SleepWell24, a Smartphone Application to Promote Adherence to Positive Airway Pressure Therapy: Feasibility and Acceptability in a Randomized Controlled Trial.

OBJECTIVE: To investigate the feasibility and acceptability of SleepWell24, a multicomponent, evidence-based smartphone application, to improve positive airway pressure therapy (PAP) adherence, among patients with obstructive sleep apnea (OSA) naive to PAP. METHODS: In a single-blind randomized controlled trial, SleepWell24, with a companion activity monitor was compared to usual care plus the activity monitor and its associated app. SleepWell24 provides objective feedback on PAP usage and sleep/physical activity patterns, and chronic disease management. Patients were recruited from two sleep medicine centers and followed over the first 60 days of PAP. Feasibility and acceptability were measured by recruitment/retention rates, app usage, differences in post-trial Treatment Evaluation Questionnaire (TEQ) scores, and patient interviews. Exploratory, intent-to-treat logistic and linear mixed models estimated PAP adherence and clinical outcomes. RESULTS: Of 103 eligible participants, 87 were enrolled (SleepWell24 n = 40, control n = 47; mean 57.6y [SD = 12.3], 44.8% female). Retention was ≥95% across arms. There were no significant differences in TEQ scores. SleepWell24 participants engaged with the app on 62.9% of trial days. PAP use was high across both arms (SleepWell24 vs. Control: mean hours 5.98 vs. 5.86). There were no differences in PAP adherence or clinical outcomes. CONCLUSIONS: SleepWell24 was feasible and acceptable among PAP-naive patients with OSA. CLINICAL TRIAL REGISTRATION: NCT03156283https://www.clinicaltrials.gov/study/NCT03156283.

Assessing the Pragmatic Nature of Mobile Health Interventions Promoting Physical Activity: Systematic Review and Meta-analysis.

BACKGROUND: Mobile health (mHealth) apps can promote physical activity; however, the pragmatic nature (ie, how well research translates into real-world settings) of these studies is unknown. The impact of study design choices, for example, intervention duration, on intervention effect sizes is also understudied. OBJECTIVE: This review and meta-analysis aims to describe the pragmatic nature of recent mHealth interventions for promoting physical activity and examine the associations between study effect size and pragmatic study design choices. METHODS: The PubMed, Scopus, Web of Science, and PsycINFO databases were searched until April 2020. Studies were eligible if they incorporated apps as the primary intervention, were conducted in health promotion or preventive care settings, included a device-based physical activity outcome, and used randomized study designs. Studies were assessed using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) frameworks. Study effect sizes were summarized using random effect models, and meta-regression was used to examine treatment effect heterogeneity by study characteristics. RESULTS: Overall, 3555 participants were included across 22 interventions, with sample sizes ranging from 27 to 833 (mean 161.6, SD 193.9, median 93) participants. The study populations' mean age ranged from 10.6 to 61.5 (mean 39.6, SD 6.5) years, and the proportion of males included across all studies was 42.8% (1521/3555). Additionally, intervention lengths varied from 2 weeks to 6 months (mean 60.9, SD 34.9 days). The primary app- or device-based physical activity outcome differed among interventions: most interventions (17/22, 77%) used activity monitors or fitness trackers, whereas the rest (5/22, 23%) used app-based accelerometry measures. Data reporting across the RE-AIM framework was low (5.64/31, 18%) and varied within specific dimensions (Reach=44%; Effectiveness=52%; Adoption=3%; Implementation=10%; Maintenance=12.4%). PRECIS-2 results indicated that most study designs (14/22, 63%) were equally explanatory and pragmatic, with an overall PRECIS-2 score across all interventions of 2.93/5 (SD 0.54). The most pragmatic dimension was flexibility (adherence), with an average score of 3.73 (SD 0.92), whereas follow-up, organization, and flexibility (delivery) appeared more explanatory with means of 2.18 (SD 0.75), 2.36 (SD 1.07), and 2.41 (SD 0.72), respectively. An overall positive treatment effect was observed (Cohen d=0.29, 95% CI 0.13-0.46). Meta-regression analyses revealed that more pragmatic studies (-0.81, 95% CI -1.36 to -0.25) were associated with smaller increases in physical activity. Treatment effect sizes were homogenous across study duration, participants' age and gender, and RE-AIM scores. CONCLUSIONS: App-based mHealth physical activity studies continue to underreport several key study characteristics and have limited pragmatic use and generalizability. In addition, more pragmatic interventions observe smaller treatment effects, whereas study duration appears to be unrelated to the effect size. Future app-based studies should more comprehensively report real-world applicability, and more pragmatic approaches are needed for maximal population health impacts. TRIAL REGISTRATION: PROSPERO CRD42020169102; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=169102.

Cultural adaptations and cultural factors in EBI implementation with Latinx communities.

Introduction: Cultural factors are constructs that capture important life experiences of Latinx/Hispanic individuals, families, and communities. Despite their importance for Latinx communities, Latinx cultural factors have yet to be fully incorporated into the literature of many social, behavioral science, and health service fields, including implementation science. This significant gap in the literature has limited in-depth assessments and a more complete understanding of the cultural life experiences of diverse Latinx community residents. This gap has also stifled the cultural adaptation, dissemination, and implementation of evidence based interventions (EBIs). Addressing this gap can inform the design, dissemination, adoption, implementation, and sustainability of EBIs developed to serve Latinx and other ethnocultural groups. Methods: Based on a prior Framework Synthesis systematic review of Latinx stress-coping research for the years 2000-2020, our research team conducted a thematic analysis to identify salient Latinx cultural factors in this research field. This thematic analysis examined the Discussion sections of 60 quality empirical journal articles previously included into this prior Framework Synthesis literature review. In Part 1, our team conducted an exploratory analysis of potential Latinx cultural factors mentioned in these Discussion sections. In Part 2 we conducted a confirmatory analysis using NVivo 12 for a rigorous confirmatory thematic analysis. Results: This procedure identified 13 salient Latinx cultural factors mentioned frequently in quality empirical research within the field of Latinx stress-coping research during the years 2000-2020. Discussion: We defined and examined how these salient Latinx cultural factors can be incorporated into intervention implementation strategies and can be expanded to facilitate EBI implementation within diverse Latinx community settings.

Impact of the COVID-19 pandemic on change in sleep patterns in an exploratory, cross-sectional online sample of 79 countries.

OBJECTIVES: To describe changes in sleep patterns during the coronavirus disease 2019 (COVID-19) pandemic, develop profiles according to these patterns, and assess sociodemographic, economic, COVID-19 related, and sleep and mental health factors associated with these profiles. DESIGN, SETTING, AND PARTICIPANTS: A 25-minute online survey was distributed worldwide through social media from 5/21/2020 to 7/1/2020. MEASUREMENTS: Participants reported sociodemographic/economic information, the impact of the pandemic on major life domains, insomnia and depressive symptoms, and changes in sleep midpoint, time-in-bed, total sleep time (TST), sleep efficiency (SE), and nightmare and nap frequency from prior to during the pandemic. Sleep pattern changes were subjected to latent profile analysis. The identified profiles were compared to one another on all aforementioned factors using probit regression analyses. RESULTS: The sample of 991 participants (ages: 18-80 years; 72.5% women; 60.3% residing outside of the United States) reported significantly delayed sleep midpoint, reductions in TST and SE, and increases in nightmares and naps. Over half reported significant insomnia symptoms, and almost two-thirds reported significant depressive symptoms. Latent profile analysis revealed 4 sleep pattern change profiles that were significantly differentiated by pre-pandemic sleep patterns, gender, and various COVID-19-related impacts on daily living such as severity of change in routines, and family stress and discord. CONCLUSIONS: In an international online sample, poor sleep and depressive symptoms were widespread, and negative shifts in sleep patterns from pre-pandemic patterns were common. Differences in sleep pattern response to the COVID-19 crisis suggest potential and early targets for behavioral sleep health interventions.

Brain boosters: Evaluating a pilot program for memory complaints in veterans.

This study investigated the feasibility and preliminary effectiveness of a pilot program designed to address subjective memory complaints among Veterans. The program, Brain Boosters, consisted of 10 once-weekly group sessions, during which psychoeducation and cognitive enhancement strategies were used to target memory concerns and related processes, specifically attentional difficulties. Given that memory complaints often are associated with psychiatric comorbidities, sessions also incorporated strategies for reducing symptoms of depression, posttraumatic stress, and insomnia. Controlling for age, we examined pre- to posttreatment change in symptom ratings for 96 Veterans (aged 22 to 87 years) who participated in the Brain Boosters program. The effect of Brain Boosters on memory complaints interacted with age: younger (but not older) Veterans reported reductions in memory impairment from pre- to posttreatment. Additionally, irrespective of age, from pre- to posttreatment Veterans reported fewer attentional difficulties and fewer depression symptoms. Ratings of posttraumatic stress and insomnia symptoms did not change, although insomnia was negatively associated with age. Linear regression controlling for age revealed that reductions in attention problems predicted reductions in perceived memory impairment. Findings from this exploratory, uncontrolled pilot study suggest that a psychoeducational cognitive enhancement group is feasible to conduct in a heterogeneous Veteran population, and may be associated with improvements in perceived memory functioning for younger Veterans, and in attention and depression symptoms for Veterans across age groups. (PsycINFO Database Record (c) 2020 APA, all rights reserved).

Cognitive Processing Therapy for Posttraumatic Stress Disorder Is Associated with Negligible Change in Subjective and Objective Sleep.

Background: Patients receiving Cognitive Processing Therapy (CPT), an evidence based therapy for posttraumatic stress disorder (PTSD), report improved sleep quality. However, the majority of studies have examined residual sleep disturbance via self-report surveys or separate items on PTSD measures. This study examined whether CPT delivered to veterans in a VA setting improved sleep indices using state-of-the-art objective and subjective insomnia measures. Participants: Participants were war veterans with a current PTSD diagnosis scheduled to begin outpatient individual or group CPT at two Veteran's Affairs (VA) locations (n = 37). Methods: Sleep symptom severity was assessed using the recommended research consensus insomnia assessment, the consensus daily sleep diary and actigraphy. PTSD symptomatology pre- and post-treatment were assessed using the Clinician Administered PTSD Scale. Results: A small to moderate benefit was observed for the change in PTSD symptoms across treatment (ESRMC = .43). Effect sizes for changes on daily sleep diary and actigraphy variables after CPT were found to be negligible (Range ESRMC = - .16 to .17). Sleep indices remained at symptomatic clinical levels post-treatment. Discussion: These findings support previous research demonstrating a need for independent clinical attention to address insomnia either before, during, or after PTSD treatment.

Rationale, design, and development of SleepWell24: A smartphone application to promote adherence to positive airway pressure therapy among patients with obstructive sleep apnea.

BACKGROUND: Positive airway pressure (PAP) therapy is the gold standard treatment for obstructive sleep apnea (OSA), a chronic disorder that affects 6-13% of the adult population. However, adherence to PAP therapy is challenging, and current approaches to improve adherence have limited efficacy and scalability. METHODS/DESIGN: To promote PAP adherence, we developed SleepWell24, a multicomponent, evidence-based smartphone application that delivers objective biofeedback concerning PAP use and sleep/physical activity patterns via cloud-based PAP machine and wearable sensor data, and behavior change strategies and troubleshooting of PAP therapy interface use. This randomized controlled trial will evaluate the feasibility, acceptability, and initial efficacy of SleepWell24 compared to a usual care control condition during the first 60 days of PAP therapy among patients newly diagnosed with OSA. DISCUSSION: SleepWell24 is an innovative, multi-component behavior change intervention, designed as a self-management approach to addressing the psychosocial determinants of adherence to PAP therapy among new users. The results will guide lengthier future trials that assess numerous patient-centered and clinical outcomes.

Comparing the Effects of Single- and Multiple-Component Therapies for Insomnia on Sleep Outcomes.

BACKGROUND: Single- and multiple-component therapies are recommended in professional guidelines for managing chronic insomnia. Systematic reviews point to insufficient evidence of the comparative effectiveness of these therapies, which is required for treatment decision making. PURPOSE: To compare the effectiveness of three single-component and one multiple-component therapies on short-term sleep outcomes. METHODS: The data were obtained from 517 persons with chronic insomnia, enrolled in a partially randomized preference trial. They were allocated to the single-component therapies: sleep education and hygiene (SEH), stimulus control therapy (SCT), and sleep restriction therapy (SRT), or the multiple-component therapy (MCT). The outcomes, perceived insomnia severity and sleep parameters, were assessed with established measures at pre and posttest. Repeated measure analysis of variance was used to compare the outcomes across therapy groups over time. The clinical relevance of the therapies' effects was evaluated by examining the effect size and remission rate. RESULTS: The four therapies differed in their effectiveness in reducing perceived insomnia severity and improving sleep outcomes. SEH was least effective. SCT, SRT, and MCT were moderately effective. SCT and SRT demonstrated slightly higher remission rates than MCT for perceived insomnia severity and some sleep parameters. LINKING EVIDENCE TO ACTION: SCT and SRT are viable single-component therapies that produce clinical benefits. Single-component insomnia treatment may be more convenient to implement in the primary care setting due to the reduced number of treatment recommendations compared to MCT.

The "House of Quality for Behavioral Science"-a user-centered tool to design behavioral interventions.

Within the behavioral field, a plethora of conceptual frameworks and tools have been developed to improve transition from efficacy to effectiveness trials; however, they are limited in their ability to support new, iterative intervention design decision-making methodologies beyond traditional randomized controlled trial design. Emerging theories suggest that researchers should employ engineering based user-centered design (UCD) methods to support more iterative intervention design decision-making in the behavioral field. We present, an adaptation of a UCD tool used in the engineering field-the Quality Function Deployment "House of Quality" correlation matrix, to support iterative intervention design decision-making and documentation for multicomponent behavioral interventions and factorial trial designs. We provide a detailed description of the adapted tool-"House of Quality for Behavioral Science", and a step-by-step use-case scenario to demonstrate the early identification of intervention flaws and prioritization of requirements. Four intervention design flaws were identified via the tool application. Completion of the relationship correlation matrix increased requirement ranking variance for the researcher (σ2 = 0.47 to 7.19) and participant (σ2 = 0.56 to 3.89) perspective. Requirement prioritization (ranking) was facilitated by factoring in the strength of the correlation between each perspective and corresponding importance. A correlational matrix tool such as the "House of Quality for Behavioral Science" may provide a structured, UCD approach that balances researcher and participant needs and identifies design flaws for pragmatic behavioral intervention design. This tool may support iterative design decision-making for multicomponent and factorial trial designs.

The contribution of participant, treatment, and outcome factors to treatment satisfaction.

Treatment satisfaction, which refers to the positive appraisal of process and outcome attributes of a treatment, is a prominent indicator of quality care. Although it is known that participant, treatment, and outcome factors influence treatment satisfaction, it remains unclear which factors contribute to satisfaction with each process and outcome attribute. In this study, we examined the extent to which participant (age, gender, education, race, employment), treatment (type of therapy, method of assignment to therapy), and outcome (self-reported improvement in outcome) factors contribute to satisfaction with the process and outcome attributes of therapies for insomnia. This study consists of a secondary analysis of data obtained from a partially randomized preference trial in which persons with chronic insomnia (N = 517) were assigned to treatment randomly or by preference. Four types of behavioral therapies were included: sleep hygiene, stimulus control therapy, sleep restriction therapy, and multi-component therapy. Self-reported improvement in insomnia and satisfaction were assessed with validated measures at post-test. Multiple regression analysis was used to examine which factors influenced satisfaction with each treatment attribute. The findings showed that treatment and outcome, more so than participant, factors influenced satisfaction with the process and outcome attributes of the behavioral therapies for insomnia. Future research on satisfaction should explore the contribution of treatment (type and preference-matching) and outcome factors on satisfaction to build a better understanding of treatment attributes viewed favorably. Such understanding has the potential to inform modifying or tailoring treatments to improve their acceptance to participants and optimize their effectiveness.

Psychometric Properties of the Treatment Perception and Preferences Measure.

Patient-centered care involves the provision of treatments that are responsive to patients' preferences. This study aimed to examine the psychometric properties of the Treatment Perception and Preferences measure. Participants ( n = 128) completed the measure relative to pharmacological, educational, and behavioral treatments for the management of insomnia. For each treatment, the measure presents a description of its goal, activities, mode and dose of delivery, and nine items to rate its perceived acceptability. All items measuring perception of treatment were internally consistent (α > .85) and loaded on one factor, except the item assessing severity of side effects. Differences in the measure's scores between groups of participants provided evidence of validity: participants with a preference for a particular treatment rated it more favorably than alternative treatments. The measure provides a systematic and efficient method for eliciting well-informed treatment preferences. Its use in practice should be investigated.

The Effect of Sleep Disorders, Sedating Medications, and Depression on Cognitive Processing Therapy Outcomes: A Fuzzy Set Qualitative Comparative Analysis.

Cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) is an effortful process requiring engagement in cognitive restructuring. Sleep disorders may lead to avoidance of effortful tasks and cognitive performance deficits. We explored whether sleep disorders, as assessed by polysomnography, were consistently associated with treatment response in combination with other factors. This study included 32 U.S. veterans who were examined both before and after CPT for combat-related PTSD. We employed a novel, case-comparative technique, fuzzy set qualitative comparative analysis (fsQCA), to identify combinations of fuzzy and crisp factors (recipes) that achieve a clinically significant outcome. Approximately one-quarter of cases experiencing clinically significant change were either (a) Vietnam era veterans without sedating medications, moderate sleep disordered breathing, and severe depression; or (b) non-Vietnam era veterans with sedating medications and without severe periodic limb movements (or significant periodic limb movement arousals). Recipes involving the absence of the relevant sleep disorder were associated with the highest coverage values. These results using fsQCA (a) provide valuable information about the heterogeneity of CPT response and (b) suggest that sleep disorders are important factors to consider in theoretical discussions of who responds to CPT for PTSD.

Psychometric evaluation of a multi-dimensional measure of satisfaction with behavioral interventions.

Treatment satisfaction is recognized as an essential aspect in the evaluation of an intervention's effectiveness, but there is no measure that provides for its comprehensive assessment with regard to behavioral interventions. Informed by a conceptualization generated from a literature review, we developed a measure that covers several domains of satisfaction with behavioral interventions. In this paper, we briefly review its conceptualization and describe the Multi-Dimensional Treatment Satisfaction Measure (MDTSM) subscales. Satisfaction refers to the appraisal of the treatment's process and outcome attributes. The MDTSM has 11 subscales assessing treatment process and outcome attributes: treatment components' suitability and utility, attitude toward treatment, desire for continued treatment use, therapist competence and interpersonal style, format and dose, perceived benefits of the health problem and everyday functioning, discomfort, and attribution of outcomes to treatment. The MDTSM was completed by persons (N = 213) in the intervention group in a large trial of a multi-component behavioral intervention for insomnia within 1 week following treatment completion. The MDTSM's subscales demonstrated internal consistency reliability (α: .65 - .93) and validity (correlated with self-reported adherence and perceived insomnia severity at post-test). The MDTSM subscales can be used to assess satisfaction with behavioral interventions and point to aspects of treatments that are viewed favorably or unfavorably.

Validation of a Smartphone App for the Assessment of Sedentary and Active Behaviors.

BACKGROUND: Although current technological advancements have allowed for objective measurements of sedentary behavior via accelerometers, these devices do not provide the contextual information needed to identify targets for behavioral interventions and generate public health guidelines to reduce sedentary behavior. Thus, self-reports still remain an important method of measurement for physical activity and sedentary behaviors. OBJECTIVE: This study evaluated the reliability, validity, and sensitivity to change of a smartphone app in assessing sitting, light-intensity physical activity (LPA), and moderate-vigorous physical activity (MVPA). METHODS: Adults (N=28; 49.0 years old, standard deviation [SD] 8.9; 85% men; 73% Caucasian; body mass index=35.0, SD 8.3 kg/m2) reported their sitting, LPA, and MVPA over an 11-week behavioral intervention. During three separate 7-day periods, participants wore the activPAL3c accelerometer/inclinometer as a criterion measure. Intraclass correlation (ICC; 95% CI) and bias estimates (mean difference [δ] and root of mean square error [RMSE]) were used to compare app-based reported behaviors to measured sitting time (lying/seated position), LPA (standing or stepping at <100 steps/minute), and MVPA (stepping at >100 steps/minute). RESULTS: Test-retest results suggested moderate agreement with the criterion for sedentary time, LPA, and MVPA (ICC=0.65 [0.43-0.82], 0.67 [0.44-0.83] and 0.69 [0.48-0.84], respectively). The agreement between the two measures was poor (ICC=0.05-0.40). The app underestimated sedentary time (δ=-45.9 [-67.6, -24.2] minutes/day, RMSE=201.6) and overestimated LPA and MVPA (δ=18.8 [-1.30 to 38.9] minutes/day, RMSE=183; and δ=29.3 [25.3 to 33.2] minutes/day, RMSE=71.6, respectively). The app underestimated change in time spent during LPA and MVPA but overestimated change in sedentary time. Both measures showed similar directions in changed scores on sedentary time and LPA. CONCLUSIONS: Despite its inaccuracy, the app may be useful as a self-monitoring tool in the context of a behavioral intervention. Future research may help to clarify reasons for under- or over-reporting of behaviors.

Contribution of treatment acceptability to acceptance of randomization: an exploration.

RATIONALE, AIMS AND OBJECTIVES: Randomization to treatment is viewed unfavourably by many trial participants. There is limited research that investigated factors contributing to acceptance of randomization. This study explored the influence of participants' socio-demographic and clinical characteristics, and their perceived acceptability of the treatments on their acceptance of randomization (i.e. willingness to be randomized) in a clinical trial. METHODS: Persons with insomnia (n = 383) were asked about their acceptance of randomization before and after they rated the acceptability of behavioural therapies for managing insomnia (sleep education and hygiene booklet, stimulus control therapy and sleep restriction therapy). Socio-demographic and clinical characteristics, and treatment acceptability, were measured with established instruments. Logistic regression was applied to explore the association between participants' characteristics and treatment acceptability, and reported acceptance of randomization. RESULTS: Prior to rating treatments' acceptability, 54.6% of participants were willing to be randomized; socio-demographic (age and ethnicity) and clinical (severity of insomnia's impact, state anxiety, depression, vitality and mental and social functions) contributed to acceptance of randomization. After rating the treatments' acceptability, 87.8% of participants were unwilling to be randomized; age, severity of insomnia's impact and acceptability of behavioural therapy were significantly associated with acceptance of randomization. CONCLUSIONS: The study findings indicated that participants are likely to express unwillingness to be randomized once they receive treatment information and rate the acceptability of treatments. The reported non-acceptance may influence participants' behaviour (e.g. withdrawal, non-adherence) during the trial, suggesting the need to explore alternative designs for intervention evaluation.

BeWell24: development and process evaluation of a smartphone "app" to improve sleep, sedentary, and active behaviors in US Veterans with increased metabolic risk.

Lifestyle behaviors across the 24-h spectrum (i.e., sleep, sedentary, and active behaviors) drive metabolic risk. We describe the development and process evaluation of BeWell24, a multicomponent smartphone application (or "app") that targets behavior change in these interdependent behaviors. A community-embedded iterative design framework was used to develop the app. An 8-week multiphase optimization strategy design study was used to test the initial efficacy of the sleep, sedentary, and exercise components of the app. Process evaluation outcomes included objectively measured app usage statistics (e.g., minutes of usage, self-monitoring patterns), user experience interviews, and satisfaction ratings. Participants (N = 26) logged approximately 60 % of their sleep, sedentary, and exercise behaviors, which took 3-4 min/day to complete. Usage of the sleep and sedentary components peaked at week 2 and remained high throughout the intervention. Exercise component use was low. User experiences were mixed, and overall satisfaction was modest.

Behavioral Periodicity Detection from 24 h Wrist Accelerometry and Associations with Cardiometabolic Risk and Health-Related Quality of Life.

Periodicities (repeating patterns) are observed in many human behaviors. Their strength may capture untapped patterns that incorporate sleep, sedentary, and active behaviors into a single metric indicative of better health. We present a framework to detect periodicities from longitudinal wrist-worn accelerometry data. GENEActiv accelerometer data were collected from 20 participants (17 men, 3 women, aged 35-65) continuously for 64.4 ± 26.2 (range: 13.9 to 102.0) consecutive days. Cardiometabolic risk biomarkers and health-related quality of life metrics were assessed at baseline. Periodograms were constructed to determine patterns emergent from the accelerometer data. Periodicity strength was calculated using circular autocorrelations for time-lagged windows. The most notable periodicity was at 24 h, indicating a circadian rest-activity cycle; however, its strength varied significantly across participants. Periodicity strength was most consistently associated with LDL-cholesterol (r's = 0.40-0.79, P's < 0.05) and triglycerides (r's = 0.68-0.86, P's < 0.05) but also associated with hs-CRP and health-related quality of life, even after adjusting for demographics and self-rated physical activity and insomnia symptoms. Our framework demonstrates a new method for characterizing behavior patterns longitudinally which captures relationships between 24 h accelerometry data and health outcomes.

Transitions in Symptom Cluster Subgroups Among Men Undergoing Prostate Cancer Radiation Therapy.

BACKGROUND: Prostate cancer is a common type of cancer worldwide and in the United States. However, little information has been reported on the symptoms of men over time who receive radiation therapy. OBJECTIVE: The objectives of this study were to identify subgroups of men at pre- and post-radiation therapy on general and treatment-related symptoms and to determine transitions in subgroup membership over time. METHODS: Men (n = 84) receiving radiation therapy completed questionnaires on fatigue, insomnia, pain, depression, anxiety, and sexual, urinary, and bowel problems at pretreatment and posttreatment. Latent class analysis identified subgroups. One-way analyses of variance determined subgroups differed on symptoms, participant characteristics, and quality of life. Latent transition analysis examined subgroup transitions over time. RESULTS: At pretreatment, 4 subgroups were identified: resilient group, with little to no symptom reporting; adjusted group, with moderately high treatment-related symptoms, low insomnia, depression, and anxiety; distressed group, consistently high on most symptoms; and emerging group, with moderately high fatigue, depression, and anxiety with few treatment-related symptoms. At posttreatment, similar results were seen in groups to those at pretreatment: resilient, adjusted. and distressed groups with an impacted group having high pain, insomnia, depression, and urinary and bowel symptoms. Quality of life and participant characteristics further distinguished groups at pretreatment and posttreatment. Income level predicted a transition in group membership. CONCLUSIONS: Men can be classified into distinctly different subgroups over time. IMPLICATIONS FOR PRACTICE: Assessment and intervention with men in subgroups such as distressed and emerging before and during treatment may lessen potential for remaining distressed or moving into impacted group where symptom severity is high at posttreatment. Interventions to reduce multiple symptoms are vitally needed.

Toward a Conceptualization and Operationalization of Satisfaction With Nonpharmacological Interventions.

BACKGROUND: Although satisfaction is recognized as an essential aspect in the evaluation of interventions' effectiveness, there is lack of clarity on its conceptualization and operationalization. In this article, we present conceptual and operational definitions that specify the domains and attributes of satisfaction with nonpharmacological interventions. METHODS: An integrative review of conceptual and empirical literature was conducted to generate the conceptual and operational definitions of satisfaction with interventions. Fifty-six publications were included in the review. The definitions of satisfaction and the content of instruments measuring satisfaction were reviewed, compared, and contrasted to identify the domains and attributes of the concept. RESULTS: Satisfaction is defined as the appraisal of the interventions' process and outcome. It is operationalized in 4 domains of process: (a) suitability and utility of the intervention's components, (b) attitude toward and desire to continue with the intervention, (c) competence and interpersonal style of interventionist, and (d) implementation (format and dose) of the intervention. The outcome domain includes improvement in the health problem and in everyday functions, discomfort, and attribution of the outcomes to the intervention. CONCLUSIONS: The conceptual and operational definitions can guide the development of instruments to assess satisfaction with nonpharmacological interventions, which can point to aspects of interventions that are viewed favorably or unfavorably.

Challenges in Using the Randomized Trial Design to Examine the Influence of Treatment Preferences.

The overall purpose of this methodological study was to investigate the strengths and limitations of the randomized clinical trial design in examining the influence of treatment preferences on outcomes. The study was a secondary analysis of data obtained in two randomized clinical trials that evaluated behavioral therapies for insomnia. In both trials, the same design and methods were used to assess participants' treatment preferences and outcomes, however, the treatments differed. The results illustrated the challenges encountered in using the randomized clinical trial design. The challenges were related to the unbalanced distribution of participants with preferences for the study treatments, non-comparability of the subgroups with treatments matched or mismatched to their preferences, differential attrition, which compromised the sample size and composition of the subgroups and limited the use of the planned statistical analyses. Whether these challenges occur in trials of other types of treatments and target populations should be explored in future research. Some strategies were proposed and should be evaluated for their utility in addressing these challenges.