Paradoxical intention as a treatment for insomnia disorder: study protocol for a mixed-methods pilot trial.

INTRODUCTION: Paradoxical intention (PI) is an insomnia treatment developed in the 1970s, which instructs patients to gently attempt to remain awake while in bed at night with the lights off. Previous research indicates PI's potential in improving insomnia, although no study has been conducted in the last few decades during which the insomnia diagnostic criteria have changed. Additionally, there are knowledge gaps regarding outcomes related to wake after sleep onset, the treatment mechanisms as well as the acceptability and feasibility of the treatment. This study therefore aims to address these gaps by assessing the potential mechanisms, preliminary efficacy, and patient experience and acceptability of PI. METHODS AND ANALYSIS: We aim to include 40 adult participants with insomnia, aged 18 and above, from the Swedish general population. In this uncontrolled pilot study using a mixed-methods approach, both qualitative and quantitative data will be collected. The trial will be conducted on a self-help online platform, accessible from participants' homes, with weekly phone call support by therapists. Process and outcome measures will be assessed weekly across a 4-week intervention period and at a 3-month follow-up. A subset of participants will be asked to participate in qualitative semistructured interviews regarding the treatment. ETHICS AND DISSEMINATION: Ethical approval for this project has been granted by the Swedish Ethical Review Authority (Dnr: 2023-06594-01). All participants will sign informed consent forms on a web service application prior to enrolment. From this mixed-methods study, we anticipate insights into the preliminary efficacy and mechanisms of paradoxical intention for treating insomnia, enriched by patient experience data. Results will be disseminated through peer-reviewed publications. The findings will inform adaptations to the treatment protocol and serve as groundwork for a possible larger scale randomised controlled trial. TRIAL REGISTRATION NUMBER: NCT06259682.

Knowledge, attitude, and practice of chronic insomnia management among general practitioners in China: a cross-sectional survey.

BACKGROUND: Chronic insomnia is a common yet often overlooked issue in primary health care. This study investigated the knowledge, attitude, and practices of chronic insomnia management among general practitioners (GPs). METHODS: A cross-sectional online survey was conducted among GPs providing routine care to adults with insomnia in health facilities at all levels in Sichuan Province, China. Additionally, we designed an online questionnaire that included basic information and knowledge, attitudes, and practices regarding chronic insomnia management. RESULTS: We included 420 GPs, 66.2% of whom were female and 58.1% were from community health service centers. Total 198 (47.1%) GPs had received specific training and only 2 GPs (0.5%) correctly answered the knowledge-related questions. Furthermore, only 44 GPs (10.5%) demonstrated excellent practice behaviors, while most GPs (70.2%) expressed high demand for training in insomnia management. Insomnia training experience was associated with higher practice scores (ß = 3.318, p < 0.001). CONCLUSION: This study established an association and correlation between knowledge, attitude, and practice scores in treating insomnia and the sociodemographic characteristics of GPs in China. Although knowledge and practice performance in this field need to be improved, they mostly displayed a positive attitude towards insomnia management. Thus, offering continuing education opportunities to GPs would be highly beneficial.

The effect of MIND diet on sleep status, anxiety, depression, and cardiometabolic indices in obese diabetic women with insomnia: study protocol for a randomized controlled clinical trial {1}.

BACKGROUND: The Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet is a plant-based and anti-inflammatory diet that has the ability to protect and manage cardiovascular and nervous system diseases. Regarding that insomnia and cardiovascular problems are x`common in type 2 diabetes mellitus (T2DM), the present study will assess the effectiveness of the MIND dietary pattern on sleep quality, cardiometabolic indicators, and other psychological indicators. METHODS: Forty-four overweight/obese T2DM women with insomnia, aged 30-65 years, will voluntarily participate in this randomized controlled trial and will be randomized to receive either a MIND low-calorie diet (MLCD) or a low-calorie diet (LCD) over a 3-month period. Before and after the study, sleep quality, some biochemical and cardiometabolic indices, cortisol, brain-derived neurotrophic factor (BDNF), high-sensitivity C-reactive protein (hs-CRP), and oxidative stress indicators will be assessed. DISCUSSION: The use of dietary interventions in the management of T2DM complications is practical and safe. This research seeks to investigate the capacity of the MIND diet in the management of insomnia and cardiovascular problems of DM. It is expected that the results of this research will provide new perspectives on using an ideal dietary regimen to treat these health conditions. TRIAL REGISTRATION: IRCT20181111041611N8. Registered on August 7, 2023. https://www.irct.ir/trial/71772.

Efficacy and safety of auricular acupressure on reduction of estazolam in patients with insomnia: a study protocol for a three-arm, blinded randomized controlled trial.

BACKGROUND: Drug-dependent insomnia refers to insomnia patients taking sedatives and sleeping pills regularly for a long period. Auricular acupressure (AA) has attracted growing attention as a complementary treatment for insomnia. Nevertheless, there is a lack of rigorous studies evaluating AA specifically for estazolam-dependent insomnia. Our proposed trial aims to assess the therapeutic effect of AA on estazolam-dependent insomnia. METHODS: This study is a randomized, single-blinded, three-arm controlled trial. No less than 108 participants will be randomized into one of three groups: AA group, sham auricular acupressure (SAA) group, and conventional dosage reduction group. All treatments will be administered for 4 weeks, with a follow-up period of 1 month. The primary clinical outcomes will be estazolam dosing and reduction rates, serum gamma-aminobutyric acid (GABA) and cortisol (CORT) levels. Secondary outcomes will concern the Pittsburgh sleep quality index (PSQI) and Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ). Both intention-to-treat and per-protocol analyses will be performed, with the significance level determined as 5%. DISCUSSION: The study results will provide evidence on the efficacy and safety of AA in managing estazolam-dependent insomnia by analyzing its immediate effect, time-effect relationship, and reduction of estazolam use. TRIAL REGISTRATION: Clinicaltrials.gov (identification number: NCT06258226; Registered 5 February 2024, https://clinicaltrials.gov/ct2/show/NCT06258226 ).

Applicability of a digital health application for cancer patients: a qualitative non-participation analysis.

BACKGROUND: The use of digital health applications (German acronym DiGA) for comprehensive patient care is increasing rapidly. Patients with non-organic insomnia can be prescribed an application to manage insomnia. Due to the high prevalence of insomnia in patients with cancer, we were interested in the effect of it and what barriers need to be overcome for its use. The focus of existing studies on acceptance and benefits prompted us to emphasise the analysis of barriers and thus to formulate possible solutions. METHODS: To analyse the barriers of use, the study population (patients with self-reported tiredness or sleep disturbance via validated instruments and cancer disease) was divided into 3 groups. In groups 1 (patients who refused to participate in advance) and 2 (patients who refused a prescription), short close-ended questionnaires were used for non-response assessment by treating oncologists. Problem-centred guidelines were used for the telephone interviews with group 3 (patients who did not provide information on DiGA use). Alternatively, group 3 was invited to complete and return the close-ended questionnaire. A quantitative analysis of the non-response reasons was conducted using SPSS in groups 1 and 2, while MAXQDA was used for the qualitative data in group 3. RESULTS: Patients refused to participate at several stages of our study. Quantitative data are available for groups 1 and 2. In the largest group 1, 62% of patients refused to participate due to non-subjective sleep disturbance (177 out of 189 patients) during recruitment by treating oncologists, despite high scores on the screening tool. In the small group 2 (11 out of 15), the most common reasons for withdrawal documented by the oncologists were loss of interest and deteriorating health. The problem-centred qualitative interviews with group 3 (17 patients) revealed that some of them used the prescribed DiGA, despite not being included in the main study and being categorized as lost to follow-up. CONCLUSION: Analysis of barriers to DiGA use showed that reducing administrative barriers and providing digital and personal support can increase acceptance of the use of DiGAs among cancer patients. Additionally, screening tools can act as a door opener to further communication regarding DiGAs. TRIAL REGISTRATION: German Register of Clinical Trials DRKS00034198, registration date: 7/05/24 (retrospectively registered).

Insomnia in Adults in the Primary Care Clinic Setting.

Insomnia is one of the most common sleep concerns raised by patients both to primary care as well as sleep specialists. Chronic insomnia has a lifetime prevalence of approximately 30% in the general population, resulting in roughly $100 billion dollars healthcare expenditures annually. Given the complexity of insomnia this can become burdensome for primary care providers. In this article we will highlight the main issues and how to manage these individuals in the primary care clinic.

Exploring the Role of Mobile Apps for Insomnia in Depression: Systematic Review.

BACKGROUND: The COVID-19 pandemic has profoundly affected mental health, leading to an increased prevalence of depression and insomnia. Currently, artificial intelligence (AI) and deep learning have thoroughly transformed health care-related mobile apps, offered more effective mental health support, and alleviated the psychological stress that may have emerged during the pandemic. Early reviews outlined the use of mobile apps for dealing with depression and insomnia separately. However, there is now an urgent need for a systematic evaluation of mobile apps that address both depression and insomnia to reveal new applications and research gaps. OBJECTIVE: This study aims to systematically review and evaluate mobile apps targeting depression and insomnia, highlighting their features, effectiveness, and gaps in the current research. METHODS: We systematically searched PubMed, Scopus, and Web of Science for peer-reviewed journal articles published between 2017 and 2023. The inclusion criteria were studies that (1) focused on mobile apps addressing both depression and insomnia, (2) involved young people or adult participants, and (3) provided data on treatment efficacy. Data extraction was independently conducted by 2 reviewers. Title and abstract screening, as well as full-text screening, were completed in duplicate. Data were extracted by a single reviewer and verified by a second reviewer, and risk of bias assessments were completed accordingly. RESULTS: Of the initial 383 studies we found, 365 were excluded after title, abstract screening, and removal of duplicates. Eventually, 18 full-text articles met our criteria and underwent full-text screening. The analysis revealed that mobile apps related to depression and insomnia were primarily utilized for early detection, assessment, and screening (n=5 studies); counseling and psychological support (n=3 studies); and cognitive behavioral therapy (CBT; n=10 studies). Among the 10 studies related to depression, our findings showed that chatbots demonstrated significant advantages in improving depression symptoms, a promising development in the field. Additionally, 2 studies evaluated the effectiveness of mobile apps as alternative interventions for depression and sleep, further expanding the potential applications of this technology. CONCLUSIONS: The integration of AI and deep learning into mobile apps, particularly chatbots, is a promising avenue for personalized mental health support. Through innovative features, such as early detection, assessment, counseling, and CBT, these apps significantly contribute toward improving sleep quality and addressing depression. The reviewed chatbots leveraged advanced technologies, including natural language processing, machine learning, and generative dialog, to provide intelligent and autonomous interactions. Compared with traditional face-to-face therapies, their feasibility, acceptability, and potential efficacy highlight their user-friendly, cost-effective, and accessible nature with the aim of enhancing sleep and mental health outcomes.

SoundMind Trial: a study protocol for a randomised controlled trial for online acceptance and commitment therapy and sound therapy for tinnitus.

INTRODUCTION: Tinnitus is a common ailment that affects 10%-15% of adults worldwide. Comorbidities associated with tinnitus often include hearing loss, emotional distress and sleep disorders, with insomnia being a common issue among patients with tinnitus. Audiological and psychological approaches are typically used to treat chronic subjective tinnitus, with the combination of sound therapy and cognitive-behavioural therapy-based counselling having the strongest evidence for effectiveness. Acceptance and commitment therapy (ACT) has also shown promising effects in reducing the impact of tinnitus when delivered in groups or online. However, there is a lack of evidence on the effects of combining ACT with sound therapy for patients with tinnitus-related insomnia. Therefore, this study aims to compare the efficacy of internet-delivered ACT combined with sound therapy versus sound therapy alone for tinnitus in a superiority, two-arm randomised controlled trial. METHODS AND ANALYSIS: A total of 164 patients with chronic subjective tinnitus and insomnia will be randomised to receive internet-delivered guided self-help tinnitus treatment based on ACT combined with tailored sound therapy or tailored sound therapy alone. The primary outcome is the variation in Tinnitus Handicap Inventory scores observed 2 months after randomisation between the two study groups. Secondary outcomes will include insomnia severity, sleep parameters, tinnitus loudness, tinnitus acceptance, depression and anxiety. The outcomes will be assessed at 2, 3 and 6 months post randomisation. ETHICS AND DISSEMINATION: The study is approved by the review board and ethics committee of the Eye and ENT Hospital of Fudan University (approval number: 2023066-1). The findings will be disseminated through presentations at relevant conferences and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05963542.

Insomnia as a predictor of treatment outcomes in adolescents receiving concentrated exposure treatment for OCD.

BACKGROUND: Research suggests that individuals with obsessive-compulsive disorder (OCD) frequently experience insomnia. Some previous studies have suggested that insomnia may predict treatment outcomes, but the evidence is limited, especially for adolescents. This study examined the prevalence of insomnia in an adolescent OCD patient sample, explored the correlation between OCD and insomnia, and tested whether levels of insomnia at baseline predict outcomes for adolescent patients receiving the Bergen 4-Day Treatment (B4DT) for OCD. METHODS: Forty-three adolescent OCD patients who received B4DT were selected for this study. Treatment outcome was quantified as change in Children Yale-Brown Obsessive Compulsive Scale (CY-BOCS) scores across time from pre- to posttreatment and 3-month follow-up. Insomnia symptoms were measured by the Bergen Insomnia Scale (BIS). Linear mixed models were used to examine the relationship between the BIS and changes in CY-BOCS scores. We controlled for symptoms of general anxiety disorder measured by the GAD-7 and depression symptoms measured by the PHQ-9. RESULTS: In this sample, 68.4% of the patients scored above the cutoff for insomnia on the BIS. There was a moderate correlation between baseline CY-BOCS and BIS that did not reach statistical significance (r = .32, p = .051). High BIS scores before treatment were significantly associated with poorer treatment outcomes, as measured by changes in CY-BOCS over time (p = .002). The association between baseline insomnia and change in OCD symptoms remained significant (p = .033) while controlling for GAD-7 and PHQ-9. CONCLUSION: Insomnia is common among adolescents with OCD, and these data suggest that these patients may be at increased risk for poor treatment outcomes. Future research to explore mechanisms and adjunctive treatments is warranted. TRIAL REGISTRATION: The study was approved by the Regional Committee for Medical and Health Research Ethics of Northern Norway (REK Nord: 2023/606482).

The Efficacy of Internet-Based Cognitive Behavioral Therapy for Patients With Breast Cancer: A Systematic Review and Meta-Analysis.

OBJECTIVE: To systematically review and analyze the effects of Internet-based cognitive behavioral therapy (ICBT) on physical, psychological, and daily life outcomes in patients with breast cancer. METHODS: Relevant studies were retrieved from Wanfang, CBM, CNKI, CINAHL, PsycINFO, Web of Science, The Cochrane Central Register of Controlled Trials, Embase and PubMed from inception to December 2023. Two independent authors conducted the literature search and data extraction. The Cochrane bias risk assessment tool was used to evaluate the included studies for methodological quality, and the data analysis was performed using Stata (Version 15.0). RESULTS: Among 700 records, 11 randomized controlled trials were identified in this study. The meta-analysis showed statistically significant effects of ICBT on depression (standardized mean difference (SMD) = -0.38, 95% confidence interval (CI): -0.70 to -0.06, P = .019) and insomnia severity (SMD = -0.71, 95% CI: -1.24 to -0.19, P = .008). However, there were no statistically significant effects on anxiety, fatigue, sleep quality and quality of life. CONCLUSIONS: ICBT appears to be effective for improving depression and reducing insomnia severity in patients with breast cancer, but the effects on anxiety, fatigue, sleep quality and quality of life are non-significant. This low-cost treatment needs to be further investigated. More randomized controlled trials with a larger sample size, strict study design and multiple follow-ups are required to determine the effects of ICBT on patients with breast cancer.

[Brian effects of electroacupuncture on sleep quality and cognitive function in patients with insomnia related to cerebral infarction].

OBJECTIVE: To observe the effects of electroacupuncture (EA) on sleep quality, sleep structure, and cognitive function in patients with insomnia related to cerebral infarction, and to explore the brain effect mechanism of EA on insomnia related to cerebral infarction. METHODS: Thirty-six patients with insomnia related to cerebral infarction were randomly divided into an EA group (18 cases, 1 case was eliminated and 1 case dropped out) and a sham acupuncture group (18 cases, 1 case was eliminated and 2 cases dropped out). Both groups received conventional treatment for cerebral infarction. The EA group received EA at Sishencong (EX-HN 1) with continuous waves at a frequency of 2 Hz, at an intensity tolerable to the patient. The sham acupuncture group received sham acupuncture at non-acupoints with the same EA parameters but electrical stimulation was interrupted after 30 s. Both groups were treated for 20 min each session, once daily, 5 days per week, for a total of 4 weeks. Pittsburgh sleep quality index (PSQI), Montreal cognitive assessment-basic (MoCA-B) scores, and short-term memory (STM) encoding test accuracy and average reaction time were observed before and after treatment in the two groups. Polysomnography (PSG) was used to evaluate sleep structure, and electroencephalogram (EEG) data were collected to observe the standardized power value of the Theta frequency band before and after treatment. RESULTS: Compared with before treatment, PSQI score was decreased and MoCA-B score was increased in the EA group after treatment (P<0.001); the EA group had lower PSQI score and higher MoCA-B score than those in the sham acupuncture group (P<0.001, P<0.01). Compared with before treatment, STM encoding test accuracy was increased and average reaction time was shortened in the EA group after treatment (P<0.01, P<0.001); sleep efficiency (SE) was increased (P<0.01), total sleep time (TST), REM, and N3 stages were prolonged (P<0.01, P<0.05), and sleep latency (SL) was shortened (P<0.01). The standardized power value of the Theta frequency band in EEG channels F3, C3, C4, O1 and O2 was decreased (P<0.05). After treatment, the EA group had higher STM encoding test accuracy, shorter average reaction time (P<0.05), higher SE (P<0.01), longer TST, REM and N3 stages (P<0.01), and shorter SL (P<0.01) than those in the sham acupuncture group. There was no statistically significant difference in the standardized power value of the Theta frequency band between the two groups (P>0.05). CONCLUSION: EA could regulate sleep quality and structure in patients with insomnia related to cerebral infarction, and improve cognitive function, possibly related to the reduction of slow-wave activity in EEG.

[Investigation on cognition for insomnia and preference for acupuncture in breast cancer survivors: a in-depth interview study].

OBJECTIVE: To understand the cognition for insomnia and preference for acupuncture in breast cancer survivors based on the in-depth interview. METHODS: Thirty breast cancer survivors with insomnia symptoms were collected for in-depth interview. The interview questions included three aspects, i.e. sleep expectation, cognition for insomnia (discomfort caused by insomnia, and underlying inducing factors of insomnia) and the preference for acupuncture (treatment methods used in the past, the reasons for not choosing acupuncture, and the tendency of acupuncture treatment). Using Colaizzi content analysis method, the data was analyzed. RESULTS: Regarding sleep expectation, most breast cancer survivors with insomnia symptoms were able to maintain normal activity in daytime. Insomnia symptoms often led to fatigue, and the inducing factors of insomnia referred to the treatment with endocrine therapy, anticipatory anxiety and inadequate sleep hygiene. All of the patients had received pharmacotherapy. The use proportion of non-pharmacological therapies was relatively low, and acupuncture was not chosen due to "not familiar with" and "fear of pain". Concerning to the preference for acupuncture, patients preferred the therapeutic methods of acupuncture with mild pain sensation and gentle stimulation; and the treatment should be more acceptable if delivered 2 or 3 times a week. CONCLUSION: Breast cancer survivors have the expectations for sleep, and are willing to receive the treatment with medication for their sleep disorders. Because of lack of the knowledge for acupuncture effect on insomnia and fear of strong needling sensation, a part of patients are unwilling to be treated with acupuncture therapy, but they are expected to receive the treatment with acupuncture while feeling more comfortable.

Voice-Activated Cognitive Behavioral Therapy for Insomnia: A Randomized Clinical Trial.

Importance: Insomnia symptoms affect an estimated 30% to 50% of the 4 million US breast cancer survivors. Previous studies have shown the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), but high insomnia prevalence suggests continued opportunities for delivery via new modalities. Objective: To determine the efficacy of a CBT-I-informed, voice-activated, internet-delivered program for improving insomnia symptoms among breast cancer survivors. Design, Setting, and Participants: In this randomized clinical trial, breast cancer survivors with insomnia (Insomnia Severity Index [ISI] score >7) were recruited from advocacy and survivorship groups and an oncology clinic. Eligible patients were females aged 18 years or older who had completed curative treatment more than 3 months before enrollment and had not undergone other behavioral sleep treatments in the prior year. Individuals were assessed for eligibility and randomized between March 2022 and October 2023, with data collection completed by December 2023. Intervention: Participants were randomized 1:1 to a smart speaker with a voice-interactive CBT-I program or educational control for 6 weeks. Main Outcomes and Measures: Linear mixed models and Cohen d estimates were used to evaluate the primary outcome of changes in ISI scores and secondary outcomes of sleep quality, wake after sleep onset, sleep onset latency, total sleep time, and sleep efficiency. Results: Of 76 women enrolled (38 each in the intervention and control groups), 70 (92.1%) completed the study. Mean (SD) age was 61.2 (9.3) years; 49 (64.5%) were married or partnered, and participants were a mean (SD) of 9.6 (6.8) years from diagnosis. From baseline to follow-up, ISI scores changed by a mean (SD) of -8.4 (4.7) points in the intervention group compared with -2.6 (3.5) in the control group (P < .001) (Cohen d, 1.41; 95% CI, 0.87-1.94). Sleep diary data showed statistically significant improvements in the intervention group compared with the control group for sleep quality (0.56; 95% CI, 0.39-0.74), wake after sleep onset (9.54 minutes; 95% CI, 1.93-17.10 minutes), sleep onset latency (8.32 minutes; 95% CI, 1.91-14.70 minutes), and sleep efficiency (-0.04%; 95% CI, -0.07% to -0.01%) but not for total sleep time (0.01 hours; 95% CI, -0.27 to 0.29 hours). Conclusions and Relevance: This randomized clinical trial of an in-home, voice-activated CBT-I program among breast cancer survivors found that the intervention improved insomnia symptoms. Future studies may explore how this program can be taken to scale and integrated into ambulatory care. Trial Registration: ClinicalTrials.gov Identifier: NCT05233800.

Cognitive behavioral therapy for insomnia to treat major depressive disorder with comorbid insomnia: A systematic review and meta-analysis.

OBJECTIVE: Cognitive behavioral therapy for insomnia (CBT-I) has demonstrated efficacy for both insomnia and depression. With a tenfold increase in expected participant numbers, we aimed to update the systematic review and meta-analysis of CBT-I for major depressive disorders (MDD). METHODS: Multiple databases were searched up to March 27th 2024 to include all randomized controlled trials examining CBT-I among adults with MDD. The certainty of evidence was evaluated using GRADE. The primary outcome was depression response at post-treatment. Secondary outcomes included insomnia remission and all-cause dropout at post-treatment. Frequentist random-effects pairwise meta-analyses were performed using odds ratio (OR) for dichotomous outcomes. This study was prospectively registered (https://osf.io/kcndz/). RESULTS: Nineteen trials with 4808 randomized participants were identified (mean age, 33.2 [standardized deviation 15.0] years, 73.2 % women. Mean Insomnia Severity Index 19.2 [5.4], median Patient Health Questionnaire-9 16 [range, 8-21]). CBT-I was more beneficial than control conditions for depression response (OR 2.28 [95 % Confidence Interval (CI), 1.67-3.12; GRADE certainty of evidence: moderate), insomnia remission (OR 3.57 [95%CI, 2.48-5.14]: moderate) but could lead to more dropout (OR 1.69 [95%CI, 0.98-2.89]: low). Depression improvement was seen beyond the sleep domain. With a control condition depression response rate of 17 % at post-treatment (median 8 weeks), CBT-I yielded a 32 % response rate (95 % CI, 26 %-39 %). CONCLUSIONS: This meta-analysis indicates that CBT-I has significant effects on depressive symptoms beyond the sleep domain among people with MDD. Despite higher dropout rates, these findings suggest CBT-I is an effective treatment for depression comorbid with insomnia.

Efficacy and safety of acupuncture for the treatment of insomnia in breast cancer patients: A systematic review and meta-analysis.

BACKGROUND: Breast cancer-related insomnia is one of the most common symptoms in patients with breast cancer, and acupuncture has been increasingly used in the treatment. However, there has been no meta-analysis that specifically explores the efficacy and safety of acupuncture in treating insomnia related to breast cancer. OBJECTIVE: The aim of this review was to systematically analyze the existing literature through a meta-analysis to evaluate the effectiveness and safety of acupuncture for breast cancer-related insomnia. METHODS: Six medical databases were comprehensively searched for previous randomized controlled trials (RCTs) up to April 2024. The Pittsburgh Sleep Quality Index (PSQI) score was the primary outcome. The secondary outcomes include the Insomnia Severity Index (ISI), Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), Total Sleep Time (TST), and Sleep Efficiency (SE), and the later four outcomes were measured by Actiwatch and sleep diary, respectively. RESULTS: A total of seven articles with 434 participants were included. The meta-analysis revealed that acupuncture produced a significant improvement in the total PSQI score (MD 95 %CI = -2.16[-2.88, - 1.45], P < 0.001), but had no statistical significance on ISI scores compared with controls (MD 95 %CI = -1.53[-3.97, 0.91], P = 0.22). From the Actiwatch, there was no substantial disparity observed in the enhancement of Sleep Onset Latency (SOL) (MD 95 %CI = -6.40[-13.19, 0.39], P = 0.06), Wake After Sleep Onset (WASO) (MD 95 %CI = -1.45[-7.09, 4.20], P = 0.62), or Total Sleep Time (TST) (MD 95 %CI = 3.54 [-4.71, 11.79], P = 0.40) between the experimental group and the control group. However, a significant distinction was observed in Sleep Efficiency (SE) improvement (MD 95 %CI = 2.43 [0.14, 4.72], P = 0.04). From the sleep diary, there was a significant difference in the amelioration of SOL (MD 95 %CI = -9.15[-16.48, - 1.81], P = 0.01), TST (MD 95 %CI = 29.92 [16.74, 43.10], P < 0.001), and SE (MD 95 %CI = 4.57 [1.92, 7.23], P = 0.0007) between the experimental group and the control group. However, no significant divergence was observed in the improvement of WASO (MD 95 %CI = 4.53[-4.81, 13.87], P = 0.34). All reported acupuncture-related adverse events were mild in severity. CONCLUSIONS: Acupuncture can partially alleviate insomnia symptoms in breast cancer patients. Moreover, acupuncture is safe and may serve as a dependable alternative therapy in clinical settings. Owing to the limited number of studies included, potential biases of heterogeneous interventions, and methodological weaknesses of long-term follow-up, more high-quality RCTs with large sample sizes should be conducted to evaluate acupuncture treatment.

Mindfulness-based therapy for insomnia in Black women: a pilot randomized controlled trial.

The purpose of the study was to evaluate the feasibility, acceptability, and preliminary efficacy of mindfulness-based therapy for insomnia (MBT-I) among Black women. The MBT-I group received weekly sessions that included mindfulness meditation and behavioral sleep strategies. The time and attention control group received lifestyle health education (HE) that included healthy eating, physical activity, and sleep hygiene. The primary outcome was post-intervention changes in insomnia severity score by the Insomnia Severity Index (ISI) at week 10. Other measures included: Pittsburgh Sleep Quality Index, Sleep Hygiene Practice, Spielberger State-Trait Anxiety Inventory (STAI), and Patient Health Questionnaire-9 (PHQ-9). Objective sleep was measured by Actiwatch™ at baseline and week 10. Thirty Black women completed the interventions with no attrition. About 97% of all participants attended 6-8 out of 8 sessions. The ISI scores were reduced at week 10 (MBT-I vs. HE: -7.67 vs. -7.22, p < .05). Anxiety and depression symptoms were significantly improved only in the MBT-I group. This is the first MBT-I for Black women with insomnia. Online MBT-I may be feasible and acceptable for Black women. The MBT-I and HE showed a clinically significant improvement in insomnia symptoms (ISI reduction > 7). MBT-I may be more effective in improving anxiety and depression symptoms than HE. Our findings encourage further study efforts with a longer follow-up and larger sample size to address sleep health disparities among Black women.

Acute Augmented Effect of Virtual Reality (VR)-Integrated Relaxation and Mindfulness Exercising on Anxiety and Insomnia Symptoms: A Retrospective Analysis of 103 Anxiety Disorder Patients With Prominent Insomnia.

BACKGROUND: Anxiety disorder is one of the most common mental disorders and often accompanied with sleep disturbance which can in turn exacerbate anxiety symptoms, creating a vicious cycle. In addition to psychopharmacological therapy, the effectiveness of psychotherapy as cognitive behavioral therapy (CBT) for treating anxiety disorders and insomnia has been well documented and widely accepted, but it is labor-intensive and costly. However, virtual reality (VR)-integrated CBT may improve this condition but needs more evidences to support its extensive application in routine clinical practice. OBJECTIVES: This explorative study was aimed to conduct a retrospective analysis to evaluate the acute (2 weeks) augmented effect of VR-integrated relaxation and mindfulness exercising in improving anxiety and insomnia symptoms for patients who were diagnosed with anxiety disorders and concurrently with prominent insomnia symptoms and admitted to the Department of Psychiatry, The Affiliated Guangdong Second Provincial General Hospital of Jinan University during January 2021 to June 2021. METHODS: All patients who were admitted to the department of psychiatry during January 1, 2021 to June 30, 2021 were screened with inclusion criteria and exclusion criteria, and the sociodemographic and clinical data of those included patients were collected from the electronic medical record system of the hospital using a self-designed case report form (CRF). Subjects who were administrated with medication alone were designated as conventional group, and those receiving treatment of medication combined with VR-integrated CBT (VR relaxation and mindfulness exercising) as VR group. The baseline and 2-week posttreatment data were compared between the two groups. RESULTS: In total, there were 103 patients (70 female, 68%) included in the study. Among all, 68 (66.02%) were designated as the "VR group," and 35 (33.98%) as the "conventional group." The majority of patients (67%) were diagnosed with generalized anxiety disorder (GAD). Twenty-three (22.3%) patients had a comorbid diagnosis with primary insomnia, and insomnia was just one of the accompanying symptoms with anxiety for the rest 80 subjects. No statistically significant differences were found between VR and conventional groups in all baseline sociodemographic and clinical characteristics except for occupation. There were statistically significant differences for the remission rates of anxiety symptoms or insomnia symptoms and reduction of Hamilton Anxiety Rating Scale or Insomnia Severity Index total scores between conventional and VR groups. Greater remission rates or score reductions were found in VR group than in conventional group either for anxiety or for insomnia. Robust differences still existed when controlled for the variable "occupation." CONCLUSIONS: Two-week augmented VR-integrated relaxation and mindfulness exercising is acutely beneficial for relieving both anxiety and insomnia symptoms and worth being recommended for routine clinical practice. Further prospective and randomized study compared to traditional CBT to explore its acute and long-term effect on anxiety and insomnia is needed.

The Association Between Sleep Disturbances and Perceived Stress in Substance Use Disorder Treatment.

Abstract.Introduction: Sleep disturbances and elevated stress levels are commonly reported among individuals seeking treatment for substance use disorders (SUDs). However, it remains unclear whether the relationship between sleep and stress differs based on the primary substance of use or if there are commonalities across different substances. This study aimed to investigate the association between sleep disturbances and perceived stress among individuals in SUD treatment and examine whether primary substance influences this relationship.Method: A sample of 4,201 individuals from 59 SUD treatment programs completed assessments including the Insomnia Severity Index and Perceived Stress Scale in 2021. Cross-sectional and longitudinal analyses were conducted to evaluate the relationship between sleep and stress across different primary substances during treatment.Results: The results demonstrated that higher stress was associated with more severe insomnia, and vice versa, both at treatment intake and over the course of treatment, regardless of primary substance. Persons using heroin/ fentanyl evidenced a stronger association of sleep on stress, and persons using cocaine evidenced a stronger relationship of stress on sleep.Discussion: The findings suggest that sleep/stress associations are ubiquitous across different classes of drugs, although sleep might have more influence on stress in persons primarily using heroin/ fentanyl, and stress might have more influence on sleep in persons primarily using cocaine, relative to other substances. Interventions targeting either sleep or stress could have positive effects on SUD outcomes, but further research is needed to investigate the underlying neurobiological mechanisms and inform the development of effective interventions for sleep and stress in SUD populations.

Older adults exercising ON TIME: protocol for a randomized controlled cross-over study to assess the effect of physical activity timing on insomnia severity.

BACKGROUND: There are increased indications that physical activity timing, irrespective of intensity, impacts insomnia and circadian clock function. Here, we describe the rationale and design of a randomized cross-over study, called ON TIME, to examine the effects of (changing) physical activity timing on insomnia severity and on multiple exploratory outcomes that are linked to circadian clock function. METHODS: We will conduct a randomized cross-over trial in 40 healthy older adults (aged 65 to 75 years) with subclinical or clinical insomnia (Insomnia Severity Index (ISI) scores of ≥ 10) from the Dutch municipality of Leiden and surroundings. Participants will undergo 3 intervention periods (14 days each) consecutively: one sedentary period and two periods of increased physical activity (one period with morning activity and one period with evening activity). The intervention periods are separated by a wash-out period of 1 week. In both active intervention arms, participants will follow coached or uncoached outdoor physical exercise sessions comprising endurance, strength, and flexibility exercises for 14 days. The primary outcome is change in insomnia severity as measured by the ISI. Additional exploratory outcomes include multiple components of objective sleep quality measured with tri-axial accelerometry and subjective sleep quality assessed by questionnaires as well as dim light melatonin onset and 24-h rhythms in heart rate, heart rate variability, breathing rate, oxygen saturation, mood, and objective emotional arousal and stress. Additionally, we will collect diary data on eating patterns (timing and composition). Finally, fasting blood samples will be collected at baseline and after each intervention period for measurements of biomarkers of metabolic and physiological functioning and expression of genes involved in regulation of the biological clock. DISCUSSION: We anticipate that this study will make a significant contribution to the limited knowledge on the effect of physical activity timing. Optimizing physical activity timing has the potential to augment the health benefits of increased physical exercise in the aging population. TRIAL REGISTRATION: Trial was approved by the Medical Ethics Committee Leiden, The Hague, Delft, The Netherlands (June, 2023). The trial was registered in the CCMO-register https://www.toetsingonline.nl/to/ccmo_search.nsf/Searchform?OpenForm under study ID NL82335.058.22 and named ("Ouderen op tijd in beweging" or in English "Older adults exercising on time"). At time of manuscript submission, the trial was additionally registered at ClinicalTrials.gov under study ID: NL82335.058.22 and is awaiting approval.