-
JAMA Network Open Jul 2022Electroacupuncture (EA) is a widely recognized therapy for depression and sleep disorders in clinical practice, but its efficacy in the treatment of comorbid insomnia... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Electroacupuncture (EA) is a widely recognized therapy for depression and sleep disorders in clinical practice, but its efficacy in the treatment of comorbid insomnia and depression remains uncertain.
OBJECTIVE
To assess the efficacy and safety of EA as an alternative therapy in improving sleep quality and mental state for patients with insomnia and depression.
DESIGN, SETTING, AND PARTICIPANTS
A 32-week patient- and assessor-blinded, randomized, sham-controlled clinical trial (8-week intervention plus 24-week observational follow-up) was conducted from September 1, 2016, to July 30, 2019, at 3 tertiary hospitals in Shanghai, China. Patients were randomized to receive EA treatment and standard care, sham acupuncture (SA) treatment and standard care, or standard care only as control. Patients were 18 to 70 years of age, had insomnia, and met the criteria for depression as classified in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). Data were analyzed from May 4 to September 13, 2020.
INTERVENTIONS
All patients in the 3 groups were provided with standard care guided by psychiatrists. Patients in the EA and SA groups received real or sham acupuncture treatment, 3 sessions per week for 8 weeks, for a total of 24 sessions.
MAIN OUTCOMES AND MEASURES
The primary outcome was change in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8. Secondary outcomes included PSQI at 12, 20, and 32 weeks of follow-up; sleep parameters recorded in actigraphy; Insomnia Severity Index; 17-item Hamilton Depression Rating Scale score; and Self-rating Anxiety Scale score.
RESULTS
Among the 270 patients (194 women [71.9%] and 76 men [28.1%]; mean [SD] age, 50.3 [14.2] years) included in the intention-to-treat analysis, 247 (91.5%) completed all outcome measurements at week 32, and 23 (8.5%) dropped out of the trial. The mean difference in PSQI from baseline to week 8 within the EA group was -6.2 (95% CI, -6.9 to -5.6). At week 8, the difference in PSQI score was -3.6 (95% CI, -4.4 to -2.8; P < .001) between the EA and SA groups and -5.1 (95% CI, -6.0 to -4.2; P < .001) between the EA and control groups. The efficacy of EA in treating insomnia was sustained during the 24-week postintervention follow-up. Significant improvement in the 17-item Hamilton Depression Rating Scale (-10.7 [95% CI, -11.8 to -9.7]), Insomnia Severity Index (-7.6 [95% CI, -8.5 to -6.7]), and Self-rating Anxiety Scale (-2.9 [95% CI, -4.1 to -1.7]) scores and the total sleep time recorded in the actigraphy (29.1 [95% CI, 21.5-36.7] minutes) was observed in the EA group during the 8-week intervention period (P < .001 for all). No between-group differences were found in the frequency of sleep awakenings. No serious adverse events were reported.
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial of EA treatment for insomnia in patients with depression, quality of sleep improved significantly in the EA group compared with the SA or control group at week 8 and was sustained at week 32.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03122080.
Topics: China; Depression; Electroacupuncture; Female; Humans; Male; Middle Aged; Sleep Initiation and Maintenance Disorders; Treatment Outcome
PubMed: 35797047
DOI: 10.1001/jamanetworkopen.2022.20563 -
Journal of Evidence-based Integrative... 2020Sleep problems are widely prevalent and associated with various comorbidities including anxiety. Valerian ( L.) is a popular herbal medicine used as a sleep aid, however... (Meta-Analysis)
Meta-Analysis
Sleep problems are widely prevalent and associated with various comorbidities including anxiety. Valerian ( L.) is a popular herbal medicine used as a sleep aid, however the outcomes of previous clinical studies are inconsistent. This study was conducted to update and re-evaluate the available data in order to understand the reason behind the inconsistent outcomes and to provide a broader view of the use of valerian for associated disorders. PubMed, ScienceDirect, and Cochrane Library were searched to retrieve publications relevant to the effectiveness of valerian as a treatment of sleep problems and associated disorders. A total of 60 studies (n=6,894) were included in this review, and meta-analyses were performed to evaluate the effectiveness to improve subjective sleep quality (10 studies, n=1,065) and to reduce anxiety (8 studies, n=535). Results suggested that inconsistent outcomes were possibly due to the variable quality of herbal extracts and that more reliable effects could be expected from the whole root/rhizome. In addition, therapeutic benefits could be optimized when it was combined with appropriate herbal partners. There were no severe adverse events associated with valerian intake in subjects aged between 7 and 80 years. In conclusion, valerian could be a safe and effective herb to promote sleep and prevent associated disorders. However, due to the presence of multiple active constituents and relatively unstable nature of some of the active constituents, it may be necessary to revise the quality control processes, including standardization methods and shelf life.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anxiety; Anxiety Disorders; Child; Female; Humans; Hypnotics and Sedatives; Male; Middle Aged; Phytotherapy; Plant Extracts; Plant Roots; Rhizome; Sleep; Sleep Initiation and Maintenance Disorders; Valerian; Young Adult
PubMed: 33086877
DOI: 10.1177/2515690X20967323 -
JAMA Network Open Feb 2021Previous studies that have shown tai chi to improve sleep were mainly based on subjective assessments, which might have produced results confounded by self-reporting... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Previous studies that have shown tai chi to improve sleep were mainly based on subjective assessments, which might have produced results confounded by self-reporting bias.
OBJECTIVE
To compare the effectiveness of tai chi for improving sleep in older adults with insomnia with conventional exercise and a passive control group using actigraphy-based objective measurements.
DESIGN, SETTING, AND PARTICIPANTS
This randomized, 3-arm, parallel group, assessor-masked clinical trial was conducted at a single research unit in Hong Kong between August 2014 and August 2018. Eligible participants, aged 60 years or older and with chronic insomnia, were randomly allocated into tai chi training, exercise, and control groups.
INTERVENTIONS
12-week tai chi training, 12-week conventional exercise, and no intervention control.
MAIN OUTCOMES AND MEASURES
Primary outcomes were measures taken from actigraphy sleep assessment. Secondary outcomes included remission of insomnia, insomnia treatment response, Pittsburgh Sleep Quality Index score, Insomnia Severity Index score, and self-reported sleep using a 7-day sleep diary. Assessments were performed at baseline, end of the intervention (postintervention), and 24 months after the intervention (follow-up). Data analysis was performed from September 2018 to August 2020.
RESULTS
A total of 320 participants (mean [SD] age, 67.3 [6.8] years; mean [SD] insomnia duration, 124.4 [134.5] months; 256 [80.0%] women) were randomly allocated into control (110 participants), exercise (105 participants), and tai chi (105 participants) groups and included in the data analysis. Compared with the control group, the exercise and tai chi groups showed improved sleep efficiency (exercise vs control: adjusted mean difference, +3.5%; 95% CI, 1.8-5.2; P < .001; tai chi vs control: adjusted mean difference, +3.4%; 95% CI, 1.6-5.1; P < .001) and reductions of wake time after sleep onset (exercise vs control: -17.0 minutes; 95% CI, -24.9 to -9.0; P < .001; tai chi vs control: -13.3 minutes; 95% CI, -21.3 to -5.2; P = .001) and number of awakenings (exercise vs control: -2.8 times; 95% CI, -4.0 to -1.6; P < .001; tai chi vs control: -2.2 times; 95% CI, -3.5 to -1.0; P < .001) as assessed by actigraphy at postintervention; although there were no significant differences between the exercise and tai chi groups. The actigraphy-assessed beneficial effects were maintained in both intervention groups at follow-up.
CONCLUSIONS AND RELEVANCE
Conventional exercise and tai chi improved sleep and the beneficial effects sustained for 24 months, although the absolute improvements in sleep parameters were modest. Improvements in objective sleep parameters were not different between the tai chi and exercise groups, suggesting that tai chi can be an alternative approach for managing insomnia.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02260843.
Topics: Actigraphy; Aged; Exercise; Female; Humans; Male; Middle Aged; Sleep Initiation and Maintenance Disorders; Tai Ji; Treatment Outcome
PubMed: 33587135
DOI: 10.1001/jamanetworkopen.2020.37199 -
Journal of the National Cancer Institute Dec 2019Insomnia is a common and debilitating disorder experienced by cancer survivors. Although cancer survivors express a preference for using nonpharmacological treatment to... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Insomnia is a common and debilitating disorder experienced by cancer survivors. Although cancer survivors express a preference for using nonpharmacological treatment to manage insomnia, the comparative effectiveness between acupuncture and Cognitive Behavioral Therapy for Insomnia (CBT-I) for this disorder is unknown.
METHODS
This randomized trial compared 8 weeks of acupuncture (n = 80) and CBT-I (n = 80) in cancer survivors. Acupuncture involved stimulating specific points on the body with needles. CBT-I included sleep restriction, stimulus control, cognitive restructuring, relaxation training, and education. We measured insomnia severity (primary outcome), pain, fatigue, mood, and quality of life posttreatment (8 weeks) with follow-up until 20 weeks. We used linear mixed-effects models for analyses. All statistical tests were two-sided.
RESULTS
The mean age was 61.5 years and 56.9% were women. CBT-I was more effective than acupuncture posttreatment (P < .001); however, both acupuncture and CBT-I produced clinically meaningful reductions in insomnia severity (acupuncture: -8.31 points, 95% confidence interval = -9.36 to -7.26; CBT-I: -10.91 points, 95% confidence interval = -11.97 to -9.85) and maintained improvements up to 20 weeks. Acupuncture was more effective for pain at the end of treatment; both groups had similar improvements in fatigue, mood, and quality of life and reduced prescription hypnotic medication use. CBT-I was more effective for those who were male (P < .001), white (P = .003), highly educated (P < .001), and had no pain at baseline (P < .001).
CONCLUSIONS
Although both treatments produced meaningful and durable improvements, CBT-I was more effective and should be the first line of therapy. The relative differences in the comparative effectiveness between the two interventions for specific groups should be confirmed in future adequately powered trials to guide more tailored interventions for insomnia.
Topics: Acupuncture Therapy; Affect; Cancer Survivors; Cognitive Behavioral Therapy; Confidence Intervals; Fatigue; Female; Humans; Male; Middle Aged; Neoplasms; Quality of Life; Sleep Initiation and Maintenance Disorders; Socioeconomic Factors; Treatment Outcome
PubMed: 31081899
DOI: 10.1093/jnci/djz050 -
JAMA Psychiatry Jan 2022Older adults with insomnia have a high risk of incident and recurrent depression. Depression prevention is urgently needed, and such efforts have been neglected for... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Older adults with insomnia have a high risk of incident and recurrent depression. Depression prevention is urgently needed, and such efforts have been neglected for older adults.
OBJECTIVE
To examine whether treatment of insomnia disorder with cognitive behavioral therapy for insomnia (CBT-I) compared with an active comparator condition, sleep education therapy (SET), prevents major depressive disorder in older adults.
DESIGN, SETTING, AND PARTICIPANTS
This assessor-blinded, parallel-group, single-site randomized clinical trial assessed a community-based sample of 431 people and enrolled 291 adults 60 years or older with insomnia disorder who had no major depression or major health events in past year. Study recruitment was performed from July 1, 2012, to April 30, 2015. The trial protocol was modified to extend follow-up from 24 to 36 months, with follow-up completion in July 2018. Data analysis was performed from March 1, 2019, to March 30, 2020.
INTERVENTIONS
Participants were randomized to 2 months of CBT-I (n = 156) or SET (n = 135).
MAIN OUTCOMES AND MEASURES
The primary outcome was time to incident major depressive disorder as diagnosed by interview and Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) criteria. Secondary outcome was sustained remission of insomnia disorder before depression event or duration of follow-up.
RESULTS
Among 291 randomized participants (mean [SD] age, 70.1 [6.7] years; 168 [57.7%] female; 7 [2.4%] Asian, 32 [11.0%] Black, 3 [1.0%] Pacific Islander, 241 [82.8%] White, 6 [2.1%] multiracial, and 2 [0.7%] unknown), 156 were randomized to CBT-I and 135 to SET. A total of 140 participants (89.7%) completed CBT-I and 130 (96.3%) participants completed SET (χ2 = 4.9, P = .03), with 114 (73.1%) completing 24 months of follow-up in the CBT-I group and 117 (86.7%) in the SET group (χ2 = 8.4, P = .004). After protocol modification, 92 (59.0%) of the CBT-I participants and 86 (63.7%) of the SET participants agreed to extended follow-up (χ2 = 0.7, P = .41), with 81 (51.9%) of the CBT-I participants and 77 (57.0%) of the SET group completing 36 months of follow-up (χ2 = 0.8; P = .39). Incident or recurrent major depression occurred in 19 participants (12.2%) in the CBT-I group and in 35 participants (25.9%) in the SET group, with an overall benefit (hazard ratio, 0.51; 95%, CI 0.29-0.88; P = .02) consistent across subgroups. Remission of insomnia disorder continuously sustained before depression event or during follow-up was more likely in CBT-I participants (41 [26.3%]) compared with the SET participants (26 [19.3%], P = .03). Those in the CBT-I group with sustained remission of insomnia disorder had an 82.6% decreased likelihood of depression (hazard ratio, 0.17; 95%, CI 0.04-0.73; P = .02) compared with those in the SET group without sustained remission of insomnia disorder.
CONCLUSIONS AND RELEVANCE
The findings of this randomized clinical trial indicate that treatment of insomnia with CBT-I has an overall benefit in the prevention of incident and recurrent major depression in older adults with insomnia disorder. Community-level screening for insomnia concerns in older adults and wide delivery of CBT-I-based treatment for insomnia could substantially advance public health efforts to treat insomnia and prevent depression in this vulnerable older adult population.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01641263.
Topics: Aged; Aged, 80 and over; Cognitive Behavioral Therapy; Depressive Disorder, Major; Female; Humans; Male; Middle Aged; Sleep Initiation and Maintenance Disorders; Surveys and Questionnaires; Treatment Outcome
PubMed: 34817561
DOI: 10.1001/jamapsychiatry.2021.3422 -
Sleep Nov 2021This randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract... (Randomized Controlled Trial)
Randomized Controlled Trial
STUDY OBJECTIVES
This randomized, double-blind, placebo-controlled, crossover study was conducted to evaluate the safety and efficacy of 2 weeks of nightly sublingual cannabinoid extract (ZTL-101) in treating chronic insomnia (symptoms ≥3 months).
METHODS
Co-primary study endpoints were safety of the medication based on adverse event reporting and global insomnia symptoms (Insomnia Severity Index [ISI]). Secondary endpoints included: self-reported (sleep diary), actigraphy-derived, and polysomnography measurements of sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), sleep efficiency (SE); and self-reported assessments of sleep quality (sSQ) and feeling rested upon waking. Adjusted mean differences between placebo and ZTL-101 were calculated.
RESULTS
Twenty-three of 24 randomized participants (n = 20 female, mean age 53 ± 9 years) completed the protocol. No serious adverse events were reported. Forty mild, nonserious, adverse events were reported (36 during ZTL-101) with all but one resolving overnight or soon after waking. Compared to placebo, ZTL-101 decreased ISI (-5.07 units [95% CI: -7.28 to -2.86]; p = 0.0001) and self-reported SOL (-8.45 min [95% CI: -16.33 to -0.57]; p = 0.04) and increased self-reported TST (64.6 min [95% CI: 41.70 to 87.46]; p < 0.0001), sSQ (0.74 units [95% CI: 0.51 to 0.97]; p < 0.0001), and feeling of being rested on waking (0.51 units [95% CI: 0.24 to 0.78]; p = 0.0007). ZTL-101 also decreased actigraphy-derived WASO (-10.2 min [95% CI: -16.2 to -4.2]; p = 0.002), and increased actigraphy-derived TST (33.4 min [95% CI: 23.07 to 43.76]; p < 0.001) and SE (2.9% [95% CI: 2.0 to 3.8]; p = 0.005).
CONCLUSIONS
Two weeks of nightly sublingual administration of a cannabinoid extract (ZTL-101) is well tolerated and improves insomnia symptoms and sleep quality in individuals with chronic insomnia symptoms.
CLINICAL TRIAL
ANZCTR; anzctr.org.au; ACTRN12618000078257.
Topics: Adult; Cannabinoids; Cross-Over Studies; Double-Blind Method; Female; Humans; Medical Marijuana; Middle Aged; Sleep; Sleep Initiation and Maintenance Disorders; Treatment Outcome
PubMed: 34115851
DOI: 10.1093/sleep/zsab149 -
Sleep Jan 2022Insomnia is common among adults with chronic heart failure (HF) and associated with daytime symptoms and decrements in function. The purpose of this randomized... (Randomized Controlled Trial)
Randomized Controlled Trial
Cognitive behavioral therapy for insomnia has sustained effects on insomnia, fatigue, and function among people with chronic heart failure and insomnia: the HeartSleep Study.
STUDY OBJECTIVES
Insomnia is common among adults with chronic heart failure (HF) and associated with daytime symptoms and decrements in function. The purpose of this randomized controlled trial (RCT) was to evaluate the sustained effects over one year of CBT-I (Healthy Sleep: HS) compared with HF self-management education (Healthy Hearts; attention control: HH) on insomnia severity, sleep characteristics, symptoms, and function among people with stable HF. The primary outcomes were insomnia severity, actigraph-recorded sleep efficiency, and fatigue.
METHODS
We randomized adults with stable HF with preserved or reduced ejection fraction who had at least mild insomnia (Insomnia severity index >7) in groups to HS or HH (4 sessions/8 weeks). We obtained wrist actigraphy and measured insomnia severity, self-reported sleep characteristics, symptoms (fatigue, excessive daytime sleepiness, anxiety, depression), and six-minute walk distance at baseline, within one month of treatment, and at 6 and 12 months. We used general linear mixed models (GLMM) and generalized estimating equations (GEE) to evaluate the effects.
RESULTS
The sample included 175 participants (M age = 63 ± 12.9 years; 43% women; 18% Black; 68% New York Heart Association Class II or II; 33%; LVEF < 45%) randomized to HS (n = 91) or HH (n = 84). HS had sustained effects on insomnia severity, sleep quality, self-reported sleep latency and efficiency, fatigue, excessive daytime sleepiness, and six-minute walk distance at 12 months.
CONCLUSIONS
CBT-I produced sustained improvements in insomnia, fatigue, daytime sleepiness, and objectively measured physical function among adults with chronic HF, compared with a robust HF self-management program that included sleep hygiene education.
CLINICAL TRIAL INFORMATION
Insomnia Self-Management in Heart Failure; https://clinicaltrials.gov/ct2/show/NCT02660385; NCT02660385.
Topics: Adult; Aged; Cognitive Behavioral Therapy; Fatigue; Female; Heart Failure; Humans; Male; Middle Aged; Sleep; Sleep Initiation and Maintenance Disorders; Treatment Outcome
PubMed: 34657160
DOI: 10.1093/sleep/zsab252 -
BMJ Open May 2020Insomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally, cannabis use is frequently...
Cannabidiol (CBD) and Δ-tetrahydrocannabinol (THC) for chronic insomnia disorder ('CANSLEEP' trial): protocol for a randomised, placebo-controlled, double-blinded, proof-of-concept trial.
INTRODUCTION
Insomnia is a highly prevalent and costly condition that is associated with increased health risks and healthcare utilisation. Anecdotally, cannabis use is frequently reported by consumers to promote sleep. However, there is limited research on the effects of cannabis on sleep and daytime function in people with insomnia disorder using objective measures. This proof-of-concept study will evaluate the effects of a single dose of an oral cannabis-based medicine on sleep and daytime function in participants with chronic insomnia disorder.
METHODS AND ANALYSIS
A randomised, crossover, placebo-controlled, single-dose study design will be used to test the safety and efficacy of an oral oil solution ('ETC120') containing 10 mg Δ-tetrahydrocannabinol (THC) and 200 mg cannabidiol (CBD) in 20 participants diagnosed with chronic insomnia disorder. Participants aged 35-60 years will be recruited over an 18-month period commencing August 2019. Each participant will receive both the active drug and matched placebo, in a counterbalanced order, during two overnight study assessment visits, with at least a 1-week washout period between each visit. The primary outcomes are total sleep time and wake after sleep onset assessed via polysomnography. In addition, 256-channel high-density electroencephalography and source modelling using structural brain MRI will be used to comprehensively examine brain activation during sleep and wake periods on ETC120 versus placebo. Next-day cognitive function, alertness and simulated driving performance will also be investigated.
ETHICS AND DISSEMINATION
Ethics approval was received from Bellberry Human Research Ethics Committee (2018-04-284). The findings will be disseminated in a peer-reviewed open-access journal and at academic conferences.
TRIAL REGISTRATION NUMBER
ANZCTRN12619000714189.
Topics: Adult; Cannabidiol; Cannabis; Double-Blind Method; Dronabinol; Humans; Middle Aged; Randomized Controlled Trials as Topic; Sleep Initiation and Maintenance Disorders
PubMed: 32430450
DOI: 10.1136/bmjopen-2019-034421 -
Depression and Anxiety Oct 2019Actigraphy may provide a more valid assessment of sleep, circadian rhythm (CR), and physical activity (PA) than self-reported questionnaires, but has not been used...
BACKGROUND
Actigraphy may provide a more valid assessment of sleep, circadian rhythm (CR), and physical activity (PA) than self-reported questionnaires, but has not been used widely to study the association with depression/anxiety and their clinical characteristics.
METHODS
Fourteen-day actigraphy data of 359 participants with current (n = 93), remitted (n = 176), or no (n = 90) composite international diagnostic interview depression/anxiety diagnoses were obtained from the Netherlands Study of Depression and Anxiety. Objective estimates included sleep duration (SD), sleep efficiency, relative amplitude (RA) between day-time and night-time activity, mid sleep on free days (MSF), gross motor activity (GMA), and moderate-to-vigorous PA (MVPA). Self-reported measures included insomnia rating scale, SD, MSF, metabolic equivalent total, and MVPA.
RESULTS
Compared to controls, individuals with current depression/anxiety had a significantly different objective, but not self-reported, PA and CR: lower GMA (23.83 vs. 27.4 milli-gravity/day, p = .022), lower MVPA (35.32 vs. 47.64 min/day, p = .023), lower RA (0.82 vs. 0.83, p = .033). In contrast, self-reported, but not objective, sleep differed between people with current depression/anxiety compared to those without current disorders; people with current depression/anxiety reported both shorter and longer SD and more insomnia. More depressive/anxiety symptoms and number of depressive/anxiety diagnoses were associated with larger disturbances of the actigraphy measures.
CONCLUSION
Actigraphy provides ecologically valid information on sleep, CR, and PA that enhances data from self-reported questionnaires. As those with more severe or comorbid forms showed the lowest PA and most CR disruptions, the potential for adjunctive behavioral and chronotherapy interventions should be explored, as well as the potential of actigraphy to monitor treatment response to such interventions.
Topics: Actigraphy; Anxiety; Anxiety Disorders; Circadian Rhythm; Comorbidity; Depression; Depressive Disorder; Exercise; Female; Humans; Male; Middle Aged; Netherlands; Self Report; Sleep; Sleep Initiation and Maintenance Disorders; Surveys and Questionnaires; Time Factors
PubMed: 31348850
DOI: 10.1002/da.22949 -
Lancet (London, England) Sep 2023Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical... (Randomized Controlled Trial)
Randomized Controlled Trial
Clinical and cost-effectiveness of nurse-delivered sleep restriction therapy for insomnia in primary care (HABIT): a pragmatic, superiority, open-label, randomised controlled trial.
BACKGROUND
Insomnia is prevalent and distressing but access to the first-line treatment, cognitive behavioural therapy (CBT), is extremely limited. We aimed to assess the clinical and cost-effectiveness of sleep restriction therapy, a key component of CBT, which has the potential to be widely implemented.
METHODS
We did a pragmatic, superiority, open-label, randomised controlled trial of sleep restriction therapy versus sleep hygiene. Adults with insomnia disorder were recruited from 35 general practices across England and randomly assigned (1:1) using a web-based randomisation programme to either four sessions of nurse-delivered sleep restriction therapy plus a sleep hygiene booklet or a sleep hygiene booklet only. There was no restriction on usual care for either group. Outcomes were assessed at 3 months, 6 months, and 12 months. The primary endpoint was self-reported insomnia severity at 6 months measured with the insomnia severity index (ISI). The primary analysis included participants according to their allocated group and who contributed at least one outcome measurement. Cost-effectiveness was evaluated from the UK National Health Service and personal social services perspective and expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The trial was prospectively registered (ISRCTN42499563).
FINDINGS
Between Aug 29, 2018, and March 23, 2020 we randomly assigned 642 participants to sleep restriction therapy (n=321) or sleep hygiene (n=321). Mean age was 55·4 years (range 19-88), with 489 (76·2%) participants being female and 153 (23·8%) being male. 580 (90·3%) participants provided data for at least one outcome measurement. At 6 months, mean ISI score was 10·9 (SD 5·5) for sleep restriction therapy and 13·9 (5·2) for sleep hygiene (adjusted mean difference -3·05, 95% CI -3·83 to -2·28; p<0·0001; Cohen's d -0·74), indicating that participants in the sleep restriction therapy group reported lower insomnia severity than the sleep hygiene group. The incremental cost per QALY gained was £2076, giving a 95·3% probability that treatment was cost-effective at a cost-effectiveness threshold of £20 000. Eight participants in each group had serious adverse events, none of which were judged to be related to intervention.
INTERPRETATION
Brief nurse-delivered sleep restriction therapy in primary care reduces insomnia symptoms, is likely to be cost-effective, and has the potential to be widely implemented as a first-line treatment for insomnia disorder.
FUNDING
The National Institute for Health and Care Research Health Technology Assessment Programme.
Topics: Adult; Humans; Male; Female; Young Adult; Middle Aged; Aged; Aged, 80 and over; Cost-Benefit Analysis; Sleep Initiation and Maintenance Disorders; Treatment Outcome; State Medicine; Habits; Primary Health Care; Sleep; Quality of Life
PubMed: 37573859
DOI: 10.1016/S0140-6736(23)00683-9