurrence of the most prevalent and impacting sleep disorders. Meanwhile, both insomnia and sleep apnea have been shown to be associated with increased stress levels and cardiometabolic risk, a major cause of mortality. The better knowledge about such convergence would be critical for better understanding pathophysiological pathways and mechanisms. This article provides an overview of epidemiologic aspects, clinical findings, and mechanisms subsiding COMISA. Odontostomatological approach with mandibular advancement devices are discussed as an effective therapeutic approach in these patients.

Sleep health primary care clinical resource.

BACKGROUND: Obstructive sleep apnoea (OSA) and insomnia are the two most common sleep disorders and are frequent reasons for presentation in Australian general practice. OBJECTIVE: 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. DISCUSSION: 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).

[Interaction between depression and insomnia under acupuncture treatment: a secondary analysis of a randomized controlled trial].

OBJECTIVE: To explore the interaction between emotional and insomnia symptom improvement in comorbid depression and insomnia patients treated with optimized acupuncture. METHODS: A secondary analysis was conducted on a multicenter randomized controlled trial of acupuncture treatment for comorbid depression and insomnia. One hundred and forty patients with comorbid depression and insomnia were randomly assigned to an optimized acupuncture group (70 cases, 8 cases dropped out) and a conventional acupuncture group (70 cases, 8 cases dropped out). The patients in the conventional acupuncture group were treated with acupuncture at Yintang (GV 24+), Baihui (GV 20), bilateral Hegu (LI 4) and Taichong (LR 3); the patients in the optimized acupuncture group were treated with additional acupuncture at bilateral Lieque (LU 7), Zhaohai (KI 6), and intradermal needling was applied alternately at bilateral Xinshu (BL 15) and Danshu (BL 19), Shenshu (BL 23) and Anmian (Extra). Both groups received treatments twice a week for six weeks. The Hamilton depression scale-24 (HAMD-24) and Pittsburgh sleep quality index (PSQI) scores were observed before and after treatment for both groups. Mediation analysis was used to assess the mesomeric effect of PSQI and HAMD-24 emotional factors, and latent profile analysis categorized patients into subgroups based on HAMD-24 scores, followed by between-group efficacy comparisons. RESULTS: The indirect effect of the optimized acupuncture on improving depression emotions through PSQI was 3.052 (95%CI [1.407, 4.697]), accounting for 77.5% of the total effect. Conversely, the indirect effect of improving PSQI through the optimized protocol on depression emotions was 0.479 (95%CI [0.024, 0.935]), representing 14.8% of the total effect. Latent profile analysis identified 3 categories based on emotional and insomnia symptoms, and statistically significant differences in efficacy favoring the optimized acupuncture protocol over the conventional acupuncture protocol were observed only in the subgroup with relatively mild depression and insomnia symptoms (PSQI: 95%CI [-10.98, -5.44], P<0.001; HAMD-24: 95%CI [-12.31, -3.73], P =0.001). CONCLUSION: The optimized acupuncture protocol primarily improves insomnia symptoms and further improves depression emotions. Its efficacy advantages are more evident in patients with mild symptoms compared with the conventional acupuncture protocol.

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

BACKGROUND: It 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. METHODS: One-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. RESULTS: Regarding 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. CONCLUSION: This 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.

Efficacy and underlying mechanisms of three-circle post standing qigong on insomnia in college students: a four-arm, double-blind, randomized controlled trial protocol.

BACKGROUND: Insomnia is common in college students, but its impact on health and wellbeing is often neglected. Enhancing sleep quality through targeted interventions could improve overall health and reduce the risk of consequent co-morbidities and mental health problems. Qigong exercises have been shown to significantly improve sleep quality and relieve insomnia. Three-circle Post Standing (TCPS) can help integrate body, breath, and mind, a fundamental principle of Qigong that promotes holistic wellbeing. In this clinical trial, we aim to (1) evaluate the feasibility, safety, and therapeutic efficacy of administering TCPS to improve sleep quality and quality of life in college students with insomnia; (2) explore the neurophysiological mechanisms underlying the mind adjustments mediated by TCPS in insomnia; (3) investigate body and breath pathophysiology mediated by TCPS in insomnia; and (4) assess the long-term efficacy of TCPS in terms of sleep quality and quality of life. METHODS: This will be a prospective, parallel, four-arm, double-blind randomized controlled trial to investigate the effects and underlying mechanisms of TCPS on college students with insomnia. One hundred college students meeting diagnostic criteria for insomnia will be randomly assigned to receive either 14 weeks of standardized TCPS training (two weeks of centralized training followed by 12 weeks of supervised training) or sham-control Post Standing training. Efficacy outcomes including sleep quality, quality of life, neurophysiological assessments, plantar pressure, biomechanical balance, and physical measures will be collected at baseline, eight weeks (mid-point of supervised training), and 14 weeks (end of supervised training). Sleep quality and quality of life will also be evaluated during the four- and eight-week follow-up. DISCUSSION: This trial will be an important milestone in the development of new therapeutic approaches for insomnia and should be easily implementable by college students with insomnia. The neuro- and pathophysiological assessments will provide new insights into the mechanisms underlying TCPS. CLINICAL TRIAL REGISTRATION: This trial has been registered in the China Clinical Trials Registry (registration number: ChiCTR2400080763).

A randomized controlled trial of alpha phase-locked auditory stimulation to treat symptoms of sleep onset insomnia.

Sleep onset insomnia is a pervasive problem that contributes significantly to the poor health outcomes associated with insufficient sleep. Auditory stimuli phase-locked to slow-wave sleep oscillations have been shown to augment deep sleep, but it is unknown whether a similar approach can be used to accelerate sleep onset. The present randomized controlled crossover trial enrolled adults with objectively verified sleep onset latencies (SOLs) greater than 30 min to test the effect of auditory stimuli delivered at specific phases of participants' alpha oscillations prior to sleep onset. During the intervention week, participants wore an electroencephalogram (EEG)-enabled headband that delivered acoustic pulses timed to arrive anti-phase with alpha for 30 min (Stimulation). During the Sham week, the headband silently recorded EEG. The primary outcome was SOL determined by blinded scoring of EEG records. For the 21 subjects included in the analyses, stimulation had a significant effect on SOL according to a linear mixed effects model (p = 0.0019), and weekly average SOL decreased by 10.5 ± 15.9 min (29.3 ± 44.4%). These data suggest that phase-locked acoustic stimulation can be a viable alternative to pharmaceuticals to accelerate sleep onset in individuals with prolonged sleep onset latencies. Trial Registration: This trial was first registered on clinicaltrials.gov on 24/02/2023 under the name Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time (SLEEPFAST), and assigned registry number NCT05743114.

Effectiveness of repetitive transcranial magnetic stimulation for insomnia disorder on fear memory extinction: study protocol for a randomised controlled trial.

BACKGROUND: Fear memory extinction is closely related to insomnia. Repetitive transcranial magnetic stimulation (rTMS) is safe and effective for treating insomnia disorder (ID), and it has been shown to be an efficient method for modulating fear extinction. However, whether rTMS can improve fear extinction memory in ID patients remains to be studied. In this study, we specifically aim to (1) show that 1 Hz rTMS stimulation could improve fear extinction memory in ID patients and (2) examine whether changes in sleep mediate this impact. METHODS AND DESIGN: We propose a parallel group randomised controlled trial of 62 ID participants who meet the inclusion criteria. Participants will be assigned to a real rTMS group or a sham rTMS group. The allocation ratio will be 1:1, with 31 subjects in each group. Interventions will be administered five times per week over a 4-week period. The assessments will take place at baseline (week 0), post-intervention (week 4), and 8-week follow-up (week 8). The primary outcome measure of this study will be the mean change in the Pittsburgh Sleep Quality Index (PSQI) scores from baseline to post-intervention at week 4. The secondary outcome measures include the mean change in skin conductance response (SCR), fear expectation during fear extinction, Insomnia Severity Index (ISI), Zung Self-Rating Anxiety Scale (SAS), and the Zung Self-Rating Depression Scale (SDS). DISCUSSION: This study will be the first examination of the impact of rTMS on fear memory extinction in ID patients. TRIAL REGISTRATION: Chinese Clinical Trials Register ChiCTR2300076097. Registered on 25 September 2021.

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

BACKGROUND: Insomnia 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. METHODS: This 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). DISCUSSION: The 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 REGISTRATION: Trial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.

Promoting sleep health during pregnancy for enhancing women's health: a longitudinal randomized controlled trial combining biological, physiological and psychological measures, Maternal Outcome after THERapy for Sleep (MOTHERS).

BACKGROUND: Sleep is vital for maintaining individuals' physical and mental health and is particularly challenged during pregnancy. More than 70% of women during the gestational period report insomnia symptoms. Sleep dysfunction in the peripartum increases the risk for a cascade of negative health outcomes during late pregnancy, birth, and postpartum. While psychological interventions are considered the first line treatment for sleep difficulties, they are still scarcely offered during pregnancy and there is a lack of longitudinal research combining psychological and physiological indices. METHODS: The present protocol outlines a randomized controlled trial aimed at testing the long-term effectiveness of an automatized digitalized psychoeducational intervention for insomnia for expectant mothers complaining insomnia symptoms without comorbidity. Outcomes include physiological, hormonal, and subjective indices of maternal psychopathology, stress, and emotional processes, and sleep and wellbeing of the family system. The trial is part of a longitudinal study evaluating expectant mothers from early pregnancy (within the 15th gestational week) to 6-months postpartum through 6 observational phases: baseline (BSL), 6- and 12-weeks from BSL (FU1-FU2), 2-to-4 weeks after delivery (FU3), and 3- and 6-months after delivery (FU4-5). We plan to recruit 38 women without sleep difficulties (Group A) and 76 women with sleep difficulties (Group B). Group B will be randomly assigned to digital psychological control intervention (B1) or experimental psychoeducational intervention targeting insomnia (B2). At 3 time points, an ecological-momentary-assessment (EMA) design will be used to collect data on sleep and emotions (diaries), sleep-wake parameters (actigraphy) and stress reactivity (salivary cortisol). We will also test the DNA methylation of genes involved in the stress response as biomarkers of prenatal poor sleep. Information on partner's insomnia symptoms and new-borns' sleep will be collected at each stage. DISCUSSION: The proposed protocol aims at testing an easily accessible evidence-based psychoeducational intervention for expectant mothers to help them improving sleep, health, and wellbeing in the peripartum. The results could improve the understanding and management of sleep difficulties and peripartum depression. TRIAL REGISTRATION: The study protocol has been registered on 22 April 2024 with ClinicalTrials.gov Protocol Registration and Results System (PRS), ID: NCT06379074. PROTOCOL VERSION: April 23, 2024.

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

INTRODUCTION: Insomnia 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 recommended treatment for insomnia is cognitive behavioural therapy (CBT-I). There is some evidence that CBT-I can also be used to treat insomnia in patients with schizophrenia, but only a few randomised controlled trials (RCTs) have been published. The aim of this ongoing RCT is to determine whether we can alleviate symptoms of insomnia and improve the quality of life in patients with schizophrenia and schizoaffective disorder through CBT-I delivered via the internet or in a group mode. METHODS AND ANALYSES: The aim of this study is to recruit 84-120 outpatients from the Psychosis Clinics of Helsinki University Hospital and the City of Helsinki Health Services. The main inclusion criteria are a diagnosis of schizophrenia or schizoaffective disorder and self-reported sleep problems. The study will be performed on a cyclic basis, with a target of 12-24 patients per cycle. Participants are randomly assigned into three groups: (1) a group receiving only treatment as usual (TAU), (2) internet-based individual therapy for insomnia (iCBT-I)+TAU or (3) group therapy for insomnia (GCBT-I) conducted via a virtual platform+TAU. The primary outcome measures are quantitative changes in the Insomnia Severity Index score and/or changes in health-related quality of life using the 15D quality of life measure. Secondary outcomes include self-reported variables for sleep, health, stress and the severity of psychotic and depressive symptoms; objective outcomes include actigraphy and bed sensor data to evaluate circadian rhythms and motor activity. Outcome measures are assessed at baseline and after the treatment period at weeks 12, 24 and 36. ETHICS AND DISSEMINATION: The Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa, Finland, approved the study protocol. The results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04144231.

The effect of cognitive behavioral therapy for insomnia on sleep and glycemic outcomes in people with type 2 diabetes: A randomized controlled trial.

STUDY OBJECTIVES: Investigate whether aiding sleep by online cognitive behavioral therapy for insomnia (CBT-I) can improve glycemic and metabolic control, mood, quality of life (QoL) and insomnia symptoms in people with type 2 diabetes and assess the mediating role of lifestyle factors. METHODS: Adults with type 2 diabetes and insomnia symptoms were randomly assigned to CBT-I or care as usual. At baseline, three and six months we assessed HbA1c as primary outcome and glycemic control, metabolic outcomes, sleep, mood and QoL as secondary outcomes. Mixed models were used to determine within-person and between-persons differences in outcomes and mediation analysis for lifestyle factors. RESULTS: We randomized 29 participants to CBT-I and 28 to care as usual. Intention-to-treat analysis showed no significant differences in glycemic control, metabolic outcomes, anger, distress or QoL, but showed a significantly larger decrease in insomnia (-1.37(2.65: 0.09)) and depressive symptoms (-0.92(-1.77: 0.06)) and increase in BMI (0.29 kg/m2(0.00:0.57)) in the intervention compared to the control group. Only half of the intervention participants completed the CBT-I. Per protocol analysis showed a not statistically significant decrease in HbA1c (-2.10 mmol/l(-4.83:0.63)) and glucose (-0.39 mmol/l(-1.19:0.42)), metabolic outcomes and increase in QoL. Furthermore, the intervention group showed a significant decrease in insomnia (-2.22(-3.65: 0.78)) and depressive symptoms (-1.18(-2.17: 0.19)) compared to the control group. Lifestyle factors partially mediated the effect of the intervention. CONCLUSIONS: CBT-I might improve insomnia symptoms and mood, and perhaps improves glycemic control, albeit not significant, in people with type 2 diabetes and insomnia symptoms, compared to care as usual.

Online acceptance and commitment therapy (iACT) for adults with persistent physical symptoms - 3-month follow-up study of a randomized controlled trial.

OBJECTIVE: Persistent physical symptoms (PPS) represent a major health problem affecting daily functioning. This RCT aimed to examine whether a guided Internet-based treatment based on acceptance and commitment therapy (ACT) provided additional benefits compared to Treatment as Usual (TAU) in reducing somatic complaints and psychological distress in adults with PPS. METHODS: A total of 103 adults with PPS related to indoor environments, chronic fatigue or both conditions were assigned to receive either either a 14-week intervention (video-based case conceptualization + Internet-based ACT) combined with TAU (iACT + TAU; n = 50) or TAU alone (n = 53). Somatic symptoms, depression, anxiety, insomnia, and psychological flexibility were assessed from pre-intervention to a 3-month follow-up. Additionally, the association between changes in psychological flexibility from pre- to post-intervention and changes in symptoms from pre to 3-month follow-up was explored. Analyses were conducted using a multigroup method with full information maximum likelihood estimator. RESULTS: The results revealed a significant interaction effect, indicating reductions in somatic symptoms and symptoms of depression and anxiety with moderate to large between-group effects (d = 0.71-1.09). No significant interaction effect was observed in insomnia and measures of psychological flexibility. CONCLUSION: Internet-based ACT, when combined with Treatment as Usual, demonstrated efficacy for individuals with PPS associated with indoor environments and chronic fatigue. These findings are pertinent for primary healthcare providers, suggesting that the current treatment model could serve as a low-threshold first-line treatment option. THE CLINICAL TRIAL REGISTRATION NUMBER: NCT04532827.

[Cognitive behavioral therapy in the treatment of patients with chronic migraine and concomitant chronic insomnia: a prospective, randomized trial]. / Kognitivno-povedencheskaya terapiya pri khronicheskoi migreni i sochetannoi khronicheskoi insomnii: prospektivnoe randomizirovannoe issledovanie.

OBJECTIVE: To evaluate the effectiveness of a multidisciplinary program, including Cognitive behavioral therapy (CBT), in the treatment of patients with chronic migraine (CM) and concomitant chronic insomnia (CI). MATERIAL AND METHODS: The study included 96 patients with CM and CI, average age 35.7±8.6. All patients underwent clinical interviews and testing using clinical and psychological techniques. Patients were randomized into two groups: group 1 received study treatment (an multudisciplinary program including CBT for pain and insomnia, combined with standard treatment for migraine), group 2 received standard treatment for migraine (preventive and acute pharmacotherapy for migraine, recommendations about lifestyle and sleep hygiene). All patients were assessed for clinical and psychological parameters before treatment and at 3, 6, 12 and 18 months follow-up. RESULTS: At 3 month follow-up a statistically significant improvement was observed in group 1: a decrease in the frequency of headaches and the use of painkillers, parameters on the Insomnia Severity Index (ITI), the State-Trait Anxiety Inventory (STAI), the Beck Depression Inventory, and the Migraine Disability Assessment (MIDAS) (p<0.05). At 6, 12 and 18 months follow-up the achieved improvements were maintained. At 3 month follow-up, group 2 showed a statistically significant improvement in only 4 parameters: a decrease in the frequency of headaches and painkiller use, and parameters for ITI and MIDAS. These parameters increased to values that were not statistically significantly different from the parameters before treatment in group 2 at 6 month follow-up. At 3 month follow-up in group 165% of patients achieved clinical effect (CE) according to CM (headache frequency decreased by 50% or more), in group 2 - 40%, which was not statistically significantly different (p>0.001); in group 1, 76% of patients achieved CE according to CI (ITI decreased by 8 points or more), which is statistically significantly more than in group 2 with 45% of patients with CE (p<0.001). At 18 month follow-up, in group 1, 81.5% of patients achieved CE according to CM, which is statistically significantly more than in group 2 with 33% of patients with CE (p<0.001); in group 1, 85% of patients achieved CE according to CI, which is statistically significantly more than in group 2, where 38% of patients had CE (p<0.001). CONCLUSION: High effectiveness of CBT in patients with CM and combined CI was noted.

Digital cognitive-behavioural therapy application compared with zolpidem for the treatment of insomnia: protocol for an exploratory randomised controlled trial.

INTRODUCTION: Insomnia is a common health problem and cognitive-behavioural therapy (CBT) is recommended as a treatment. As there is a critical shortage of CBT-trained therapists, we developed a digital CBT application (IIIP MED: Sleepy Med) as Software as a Medical Device for insomnia. This paper describes the study protocol for an exploratory randomised controlled trial (RCT) to evaluate effectiveness and safety of our developed digital CBT (dCBT) for 5 weeks compared with zolpidem tartrate for patients with insomnia disorder. METHODS AND ANALYSIS: This proposed multicentre exploratory RCT will be conducted at the outpatient clinic of Chiba University Hospital, Akita University Hospital and Yoyogi Sleep Disorder Center, Japan. The study population comprises two parallel groups (dCBT and zolpidem) consisting of 15 participants each (n=30 in total) diagnosed with insomnia disorder who remain symptomatic at 4 weeks after sleep hygiene education. We will evaluate the effectiveness at baseline, week 5 (post-intervention) and week 10 (follow-up). The primary outcome will be the change of subjective sleep onset latency at week 5 from baseline. Secondary outcomes include sleep-related outcomes, such as objective sleep onset latency measured by mobile electroencephalography, functional improvement during the daytime and quality of life. ETHICS AND DISSEMINATION: Ethics approval was granted by the Institutional Review Board of Chiba University Hospital (K2023001). All participants will be required to provide written informed consent. Results will be published in international journals. TRIAL REGISTRATION NUMBER: jRCT2032230353.

[Management of patients with insomnia and polymorbidity. A draft of the clinical guidelines]. / Vedenie patsientov s insomniei pri polimorbidnoi patologii. Proekt klinicheskikh rekomendatsii. Obshcherossiiskaya obshchestvennaya organizatsiya «Rossiiskoe obshchestvo somnologov¼.

Insomnia is a serious and widespread public health problem, but is often undetected and patients do not receive needed treatment. Insomnia is often comorbid with other diseases and conditions, such as arterial hypertension, type 2 diabetes mellitus, pain syndromes, anxiety and depressive disorders, etc. A separate problem is drug-induced insomnia, when patients develop symptoms due to other diseases treatments. Insomnia has a negative effect on the prognosis of comorbid diseases, including an increased risk of death, more severe disease, and decreased quality of life. The presence of sleep disorders makes it difficult to effectively treat the underlying disease, so clinical guidelines draft for the evaluation and treatment of insomnia in multimorbid patients is proposed. Diagnostic methods are reviewed and recommendations are given for the treatment of acute and chronic insomnia and features of the treatment of insomnia in multimorbid patients. A clinical algorithm has been proposed to determine treatment tactics in multimorbid patients.