Acupuncture for chemotherapy-associated insomnia in breast cancer patients: an assessor-participant blinded, randomized, sham-controlled trial.

BACKGROUND: Insomnia is a highly prevalent symptom occurred during and post-chemotherapy. Acupuncture may have beneficial effects in the management of chemotherapy-associated insomnia. This study was conducted to determine the efficacy and safety of acupuncture in improving chemotherapy-associated insomnia in breast cancer patients. METHODS: This assessor-participant blinded, randomized, sham-controlled trial was conducted from November 2019 to January 2022 (follow-up completed July 2022). Participants were referred by oncologists from two Hong Kong hospitals. Assessments and interventions were conducted at the outpatient clinic of School of Chinese Medicine, the University of Hong Kong. The 138 breast cancer patients with chemotherapy-associated insomnia were randomly assigned to receive either 15 sessions of active acupuncture regimen by combining needling into body acupoints and acupressure on auricular acupoints or sham acupuncture control (69 each) for 18 weeks, followed by 24 weeks of follow-up. The primary outcome was measured using Insomnia Severity Index (ISI). Secondary outcomes included the Pittsburgh Sleep Quality Index, Actiwatch and sleep diary for sleep parameters, depression and anxiety, fatigue and pain, and quality of life. RESULTS: There were 87.7% (121/138) participants who completed the primary endpoint (week-6). The active acupuncture regimen was not superior to the sham control in reducing ISI score from baseline to 6 weeks (mean difference: - 0.4, 95% CI - 1.8-1.1; P = 0.609), but produced short-term treatment and long-term follow-up better outcomes in improving sleep onset latency, total sleep time, sleep efficiency, anxiety, depression, and quality of life. Participants of the active acupuncture group had a pronouncedly higher cessation rate of sleeping medications than the sham control (56.5% vs. 14.3%, P = 0.011). All treatment-related adverse events were mild. No participants discontinued treatments due to adverse events. CONCLUSION: The active acupuncture regimen could be considered as an effective option for the management of chemotherapy-associated insomnia. It also could serve as a tapering approach to reduce and even replace the use of sleeping medications in breast cancer patients. Trial registration Clinicaltrials.gov : NCT04144309. Registered 30 October 2019.

Effects of Tai Chi and cognitive behavioral therapy for insomnia on improving sleep in older adults: Study protocol for a non-inferiority trial.

Background: Insomnia is a prevailing health problem among older adults. Tai Chi, a popular mind-body exercise practiced by older people in various oriental communities, has been shown to improve sleep. However, Tai Chi has not been directly compared to cognitive behavioral therapy for insomnia (CBT-I), which is the first-line non-pharmacological treatment for insomnia in older adults. This study aims to examine whether Tai Chi is non-inferior to CBT-I as a treatment for insomnia in older adults. Methods: This is a single-center, assessor-blinded, non-inferiority randomized controlled trial comparing Tai Chi and CBT-I in 180 older adults aged ≥50 years with chronic insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Participants will be randomly assigned to either the Tai Chi or CBT-I group. Interventions will last for 3 months with a 12-month follow-up. The primary outcome is self-perceived insomnia severity measured by Insomnia Severity Index (ISI) at 3 months and at 15 months. The secondary outcomes include the remission rate of chronic insomnia, insomnia treatment response, subjective sleep quantity and quality, 7-day actigraphy, 7-day sleep diary, sleep medication, health-related quality of life, mental health, body balance and lower extremity function, adverse events, habitual physical activity, and dietary intake. Measurements will be conducted at baseline, 3 months, and 15 months by outcome assessors who are blinded to the group allocation. Discussion: This will be the first non-inferiority randomized controlled trial to compare the efficacy and long-term outcomes of Tai Chi versus CBT-I for treating insomnia in older adults. This study will be of clinical importance as it supports the use of Tai Chi as an alternative non-pharmacological approach for insomnia treatment and sustainable management.

Impact of mind-body intervention on proinflammatory cytokines interleukin 6 and 1ß: A three-arm randomized controlled trial for persons with sleep disturbance and depression.

Depressed people are prone to sleep disturbance, which may in return perpetuate the depression. Both depression and sleep disturbance influence proinflammatory cytokines interleukin (IL) 6 and 1ß. Thus interventions for depression should consider the effect on sleep disturbance, and vice versa. Integrative Body-Mind-Spirit (IBMS) and Qigong interventions have been applied in a wide range of health and mental health conditions, including depression and sleep disturbance. This study aimed to evaluate the effect of these two mind-body therapies for persons with both depressive symptoms and sleep disturbance. A three-arm randomized controlled trial was conducted among 281 participants, who were randomly assigned to either IBMS, Qigong or wait list control group. Participants in IBMS and Qigong groups received eight weekly sessions of intervention. Outcome measures were plasma concentrations of IL-6 and IL-1ß, and a questionnaire containing Pittsburgh Sleep Quality Index, Center for Epidemiologic Studies Depression Scale, Somatic Symptom Inventory, Perceived Stress Scale and Body-Mind-Spirit Holistic Well-being Scale. Outcomes were assessed at baseline (T0), immediate post-intervention (T1) and at three-months post-intervention (T2). Besides intervention efficacy analysis, path analysis was performed to explore the relations among perceived stress, depression, sleep disturbance, and IL-6 and IL-1ß values. The study found both IBMS and Qigong reduced depression, sleep disturbance, painful and painless somatic symptoms, IL-6 and IL-1ß levels, and increased holistic well-being. The effect sizes of IBMS and Qigong, mostly in the medium magnitude range, were approximatively equivalent. Path analysis models revealed a predictive role of perceived stress in depression and sleep disturbance, a bidirectional relationship between depression and sleep disturbance, and significant influence of depression and sleep disturbance on IL-6 and IL-1ß. Compared with control, the findings support the efficacy of IBMS and Qigong interventions in relieving depression and sleep disturbance, and in reducing IL-6 and IL-1ß levels.

Sleep and Inhibitory Control Over Mood-Congruent Information in Emerging Adults With Depressive Disorder.

OBJECTIVE: Accumulating evidence has suggested bidirectionality between sleep problems and depression, but the underlying mechanism is unclear. We assessed the role of sleep in inhibitory control ability with emotional stimuli, which has been shown to be suboptimal among individuals with depression and proposed to perpetuate depressive symptoms. METHODS: Emerging adults (aged 18-25 years, 64.6% female) were screened for depressive and other mental disorders by structured clinical interview and questionnaire. Individuals with depressive disorders were assigned to have a polysomnography-monitored daytime sleep opportunity (Sleep-Dep, n = 20), whereas nondepressed individuals were randomized to either have daytime sleep (Sleep-Ctrl, n = 27) or stay awake (Wake-Ctrl, n = 18). Participants completed the Affective Go/No-Go Task two times, separated by experimental conditions. RESULTS: A factorial model with a between-subject factor (Sleep-Dep/Sleep-Ctrl/Wake-Ctrl) and a within-subject factor (test 1/test 2) was used to assess if the groups differed in inhibitory control across test sessions, as inferred by changes in d-prime and false alarm rates (FA). Results from mixed factorial models showed a significant interaction effect between time and group on FA in the block with neutral faces as the target and happy faces as the nontarget (F(2,61) = 5.15, pfdr = .045). Although Sleep-Dep had decreased FA after sleep (t(19) = 2.94, pfdr = .050), Sleep-Ctrl and Wake-Ctrl had no significant between-session changes (p values > .05). Postsleep improvement in FA in Sleep-Dep correlated with longer stage 2 sleep (r(20) = 0.788, pfdr < .001) and stage 2 fast spindle number at O1 (r(18) = 0.692, pfdr = .015). CONCLUSIONS: Sleep gain, particularly stage 2 sleep and related physiology, potentially enhances inhibitory control ability responding to emotional information among individuals with depressive disorders.

Hypomanic symptoms in early pregnancy: prevalence and associated factors.

Given that the perinatal period is a time of increased risk for pregnant women to manifest mental health problems, the identification of antenatal hypomanic symptoms is particularly important. However, data on antenatal hypomanic symptoms is lacking. The present study was aimed at filling this research gap by investigating the prevalence of hypomanic symptoms, including the "active-elated" and "irritable/risk-taking" sides of hypomanic symptoms at the first trimester, and examining their associations with anxiety and depressive symptoms at the following time points: the first trimester, the second trimester, and up to 6-week postpartum. A prospective longitudinal design with a quantitative approach was adopted. A consecutive sample of 229 pregnant Chinese women in Hong Kong was assessed. Hypomanic symptoms were assessed with the Hypomania Checklist-32 (HCL-32). Of the sample, 43.6% had elevated levels of hypomanic symptoms in the first trimester. Multiple regression analysis showed that after adjusting for potential confounding factors, irritable/risk-taking symptoms were independently associated with higher anxiety symptoms in the first and second trimesters and in the 6-week postpartum period. Primary healthcare practitioners should be made aware of antenatal hypomanic symptoms in pregnant women to facilitate early identification and intervention for anxiety and depression to improve the well-being of both mothers and infants.

Low-Intensity Cognitive Behavioral Therapy for Insomnia as the Entry of the Stepped-Care Model in the Community: A Randomized Controlled Trial.

Background/Objectives: Diverse low-intensity interventions are available as the entry points in the stepped-care model for insomnia. The study aims to compare a single-session cognitive behavioral therapy for insomnia (CBTI) workshop, self-help CBTI and sleep hygiene education (SHE) workshop among adults with insomnia in the community, in terms of insomnia severity, anxiety and depressive symptoms, the quality of life, treatment adherence and credibility.Participants: Two-hundred-and-ten Hong Kong adults with DSM-5 defined insomnia disorder for at least one month were recruited in the community.Methods: A three-arm-parallel, active-treatment-controlled and assessor-blinded randomized controlled trial was performed. Participants were block-randomized to the half-day CBTI workshop, self-help Internet-delivered CBTI and half-day SHE workshop groups evenly. Eight-week and 16-week post-baseline follow-ups were conducted. The primary outcome measure was the Insomnia Severity Index whereas the secondary measures included the Hospital Anxiety and Depression Scale, the Short-Form Six-Dimension Health Survey, treatment adherence and credibility.Results: All arms demonstrated a significant treatment effect on insomnia severity, anxiety and depressive symptoms and the quality of life. However, there was no difference between arms. Treatment adherence did not vary among the three groups, but treatment credibility of the self-help group dropped whereas that of the CBTI workshop group rose after interventions (p = .037).Conclusions: Despite the lack of between-group differences, self-help CBTI can be considered as the preferred entry point of the stepped-care model for insomnia. It demonstrates comparable efficacy and adherence rate to the workshop-based interventions, and is highly accessible and convenient with few resources required.

Insomnia identity and its correlates in adolescents.

OBJECTIVE: Insomnia identity, defined as a conviction that one has insomnia, is a cognitive appraisal process that influences help-seeking, diagnosis, and treatment of insomnia. Previous studies in adults showed that about 50% of poor sleepers did not label themselves as having insomnia, while 10% of good sleepers endorsed insomnia identity. This analysis aimed to examine the proportions and characteristics of complaining and noncomplaining poor and good sleepers and the factors that determine self-labeling of insomnia in adolescents. METHODS: Data from a school-based study were analyzed. We defined insomnia identity as an endorsement of "insomnia" occurring 3-7 nights per week, while 3 criteria of poor sleep were examined. A total of 1447 students were included, the mean age was 14.5 years and 55.5% were females. RESULTS: Using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria to define poor sleep (insomnia symptoms ≥ 3 times per week), the proportions of complaining and noncomplaining poor sleepers were 2.3% and 8.8%, while complaining and noncomplaining good sleepers were 0.8% and 88.2%, respectively. The ratio between complaining and noncomplaining poor sleepers was 1 to 3.8. Complaining poor sleepers had the highest level of insomnia and daytime symptoms, while complaining good sleepers had the highest proportion of smokers and drinkers. Multivariate logistic regression showed that insomnia symptoms and sleep dissatisfaction were independent predictors of insomnia identity. CONCLUSIONS: In view of the high proportion of noncomplaining poor sleepers, educational programs should address the under-appraisal of insomnia among adolescents.

Subjective-Objective Sleep Discrepancy in Schizophrenia.

OBJECTIVE/BACKGROUND: Subjective methods are often employed for sleep assessment due to their ease of use, but the results may not concur with objective findings. This discrepancy may be present in schizophrenia; however, limited data are available. We performed a secondary analysis to evaluate the agreement between 1-week actigraphy and sleep diary-derived parameters and factors that contribute to subjective-objective sleep discrepancy. PARTICIPANTS: 66 outpatients with schizophrenia (mean age = 44.08 years; 45.45% males). METHODS: Agreement between subjective-objective parameters was assessed using two-way repeated measures ANOVA, Pearson's correlation, and Bland-Altman plot. The magnitude of discrepancy was quantified using Cohen's d. Pearson's correlation was used to determine the significant factors of subjective-objective sleep discrepancy. Benjamini-Hochberg adjustment was performed to account for multiple testing. RESULTS: On average, sleep diaries overestimated sleep onset latency by 20.45 min, total sleep time by 37.63 min, and sleep efficiency by 4.29%, but underestimated wake after sleep onset by 33.28 min. Cohen's d ranged between 0.61 and 1.41. Subjective-objective discrepancies were significantly associated with marital and employment status, self-reported sleep disturbance, delayed sleep-wake phase disorder, chronotype, and psychosocial functioning (r = 0.32-0.44; Benjamini-Hochberg corrected p < .05). CONCLUSIONS: Our findings show that differences between subjective and objective measurements of sleep are present in schizophrenia. Although actigraphy is not a standard procedure for sleep disturbance in schizophrenia, clinical judgment should be used if patients are suspected to have overestimated their sleep difficulties. Further studies should examine whether feedback based on actigraphy can benefit patients with schizophrenia and comorbid sleep disturbances.

Changes in Stigma Experience Among Mental Health Service Users over Time: A Qualitative Study with Focus Groups.

Public expenditure on mental health education has grown exponentially in the past two decades. A qualitative study using focus groups was used to explore whether the experience of stigma among 22 mental health service users improved over time. We identified five major themes on changes in social stigma, perceived stigma, and stigma coping. Stigmatizing and discriminatory experiences were still common in workplace, healthcare system, and relational aspects but some participants perceived that there were reductions in social stigma. Participants believed that media portrayal and celebrity effect were important in fostering greater acceptance toward people with mental illness and the importance of family support and stigma resistance for minimizing the harmful impacts of stigma. The findings are important in the future design of public educational and stigma reduction programs.

Integrative body-mind-spirit intervention for concurrent sleep and mood disturbances: sleep-specific daytime functioning mediates sleep and mood improvements.

Sleep disturbances and depressive symptoms are associated closely with daytime dysfunctions, yet few studies have investigated their temporal relationship in a randomized controlled trial. We investigated the inter-relationships among sleep, depressive symptoms and daytime functioning following an integrative body-mind-spirit (I-BMS) intervention. One hundred and eighty-five participants (mean age 55.28 years, 75.1% female) with co-existing sleep and depressive symptoms were randomized to I-BMS or waiting-list. Daytime functioning variables included the daytime dysfunction items of the Pittsburg Sleep Quality Index (PSQI-day), Somatic Symptom Inventory, Hospital Anxiety Depression Scale and Short Form Health Survey collected at baseline, post-treatment and 3-month follow-up. Sleep and depressive symptoms were measured by the sleep items of the PSQI (PSQI-night) and Center for Epidemiological Studies Depression Scale (excluding the sleep item) (CESD-M). Regression and path analyses were used to understand the role of daytime functioning in sleep and depressive symptoms. We found significant group and time effects on almost all daytime variables and significant group × time interactions on PSQI-day and somatic symptoms. The adjusted regression model showed that CESD-M was associated with all daytime variables. However, PSQI-night was associated only with PSQI-day. Path analyses indicated that PSQI-day bridged PSQI-night and CESD-M in a two-way direction after the I-BMS intervention. The conclusion was that, following I-BMS intervention, improvement in daytime functioning was related predominantly to improvement in depressive symptoms. Night-time sleep related only to daytime dysfunction that was specific to sleep disturbances. Therefore, 'sleep-specific daytime impairment' could be regarded as a major link from night-time sleep to depressive symptoms. More studies are required to understand the concept of 'sleep-specific daytime impairment'.

Self-administered acupressure for insomnia disorder: a pilot randomized controlled trial.

Self-administered acupressure has potential as a low-cost alternative treatment for insomnia. To evaluate the short-term effects of self-administered acupressure for alleviating insomnia, a pilot randomized controlled trial was conducted. Thirty-one subjects (mean age: 53.2 years; 77.4% female) with insomnia disorder were recruited from a community. The participants were randomized to receive two lessons on either self-administered acupressure or sleep hygiene education. The subjects in the self-administered acupressure group (n = 15) were taught to practise self-administered acupressure daily for 4 weeks. The subjects in the comparison group (n = 16) were advised to follow sleep hygiene education. The primary outcome was the Insomnia Severity Index (ISI). Other measures included a sleep diary, Hospital Anxiety and Depression Scale and Short-form Six-Dimension. The subjects in the self-administered acupressure group had a significantly lower ISI score than the subjects in the sleep hygiene education group at week 8 (effect size = 0.56, P = 0.03). However, this observed group difference did not reach a statistically significant level after Bonferroni correction. With regard to the secondary outcomes, moderate between-group effect sizes were observed in sleep onset latency and wake after sleep onset based on the sleep diary, although the differences were not significant. The adherence to self-administered acupressure practice was satisfactory, with 92.3% of the subjects who completed the lessons still practising acupressure at week 8. In conclusion, self-administered acupressure taught in a short training course may be a feasible approach to improve insomnia. Further fully powered confirmatory trials are warranted.

Sleep hygiene education as a treatment of insomnia: a systematic review and meta-analysis.

Background: Sleep hygiene education (SHE) is commonly used as a treatment of insomnia in general practice. Whether SHE or cognitive-behavioural therapy for insomnia (CBT-I), a treatment with stronger evidence base, should be provided first remains unclear. Objective: To review the efficacy of SHE for poor sleep or insomnia. Methods: We systematically searched six key electronic databases up until May 2017. Two researchers independently selected relevant publications, extracted data and evaluated methodological quality according to the Cochrane criteria. Results: Twelve of 15 studies compared SHE with CBT-I, three with mindfulness-based therapy, but none with sham or no treatment. General knowledge about sleep, substance use, regular exercise and bedroom arrangement were commonly covered; sleep-wake regularity and avoidance of daytime naps in seven programs, but stress management in only five programs. Major findings include (i) there were significant pre- to post-treatment improvements following SHE, with small to medium effect size; (ii) SHE was significantly less efficacious than CBT-I, with difference in effect size ranging from medium to large; (iii) pre- to post-treatment improvement and SHE-CBT-I difference averaged at 5% and 8% in sleep-diary-derived sleep efficiency, respectively, and two points in Pittsburgh Sleep Quality Index; (iv) only subjective measures were significant and (v) no data on acceptability, adherence, understanding and cost-effectiveness. Conclusions: Although SHE is less effective than CBT-I, unanswered methodological and implementation issues prevent a firm conclusion to be made on whether SHE has a role in a stepped-care model for insomnia in primary care.

Predictors of Daytime Consequences of Insomnia: The Roles of Quantitative Criteria and Nonrestorative Sleep.

BACKGROUND: The implications of removing nonrestorative sleep (NRS) and adding quantitative criteria in the most recent diagnostic criteria of insomnia disorder remain unresolved. The study was aimed to investigate how nighttime quantitative measures of sleep quality and NRS relate to daytime functioning in a general population sample. SAMPLING AND METHODS: Data of 905 subjects (mean age = 47.0 years; 64.5% females) in a population-based survey who had insomnia symptoms or NRS at least 1 night in a typical week were analyzed to evaluate their relationship with "functional impairment," "concerns/distress," and "interference with daily activities" over the past 30 days. Receiver-operating characteristic curve analysis was performed, while controlling for age and gender. RESULTS: Moderate to severe NRS was the first-level predictor of all 3 daytime variables. Insomnia frequency ≥3 times per week and sleep onset latency ≥10-20 min were second-level predictors. CONCLUSIONS: We found that NRS was more important than insomnia symptoms in determining daytime consequences of insomnia. On the basis of our findings we express concerns whether the removal of NRS from the most recent diagnostic criteria may lead to its underrecognition, but support the quantitative criteria on insomnia frequency of at least 3 nights per week.

A population-based 2-year longitudinal study of insomnia disorder in a Chinese population in Hong Kong.

There is a paucity of literature examining the longitudinal course of insomnia using standardized diagnostic criteria. This study aims to evaluate the persistence, remission, relapse, and incidence rates of insomnia symptoms and insomnia disorders according to the Diagnostic and Statistical Manual of Mental Disorders, 4th and 5th edition (DSM-IV and DSM-5). A total of 398 community dwellers were interviewed annually over two years using the Brief Insomnia Questionnaire, a validated questionnaire for deriving insomnia diagnoses. Normal sleepers were defined according to the DSM-5 quantitative criteria as having insomnia symptoms at most twice per week. Estimates were weighted against population age and sex distribution. Persistence for two consecutive years was 26.3, 26.4, and 23.0% for insomnia symptoms, DSM-IV, and DSM-5 insomnia disorders; remission rate was 55.8, 22.9, and 26.1%, relapse rate was 21.8, 1.3, and 0%, while incidence rate was 62.4, 19.6, and 4.5%. The common trajectories for DSM-IV insomnia disorder were to remain the same (26.4%), followed by a change to insomnia symptoms at the second year (25.7%), and at the third year (17.3%). For DSM-5 insomnia disorder, a change to insomnia symptoms at the second year was the commonest (28.3%), followed by continuing the same (23.0%), and a change to insomnia symptoms at the third year (14.0%). Over a two-year naturalistic follow-up, persistence of insomnia disorder was roughly 25%. Changes from insomnia disorder to insomnia symptoms were common; however, remission only occurred in about 25%, highlighting the chronic course of insomnia, perhaps due to a lack of treatment, under-treatment, or resistance to treatment. Incidence of insomnia symptoms was 62.4%, suggesting a high risk of developing insomnia in the general population.

Dyadic associations between psychological distress and sleep disturbance among Chinese patients with cancer and their spouses.

BACKGROUND: Patients with cancer and their spouses usually both suffer, but the dyadic effects have not been thoroughly investigated. This study examined the dyadic effects of psychological distress on sleep disturbance in Chinese couples affected by cancer. METHODS: Patients with cancer and their spouses (N = 135) participated in this study. The Hospital Anxiety and Depression Scale and Pittsburgh Sleep Quality Index were used to measure anxiety, depression, and sleep disturbance. RESULTS: There were significant patient-spouse associations on anxiety (r = 0.48, P < .01), depression (r = 0.55, P < .01), and sleep disturbance (r = 0.30, P < .01). Analyses using the actor-partner interdependence model showed that anxiety had significant actor effects, rather than partner effects, on sleep disturbance in both patients and their spouses, but depression had both actor and partner effects. In addition to providing evidence for the concordance in distress and sleep disturbance in patients with cancer and their spouses, the findings indicate a mutual influence of depression on sleep disturbance among the couples. CONCLUSIONS: Clinicians and health care providers are suggested to integrate depression management as a component of sleep therapies and involve both patients and their spouses in treatment programs.

The effect of a telephone-based cognitive behavioral therapy on quality of life: a randomized controlled trial.

Health-related quality of life (HRQoL) has emerged as a major public health concern in perinatal care. The purpose of this study was to examine the effect of telephone-based cognitive behavioral therapy (T-CBT) on HRQoL among Chinese mothers at risk of postnatal depression at 6 weeks and 6 months postpartum. A multi-center randomized controlled trial was conducted at the postnatal units of three regional hospitals. Three hundred and ninety-seven women at risk of postnatal depression were recruited and were randomly assigned to the T-CBT (n = 197) or usual care (n = 200). Assessment was conducted at baseline, 6 weeks and 6 months postpartum for HRQoL. Women in the T-CBT experienced greater improvement in the physical component of HRQoL from baseline to 6 weeks and 6 months postpartum than the usual care group. At 6 months postpartum, the T-CBT group also experienced better HRQoL in the mental component of HRQoL than the usual care group. The T-CBT appears to be feasible and effective in improving HRQoL in women at risk of postnatal depression in the primary care practice.

Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

BACKGROUND: Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. METHODS/DESIGN: The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. DISCUSSION: Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. TRIAL REGISTRATION: ClinicalTrials.gov NCT02475538 .

Correlates and prognostic relevance of sleep irregularity in inter-episode bipolar disorder.

OBJECTIVES: Sleep-wake disturbances, such as sleep irregularity, are common in bipolar disorder. Early studies suggest that sleep irregularity is associated with mood symptoms in bipolar disorder, but little research has been conducted to identify other correlates of sleep irregularity. We investigated the relationship between sleep irregularity and sleep quality, social rhythms, eveningness, sleep-related cognitions and behaviors, and past and future mood episodes in 84 patients with inter-episode bipolar I or II disorder. METHODS: This is a retrospective and prospective, naturalistic follow-up study. The Expanded Consensus Sleep Diary, Pittsburgh Sleep Quality Index (PSQI), Social Rhythm Metric (SRM-II-5), Composite Scale of Morningness (CSM), Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS-16), and Sleep Hygiene Practice Scale (SHPS) were administered. The Square Successive Difference (SSD), derived from a week-long sleep diary, was used as an index of sleep irregularity. Multilevel modeling analysis, which adjusts for biases in parameter estimates, was used to minimize the impact of missing data. Bonferroni correction was performed to account for multiple testing. RESULTS: Higher SSD scores of sleep diary variables were significantly associated with higher PSQI, SRM-II-5, DBAS-16, and SHPS scores. Irregularity in total sleep time was related to more depressive episodes in the past 5years (p=.002), while irregularity in wake after sleep onset predicted the onset of depressive episodes over the next 2years (p=.002). CONCLUSION: Sleep irregularity was associated with poor sleep quality, irregular social rhythms, dysfunctional sleep-related cognitions and behaviors, and greater number of depressive episodes in bipolar disorder.

The Experience of Chronic Insomnia in Chinese Adults: A Study Using Focus Groups and Insomnia Experience Diaries.

The subjective experience in 43 Chinese adults with chronic primary insomnia was assessed using focus groups and insomnia experience diaries. Participants recruited from the community and a sleep clinic were diagnosed with DSM-IV-TR insomnia disorder and had sleep difficulties on 3 or more nights per week for at least 6 months. Six focus groups, of 6-8 participants each, were conducted; it was stopped as thematic saturation emerged in the last 2 groups. Using grounded theory approach, we identified 4 themes and 16 subthemes, covering beliefs about the nature and treatment of insomnia, behavioral responses to insomnia, cognitive-emotional and physiological arousal, and emotional experiences associated with insomnia. The findings are in general compatible with qualitative studies in the West, but some subthemes are influenced by Chinese cultural beliefs and values, in particular, use of the traditional Chinese medicine concept, being modest in sleep expectation, and a letting go attitude. Strategies for cultural adaptation of cognitive-behavioral therapy for insomnia in a Chinese society using patients' subjective experience are discussed.