Acupuncture Versus Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: A Randomized Clinical Trial.
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ABSTRACT:
SUBMITTER: Garland SN
PROVIDER: S-EPMC6910189 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
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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]
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Project description:Pain and insomnia often co-occur and impair the quality of life in cancer survivors. This study evaluated the effect of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on pain severity among cancer survivors with comorbid pain and insomnia. Using data from the CHOICE trial that compared acupuncture versus CBT-I for insomnia among cancer survivors, we analyzed the effect of interventions on pain outcomes in 70 patients with moderate to severe baseline pain. Interventions were delivered over eight weeks. We assessed average pain severity (primary outcome) and pain interference at baseline, week 8, and week 20. We further defined insomnia and pain responders as patients who achieved clinically meaningful improvement in insomnia and pain outcomes, respectively, at week 8. We found that compared with baseline, the between-group difference (-1.0, 95% CI -1.8 to -0.2) was statistically significant favoring acupuncture for reduced pain severity at week 8 (-1.4, 95% CI -2.0 to -0.8) relative to CBT-I (-0.4, 95% CI-1.0 to 0.2). Responder analysis showed that 1) with acupuncture, insomnia responders reported significantly greater pain reduction from baseline to week 4, compared with insomnia non-responders (-1.5, 95% CI -2.7 to -0.3); 2) with CBT-I, pain responders reported significantly greater insomnia reduction at week 8, compared with pain non-responders (-4.7, 95% CI -8.7 to -1.0). These findings suggest that among cancer survivors with comorbid pain and insomnia, acupuncture led to rapid pain reductions, which contributed to a decrease in insomnia, whereas CBT-I had a delayed effect on pain, possibly achieved by insomnia improvement.
| S-EPMC8633385 | biostudies-literature
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.
| S-EPMC7992052 | biostudies-literature
Project description: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.
| S-EPMC6093474 | biostudies-literature
Project description:IntroductionDecreased brain-derived neurotrophic factor (BDNF) is associated with poor sleep. This study examined the effects of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on serum BDNF and sleep outcomes in cancer survivors with insomnia.MethodsThis was an exploratory analysis of a randomized clinical trial (n = 160) comparing acupuncture versus CBT-I for cancer survivors with insomnia. Interventions were delivered over 8 weeks. Outcomes were assessed at baseline and week 8. Serum BDNF was evaluated with enzyme-linked immunosorbent assay (ELISA). Sleep was evaluated with the insomnia severity index and consensus sleep diary. Pearson correlations between BDNF and sleep outcomes were calculated. Data analysis was limited to 87 survivors who provided serum samples.ResultsAmong 87 survivors, the mean age was 61.9 (SD: 11.4) years, 51.7% were women, and 24.1% were non-White. Mean serum BDNF did not significantly increase in acupuncture (n = 50) or CBT-I (n = 37) groups. When analysis was restricted to patients with low baseline BDNF (i.e. levels below the sample median of 47.1 ng/mL), the acupuncture group (n = 22) demonstrated a significant 7.2 ng/mL increase in mean serum BDNF (P = 0.03), whereas the CBT-I group (n = 21) demonstrated a non-significant 2.9 ng/mL increase (P = 0.28). Serum BDNF was not significantly correlated with sleep outcomes (all P > 0.05).ConclusionAmong cancer survivors with insomnia and low baseline BDNF, acupuncture significantly increased serum BDNF levels; however, the clinical significance of this finding requires further investigation.Trial registration no. NCT02356575 (ClinicalTrials.gov).
| S-EPMC9281995 | biostudies-literature
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.
| S-EPMC4805518 | biostudies-literature
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.
| S-EPMC6485299 | biostudies-literature
Project description:STUDY OBJECTIVES:The current archival analyses examine the direct and indirect effects of cognitive behavioral therapy for insomnia (CBT-I) on depression in cancer survivors. METHODS:We report on 67 cancer survivors from a 2 × 2 randomized controlled trial of CBT-I and armodafinil for insomnia, after collapsing across the noneffective study medication conditions (armodafinil/placebo) to create CBT-I (yes/no). Depression and insomnia were assessed before, during the 7-week CBT-I intervention, at postintervention, and 3 months later by the Patient Health Questionnaire and the Insomnia Severity Index, respectively. RESULTS:Mean depression at baseline for all participants was 6.44 (standard error = 0.41, range 0-15). Paired t tests showed that depression improved from baseline to postintervention by 48% (P < .001) in the CBT-I group versus 15% (P = .016) in the non-CBT-I group. Analysis of covariance controlling for baseline found that participants receiving CBT-I had significantly less depression at postintervention (effect size = -0.62; P = .001), compared to those who did not receive CBT-I. These benefits were maintained at the 3-month follow-up. Spearman rank correlations showed that changes in insomnia severity from baseline to postintervention were significantly correlated with concurrent changes in depression (r = .73; P < .001). Path analysis revealed that improvement in depression was mediated by improvement in insomnia severity (P < .001). CONCLUSIONS:Our findings provide preliminary support that in cancer survivors, CBT-I reduces depression via improvement in insomnia. Further, this reduction in depression remained stable 3 months after completing CBT-I. This suggests that a CBT-I intervention has a meaningful effect on depression. CLINICAL TRIAL REGISTRATION:Registry: ClinicalTrials.gov; Title: Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy; Identifier: NCT01091974; URL: https://clinicaltrials.gov/ct2/show/record/NCT01091974.
| S-EPMC6329536 | biostudies-literature
Project description:OBJECTIVE:The aim of this study was to investigate in a randomized clinical trial the role of sleep-related cognitive variables in the long-term efficacy of an online, fully automated cognitive behavioral therapy intervention for insomnia (CBT-I) (Sleep Healthy Using the Internet [SHUTi]). METHOD:Three hundred and three participants (Mage = 43.3 years; SD = 11.6) were randomly assigned to SHUTi or an online patient education condition and assessed at baseline, postintervention (nine weeks after baseline), and six and 12 months after the intervention period. Cognitive variables were self-reported internal and chance sleep locus of control, dysfunctional beliefs and attitudes about sleep (DBAS), sleep specific self-efficacy, and insomnia knowledge. Primary outcomes were self-reported online ratings of insomnia severity (Insomnia Severity Index), and sleep onset latency and wake after sleep onset from online sleep diaries, collected 12 months after the intervention period. RESULTS:Those who received SHUTi had, at postassessment, higher levels of insomnia knowledge (95% confidence interval [CI] = 0.10-0.16) and internal sleep locus of control (95% CI = 0.04-0.55) as well as lower DBAS (95% CI = 1.52-2.39) and sleep locus of control attributed to chance (95% CI = 0.15-0.71). Insomnia knowledge, chance sleep locus of control, and DBAS mediated the relationship between condition and at least one 12-month postassessment sleep outcome. Within the SHUTi condition, changes in each cognitive variable (with the exception of internal sleep locus of control) predicted improvement in at least one sleep outcome one year later. CONCLUSION:Online CBT-I may reduce the enormous public health burden of insomnia by changing underlying cognitive variables that lead to long-term changes in sleep outcomes.
| S-EPMC5993570 | biostudies-literature
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.
| S-EPMC2663864 | biostudies-literature
Project description:ObjectiveInsomnia is prevalent among patients with knee osteoarthritis (OA). Research indicates that sleep disruption may amplify clinical pain by altering central pain modulation, suggesting that treatment of insomnia may improve pain. The aims of this study were to evaluate the efficacy of cognitive-behavioral therapy for insomnia (CBT-I) in patients with knee OA, to determine whether improvements in sleep predict reduced pain, and to determine whether alterations in pain modulation mediate improvements in clinical pain.MethodsWe conducted a randomized, double-blind, active placebo-controlled clinical trial of CBT-I in 100 patients with knee OA and insomnia (mean ± SD age 59.4 ± 9.5 years). Patients were randomized (1:1) to receive either 8 sessions of CBT-I or behavioral desensitization (placebo). We conducted in-home polysomnography (PSG), diary assessment, and sensory tests of pain modulation at baseline, posttreatment, 3 months, and 6 months.ResultsIntent-to-treat analyses demonstrated substantial improvement in sleep in both groups of patients. Patients in the CBT-I group had significantly greater reductions in wake after sleep onset (WASO), as measured by patient diary and PSG. Patients in both groups reported significant and comparable reductions in pain over 6 months, with one-third reporting a 30% reduction in pain severity. Baseline-to-posttreatment reductions in WASO as measured by diary and PSG predicted subsequent decreases in clinical pain. This effect was significantly greater for CBT-I compared with behavioral desensitization. No significant changes in laboratory measures of pain modulation were observed.ConclusionCompared with active placebo, CBT-I was efficacious in reducing sleep maintenance insomnia. CBT-I decreased clinical pain, but not pain modulation, suggesting that it has the potential to augment pain management in knee OA. Future work is needed to identify the mechanisms by which improved sleep reduces clinical pain.
| S-EPMC6040809 | biostudies-literature