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Long-Term Effects of Two Formats of Cognitive Behavioral Therapy for Insomnia Comorbid with Breast Cancer.

ABSTRACT: STUDY OBJECTIVES:The goal of this randomized controlled trial, conducted in breast cancer patients, was to assess the long-term efficacy of a video-based cognitive behavioral therapy for insomnia (VCBT-I), as compared to a professionally administered intervention (PCBT-I) and to a no-treatment group (CTL). An earlier report revealed that, at posttreatment, VCBT-I patients showed significantly greater sleep improvements than CTL, but that PCBT-I produced superior effects than VCBT-I on some sleep and secondary outcomes. In this report, long-term effects are compared. METHODS:Two hundred forty-two women with breast cancer and with insomnia symptoms or using hypnotic medications participated to this three-arm randomized controlled trial: (1) PCBT-I (n = 81); (2) VCBT-I (n = 80); or (3) no treatment (CTL; n = 81) group. PCBT-I was composed of six weekly, individual sessions of approximately 50 min, whereas VCBT-I comprised a 60-min animated video and six booklets. RESULTS:Study measures (sleep and secondary variables) were administered at pretreatment and posttreatment, and at a 3-, 6-, and 12-mo follow-up. Treatment gains were well sustained at follow-up in both PCBT-I and VCBT-I. As at posttreatment, the remission rate of insomnia at follow-up was greater in PCBT-I than in VCBT-I, which was greater than in CTL. CONCLUSIONS:Although face-to-face therapy remains the optimal format to efficaciously administer CBT for insomnia in cancer patients, a minimal intervention, such as the video-based intervention tested in this study, produces significant and sustainable treatment effects. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov identifier NCT00674830.

SUBMITTER: Savard J

PROVIDER: S-EPMC4791615 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Long-Term Effects of Two Formats of Cognitive Behavioral Therapy for Insomnia Comorbid with Breast Cancer.

Savard Josée J Ivers Hans H Savard Marie-Hélène MH Morin Charles M CM

Sleep 20160401 4

<h4>Study objectives</h4>The goal of this randomized controlled trial, conducted in breast cancer patients, was to assess the long-term efficacy of a video-based cognitive behavioral therapy for insomnia (VCBT-I), as compared to a professionally administered intervention (PCBT-I) and to a no-treatment group (CTL). An earlier report revealed that, at posttreatment, VCBT-I patients showed significantly greater sleep improvements than CTL, but that PCBT-I produced superior effects than VCBT-I on so ...[more]

PMID: 26715229

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Project description:Study objectivesThe aim of this study was to test the efficacy of fully automated Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) 18 months after the intervention period on sleep, daytime functioning, and beliefs about sleep for adults with chronic insomnia.MethodsParticipants in this study had participated in a randomized controlled trial comparing the efficacy of unguided Internet CBT-I with web-based patient education. Participants who had received Internet CBT-I (n = 95) completed online questionnaires and online sleep diaries 18 months after the intervention period. We used linear mixed models to study changes from baseline to postassessment and to 18-month follow-up, and a separate mixed-models analysis to study changes from postassessment to 18-month follow-up.ResultsMean age of the participants was 45.5 years (standard deviation = 12.6) and 64% were females. Sixty-six participants (70%) completed the 18-month follow-up assessment. There were significant improvements from baseline to 18-month follow-up on the Insomnia Severity Index (ISI) (Cohen d = 2.04 [95% confidence interval (CI) 1.66-2.42]) and the Bergen Insomnia Scale (BIS) (d = 1.64 [95% CI 1.30-1.98]), levels of daytime fatigue (d = 0.85 [95% CI 0.59-1.11]), psychological distress (d = 0.51 [95% CI 0.29-0.73]), and beliefs about sleep (d = 1.44 [95% CI 1.15-1.73]). Moderate to large effect size improvements were also shown on the diary-derived sleep variables. All improvements from baseline to postassessment were essentially maintained to 18-month follow-up.ConclusionsUnguided Internet CBT-I appears to have sustained effects on sleep, daytime functioning, and beliefs about sleep up to 18 months after the intervention period.Clinical trial registrationThis study presents long-term follow-up data of a previous clinical trial. Registry: ClinicalTrials.gov, Title: Internet-based Treatment for Insomnia in Norway, Identifier: NCT02261272, URL: https://clinicaltrials.gov/ct2/show/NCT02261272.

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:Many people with COPD report difficulties falling asleep or staying asleep, insufficient sleep duration, or nonrestorative sleep. Cognitive behavioral therapy for insomnia (CBT-I) has proved effective not only in people with primary insomnia but also in people with insomnia comorbid with psychiatric and medical illness (eg, depression, cancer, and chronic pain). However, CBT-I has rarely been tested in those with COPD who have disease-related features that interfere with sleep and may lessen the effectiveness of such therapies. The purpose of this study was to determine the feasibility of applying a CBT-I intervention for people with COPD and to assess the impact of CBT-I on insomnia severity and sleep-related outcomes, fatigue, mood, and daytime functioning.The study had two phases. In Phase 1, a 6-weekly session CBT-I intervention protocol in participants with COPD was assessed to examine feasibility and acceptability. Phase 2 was a small trial utilizing a prospective two-group pre- and post-test design with random assignment to the six-session CBT-I or a six-session wellness education (WE) program to determine the effects of each intervention, with both interventions being provided by a nurse behavioral sleep medicine specialist.Fourteen participants (five in Phase 1 and nine in Phase 2) completed six sessions of CBT-I and nine participants completed six sessions of WE. Participants indicated that both interventions were acceptable. Significant positive treatment-related effects of the CBT-I intervention were noted for insomnia severity (P = 0.000), global sleep quality (P = 0.002), wake after sleep onset (P = 0.03), sleep efficiency (P = 0.02), fatigue (P = 0.005), and beliefs and attitudes about sleep (P = 0.000). Significant positive effects were noted for depressed mood after WE (P = 0.005).Results suggest that using CBT-I in COPD is feasible and the outcomes compare favorably with those obtained in older adults with insomnia in the context of other chronic illnesses.

Project description:ImportanceChronic insomnia disorder is highly prevalent, disabling, and costly. Cognitive behavioral therapy for insomnia (CBT-I), comprising various educational, cognitive, and behavioral strategies delivered in various formats, is the recommended first-line treatment, but the effect of each component and delivery method remains unclear.ObjectiveTo examine the association of each component and delivery format of CBT-I with outcomes.Data sourcesPubMed, Cochrane Central Register of Controlled Trials, PsycInfo, and International Clinical Trials Registry Platform from database inception to July 21, 2023.Study selectionPublished randomized clinical trials comparing any form of CBT-I against another or a control condition for chronic insomnia disorder in adults aged 18 years and older. Insomnia both with and without comorbidities was included. Concomitant treatments were allowed if equally distributed among arms.Data extraction and synthesisTwo independent reviewers identified components, extracted data, and assessed trial quality. Random-effects component network meta-analyses were performed.Main outcomes and measuresThe primary outcome was treatment efficacy (remission defined as reaching a satisfactory state) posttreatment. Secondary outcomes included all-cause dropout, self-reported sleep continuity, and long-term remission.ResultsA total of 241 trials were identified including 31 452 participants (mean [SD] age, 45.4 [16.6] years; 21 048 of 31 452 [67%] women). Results suggested that critical components of CBT-I are cognitive restructuring (remission incremental odds ratio [iOR], 1.68; 95% CI, 1.28-2.20) third-wave components (iOR, 1.49; 95% CI, 1.10-2.03), sleep restriction (iOR, 1.49; 95% CI, 1.04-2.13), and stimulus control (iOR, 1.43; 95% CI, 1.00-2.05). Sleep hygiene education was not essential (iOR, 1.01; 95% CI, 0.77-1.32), and relaxation procedures were found to be potentially counterproductive(iOR, 0.81; 95% CI, 0.64-1.02). In-person therapist-led programs were most beneficial (iOR, 1.83; 95% CI, 1.19-2.81). Cognitive restructuring, third-wave components, and in-person delivery were mainly associated with improved subjective sleep quality. Sleep restriction was associated with improved subjective sleep quality, sleep efficiency, and wake after sleep onset, and stimulus control with improved subjective sleep quality, sleep efficiency, and sleep latency. The most efficacious combination-consisting of cognitive restructuring, third wave, sleep restriction, and stimulus control in the in-person format-compared with in-person psychoeducation, was associated with an increase in the remission rate by a risk difference of 0.33 (95% CI, 0.23-0.43) and a number needed to treat of 3.0 (95% CI, 2.3-4.3), given the median observed control event rate of 0.14.Conclusions and relevanceThe findings suggest that beneficial CBT-I packages may include cognitive restructuring, third-wave components, sleep restriction, stimulus control, and in-person delivery but not relaxation. However, potential undetected interactions could undermine the conclusions. Further large-scale, well-designed trials are warranted to confirm the contribution of different treatment components in CBT-I.

Project description:Study objectivesNeurocognitive impairments in comorbid insomnia and sleep apnea (COMISA) are not well documented. We explored neurocognitive functioning and treatment effects in individuals with COMISA as an ancillary study to a randomized clinical trial.MethodsParticipants with COMISA (n = 45; 51.1% female; mean age = 52.07 ± 13.29 years), from a 3-arm randomized clinical trial combining cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) concurrently (CBT-I+PAP) or sequentially, completed neurocognitive testing at baseline, and post-treatment. Using Bayesian linear mixed models, we estimated effects of CBT-I, PAP, or CBT-I+PAP, compared to baseline, and CBT-I+PAP compared to PAP on 12 metrics across five cognitive domains.ResultsThis COMISA sample had worse neurocognitive performance at baseline than reported for insomnia, sleep apnea, and controls in the literature, though short-term memory and psychomotor speed performance appears intact. When comparing PAP to baseline, performance on all measures was better after treatment. Performance after CBT-I was worse compared to baseline, and only performance in attention/vigilance, executive functioning via Stroop interference and verbal memory was better with moderate-high effect sizes and moderate probability of superiority (61-83). Comparisons of CBT-I+PAP to baseline generated results similar to PAP and comparing CBT-I+PAP to PAP revealed superior performance in only attention/vigilance via psychomotor vigilance task lapses and verbal memory for PAP.ConclusionsTreatment combinations involving CBT-I were associated with poorer neurocognitive performance. These potentially temporary effects may stem from sleep restriction, a component of CBT-I often accompanied by initially reduced total sleep time. Future studies should examine long-term effects of individual and combined COMISA treatment pathways to inform treatment recommendations.Clinical trialThis was an ancillary study from a clinical trial (Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea (MATRICS), which was preregistered at www.clinicaltrials.gov (NCT01785303)).

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Long-Term Effects of Two Formats of Cognitive Behavioral Therapy for Insomnia Comorbid with Breast Cancer.

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Long-Term Effects of Two Formats of Cognitive Behavioral Therapy for Insomnia Comorbid with Breast Cancer.

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