Dataset Information

Acupuncture Versus Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: A Randomized Clinical Trial.

ABSTRACT:

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.

SUBMITTER: Garland SN

PROVIDER: S-EPMC6910189 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Publications

Acupuncture Versus Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: A Randomized Clinical Trial.

Garland Sheila N SN Xie Sharon X SX DuHamel Kate K Bao Ting T Li Qing Q Barg Frances K FK Song Sarah S Kantoff Philip P Gehrman Philip P Mao Jun J JJ

Journal of the National Cancer Institute 20191201 12

<h4>Background</h4>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.<h4>Methods</h4>This randomized trial compared 8 weeks of acupuncture (n = 80) and CBT-I (n = 80) in cancer survivors. Acupuncture involved stimulating specific p ...[more]

PMID: 31081899

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Project description:BackgroundCancer-related cognitive impairment is a prevalent, disruptive condition potentially exacerbated by sleep disturbances. The current study was performed to evaluate the effects of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on objective and subjective cognitive function in cancer survivors with insomnia.MethodsUsing data from a randomized clinical trial (160 survivors) that compared acupuncture versus CBT-I for insomnia occurring in cancer survivors, the authors analyzed cognitive outcomes and their relationship to insomnia symptoms. Analysis was limited to 99 patients who reported baseline cognitive difficulties. Interventions were delivered over 8 weeks. Objective attention, learning, and memory were evaluated using the Buschke Selective Reminding Test. Subjective cognitive function was assessed using the Brown Attention-Deficit Disorder Scales. Insomnia symptoms were assessed using the Insomnia Severity Index. All outcomes were collected at baseline, week 8, and week 20.ResultsFrom baseline to week 8, acupuncture produced statistically significant within-group improvements in objective attention (Cohen D, 0.29), learning (Cohen D, 0.31), and memory (Cohen D, 0.33) that persisted to week 20 (all P < .05), whereas CBT-I produced a statistically significant within-group improvement in objective attention from baseline to week 20 (Cohen D, 0.50; P < .05); between-group differences were not statistically significant. Both interventions produced statistically significant within-group improvements in subjective cognitive function at weeks 8 and 20 compared with baseline (all P < .001); between-group differences were not statistically significant. In the acupuncture group, patients with clinically meaningful responses with regard to insomnia symptoms demonstrated a significantly greater improvement in subjective cognitive function compared with those without clinically meaningful insomnia responses (P = .006).ConclusionsAmong cancer survivors with insomnia, both acupuncture and CBT-I produced significant improvements in objective and subjective cognitive function. However, the effect sizes varied and only survivors in the acupuncture group demonstrated a significant relationship between cognitive and sleep outcomes. These preliminary findings warrant further investigation to guide the personalized management of patients with cancer-related cognitive impairment.

Project description:ImportanceInsomnia symptoms affect an estimated 30% to 50% of the 4 million US breast cancer survivors. Previous studies have shown the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), but high insomnia prevalence suggests continued opportunities for delivery via new modalities.ObjectiveTo determine the efficacy of a CBT-I-informed, voice-activated, internet-delivered program for improving insomnia symptoms among breast cancer survivors.Design, setting, and participantsIn this randomized clinical trial, breast cancer survivors with insomnia (Insomnia Severity Index [ISI] score >7) were recruited from advocacy and survivorship groups and an oncology clinic. Eligible patients were females aged 18 years or older who had completed curative treatment more than 3 months before enrollment and had not undergone other behavioral sleep treatments in the prior year. Individuals were assessed for eligibility and randomized between March 2022 and October 2023, with data collection completed by December 2023.InterventionParticipants were randomized 1:1 to a smart speaker with a voice-interactive CBT-I program or educational control for 6 weeks.Main outcomes and measuresLinear mixed models and Cohen d estimates were used to evaluate the primary outcome of changes in ISI scores and secondary outcomes of sleep quality, wake after sleep onset, sleep onset latency, total sleep time, and sleep efficiency.ResultsOf 76 women enrolled (38 each in the intervention and control groups), 70 (92.1%) completed the study. Mean (SD) age was 61.2 (9.3) years; 49 (64.5%) were married or partnered, and participants were a mean (SD) of 9.6 (6.8) years from diagnosis. From baseline to follow-up, ISI scores changed by a mean (SD) of -8.4 (4.7) points in the intervention group compared with -2.6 (3.5) in the control group (P < .001) (Cohen d, 1.41; 95% CI, 0.87-1.94). Sleep diary data showed statistically significant improvements in the intervention group compared with the control group for sleep quality (0.56; 95% CI, 0.39-0.74), wake after sleep onset (9.54 minutes; 95% CI, 1.93-17.10 minutes), sleep onset latency (8.32 minutes; 95% CI, 1.91-14.70 minutes), and sleep efficiency (-0.04%; 95% CI, -0.07% to -0.01%) but not for total sleep time (0.01 hours; 95% CI, -0.27 to 0.29 hours).Conclusions and relevanceThis randomized clinical trial of an in-home, voice-activated CBT-I program among breast cancer survivors found that the intervention improved insomnia symptoms. Future studies may explore how this program can be taken to scale and integrated into ambulatory care.Trial registrationClinicalTrials.gov Identifier: NCT05233800.

Project description:PurposeFatigue 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.Patients and methodsThis 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.ResultsAnalyses 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.ConclusionsCBT-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.

Project description:ObjectiveTo evaluate the effectiveness of cognitive behavioral therapy for insomnia during pregnancy.MethodsRandomized, unmasked, 3-site controlled trial. Participants were randomly allocated to cognitive behavioral therapy for insomnia (a first-line, empirically supported psychosocial intervention that addresses sleep-related behaviors and cognitions) or a control intervention consisting of imagery exercises that paired patient-identified distressing nighttime experiences with patient-identified neutral images. Participants were eligible if they met diagnostic criteria for insomnia disorder and were between 18 and 32 weeks of gestation. Patients were ineligible if they met diagnostic criteria for major psychiatric disorders, including depression, or were receiving nonstudy treatments that could affect sleep (or both). The primary outcome was the Insomnia Severity Index score, a validated brief questionnaire, with scores between 14 and 21 representing clinically meaningful insomnia of moderate severity, scores higher than 21 representing severe insomnia, and scores less than 8 representing no insomnia. Secondary outcomes included remission of insomnia (Insomnia Severity Index score less than 8), objectively measured and self-reported time awake (ie, total wake time), and the Edinburgh Postnatal Depression Scale score. All outcomes were measured weekly. Analysis included 48 participants who did not complete treatment. We estimated that 184 women would be required to have 80% power, with a two-tailed test, to detect a moderate Cohen's d effect size (.5) with α=.05.ResultsBetween May 2013 and April 2017, 194 pregnant women were randomized and 149 completed treatment; 179 with available baseline data (92%) were ultimately analyzed, 89 in the cognitive therapy group and 90 in the control group. Women assigned to cognitive behavioral therapy for insomnia experienced significantly greater reductions in insomnia severity (scores decreased from 15.4±4.3 to 8.0±5.2 in the cognitive behavioral therapy group vs from 15.9±4.4 to 11.2±4.9 in the control therapy group [P<.001, d=0.5]). Remission of insomnia (to an Insomnia Severity Index score less than 8) disorder was attained by 64% of women in the cognitive behavioral therapy for insomnia group vs 52% in the control group. Women receiving cognitive behavioral therapy for insomnia experienced faster remission of insomnia disorder, with a median of 31 days vs 48 days in the control therapy (P<.001). Cognitive behavioral therapy for insomnia led to significantly greater reduction in self-reported but not objective total wake time and a small but significantly greater decline in Edinburgh Postnatal Depression Scale scores vs the control group.ConclusionCognitive behavioral therapy for insomnia is an effective nonpharmacologic treatment for insomnia during pregnancy.Clinical trial registrationClinicalTrials.gov, NCT01846585.

Dataset Information

Acupuncture Versus Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: A Randomized Clinical Trial.

Background

Methods

Results

Conclusions

Publications

Acupuncture Versus Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: A Randomized Clinical Trial.

Similar Datasets

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