scholarly journals Comparing internet-delivered cognitive therapy and behavior therapy with telephone support for insomnia disorder: a randomized controlled trial

SLEEP ◽  
2019 ◽  
Vol 43 (2) ◽  
Author(s):  
Rikard Sunnhed ◽  
Hugo Hesser ◽  
Gerhard Andersson ◽  
Per Carlbring ◽  
Charles M Morin ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cognitive Therapy ◽  
Behavior Therapy ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Sleep Onset Latency ◽  
Unique Contribution ◽  
Telephone Support ◽  
Insomnia Disorder ◽  
And Behavior

Abstract Study Objectives Our aim was to compare the effects of Internet-delivered cognitive therapy (CT) and behavior therapy (BT) against a waitlist (WL) condition to better understand their unique contribution in the treatment of insomnia. Methods Two hundred and nineteen participants with insomnia disorder were randomized to CT (n = 72), BT (n = 73), or WL (n = 74). The treatment arms consisted of 10 weekly internet-delivered modules with 15 min of telephone support per week. At pre, post, and follow-up, participants completed measures of insomnia severity, sleep diaries, functional impairment, anxiety, depression, quality of life, adverse events, satisfaction and perception of content, workload, and activity in treatment. Measures of completed exercises, modules, therapist support, and platform logins were also measured at posttreatment. Results Moderate to large effect sizes for both CT and BT outperformed the WL on the majority of outcomes, with significant differences in favor of both therapy groups. Both treatment groups had significantly larger proportion of treatment remitters (CT: 35.8%, BT: 40%, WL: 2.7%) and responders (CT: 74.6%, BT 58.6%, WL: 10.8%) compared to the WL at posttreatment. There were no significant differences between the two therapy groups in terms of outcomes, except for sleep onset latency in favor of BT (6 min difference at posttreatment) and adverse events in favor of CT (CT 14.1% vs BT 43.2%). Conclusions This study indicates that both Internet-delivered CT and BT are effective as stand-alone therapies for insomnia disorder. Results highlight the need for examining which therapy and subcomponents that are necessary for change. ClinicalTrials.gov Identifier NCT02984670

scholarly journals 0473 Effectiveness and Safety of Lemborexant in Subjects Previously Treated with Placebo for 6 Months in SUNRISE-2

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A181-A182
Author(s):  
J Yardley ◽  
Y Inoue ◽  
K Pinner ◽  
C Perdomo ◽  
G Filippov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Sleep Onset ◽  
Sleep Diary ◽  
Sleep Onset Latency ◽  
Double Blind ◽  
Subjective Sleep ◽  
Insomnia Disorder ◽  
Previously Treated ◽  
Treatment Changes ◽  
Additional Improvement

Abstract Introduction In SUNRISE-2 (NCT02952820; E2006-G000-303), while lemborexant (LEM) provided significant benefit versus placebo (PBO) on sleep-diary measurements over 6mo, some improvement was noted in PBO subjects. We report outcomes from PBO subjects rerandomized to LEM during the last 6mo of SUNRISE-2. Methods SUNRISE-2 was a randomized, double-blind, global phase 3 study in adults (≥18y) with insomnia disorder. Subjects received PBO or LEM (5mg [LEM5]; 10mg [LEM10]) for 6mo. PBO subjects were rerandomized to LEM for another 6mo; LEM subjects continued assigned treatment. Changes from 6mo baseline (calculated after PBO completion) in subjective sleep onset latency (sSOL), subjective sleep efficiency (sSE), and subjective wake after sleep onset (sWASO) are reported for rerandomized subjects. Results At study baseline for PBO subjects (n=318), median sSOL (min) was 55.9, mean (SD) sSE (%) and sWASO (min) were 61.3 (17.8) and 132.5 (80.2), respectively. The 6mo baseline values for rerandomized PBO-LEM5 (n=133) and PBO-LEM10 (n=125) subjects, respectively, were: median sSOL, 31.2, 34.3; mean (SD) sSE, 70.5 (20.2), 71.1 (18.0); mean (SD) sWASO, 105.1 (80.6), 100.1 (84.6). Median sSOL decreased from the 6mo baseline after 1mo (PBO-LEM5, −3.2; PBO-LEM10, −2.9) and 6mo (PBO-LEM5, −2.7; PBO-LEM10, −5.0). Mean (SD) sSE increased from the 6mo baseline after 1mo (PBO-LEM5, 3.9 [12.1]; PBO-LEM10, 3.5 [8.1]) and 6mo (PBO-LEM5, 3.9 [13.6]; PBO-LEM10, 4.5 [13.0]). Mean (SD) sWASO decreased after 1mo (PBO-LEM5, −8.5 [49.4]; PBO-LEM10, −5.7 [36.1]) and 6mo (PBO-LEM5, −8.2 [49.0]; PBO-LEM10, −10.0 [58.8]). Treatment-emergent adverse events incidence was similar during PBO (62.7%) and LEM treatment (PBO-LEM5, 54.9%; PBO-LEM10, 57.7%). Adverse events were consistent with those seen in the initial 6mo of treatment for patients originally randomized to LEM. Conclusion Rerandomization to LEM was associated with additional improvement in sleep outcomes following the PBO-related response. LEM benefit was evident after 1mo and was sustained throughout treatment. LEM was well tolerated. Support Eisai Inc.

scholarly journals The effect of sleep-wake intraindividial variability in digital cognitive behaviour therapy for insomnia: A mediation analysis of a large-scale RCT

SLEEP ◽  
2021 ◽  
Author(s):  
Cecilie L Vestergaard ◽  
Øystein Vedaa ◽  
Melanie R Simpson ◽  
Patrick Faaland ◽  
Daniel Vethe ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Large Scale ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Depression Scale ◽  
Mediating Effect ◽  
Sleep Onset Latency ◽  
Composite Measures ◽  
Cognitive Behaviour ◽  
Insomnia Severity

Abstract Study Objectives Digital Cognitive Behavioural Therapy for Insomnia (dCBT-I) is an effective treatment for insomnia. However, less is known about mediators of its benefits. The aim of the present study was to test if intraindividual variability in sleep (IIV) was reduced with dCBT-I, and whether any identified reduction was a mediator of dCBT-I on insomnia severity and psychological distress. Methods In a two-arm randomized controlled trial (RCT), 1720 adults with insomnia (dCBT-I = 867; patient education about sleep = 853) completed the Insomnia Severity Index (ISI), the Hospital Anxiety and Depression Scale (HADS) and sleep diaries, at baseline and 9-week follow-up. Changes in IIV were analysed using linear mixed modelling followed by mediation analyses of ISI, HADS, and IIV in singular sleep metrics and composite measures (Behavioural Indices (BI-Z) and Sleep-disturbance Indices (SI-Z)). Results dCBT-I was associated with reduced IIV across all singular sleep metrics, with the largest between-group effect sizes observed for sleep onset latency (SOL). Reduced IIV for SOL and wake after sleep onset had the overall greatest singular mediating effect. For composite measures, SI-Z mediated change in ISI (b = -0.74; 95% Confidence Interval (CI) -1.04 to -0.52; 13.3%) and HADS (b = -0.40; 95% CI -0.73 to -0.18; 29.2%), whilst BI-Z mediated minor changes. Conclusion Reductions in IIV in key sleep metrics mediate significant changes in insomnia severity and especially psychological distress when using dCBT-I. These findings offer important evidence regarding the therapeutic action of dCBT-I and may guide the future development of this intervention.

scholarly journals O043 “My Fitbit tells me I don’t sleep” – Validation of a consumer-wearable device (Fitbit Charge 3TM) using gold standard in-laboratory polysomnography to assess sleep in adults presenting for medical evaluation in a sleep laboratory

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A19-A19
Author(s):  
M Munsif ◽  
R Jumabhoy ◽  
K Rangamuwa ◽  
D Mansfield ◽  
S Drummond ◽  
...  
Keyword(s):  
Sleep Disorders ◽  
Sleep Onset ◽  
Sleep Time ◽  
Sleep Onset Latency ◽  
Medical Evaluation ◽  
Insomnia Disorder ◽  
Epoch Analysis ◽  
A Prospective Study ◽  
Screening Device ◽  
Wake State

Abstract Background There has been a rapid growth in wearable devices marketed for sleep. Trackers such as the Fitbit collect data through an accelerometer and use heart rate variability to estimate the sleep-wake state. Currently, Fitbit validation studies have only been with “healthy” adults and Insomnia Disorder. Aims The purpose of this study is to evaluate the accuracy of Fitbit Charge3TM compared to in-lab polysomnography (PSG) in patients with sleep disorders. Our hypothesis is that Fitbit Charge 3TM will perform with less sensitivity and specificity relative to PSG in the presence of sleep disorders. Methods A prospective study of patients attending a PSG through Epworth Camberwell Sleep Lab between 2019–2021 will be conducted. Fitbit Charge3TM will be worn on the wrist with concurrent PSG monitoring. Parameters measured with both PSG and Fitbit Charge3TM will include total sleep time, Sleep onset latency, wake after sleep onset and time spent in N1, N2, N3 and REM sleep (min). Standard PSG data will be evaluated to diagnose sleep-disordered breathing. Progress to date:Ethics approval has been obtained, and 110 participants have been recruited. 30-second epoch-by-epoch analysis will now be conducted. Bland-Altman analyses will be performed to assess agreement between the Fitbit and PSG. Intended outcome and impact: Our novel study findings will provide evidence to address queries regarding the accuracy of the Fitbit trackers to evaluate sleep and may support the use of Fitbit Charge3TM as an initial screening device to assess sleep duration and sleep architecture in select patients.

scholarly journals Guided Internet-delivered cognitive behavioural treatment for insomnia: a randomized trial

2013 ◽  
Vol 44 (7) ◽  
pp. 1521-1532 ◽  
Author(s):  
A. van Straten ◽  
J. Emmelkamp ◽  
J. de Wit ◽  
J. Lancee ◽  
G. Andersson ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Sleep Onset ◽  
Intervention Group ◽  
Sleep Diary ◽  
The Internet ◽  
Control Group ◽  
Sleep Onset Latency ◽  
Cognitive Behavioural ◽  
Co Morbidity ◽  
Significant Difference

BackgroundInsomnia is a prevalent problem with a high burden of disease (e.g. reduced quality of life, reduced work capacity) and a high co-morbidity with other mental and somatic disorders. Cognitive behavioural therapy (CBT) is effective in the treatment of insomnia but is seldom offered. CBT delivered through the Internet might be a more accessible alternative. In this study we examined the effectiveness of a guided Internet-delivered CBT for adults with insomnia using a randomized controlled trial (RCT).MethodA total of 118 patients, recruited from the general population, were randomized to the 6-week guided Internet intervention (n = 59) or to a wait-list control group (n = 59). Patients filled out an online questionnaire and a 7-day sleep diary before (T0) and after (T1) the 6-week period. The intervention group received a follow-up questionnaire 3 months after baseline (T2).ResultsAlmost three-quarters (72.9%) of the patients completed the whole intervention. Intention-to-treat (ITT) analysis showed that the treatment had statistically significant medium to large effects (p < 0.05; Cohen's d between 0.40 and 1.06), and resulted more often in clinically relevant changes, on all sleep and secondary outcomes with the exception of sleep onset latency (SOL) and number of awakenings (NA). There was a non-significant difference in the reduction in sleep medication between the intervention (a decrease of 6.8%) and control (an increase of 1.8%) groups (p = 0.20). Data on longer-term effects were inconclusive.ConclusionsThis study adds to the growing body of literature that indicates that guided CBT for insomnia can be delivered through the Internet. Patients accept the format and their sleep improves.

Sleep misestimation among older adults suffering from insomnia with short and normal objective sleep duration and the effects of cognitive behavior therapy

SLEEP ◽  
2020 ◽  
Author(s):  
Nicole Lovato ◽  
Gorica Micic ◽  
Leon Lack
Keyword(s):  
Older Adults ◽  
Sleep Duration ◽  
Behavior Therapy ◽  
Cognitive Behavior Therapy ◽  
Sleep Onset ◽  
Sleep Diary ◽  
Cognitive Behavior ◽  
Sleep Onset Latency ◽  
Normal Sleep

Abstract Study Objectives Compare the degree of sleep misestimation in older adults with insomnia presenting with objectively short relative to normal sleep duration, and investigate the differential therapeutic response on sleep misestimation between the proposed sleep duration phenotypes to cognitive-behavior therapy for insomnia (CBTi). Methods Ninety-one adults (male = 43, mean age = 63.34, SD = 6.41) with sleep maintenance insomnia were classified as short sleepers (SS; &lt;6 h total sleep time [TST]) or normal sleepers (NS; ≥6 h TST) based on one night of home-based polysomnography. Participants were randomly allocated to CBTi (N = 30 SS, N = 33 NS) or to a wait-list control condition (N = 9 SS, N = 19 NS). Sleep misestimation was calculated as the difference scores of subjective (sleep diary reported) and objective (derived from actigraphy) sleep onset latency (SOL), wake after sleep onset (WASO), and TST at pre- and post-treatment, and 3-month follow-up. Results Prior to treatment, perception of SOL, WASO, and TST did not differ between patients with objectively short sleep duration relative to those with objectively normal sleep duration. Patients’ perception of WASO and TST, improved immediately following treatment and at 3-month follow-up relative to the waitlist group. These improvements did not differ significantly between those with short or normal objective sleep duration prior to treatment. Conclusions The degree of sleep misestimation is similar for older adults suffering from chronic insomnia with short or normal objective sleep duration. Irrespective of objective sleep duration prior to treatment, CBTi produces significant improvements in sleep perception. Clinical Trial Registration Number ACTRN12620000883910

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