Feasibility of a Preventive Intervention for Insomnia in Women with Breast Cancer Receiving Chemotherapy

ABSTRACT

Objective/Background: Breast cancer patients display high rates of insomnia and chemotherapy treatments appear to contribute significantly to the development of sleep disturbances among this population. The efficacy of cognitive-behavioral therapy for insomnia (CBT-I) is now well established for treating insomnia comorbid with cancer but is not widely accessible and is also fairly costly. Its capacity to prevent the onset of insomnia symptoms in cancer patients who are at a high risk of developing these difficulties remains to be demonstrated. The purpose of this study was to assess the feasibility of a brief self-administered preventive intervention of insomnia in breast cancer patients about to undergo chemotherapy.

Participants/Methods: A sample of 20 women with breast cancer and with no insomnia were recruited and received the preventive intervention, taking the form of a short booklet, at their first chemotherapy treatment. One month later, a semi-structured phone interview was conducted to assess their satisfaction with different aspects of the booklet (e.g., format, content) and their adherence to the proposed strategies and to collect qualitative information. A 3-month follow-up evaluation was also conducted.

Results: Patients reported a higher level of satisfaction than expected (mean score corresponding to “a lot” on the scale) and a moderate level of adherence falling only slightly under the hypothesized level. The open comments collected corroborated the good acceptability of this minimal preventive CBT-I in breast cancer patients initiating chemotherapy.

Conclusions: Overall, findings of this study confirm that a self-administered preventive intervention for insomnia is feasible and a promising approach in breast cancer patients about to initiate chemotherapy.     

Efficacy of a stepped care approach to deliver cognitive-behavioral therapy for insomnia in cancer patients: a noninferiority randomized controlled trial

Study ObjectivesCognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, but its accessibility is very limited in routine care. A stepped care approach has been recommended as a cost-effective way to make CBT-I more widely accessible. However, no controlled study has yet been published about the efficacy of this approach. The goal of this noninferiority randomized controlled trial (RCT) was to compare the short and long-term efficacy of a stepped care CBT-I (StepCBT-I) to a standard face-to-face CBT-I (StanCBT-I).MethodsA total of 177 cancer patients were randomized to: (1) StanCBT-I (6 face-to-face CBT-I sessions; n = 59) or (2) StepCBT-I (n = 118). In the StepCBT-I group, patients with less severe insomnia first received a web-based CBT-I (n = 65), while those with more severe insomnia received 6 face-to-face CBT-I sessions (n = 53). In both cases, patients could receive up to three booster sessions of CBT-I if they still had insomnia symptoms following this first step.ResultsResults indicated that the Step-CBT-I group showed an Insomnia Severity Index score reduction and a sleep efficiency (on a sleep diary) increase that was not significantly inferior to that of StanCBT-I at all post-treatment time points. Analyses of secondary outcomes indicated significant time effects (ps < .001) and no significant group-by-time interactions (ps from .07 to .91) on other sleep diary parameters, sleep medication use, depression, anxiety, fatigue, and quality of life scores.Conclusion(s)The efficacy of stepped care CBT-I is not inferior to that of a standard face-to-face intervention and is a valuable approach to making this treatment more widely accessible to cancer patients.Trial registrationClinicalTrials.gov Identifier: NCT01864720 (https://clinicaltrials.gov/ct2/show/NCT01864720?term=Savard&draw=2&rank=6; Stepped Care Model for the Wider Dissemination of Cognitive-Behavioural Therapy for Insomnia Among Cancer Patients).     

Dr Google and the Consumer: A Qualitative Study Exploring the Navigational Needs and Online Health Information-Seeking Behaviors of Consumers With Chronic Health Conditions

BackgroundThe abundance of health information available online provides consumers with greater access to information pertinent to the management of health conditions. This is particularly important given an increasing drive for consumer-focused health care models globally, especially in the management of chronic health conditions, and in recognition of challenges faced by lay consumers with finding, understanding, and acting on health information sourced online. There is a paucity of literature exploring the navigational needs of consumers with regards to accessing online health information. Further, existing interventions appear to be didactic in nature, and it is unclear whether such interventions appeal to consumers’ needs.ObjectiveOur goal was to explore the navigational needs of consumers with chronic health conditions in finding online health information within the broader context of consumers’ online health information-seeking behaviors. Potential barriers to online navigation were also identified.MethodsSemistructured interviews were conducted with adult consumers who reported using the Internet for health information and had at least one chronic health condition. Participants were recruited from nine metropolitan community pharmacies within Western Australia, as well as through various media channels. Interviews were audio-recorded, transcribed verbatim, and then imported into QSR NVivo 10. Two established approaches to thematic analysis were adopted. First, a data-driven approach was used to minimize potential bias in analysis and improve construct and criterion validity. A theory-driven approach was subsequently used to confirm themes identified by the former approach and to ensure identified themes were relevant to the objectives. Two levels of analysis were conducted for both data-driven and theory-driven approaches: manifest-level analysis, whereby face-value themes were identified, and latent-level analysis, whereby underlying concepts were identified.ResultsWe conducted 17 interviews, with data saturation achieved by the 14th interview. While we identified a broad range of online health information-seeking behaviors, most related to information discussed during consumer-health professional consultations such as looking for information about medication side effects. The barriers we identified included intrinsic barriers, such as limited eHealth literacy, and extrinsic barriers, such as the inconsistency of information between different online sources. The navigational needs of our participants were extrinsic in nature and included health professionals directing consumers to appropriate online resources and better filtering of online health information. Our participants’ online health information-seeking behaviors, reported barriers, and navigational needs were underpinned by the themes of trust, patient activation, and relevance.ConclusionsThis study suggests that existing interventions aimed to assist consumers with navigating online health information may not be what consumers want or perceive they need. eHealth literacy and patient activation appear to be prevalent concepts in the context of consumers’ online health information-seeking behaviors. Furthermore, the role for health professionals in guiding consumers to quality online health information is highlighted.     

Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy

Study ObjectivesDigital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity.MethodsEligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33.ResultsIndividuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was −2.8 (95% CI: −4.8 to −0.8; p = 0.007, Cohen’s d = 0.7), and −4.6 at week 9 (95% CI −6.6 to −2.7; p < 0.001), Cohen’s d = 1.2.ConclusionsAt the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I. Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.     

What employees with diabetes mellitus need to cope at work: Views of employees and health professionals

ObjectiveTo identify and compare patient and professional perspectives on what enables employees with diabetes mellitus (DM) to maintain their position in the workplace. To provide information on how professionals can help DM patients cope at work.MethodsQualitative study using concept-mapping sessions involving 23 employees with DM and 22 health professionals (GP's, occupational physicians and specialists). All of the health professionals were experts in the field of diabetes care.ResultsPatients and professionals identified five common clusters of statements on what diabetics need to enable them to cope at work: the ability to accept and cope with DM, supportive health professionals, a supportive work environment, work adaptations and good information. Patients emphasized the importance of emotional acceptance of DM and communication with colleagues, while the professionals emphasized the patient's capacity for self-care.ConclusionThe content of patient and professional perspectives on what is needed to prevent work-related problems for DM patients differed slightly. Patients rely on direct experiences in their own environment, professionals on medical knowledge accumulated in groups of patients.Practice implicationsBoth perspectives were used to suggest a topic list for health professionals, which may help identify and address the occupational problems experienced by DM patients.     

Patient Perceptions of Treatment Delivery Platforms for Cognitive Behavioral Therapy for Insomnia

Objective: Stepped care has given rise to the proliferation of abbreviated CBT-I programs and delivery formats. This includes interventions delivered by allied health professionals and those delivered electronically through the Internet. This article aims to explore patient perceptions between electronic and face-to-face (FTF) delivery platforms for (abbreviated) CBT-I. Participants: Patients with insomnia from specialist sleep or psychology clinics and those from the general community in Sydney, Australia. Method: Semistructured interviews were conducted with patients with insomnia, guided by a schedule of questions and a choice task to explore patient perceptions of the different CBT-I treatment delivery platforms (e.g., perceived advantages and disadvantages or willingness to engage with either platform). Interviews were transcribed verbatim and analyzed using Framework Analysis. Participants also completed a battery of clinical mood and insomnia measures. Results: Fifty-one interviews were conducted with patients with insomnia from specialist sleep or psychology clinics (n = 22) and the general community (n = 29). Synthesis of the qualitative data set revealed three themes pertinent to the patients’ perspective toward electronic and FTF CBT-I delivery: Concepts of Efficacy, Concerns About Treatment, and Treatment on My Terms. Participants’ choice to engage with either platform was also informed by diverse factors including perceived efficacy of treatment, personal commitments, lifestyle, and beliefs about sleep and insomnia. Conclusion: Clarifying patient treatment priorities and allaying potential concerns about engaging with an electronic treatment platform represent important steps for disseminating eCBT-I into mainstream practice.     

Meta-analytic review of the impact of cognitive-behavior therapy for insomnia on concomitant anxiety

Introduction

Concomitant anxiety and insomnia is a frequent problem encountered by mental health professionals.

Primary objective

To assess the impact of cognitive-behavior therapy for insomnia (CBT-I) on associated anxiety.

Method

Systematic search for clinical trials of CBT-I in PsycInfo, Medline, and Proquest Dissertations and Theses.

Results

Of the 216 CBT-I trials reviewed, 72 (33.3%) reported data on anxiety. The combined effect size (ES) of CBT-I on anxiety was 0.406 [95% CI 0.318-0.493], indicating a small to moderate effect of CBT-I on concomitant anxiety. Anxiety and anxiety-related constructs were measured with 31 different questionnaires or questionnaire subscales, the majority of which were used only once in the sample of studies.

Conclusions

CBT-I has only a moderate impact on anxiety in individuals who present insomnia with or without a comorbid anxiety disorder. A careful evaluation of residual anxiety should be conducted subsequent to CBT-I. Further research should focus on standardizing the assessment of anxiety in insomnia research.     

Risk awareness,medication adherence,and driving behavior as determined by the provision of drug information to patients

ObjectiveThe study identifies appropriate risk expressions by healthcare professionals in communicating the risks of driving-impairing medicine to patients, gauging changed patient behavior, preventing traffic accidents due to drugs, and improving drug adherence.MethodsAn online questionnaire survey was conducted on participants’ perception of driving-related risks, and risk awareness, as well as reports of healthcare professionals’ expressions and warning messages regarding driving-impairing drugs.ResultsApproximately 80 % of participants were aware of the effects of pharmaceutical drugs on driving ability, and 50 % responded that they had received an explanation from their respective health professionals. As reported by participants, although healthcare professionals typically used more indirect expressions, direct warning messages were associated with high-risk awareness.ConclusionThe content of the explanatory sentences and debriefing influenced risk perception among participants. Direct expressions were more desirable for appropriate risk perception by participants. Providing information from healthcare professional about the degree of risks and patients’ determining their influence on driving behavior based on risk perception was necessary to clarify the predictors of driving behavior.Practice implicationsHealth professionals should be aware that their warning messages could have a significant impact on patients’ risk perception and driving behavior.     

Humble doctors,healthy patients? Exploring the relationships between clinician humility and patient satisfaction,trust, and health status

ObjectiveIn medicine, numerous commentaries implore clinicians (e.g., physicians, physician assistants, nurse practitioners) to display more humility. However, given the complex power dynamics between patients and clinicians, one should not presume that patients desire and appreciate humble clinicians. This paper examines the relationship between clinician humility and patient outcomes, and aims to provide empirical evidence for the significance of clinician humility.MethodsIn two studies, patients (N = 497) recalled their most recent visit to a clinician through an online survey platform (Qualtrics). Patients rated their clinician’s humility, satisfaction and trust with their clinician, and health status. They also provided demographic information (e.g., gender, race, subjective SES), details about their clinician (e.g., gender, race, professional status) and information about their last medical visit with this clinician (e.g., purpose of visit, wait time during visit).ResultsThrough hierarchical multiple regression, we demonstrated that clinician humility positively predicted patient satisfaction, trust, and self-report health (only in Study 2) above and beyond patient, clinician, and visit characteristics.ConclusionThe results demonstrated that clinician humility can predict important patient outcomes above and beyond objective characteristics of the medical interaction.Practice ImplicationsThese findings may shape clinician-patient interactions by validating the pursuit of humility during medical encounters.     

Allied health professionals' use of online evidence: a survey of 790 staff working in the Australian public hospital system

OBJECTIVE: To measure the impact of a state health department policy to provide allied health professional staff with access to a point-of-care, 24h, online evidence system in terms of awareness, use and clinical impact of the system on clinical practice; to identify perceived barriers to use, and differences in measures between seven professional groups (physiotherapists, occupational therapists, speech pathologists, dieticians, clinical psychologists, pharmacists and social workers). METHOD: A convenience sample of 790 allied health professionals from 65 randomly selected hospitals in New South Wales, Australia. A self-administered questionnaire was distributed. Rates of use, frequency and types of resources accessed were calculated. Comparisons between professional groups were undertaken using Chi-square analyses and t-tests. RESULTS: The results showed that 82% of allied health professionals had heard of the online evidence system, and of those 76% had used it. Pharmacists had the highest rates of use and social workers the lowest. Of users, 90% agreed that use of the system had the potential to improve patient care and 45% reported direct experience of this. Computer skills and easy access were significantly associated with use and frequency of use. Among non-users, lack of specific training in the use of the online evidence system and lack of time were the most frequently reported reasons for not using the system. However, among users there was no relationship between this training and the frequency or effectiveness of use, i.e. the ability to find the information required. CONCLUSIONS: Allied health professionals will use an online evidence system when it is provided, however there are marked differences in use by professional groups. General training aimed at improving computer skills appears more important in encouraging use of an online evidence system, than specific system-based training. Perceptions of organisational and professional support for allied health professionals to use online evidence as a legitimate part of their work play an important role in influencing system use.     

Trajectory of self-care in people with stable heart failure and insomnia after two self-care interventions

ObjectiveTo describe (1) self-care trajectories among adults with heart failure (HF) and insomnia over 1-year; (2) the extent to which trajectories varied between cognitive behavioral therapy for insomnia (CBT-I) or HF self-care intervention; and (3) the associations between self-care trajectories and clinical and demographic characteristics, sleep, symptoms and stress, and functional performance.MethodsWe conducted secondary analysis of data from a randomized controlled trial of the effects of CBT-I compared with HF self-care education among adults with stable HF and insomnia. We used the Self-Care of Heart Failure Index v6.2. The analytic approaches included t-tests, group-based trajectory modeling, ANOVA, and chi-square.ResultsWe included 175 participants (M age=63.0 (12.9) years, White, N = 100]. We found four self-care trajectories: Low self-care (N = 47, 26.8%); Moderate self-care (N = 68, 38.9%): Adequate self-care (N = 42, 24.0%); and Optimal self-care (N = 18, 10.3%). There was no difference in self-care trajectories between interventions. The low self-care group had the most severe baseline fatigue, anxiety, and perceived stress, and lowest cognitive abilities.ConclusionBoth interventions prevented declining self-care. Future research is needed to determine the most efficacious intervention to improve self-care trajectories.Practice ImplicationsHealthcare providers should provide ongoing self-care support for those with persistently low and moderate self-care.     

Shared decision-making and patient engagement program during acute exacerbation of COPD hospitalization: A randomized control trial

ObjectiveTo evaluate the effectiveness of a shared decision-making and patient engagement (SDM-PE) program concerning in-hospital stay during acute exacerbation of COPD and determine its impact on patients’ perceived health status.MethodsPatients were randomly allocated to a control group that received standard treatment or an intervention group that received an individualized SDM-PE program in addition to standard treatment. The SDM-PE program included personalized health care focused on information about the disease, healthcare management, and reinforcement of behaviors regarding nutrition and exercise taking into account patients’ preferences.ResultsA comparative analysis between groups showed a significant improvement in perceived health status at discharge in patients included in the experimental group compared to those in the control group (60.28 ± 21.65 vs. 54.13 ± 22.69, p = 0.036). In addition, perceived health status, COPD knowledge, adherence to pharmacological treatment, general functionality, and healthy lifestyle measures were significantly better at 3-month follow-up in the intervention group.ConclusionAn SDM-PE program significantly enhanced all the clinical measures assessed during hospitalization at 3-month follow-up.Practice implicationsCOPD patients and professionals need to work together to select the best care and treatment model for patients, taking into account individual values and preferences.     

An investigation into the empowerment effects of using online support groups and how this affects health professional/patient communication

Objective

The current research investigates the potential of online support groups (OSGs) to foster empowerment and how membership might affect the patient/health professional relationship.

Methods

246 participants across 33 OSGs completed an online questionnaire.

Results

All empowerment processes and outcomes identified by van Uden-Kraan et al. [1] were found to be present. All empowerment outcomes were adequately predicted by empowerment processes. The majority (82.2%) of participants had discussed information found online with their health professional and most (74.2%) were satisfied with the response. Around 60% of participants felt membership of an OSG had affected the relationship with their health professional and from qualitative responses the effects were mostly positive.

Conclusion

OSGs have the potential to produce empowerment outcomes for those who choose to use them. Furthermore, users report a positive reaction to information found online from their health professionals.

Practice implications

Although not all patients will benefit from using OSGs, health professionals suggesting their use could ensure that they reach the maximum receptive audience. Furthermore, this research could be used to encourage a more ‘net friendly’ attitude amongst health professionals.     

Australian patients’ perception of the efficacy of the physical activity referral scheme (PARS)

BackgroundOptimum physical activity (PA) interventions could be delivered via physical activity referral schemes (PARS) if utilised adequately. However, the evidence supporting PARS effectiveness is weak due to low uptake and non-adherence to interventions.ObjectivePatients’ experiences of PARS were explored to obtain in-depth insight into their perceived quality of care and practical ways to optimise the programme’s effectiveness.MethodsA sequential explanatory mixed methods design was employed to probe cross-sectional quantitative survey data (n = 111) on patients’ knowledge and beliefs about PA and PARS and qualitative interview data (n = 15) on their experiences of PARS. Informed by Donabedian framework of healthcare quality assessment, quantitative and qualitative findings were integrated to identify practical ways to enhance PARS effectiveness.ResultsParticipants displayed good PA knowledge, had positive beliefs and perceived PARS to be useful. Nonetheless, bottlenecks in the structure and process of PARS impact on patient health outcomes and hinder the programme’s uptake.ConclusionExploring other referral mechanisms into PARS such as self or nurse-initiated referrals could improve the programme’s visibility and effectiveness.Practice implicationsImproved support, enhanced visibility of EPs, ongoing interactions between GPs and EPs and education about referral pathways would foster improved uptake, adherence and health outcomes for patients.     

Posttraumatic sleep disturbances in veterans: A pilot randomized controlled trial of cognitive behavioral therapy for insomnia and imagery rehearsal therapy

Objectives

Posttraumatic stress disorder (PTSD) is associated with sleep disturbances including insomnia and nightmares. This study compared cognitive behavioral therapy for insomnia (CBT-I) with CBT-I combined with imagery rehearsal therapy (IRT) for nightmares to evaluate if the combined treatment led to greater reductions in trauma-related sleep disturbances in Australian veterans.

Methods

Veterans with diagnosed PTSD, high insomnia symptom severity, and nightmares (N = 31) were randomized to eight group CBT-I sessions or eight group CBT-I + IRT sessions. Self-reported sleep, nightmare, and psychological measures (primary outcome: Pittsburgh Sleep Quality Index), and objective actigraphy data were collected; the effect of obstructive sleep apnea (OSA) risk on treatment outcomes was also examined.

Results

No treatment condition effects were detected for the combined treatment compared to CBT-I alone, and no moderating effect of OSA risk was detected. On average, participants from both groups improved on various self-report measures over time (baseline to 3 months posttreatment). Despite the improvements, mean scores for sleep-specific measures remained indicative of poor sleep quality. There were also no significant differences between the groups on the actigraphy indices.

Conclusions

The findings indicate that there is potential to optimize both treatments for veterans with trauma-related sleep disturbances.     

Effect of cognitive behavioural therapy for insomnia on sleep architecture and sleep EEG power spectra in psychophysiological insomnia

There is now an overwhelming preponderance of evidence that cognitive behavioural therapy for insomnia (CBT-I) is effective, as effective as sedative hypnotics during acute treatment (4-8 weeks), and is more effective in long term (following treatment). Although the efficacy of CBT-I in the treatment of chronic insomnia is well known, however there is little objective data on the effects of CBT-I on sleep architecture and sleep EEG power densities. The present study evaluated, first, subjective change in sleep quality and quantity, and secondly the modifications occurring in polysomnography and EEG power densities during sleep after 8 weeks of CBT-I. Nine free drug patients with psychophysiological insomnia, aged 33-62 years (mean age 47 +/- 9.7 years), seven female and two male participated in the study. Self-report questionnaires were administered 1 week before and 1 week after CBT-I, a sleep diary was completed each day 1 week before CBT-I, during CBT-I and 1 week after CBT-I. Subjects underwent two consecutive polysomnographic nights before and after CBT-I. Spectral analysis was performed the second night following 16 h of controlled wakefulness. After CBT-I, only scales assessing insomnia were significantly decreased, stages 2, REM sleep and SWS durations were significantly increased. Slow wave activity (SWA) was increased and the SWA decay shortened, beta and sigma activity were reduced. In conclusion CBT-I improves both subjective and objective sleep quality of sleep. CBT-I may enhance sleep pressure and improve homeostatic sleep regulation.     

Intraindividual variability in sleep schedule: effects of an internet-based cognitive-behavioral therapy for insomnia program and its relation with symptom remission

Study ObjectivesSleep schedule consistency is fundamental to cognitive-behavioral therapy for insomnia (CBT-I), although there is limited evidence suggesting whether it predicts treatment response. This analysis tested whether: (1) an Internet-based CBT-I program affects intraindividual variability (IIV) in sleep schedule and (2) sleep schedule IIV predicts insomnia symptom remission.MethodsThis secondary analysis compares participants (N = 303) randomized to an Internet-based CBT-I program (SHUTi—Sleep Healthy Using the Internet) or Internet-based patient education (PE). Participants reported daily bedtimes and rising times on 10 online sleep diaries collected over 2 weeks at baseline and 9-week post-intervention assessment. Participants completed the Insomnia Severity Index (ISI) at post-assessment and 6-month follow-up; symptom remission was defined by ISI < 8. Mixed effects location scale modeling was used to examine the effect of SHUTi on bedtime and rising time IIV; a novel two-staged analysis examined the effect of bedtime and rising time IIV on insomnia symptom remission.ResultsAt post-assessment, SHUTi participants reported about 30% less bedtime and 32% less rising time variability compared to PE (ps < 0.03). Bedtime and rising time IIV was not independently associated with likelihood of insomnia symptom remission at the subsequent time point (ps > 0.18), nor did sleep schedule IIV moderate treatment response (ps > 0.12).ConclusionsFindings demonstrate that an Internet-delivered CBT-I program can effectively increase users’ sleep schedule consistency relative to an educational control. This consistency, however, was not related to treatment outcome when defined by insomnia symptom remission, suggesting that enforcing rigid sleep schedules for patients may not be necessary for treatment success.Clinical Trial Registration{"type":"clinical-trial","attrs":{"text":"NCT00328250","term_id":"NCT00328250"}}NCT00328250