Stabilising sleep for patients admitted at acute crisis to a psychiatric hospital (OWLS): an assessor-blind pilot randomised controlled trial.
ABSTRACT: When patients are admitted onto psychiatric wards, sleep problems are highly prevalent. We carried out the first trial testing a psychological sleep treatment at acute admission (Oxford Ward sLeep Solution, OWLS).This assessor-blind parallel-group pilot trial randomised patients to receive sleep treatment at acute crisis [STAC, plus standard care (SC)], or SC alone (1 : 1). STAC included cognitive-behavioural therapy (CBT) for insomnia, sleep monitoring and light/dark exposure for circadian entrainment, delivered over 2 weeks. Assessments took place at 0, 2, 4 and 12 weeks. Feasibility outcomes assessed recruitment, retention of participants and uptake of the therapy. Primary efficacy outcomes were the Insomnia Severity Index and Warwick-Edinburgh Mental Wellbeing Scale at week 2. Analyses were intention-to-treat, estimating treatment effect with 95% confidence intervals.Between October 2015 and July 2016, 40 participants were recruited (from 43 assessed eligible). All participants offered STAC completed treatment (mean sessions received = 8.6, s.d. = 1.5). All participants completed the primary end point. Compared with SC, STAC led to large effect size (ES) reductions in insomnia at week 2 (adjusted mean difference -4.6, 95% CI -7.7 to -1.4, ES -0.9), a small improvement in psychological wellbeing (adjusted mean difference 3.7, 95% CI -2.8 to 10.1, ES 0.3) and patients were discharged 8.5 days earlier. One patient in the STAC group had an adverse event, unrelated to participation.In this challenging environment for research, the trial was feasible. Therapy uptake was high. STAC may be a highly effective treatment for sleep disturbance on wards with potential wider benefits on wellbeing and admission length.
Project description:Almost all patients admitted at acute crisis to a psychiatric ward experience clinically significant symptoms of insomnia. Ward environments pose challenges to both sleep and the delivery of therapy. Despite this, there is no description of how to adapt cognitive behavioural therapy (CBT) for insomnia to overcome these challenges.(i) To describe the key insomnia presentations observed in the Oxford Ward Sleep Solution (OWLS) trial and (ii) outline key adaptations aimed to increase accessibility and hence effectiveness of CBT for insomnia for a ward setting.Trial therapists collaboratively agreed the key insomnia presentations and therapy adaptations based on their individual reflective logs used during the trial.Three key insomnia presentations are outlined. These are used to illustrate the application of 10 CBT for insomnia therapy adaptations. These include use of sleep monitoring watches to engage patients in treatment, stabilizing circadian rhythms, reducing the impact of night-time observations and managing discharge as a sleep challenge.Whilst inpatient wards bring challenges for sleep and therapy delivery, creative adaptations can increase the accessibility of evidence based CBT for insomnia techniques. This therapy has proven popular with patients.
Project description:BACKGROUND:Longer-term pharmacologic studies for insomnia in older individuals are sparse. OBJECTIVE:To evaluate the efficacy and safety of 12 weeks of nightly eszopiclone in elderly outpatients with insomnia. METHODS:Participants (65-85 years) met DSM-IV-TR criteria for insomnia with total sleep times (TST) < or = 6 h, and wake time after sleep onset (WASO) > or = 45 min. Participants were randomized to 12 weeks of eszopiclone 2 mg (n = 194) or placebo (n = 194), followed by a 2-week single-blind placebo run-out. Subject-reported measures of sleep (sTST, sleep latency [sSL], sWASO) and daytime function (alertness, concentration, wellbeing, ability to function) were assessed. AEs were monitored. RESULTS:Subjects treated with 2 mg eszopiclone slept longer at night on average and at every individual time point compared to baseline than placebo subjects, as measured by TST over the 12-week double-blind period (P < 0.0001). Mean sTST over the double-blind period for eszopiclone-treated subjects was 360.08 min compared to 297.86 min at baseline, a mean change of 63.24 min. Over the double-blind period, eszopiclone-treated subjects also experienced a significantly greater improvement in sSL compared to placebo, with a mean decrease of 24.62 min versus a mean decrease of 19.92 min, respectively (P = 0.0014). Eszopiclone subjects also experienced a significantly greater decrease in WASO (mean decrease of 36.4 min) compared to placebo subjects (decrease of 14.8 min) (P < 0.0001). Post-discontinuation, sleep parameters were statistically improved versus baseline for eszopiclone (P-values < or = 0.01), indicating no rebound. The most common AEs (> or = 5%) were headache (eszopiclone 13.9%, placebo 12.4%), unpleasant taste (12.4%, 1.5%), and nasopharyngitis (5.7%, 6.2%). CONCLUSION:In this Phase IV trial of older adults with insomnia, eszopiclone significantly improved patient-reported sleep and daytime function relative to placebo. Improvements occurred within the first week and were maintained for 3 months, with no evidence of rebound insomnia following discontinuation. The 12 weeks of treatment were well tolerated. CLINICAL TRIAL INFORMATION:A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia; Registration #NCT00386334; URL - http://www.clinicaltrials.gov/ct2/show/NCT00386334?term=eszopiclone&rank=24
Project description:Sleep disturbance is known to be associated with psychosis, but sleep disorders (eg, insomnia, nightmare disorder, sleep apnea) have rarely been investigated. We aimed to provide the first detailed assessment of sleep disorders and their correlates in patients with early psychosis. Sixty outpatients aged between 18 and 30 with nonaffective psychosis were assessed for sleep disorder presence, severity, and treatment using a structured diagnostic interview, sleep diaries, and actigraphy. Psychotic experiences, mood, and psychological wellbeing were also measured. Forty-eight patients (80%) had at least one sleep disorder, with insomnia and nightmare disorder being the most common. Comorbidity of sleep disorders within this group was high, with an average of 3.3 sleep disorders per patient. Over half of the sleep disorders had been discussed with a clinician but almost three-quarters had received no treatment. Treatment according to clinical guidelines was rare, occurring in only 8% of cases (n = 13). Sleep disorders were significantly associated with increased psychotic experiences, depression, anxiety, fatigue, and lower quality of life. Sleep disorders are very common in patients with psychosis, may have wide-ranging negative effects, and merit routine assessment and treatment in psychiatric practice.
Project description:STUDY OBJECTIVES:Insomnia is a chief complaint among postmenopausal women, and insomnia impairs daytime functioning and reduces quality of life. Recent evidence supports the efficacy of cognitive behavioral therapy for insomnia (CBTI) for menopausal insomnia, but it remains unclear whether treating insomnia improves daytime function in this population. This study evaluated whether CBTI improves daytime fatigue, energy, self-reported sleepiness, work productivity, and quality of life in postmenopausal women with insomnia, and whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious. METHODS:Single-site, randomized control trial. One hundred fifty postmenopausal women (56.44 ± 5.64 years) with perimenopausal or postmenopausal onset or exacerbation of chronic insomnia were randomized to 3 treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI. Blinded assessments were performed at pretreatment, posttreatment, and 6-month follow-up. RESULTS:CBTI and SRT produced moderate-to-large improvements in fatigue, energy, sleepiness, and work function at posttreatment and 6 months later. The CBTI group reported better quality of life as indicated by substantial improvements in emotional wellbeing and resiliency to physical and emotional problems, whereas the SRT and SHE groups only showed improvements in resiliency to physical problems. Pain complaints decreased as sleep improved but were not associated with specific treatment conditions. Similarly, insomnia remitters reported fewer daytime and nighttime hot flashes, although reductions were not associated with any specific treatment. CONCLUSIONS:CBTI and SRT are efficacious options for postmenopausal women with chronic insomnia. Both interventions improve daytime function, quality of life, and work performance, although CBTI produces superior results including the added benefit of improved emotional health. CLINICAL TRIAL REGISTRATION:Registry: ClinicalTrials.gov; Title: Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes; Identifier: NCT01933295; URL: https://clinicaltrials.gov/ct2/show/record/NCT01933295.
Project description:Purpose Cognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC), a movement meditation, improve insomnia symptoms. Here, we evaluated whether TCC is noninferior to CBT-I for the treatment of insomnia in survivors of breast cancer. Patients and Methods This was a randomized, partially blinded, noninferiority trial that involved survivors of breast cancer with insomnia who were recruited from the Los Angeles community from April 2008 to July 2012. After a 2-month phase-in period with repeated baseline assessment, participants were randomly assigned to 3 months of CBT-I or TCC and evaluated at months 2, 3 (post-treatment), 6, and 15 (follow-up). Primary outcome was insomnia treatment response-that is, marked clinical improvement of symptoms by the Pittsburgh Sleep Quality Index-at 15 months. Secondary outcomes were clinician-assessed remission of insomnia; sleep quality; total sleep time, sleep onset latency, sleep efficiency, and awake after sleep onset, derived from sleep diaries; polysomnography; and symptoms of fatigue, sleepiness, and depression. Results Of 145 participants who were screened, 90 were randomly assigned (CBT-I: n = 45; TCC: n = 45). The proportion of participants who showed insomnia treatment response at 15 months was 43.7% and 46.7% in CBT-I and TCC, respectively. Tests of noninferiority showed that TCC was noninferior to CBT-I at 15 months ( P = .02) and at months 3 ( P = .02) and 6 ( P < .01). For secondary outcomes, insomnia remission was 46.2% and 37.9% in CBT-I and TCC, respectively. CBT-I and TCC groups showed robust improvements in sleep quality, sleep diary measures, and related symptoms (all P < .01), but not polysomnography, with similar improvements in both groups. Conclusion CBT-I and TCC produce clinically meaningful improvements in insomnia. TCC, a mindful movement meditation, was found to be statistically noninferior to CBT-I, the gold standard for behavioral treatment of insomnia.
Project description:BACKGROUND:A significant proportion of patients with chronic tinnitus report clinical levels of sleep disturbance (insomnia). Despite the significant health and functioning implications of this, no rigorous trials have investigated treatments that target tinnitus-related insomnia. This is the first randomised controlled trial evaluating Cognitive Behavioural Therapy for insomnia (CBTi) in tinnitus compared with other psychological treatments. METHODS/DESIGN:The study will test the efficacy of group CBTi as a treatment for tinnitus-related insomnia in a single-centre randomised controlled trial. Participants will be 102 patients with chronic, clinically significant tinnitus and insomnia in the absence of organic sleep disorders. Participants will be randomised to one of three intervention arms: six sessions of CBTi or six sessions of sleep support group or two sessions of audiologically based care. The primary outcomes will be changes in sleep as measured on the Insomnia Severity Index and key outcomes on a 2-week sleep diary (sleep efficiency and total sleep time). Outcomes will be collected 3, 10, 14 and 34?weeks post-randomisation. Secondary measures include sleep quality, sleep beliefs, tinnitus severity, psychological distress and quality of life. A sub-sample of participants will provide two weeks of actigraphy data at the same time points. Data on satisfaction and treatment experience will be collected at 10 and 34 weeks post-randomisation from all participants. DISCUSSION:Findings from the study will be submitted to a peer-reviewed journal. It is anticipated that findings may inform future clinical practice in the treatment of tinnitus-related insomnia. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03386123. Retrospectively registered on 29 December 2017.
Project description:Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC).The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects.This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions.ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015).
Project description:OBJECTIVE:This study was conducted to evaluate the efficacy of cognitive behavioral therapy (CBT) against a sleep hygiene education control therapy in patients with primary or comorbid insomnia. DESIGN AND SETTING:Randomized, parallel-group, clinical trial conducted at a single Veterans Affairs medical center, with recruitment from March 2001 to June 2005. PARTICIPANTS:Eighty-one adults (n = 11 women; mean age, 54.2 years) with chronic primary (n = 40) or comorbid insomnia associated predominantly with mixed psychiatric disorders (n = 41). INTERVENTIONS:Patients, screened via structured interviews and diagnostic polysomnography, were randomly assigned to receive CBT (sleep education, stimulus control, and time-in-bed restrictions; 20 patients with primary and 21 with comorbid insomnia), or sleep hygiene (SH: education about aspects of lifestyle and the bedroom environment that affect sleep; 20 patients with primary and 20 with comorbid insomnia). Outpatient treatment included 4 biweekly sessions with a posttreatment assessment and a follow-up conducted at 6 months. MEASURES AND RESULTS:Participants completed actigraphy and sleep diaries for 2 weeks prior to therapy, during a 2-week posttreatment assessment, and during 2 weeks at follow-up. They also completed questionnaires measuring global insomnia symptoms, general sleep quality, and sleep-disruptive beliefs before treatment, immediately following treatment, and at the follow-up time point. Consistent with previous studies, CBT outperformed sleep hygiene across several study outcome measures for the sample as a whole. Statistical analyses showed no significant 3-way interaction of treatment group, time, and insomnia type for any of the sleep or questionnaire measures, suggesting the benefits of CBT over sleep hygiene were comparable for patients with primary insomnia and comorbid insomnia. Moreover, only 1 of several indexes of clinically notable improvement suggested a significantly better response to CBT by patients with primary insomnia, as compared with those with comorbid insomnia. CONCLUSIONS:A fixed 4-session "dose" of CBT produced similar benefits for patients with primary and those with comorbid insomnia across most measures examined. Thus, CBT appears to be a viable psychological insomnia therapy both for those with primary insomnia and for groups composed mainly of patients with insomnia and nonpsychotic psychiatric conditions.
Project description:In this retrospective cohort study, we describe acceptability, tolerability and potential efficacy of cognitive behavioural therapy (CBT) in Insomnia Disorder subtypes, derived from polysomnography (PSG): insomnia with normal-sleep duration (I-NSD) and insomnia with short-sleep duration (I-SSD). All research volunteers were offered access to digital CBT, single component sleep restriction therapy and face-to-face group CBT. Follow-up occurred at three months post-treatment using the insomnia severity index (ISI). 96 participants (61 females, mean age of 41 years) were grouped into either normal-sleep (n?=?53) or short-sleep (n?=?43). CBT was acceptable to 63% of participants (normal-sleep?=?31, short-sleep?=?29), with 28 completing therapy (tolerability: normal-sleep?=?11, short-sleep?=?17). For potential efficacy, 39 (normal-sleep?=?20, short-sleep?=?19) out of 96 participants (41%) completed a follow-up ISI assessment. In this reduced sample, mean (SD) ISI scores decreased across both groups (normal-sleep: 18.0 (4.0) to 10.7 (4.6); short-sleep: 16.5 (5.5) to 11.0 (6.3); both P?<?0.01). Those with normal-sleep were more likely to respond (?6-point ISI reduction) to CBT compared to short-sleep (70%, n?=?14/20 vs. 37%, n?=?7/19 respectively, P?=?0.038). In this cohort, 60 (63%) of participants attempted CBT and of those 28 (47%) completed therapy. Results may be comparable to clinical participants with implications for the successful translation of CBT for insomnia.
Project description:This study examined whether individuals with insomnia and objective short sleep duration <6 h, a subgroup with greater risks of adverse health outcomes, differ in their response to cognitive-behavioral therapy for insomnia (CBT-I) when compared to individuals with insomnia and normal sleep duration ?6 h.Secondary analyses of a randomized, clinical trial with 60 adult participants (n = 31 women) from a single academic medical center. Outpatient treatment lasted 8 weeks, with a final follow-up conducted at 6 months. Mixed-effects models controlling for age, sex, CBT-I treatment group assignment, and treatment provider examined sleep parameters gathered via actigraphy, sleep diaries, and an Insomnia Symptom Questionnaire (ISQ) across the treatment and follow-up period.Six months post-CBT-I treatment, individuals with insomnia and normal sleep duration ?6 h fared significantly better on clinical improvement milestones than did those with insomnia and short sleep duration <6 h. Specifically, individuals with insomnia and normal sleep duration had significantly higher insomnia remission (ISQ < 36.5; ?2[1, N = 60] = 44.72, p < .0001), more normative sleep efficiency (SE) on actigraphy (SE > 80%; ?2[1, N = 60] = 21, p < .0001), normal levels of middle of the night wake after sleep onset (MWASO) <31 minutes (?2[1, N = 60] = 37.85, p < .0001), and a >50% decline in MWASO (?2[1, N = 60] = 60, p < .0001) compared to individuals with insomnia and short sleep duration. Additionally, those with insomnia and normal sleep duration had more success decreasing their total wake time (TWT) at the 6-month follow-up compared to those with insomnia and short sleep duration (?2[2, N = 60] = 44.1, p < .0001). Receiver-operating characteristic curve analysis found that using a 6-h cutoff with actigraphy provided a 95.7% sensitivity and 91.9% specificity for determining insomnia remission, with the area under the curve = 0.986.Findings suggest that individuals with insomnia and objective short sleep duration <6 h are significantly less responsive to CBT-I than those with insomnia and normal sleep duration ?6 h. Using an actigraphy TST cutoff of 6 hours to classify sleep duration groups was highly accurate and provided good discriminant value for determining insomnia remission.