Effects of yoga, cognitive behavioral therapy, and a behavioral placebo on sleep: A nationwide multicenter phase III RCT in cancer survivors.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12017-12017
Author(s):  
Po-Ju Lin ◽  
Charles E. Heckler ◽  
Eva Culakova ◽  
Huiwen Xu ◽  
Richard Francis Dunne ◽  
...  
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Cancer Survivors ◽  
Sleep Duration ◽  
Sleep Latency ◽  
Behavioral Therapy ◽  
Sleep Efficiency ◽  
Phase Iii ◽  
Post Intervention ◽  
Multicenter Phase ◽  
Impaired Sleep

12017 Background: Patients commonly experience impaired sleep throughout cancer treatment and for years into survivorship. Impaired sleep may mediate other cancer-related symptoms and can lead to the inability to complete daily activities and lower quality of life. More effective non-pharmacological treatment options for impaired sleep are needed. We conducted a nationwide, multicenter, phase III randomized controlled trial (RCT) comparing the effects of yoga (Yoga for Cancer Survivors; YOCAS), cognitive behavioral therapy for insomnia (CBT-I), and a behavioral placebo on impaired sleep in cancer survivors. Methods: This RCT was conducted via the URCC NCORP Research Base. Participants were cancer survivors 2-60 months post-treatment with insomnia. They were randomized to 1) YOCAS (75-min session biweekly for 4 wks), 2) CBT-I (90-min session weekly for 8 wks), and 3) behavioral placebo (survivorship health education per ASCO guidelines; 75-min session biweekly for 4 wks). Sleep efficiency, sleep duration, wake after sleep onset (WASO), and sleep latency were assessed via actigraphy at baseline and post-intervention. Actigraphs were worn on the non-dominant wrist 24 hours a day for 7 days. Linear mixed models were used to assess intervention effects on sleep outcomes. Results: 740 survivors were enrolled (93% female, mean age 56±11 years, 73% breast cancer). Results revealed significant group differences among survivors in the 3 arms in sleep efficiency, sleep duration, and WASO (all p<0.05), but not in sleep latency (p>0.05). YOCAS and CBT-I subjects maintained sleep efficiency (mean change= -0.8% and -0.03%, respectively, all p>0.05) while behavioral placebo subjects significantly reduced sleep efficiency (mean change= -3.4%, p<0.01). When controlling for baseline, YOCAS and CBT-I subjects demonstrated better sleep efficiency compared to behavioral placebo subjects at post-intervention (all p<0.05). YOCAS subjects also maintained sleep duration (mean change= -3.5 minutes, p>0.05) while CBT-I and behavioral placebo subjects significantly reduced sleep duration (mean change= -20.3 minutes and -26.6 minutes, respectively, all p<0.01). When controlling for baseline, YOCAS subjects demonstrated longer sleep duration compared to CBT-I and behavioral placebo subjects at post-intervention (all p<0.05). There were no significant within-group changes in WASO over time in the 3 arms. When controlling for baseline, CBT-I subjects demonstrated a trend toward lower WASO compared to YOCAS (p=0.07) and behavioral placebo (p=0.05) subjects at post-intervention. Conclusions: Both YOCAS and CBT-I maintained sleep efficiency and/or sleep duration among cancer survivors. Oncologists should consider prescribing yoga and CBT-I for treating impaired sleep in cancer survivors. Funding: NCI UG1CA189961, R01CA181064, T32CA102618. Clinical trial information: NCT02613364.

Effects of YOCAS yoga, cognitive behavioral therapy, and survivorship health education on insomnia: A URCC NCORP Research Base Phase III RCT in 740 cancer survivors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12005-12005
Author(s):  
Karen Michelle Mustian ◽  
Po-Ju Lin ◽  
Eva Culakova ◽  
Javier Bautista ◽  
Huiwen Xu ◽  
...  
Keyword(s):  
Health Education ◽  
Cognitive Behavioral Therapy ◽  
Cancer Survivors ◽  
Behavioral Therapy ◽  
Cognitive Behavioral ◽  
Phase Iii ◽  
Cancer Center ◽  
Post Intervention ◽  
Oncology Research ◽  
Better Than

12005 Background: Insomnia, a prevalent and troublesome side effect experienced by cancer survivors, significantly impairs recovery and survival. We conducted a nationwide, multicenter, phase III, blinded, randomized controlled trial testing whether 1) yoga is superior to survivorship health education (SHE) and 2) yoga is non-inferior to cognitive behavioral therapy for insomnia (CBT-I) for treating insomnia in survivors. Methods: The trial was conducted via the University of Rochester Cancer Center NCI Community Oncology Research Program (URCC NCORP) Research Base. Participants were cancer survivors between 2-60 months post adjuvant therapy, with insomnia, no metastatic disease, and no yoga participation during the previous 3 months. Survivors were randomized into 1) YOCAS yoga (2x/wk; 75 min/sess for 4 wks with pranayama, asana, and dhyana, N = 251), 2) CBT-I (1x/wk, 90 min/sess for 8 wks with sleep hygiene, stimulus control, sleep restriction, and cognitive therapy, N = 238), or 3) SHE (2x/wk; 75 min/sess for 4 wks with ASCO-recommended survivorship education, N = 251). Insomnia was assessed pre- and post-intervention via the Insomnia Severity Index. Results: 740 eligible cancer survivors were enrolled (93% female, mean age = 56 + 11, 75% breast cancer). ANCOVAs with baseline values as covariates revealed YOCAS is significantly better than SHE for treating insomnia at post-intervention (CS = change score; CS mean diff = -1.43, SE = 0.42, p < 0.01). Yoga participants demonstrated greater improvements in insomnia from pre- to post-intervention (CS = -3.61, SE = 0.30) compared to SHE participants (CS = -2.19, SE = 0.33, all p < 0.01). Intent-to-treat analyses of non-inferiority (non-inferiority margin set at 1.15 a priori) showed YOCAS is inferior to CBT-I (CS mean diff = 3.52, CI = 2.55 - 4.50, p < 0.01). However, analyses of non-inferiority using the optimal treatment effect in fully compliant survivors were inconclusive regarding whether YOCAS is non-inferior to CBT-I for treating insomnia (CS mean diff = 2.20, CI = 0.42 - 3.98, p = 0.09). Significantly more survivors withdrew from CBT-I and SHE due, in part, to disliking the interventions compared to YOCAS (30%, 25%, and 16%, respectively, p < 0.01). Conclusions: YOCAS yoga is better than SHE and results are inconclusive as to whether yoga is non-inferior to CBT-I for treating insomnia among survivors. Clinicians should consider prescribing YOCAS and CBT-I for survivors reporting insomnia. Funding: NCI UG1CA189961, R01CA181064, T32CA102618. Clinical trial information: NCT02613364 .

374 Cognitive Behavioral Therapy with Exercise in Adults with Insomnia and Short Sleep: Daytime Function Outcomes from a Pilot Study

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A149-A149
Author(s):  
Andrew Kubala ◽  
Mara Egeler ◽  
Daniel Buysse ◽  
Martica Hall ◽  
Emma Barinas-Mitchell ◽  
...  
Keyword(s):  
Sleep Duration ◽  
Behavioral Therapy ◽  
Exercise Program ◽  
Short Sleep Duration ◽  
Post Intervention ◽  
Short Sleep ◽  
Supervised Exercise ◽  
Daytime Function ◽  
Supervised Exercise Program ◽  
Insomnia Severity

Abstract Introduction Cognitive behavioral therapy for insomnia (CBT-I) is efficacious, but there is mixed evidence as to whether improvement is blunted in adults with insomnia and short sleep duration. Exercise training can reduce physiologic hyperarousal and may increase homeostatic sleep drive, which could potentiate CBT-I treatment effects. This pilot study explored changes in self-reported outcomes from a CBT-I intervention augmented by exercise training in a sample of adults with insomnia and objective short sleep duration. Methods Eight adults (50% female, 62.5% white) with insomnia disorder and short sleep duration (mean actigraphic TST &lt;6.5 hr) completed a 12-week single-arm trial. Participants self-administered the online “Sleep Healthy Using the Internet” (SHUT-I) CBT-I program with additional staff guidance while completing a supervised exercise program (EX; 150 min/wk of moderate-intensity aerobic exercise and 2 days/wk of strength training). Participants completed assessments of self-reported sleep and daytime function pre- and post-intervention, including the Insomnia Severity Index (ISI), Flinders Fatigue Scale (FFS), Ford Insomnia Response to Stress Test (FIRST), Perceived Stress Scale (PSS), and Epworth Sleepiness Scale (ESS). Differences between timepoints were analyzed using paired t-tests and Cohen’s d effect size calculations. Results Insomnia severity significantly decreased after the intervention (ISI: p&lt;0.001, d=2.99), with 75% reporting post-intervention ISI ≤ 7. Likewise, fatigue significantly decreased after the intervention (FFS: p=0.032, d=0.95). Symptoms of stress-related sleep reactivity and stress were also reduced (FIRST: p=0.012, d=1.19; PSS: p=0.014, d=1.14). Though nonsignificant, large reductions in sleepiness were additionally observed (ESS: p=0.058, d=0.80). Conclusion In this pilot trial among patients with insomnia and short sleep duration, online CBT-I plus a supervised exercise program resulted in a significant reduction in insomnia severity. The intervention also produced large and meaningful reductions in fatigue and stress, which are common daytime impairments in patients with insomnia. Future research should attempt to disentangle the independent contributions of CBT-I and exercise on outcomes in this population. Support (if any) NIH: K23HL118318

scholarly journals The Efficacy of Transdiagnostic Cognitive Behavioral Therapy on Migraine Headache: A Randomized Clinical Trial

2022 ◽  
Author(s):  
Forouzandeh Soleimanian-Boroujeni ◽  
Negin Badihian ◽  
Shervin Badihian ◽  
Vahid Shaygannejad ◽  
Yousef Gorji
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Behavioral Therapy ◽  
Intervention Group ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Post Intervention ◽  
Therapy Termination ◽  
Protocol Registration ◽  
And Control

Abstract Introduction: Psychological interventions are shown to be effective in migraine, but not utilized routinely yet. We aimed to evaluate the efficacy of transdiagnostic cognitive behavioral therapy (TCBT) on people with migraine (PwM). Method: This study was conducted on 40 PwM aged 20-50 years. We randomly assigned participants to two groups of intervention, receiving 10 sessions of TCBT, and control. Days with headache, headache severity, migraine-related disability and effects on daily life, number of pain-relivers taken for headache, depression, and anxiety were assessed pre-intervention, post-intervention (three-month follow-up), and one-month after TCBT termination (four-month follow-up).Results: Thirty-five participants suffering moderate to severe migraine completed the study (16 and 19 in TCBT and control groups, respectively). TCBT improved all measured items between study time-points (p<0.05) in the intervention group, while such an improvement was not observed in the control group. Between group comparisons revealed superiority of TCBT group compared to the control group in most measured items at three- and four-month follow-ups (p<0.05).Conclusion: Ten sessions of TCBT improved migraine severity, associated disability, anxiety, and depression in PwM, with persistent effects after one month of therapy termination. TCBT is an affordable, practical, and feasible intervention to be utilized for PwM.Protocol registration: The study protocol was registered in clinicaltrial.gov (NCT03701477) prior to enrollment.

scholarly journals Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial

2015 ◽  
Vol 24 (5) ◽  
pp. 2059-2066 ◽  
Author(s):  
Charles E. Heckler ◽  
Sheila N. Garland ◽  
Anita R. Peoples ◽  
Michael L. Perlis ◽  
Michelle Shayne ◽  
...  
Keyword(s):  
Cognitive Behavioral Therapy ◽  
Cancer Survivors ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral

scholarly journals Influence of Yoga on Cancer-Related Fatigue and on Mediational Relationships Between Changes in Sleep and Cancer-Related Fatigue: A Nationwide, Multicenter Randomized Controlled Trial of Yoga in Cancer Survivors

2019 ◽  
Vol 18 ◽  
pp. 153473541985513 ◽  
Author(s):  
Po-Ju Lin ◽  
Ian R. Kleckner ◽  
Kah Poh Loh ◽  
Julia E. Inglis ◽  
Luke J. Peppone ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Phase Iii ◽  
Survivorship Care ◽  
Yoga Therapy ◽  
Randomized Controlled ◽  
Cancer Related Fatigue ◽  
Multicenter Phase

Background: Cancer-related fatigue (CRF) often co-occurs with sleep disturbance and is one of the most pervasive toxicities resulting from cancer and its treatment. We and other investigators have previously reported that yoga therapy can improve sleep quality in cancer patients and survivors. No nationwide multicenter phase III randomized controlled trial (RCT) has investigated whether yoga therapy improves CRF or whether improvements in sleep mediate the effect of yoga on CRF. We examined the effect of a standardized, 4-week, yoga therapy program (Yoga for Cancer Survivors [YOCAS©®]) on CRF and whether YOCAS©®-induced changes in sleep mediated changes in CRF among survivors. Study Design and Methods: Four hundred and ten cancer survivors were recruited to a nationwide multicenter phase III RCT comparing the effect of YOCAS©® to standard survivorship care on CRF and examining the mediating effects of changes in sleep, stemming from yoga, on changes in CRF. CRF was assessed by the Multidimensional Fatigue Symptom Inventory. Sleep was assessed via the Pittsburgh Sleep Quality Index. Between- and within-group intervention effects on CRF were assessed by analysis of covariance and 2-tailed t test, respectively. Path analysis was used to evaluate mediation. Results: YOCAS©® participants demonstrated significantly greater improvements in CRF compared with participants in standard survivorship care at post-intervention ( P < .01). Improvements in overall sleep quality and reductions in daytime dysfunction (eg, excessive napping) resulting from yoga significantly mediated the effect of yoga on CRF (22% and 37%, respectively, both P < .01). Conclusions: YOCAS©® is effective for treating CRF among cancer survivors; 22% to 37% of the improvements in CRF from yoga therapy result from improvements in sleep quality and daytime dysfunction. Oncologists should consider prescribing yoga to cancer survivors for treating CRF and sleep disturbance.

scholarly journals Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial

2017 ◽  
Vol 11 (3) ◽  
pp. 401-409 ◽  
Author(s):  
Anita R. Peoples ◽  
Sheila N. Garland ◽  
Michael L. Perlis ◽  
Josée Savard ◽  
Charles E. Heckler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Cognitive Behavioral Therapy ◽  
Cancer Survivors ◽  
Behavioral Therapy ◽  
Controlled Trial ◽  
Cognitive Behavioral
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