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Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial.

ABSTRACT: Background:Insomnia is two to three times more prevalent in cancer survivors than in the general population, where it is estimated to be 10% to 20%. Cognitive-behavioral therapy for insomnia (CBT-I) is the recommended treatment for chronic insomnia, but meeting survivor needs remains a challenge. Internet-delivered CBT-I (iCBT-I) has been shown efficacious in otherwise healthy adults. We tested the efficacy of iCBT-I in breast cancer survivors with clinically significant sleep disturbance. Methods:Women from a national sample of Danish breast cancer survivors who experienced clinically significant sleep disturbance were randomly allocated to iCBT-I or waitlist control (55:45). The fully automated iCBT-I program consisted of six cores. Online measures of insomnia severity, sleep quality, and fatigue were collected at baseline, postintervention (nine weeks), and follow-up (15 weeks). Online sleep diaries were completed over two-week periods pre- and postintervention. Intention-to-treat analyses (time × group interactions) were conducted with mixed linear models and corrected for multiple outcomes. All statistical tests were two-sided. Results:A total of 255 women were randomly allocated to iCBT-I (n = 133) or waitlist control (n = 122). Statistically significant (P ≤ .02) time × group interactions were found for all sleep-related outcomes from pre- to postintervention. Effect sizes (Cohen's d) ranged from 0.33 (95% confidence interval [CI] = 0.06 to 0.61) for wake after sleep onset to 1.17 (95% CI = 0.87 to 1.47) for insomnia severity. Improvements were maintained for outcomes measured at follow-up (d = 0.66-1.10). Conclusions:iCBT-I appears to be effective in breast cancer survivors, with additional benefit in terms of reduced fatigue. This low-cost treatment could be incorporated in cancer rehabilitation programs.

SUBMITTER: Zachariae R

PROVIDER: S-EPMC6093474 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPatients with chronic pain often experience insomnia symptoms. Pain initiates, maintains, and exacerbates insomnia symptoms, and vice versa, indicating a complex situation with an additional burden for these patients. Hence, the evaluation of insomnia-related interventions for patients with chronic pain is important.ObjectiveThis randomized controlled trial examined the effectiveness of internet-based cognitive behavioral therapy for insomnia (ICBT-i) for reducing insomnia severity and other sleep- and pain-related parameters in patients with chronic pain. Participants were recruited from the Swedish Quality Registry for Pain Rehabilitation.MethodsWe included 54 patients (mean age 49.3, SD 12.3 years) who were randomly assigned to the ICBT-i condition and 24 to an active control condition (applied relaxation). Both treatment conditions were delivered via the internet. The Insomnia Severity Index (ISI), a sleep diary, and a battery of anxiety, depression, and pain-related parameter measurements were assessed at baseline, after treatment, and at a 6-month follow-up (only ISI, anxiety, depression, and pain-related parameters). For the ISI and sleep diary, we also recorded weekly measurements during the 5-week treatment. Negative effects were also monitored and reported.ResultsResults showed a significant immediate interaction effect (time by treatment) on the ISI and other sleep parameters, namely, sleep efficiency, sleep onset latency, early morning awakenings, and wake time after sleep onset. Participants in the applied relaxation group reported no significant immediate improvements, but both groups exhibited a time effect for anxiety and depression at the 6-month follow-up. No significant improvements on pain-related parameters were found. At the 6-month follow-up, both the ICBT-i and applied relaxation groups had similar sleep parameters. For both treatment arms, increased stress was the most frequently reported negative effect.ConclusionsIn patients with chronic pain, brief ICBT-i leads to a more rapid decline in insomnia symptoms than does applied relaxation. As these results are unique, further research is needed to investigate the effect of ICBT-i on a larger sample size of people with chronic pain. Using both treatments might lead to an even better outcome in patients with comorbid insomnia and chronic pain.Trial registrationClinicalTrials.gov NCT03425942; https://clinicaltrials.gov/ct2/show/NCT03425942.

Project description:BackgroundThis study is one of the first randomized controlled trials investigating cognitive behavioral therapy for insomnia (CBT-I) delivered by a fully automated mobile phone app. Such an app can potentially increase the accessibility of insomnia treatment for the 10% of people who have insomnia.ObjectiveThe objective of our study was to investigate the efficacy of CBT-I delivered via the Sleepcare mobile phone app, compared with a waitlist control group, in a randomized controlled trial.MethodsWe recruited participants in the Netherlands with relatively mild insomnia disorder. After answering an online pretest questionnaire, they were randomly assigned to the app (n=74) or the waitlist condition (n=77). The app packaged a sleep diary, a relaxation exercise, sleep restriction exercise, and sleep hygiene and education. The app was fully automated and adjusted itself to a participant's progress. Program duration was 6 to 7 weeks, after which participants received posttest measurements and a 3-month follow-up. The participants in the waitlist condition received the app after they completed the posttest questionnaire. The measurements consisted of questionnaires and 7-day online diaries. The questionnaires measured insomnia severity, dysfunctional beliefs about sleep, and anxiety and depression symptoms. The diary measured sleep variables such as sleep efficiency. We performed multilevel analyses to study the interaction effects between time and condition.ResultsThe results showed significant interaction effects (P<.01) favoring the app condition on the primary outcome measures of insomnia severity (d=-0.66) and sleep efficiency (d=0.71). Overall, these improvements were also retained in a 3-month follow-up.ConclusionsThis study demonstrated the efficacy of a fully automated mobile phone app in the treatment of relatively mild insomnia. The effects were in the range of what is found for Web-based treatment in general. This supports the applicability of such technical tools in the treatment of insomnia. Future work should examine the generalizability to a more diverse population. Furthermore, the separate components of such an app should be investigated. It remains to be seen how this app can best be integrated into the current health regimens.Trial registrationNetherlands Trial Register: NTR5560; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5560 (Archived by WebCite at http://www.webcitation.org/6noLaUdJ4).

Project description:BackgroundIn reality, pharmacotherapy still remains the most common treatment for insomnia.ObjectiveThis study aimed to examine the effectiveness of our internet-delivered computerized cognitive behavioral therapy (ICBT) program as an adjunct to usual care (UC) compared with UC alone in patients with insomnia who remain symptomatic following hypnotics.MethodsWe recruited 23 patients with insomnia who remained symptomatic following pharmacologic treatment including benzodiazepines, and we conducted an exploratory randomized controlled trial. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) at week 6 of the treatment. Secondary outcomes were sleep onset latency, total sleep time, sleep efficiency, number of awakenings, refreshment and soundness of sleep, anxiety by Hospital Anxiety and Depression Scale, depression measured by the Center for Epidemiologic Studies Depression Scale, and quality of life (QOL) measured by the EuroQol-5D. All parameters were measured at weeks 0 (baseline), 6 (postintervention), and 12 (follow-up).ResultsThe adjusted mean reduction (-6.11) in PSQI at week 6 from baseline in the ICBT plus UC group was significantly (P<.001) larger than the adjusted mean reduction (0.40) in the UC alone group. Significant differences were also found in favor of ICBT plus UC for PSQI, sleep onset latency, sleep efficiency, number of awakenings, and depression at all assessment points. Refreshment, soundness of sleep, anxiety, and QOL improved by week 6 in ICBT plus UC compared with UC alone. There were no reports of adverse events in either group during the study.ConclusionsThese results indicated that our 6-week ICBT program is an effective treatment adjunct to UC for improving insomnia and related symptoms even after unsuccessful pharmacotherapy.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry: UMIN000021509; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023545 (Archived by WebCite at http://www.webcitation. org/75tCmwnYt).

Project description:BackgroundInsomnia is of major public health importance. While cognitive behavioral therapy is beneficial, in-person treatment is often unavailable. We assessed the effectiveness of internet-delivered cognitive behavioral therapy for insomnia.ObjectivesThe primary objectives were to determine whether online cognitive behavioral therapy for insomnia could improve sleep efficiency and reduce the severity of insomnia in adults. Secondary outcomes included sleep quality, total sleep time, time in bed, sleep onset latency, wake time after sleep onset, and number of nocturnal awakenings.Data sourcesWe searched PubMed/MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, PsycInfo, Cochrane Library, Embase, and the Web of Science for randomized trials.MethodsStudies were eligible if they were randomized controlled trials in adults that reported application of cognitive behavioral therapy for insomnia via internet delivery. Mean differences in improvement in sleep measures were calculated using the Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis.ResultsWe found 15 trials, all utilizing a pretest-posttest randomized control group design. Sleep efficiency was 72% at baseline and improved by 7.2% (95% CI: 5.1%, 9.3%; p<0.001) with internet-delivered cognitive behavioral therapy versus control. Internet-delivered cognitive behavioral therapy resulted in a decrease in the insomnia severity index by 4.3 points (95% CI: -7.1, -1.5; p = 0.017) compared to control. Total sleep time averaged 5.7 hours at baseline and increased by 20 minutes with internet-delivered therapy versus control (95% CI: 9, 31; p = 0.004). The severity of depression decreased by 2.3 points (95% CI: -2.9, -1.7; p = 0.013) in individuals who received internet-delivered cognitive behavioral therapy compared to control. Improvements in sleep efficiency, the insomnia severity index and depression scores with internet-delivered cognitive behavioral therapy were maintained from 4 to 48 weeks after post-treatment assessment. There were no statistically significant differences between sleep efficiency, total sleep time, and insomnia severity index for internet-delivered versus in-person therapy with a trained therapist.ConclusionIn conclusion, internet-delivered cognitive behavioral therapy is effective in improving sleep in adults with insomnia. Efforts should be made to educate the public and expand access to this therapy. Registration Number, Prospero: CRD42015017622.

Project description:Background and aimsInternet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania).MethodsParticipants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures.ResultsA significant difference with a large between-group effect size in favor of iCBT was found (Cohen's d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen's d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants' functioning, as the treatment gains were maintained six months later.ConclusionsInternet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment approach in Romania.Trial registrationClinicalTrials.gov NCT01557894.

Project description:Fatigue is a prevalent, distressing side effect of cancer and cancer treatment which commonly coexists with insomnia. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia in cancer patients, but less is known about its ability to impact fatigue. This work is the analysis for a secondary aim of a four-arm randomized controlled trial (RCT) study assessing the combined and comparative effect of CBT-I and a wakefulness-promoting agent, armodafinil (A), to improve sleep and daytime functioning in cancer survivors. Herein, we examine the effect of CBT-I, with and without A, on fatigue in cancer survivors.This study was a four-arm factorial study with CBTI-I (yes/no) versus A (yes/no). It consisted of 96 cancer survivors (average age 56 years; 88 % female; 68 % breast cancer). Fatigue was assessed by the brief fatigue inventory (BFI) and the FACIT-Fatigue scale. The analysis assessed the additive effects of CBT-I and A and possible non-additive effects where the effect of CBT-I changes depending on the presence or absence of A.Analyses adjusting for baseline differences showed that CBT-I improved fatigue as measured by two separate scales (BFI: P?=?0.002, Std. error?=?0.32, effect size (ES)?=?0.46; FACIT-Fatigue: P?<?0.001, Std. error?=?1.74, ES?=?0.64). Armodafinil alone did not show a statistically significant effect on fatigue levels (all Ps?>?0.40) nor did the drug influence the efficacy of CBT-I. Structural equation analysis revealed that reductions in insomnia severity were directly responsible for improving cancer-related fatigue.CBT-I with and without armodafinil resulted in a clinically and statistically significant reduction of subjective daytime fatigue in cancer survivors with chronic insomnia. Armodafinil did not improve cancer-related fatigue (CRF) and did not change the efficacy of CBT-I. Patients reporting CRF should be screened and, if indicated, treated for insomnia as part of a comprehensive fatigue management program.

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Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial.

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