Randomized Controlled Clinical Effectiveness Trial of Cognitive Behavior Therapy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer

2008 ◽  
Vol 26 (28) ◽  
pp. 4651-4658 ◽  
Author(s):  
Colin A. Espie ◽  
Leanne Fleming ◽  
James Cassidy ◽  
Leslie Samuel ◽  
Lynne M. Taylor ◽  
...  

Purpose Persistent insomnia is a common complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavior therapy (CBT) for insomnia, delivered by oncology nurses. Patients and Methods Randomized, controlled, pragmatic, two-center trial of CBT versus treatment as usual (TAU) in 150 patients (103 females; mean age, 61 years.) who had completed active therapy for breast, prostate, colorectal, or gynecological cancer. The study conformed to CONSORT guidelines. Primary outcomes were sleep diary measures at baseline, post-treatment, and 6-month follow-up. Actigraphic sleep, health-related quality of life (QOL), psychopathology, and fatigue were secondary measures. CBT comprised five, small group sessions across consecutive weeks, after a manualized protocol. TAU represented normal clinical practice; the appropriate control for a clinical effectiveness study. Results CBT was associated with mean reductions in wakefulness of 55 minutes per night compared with no change in TAU. These outcomes were sustained 6 months after treatment. Standardized relative effect sizes were large for complaints of difficulty initiating sleep, waking from sleep during the night, and for sleep efficiency (percentage of time in bed spent asleep). CBT was associated with moderate to large effect sizes for five of seven QOL outcomes, including significant reduction in daytime fatigue. There was no significant interaction effect between any of these outcomes and baseline demographic, clinical, or sleep characteristics. Conclusion CBT for insomnia may be both clinically effective and feasible to deliver in real world practice.

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A143-A143
Author(s):  
Susan McCurry ◽  
Daniel Cukor ◽  
Carlyn Clark ◽  
Nisha Brady ◽  
Tessa Rue ◽  
...  

Abstract Introduction Patients with kidney failure treated with hemodialysis (HD) frequently report insomnia symptoms. Cognitive-behavior therapy for insomnia (CBT-I) is a first line treatment for insomnia but there are unique issues surrounding kidney failure and HD that impact patients’ ability to access CBT-I and follow standard treatment recommendations. This presentation describes CBT-I protocol modifications made to address these issues as part of an ongoing multi-center clinical trial testing the efficacy of telehealth CBT-I compared to trazodone or medication placebo control. Methods CBT-I protocol modifications were made prior to starting the SLEEP-HD randomized trial based upon unique clinical considerations for HD patients, e.g., irregular sleep-wake scheduling that HD treatment demands, and napping during HD sessions or afterwards due to post-HD treatment fatigue. Participants in the SLEEP-HD study are undergoing thrice-weekly maintenance hemodialysis for >3 months and have baseline Insomnia Severity Index scores >10 with sleep disturbances >3 nights/week for >3 months. Participants randomized into the modified CBT-I protocol receive six weekly sessions, delivered by trained CBT-I therapists (1 MSW, 1 PhD) face-to-face via a HIPPA-compliant video telehealth platform. Participants keep a daily sleep diary throughout the CBT-I treatment period. Results To date, 91 patients (mean age=56.5 years [SD=14.7], 48.4% female) recruited from community-based dialysis facilities in Seattle and Albuquerque have been randomized into the SLEEP-HD study (n=31 CBT-I). Forty-eight percent of CBT-I clients have chosen to conduct their telehealth sessions during dialysis with the remainder choosing a different location. CBT-I adaptations include therapists developing weekly bed restriction recommendations based on non-dialysis treatment days; allowing shifts in dialysis day “bed window” scheduling for patients with very early or very late dialysis schedules so long as a consistent total time in bed in maintained; and including napping during early/late dialysis sessions as part of the allowable bed window duration. Treatment modifications were also designed to accommodate the diverse socioeconomic circumstances of dialysis patients, including housing instability, which can impact adherence to some standard stimulus control and bed restriction CBT-I recommendations. Conclusion It is feasible to deliver CBT-I via telehealth to HD patients but modifications to standard protocols are required. Support (if any) This work was supported by PHS grant 5R01AG053221.


SLEEP ◽  
2020 ◽  
Author(s):  
Nicole Lovato ◽  
Gorica Micic ◽  
Leon Lack

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; <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


2017 ◽  
Vol 35 (19) ◽  
pp. 2173-2183 ◽  
Author(s):  
Marieke van de Wal ◽  
Belinda Thewes ◽  
Marieke Gielissen ◽  
Anne Speckens ◽  
Judith Prins

Purpose Fear of cancer recurrence (FCR) is a common problem experienced by cancer survivors. Approximately one third of survivors report high FCR. This study aimed to evaluate whether blended cognitive behavior therapy (bCBT) can reduce the severity of FCR in cancer survivors curatively treated for breast, prostate, or colorectal cancer. Patients and Methods This randomized controlled trial included 88 cancer survivors with high FCR (Cancer Worry Scale score ≥ 14) from 6 months to 5 years after cancer treatment. Participants were randomly allocated (ratio 1:1, stratified by cancer type) to receive bCBT, including five face-to face and three online sessions (n = 45) or care as usual (CAU; n = 43). Participants completed questionnaires at baseline (T0) and 3 months later (T1). The intervention group completed bCBT between T0 and T1. The primary outcome was FCR severity assessed with the Cancer Worry Scale. Secondary outcomes included other distress-related measures. Statistical (one-way between-group analyses of covariance) and clinical effects (clinically significant improvement) were analyzed by intention to treat. Results Participants who received bCBT reported significantly less FCR than those who received CAU (mean difference, –3.48; 95% CI, –4.69 to –2.28; P < .001) with a moderate-to-large effect size ( d = 0.76). Clinically significant improvement in FCR was significantly higher in the bCBT group than in the CAU group (13 [29%] of 45 compared with 0 [0%] of 43; P < .001); self-rated improvement was also higher in the bCBT group (30 [71%] of 42 compared with 12 [32%] of 38 in the CAU group; P < .001). Conclusion bCBT has a statistically and clinically significant effect on the severity of FCR in cancer survivors and is a promising new treatment approach.


PEDIATRICS ◽  
2013 ◽  
Vol 132 (5) ◽  
pp. e1163-e1172 ◽  
Author(s):  
Shelley M.C. van der Veek ◽  
Bert H.F. Derkx ◽  
Marc A. Benninga ◽  
Frits Boer ◽  
Else de Haan

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