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Objective: Cognitive behavioral therapy for chronic pain (CBT‐CP) is an evidence‐based treatment for improving functioning and pain intensity for people with chronic pain with extensive evidence of effectiveness. However, there has been relatively little investigation of the factors associated with successful implementation and uptake of CBT‐CP, particularly clinician and system level factors. This formative evaluation examined barriers and facilitators to the successful implementation and uptake of CBT‐CP from the perspective of CBT‐CP clinicians and referring primary care clinicians. Methods: Qualitative interviews guided by the Consolidated Framework for Implementation Research were conducted at nine geographically diverse Veterans Affairs sites as part of a pragmatic clinical trial comparing synchronous, clinician‐delivered CBT‐CP and remotely delivered, technology‐assisted CBT‐CP. Analysis was informed by a grounded theory approach. Results: Twenty‐six clinicians (CBT‐CP clinicians = 17, primary care clinicians = 9) from nine VA medical centers participated in individual qualitative interviews conducted by telephone from April 2019 to August 2020. Four themes emerged in the qualitative interviews: (1) the complexity and variability of referral pathways across sites, (2) referring clinician's lack of knowledge about CBT‐CP, (3) referring clinician's difficulty identifying suitable candidates for CBT‐CP, and (4) preference for interventions that can be completed from home. Conclusions: This formative evaluation identified clinician and system barriers to widespread implementation of CBT‐CP and allowed for refinement of the subsequent implementation of two forms of CBT‐CP in an ongoing pragmatic trial. Identification of relative difference in barriers and facilitators in the two forms of CBT‐CP may emerge more clearly in a pragmatic trial that evaluates how treatments perform in real‐world settings and may provide important information to guide future system‐wide implementation efforts. [ABSTRACT FROM AUTHOR]

Background: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. Methods: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. Discussion: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. Trial registration: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020. [ABSTRACT FROM AUTHOR]

Background: In 1979, Marvin Zelen proposed a new design for randomized clinical trials intended to facilitate clinicians' and patients' participation. The defining innovation of Zelen's proposal was random assignment of treatment prior to patient or participant consent. Following randomization, a participant would receive information and asked to consent to the assigned treatment.Methods: This narrative review examined recent examples of Zelen design trials evaluating clinical and public health interventions.Results: Zelen designs have often been applied to questions regarding real-world treatment or intervention effects under conditions of incomplete adherence. Examples include evaluating outreach or engagement interventions (especially for stigmatized conditions), evaluating treatments for which benefit may vary according to participant motivation, and situations when assignment to a control or usual care condition might prompt a disappointment effect. Specific practical considerations determine whether a Zelen design is scientifically appropriate or practicable. Zelen design trials usually depend on identifying participants automatically from existing records rather than by advertising, referral, or active recruitment. Assessments of baseline or prognostic characteristics usually depend on available records data rather than research-specific assessments. Because investigators must consider how exposure to treatments or interventions might bias ascertainment of outcomes, assessment of outcomes from routinely created records is often necessary. A Zelen design requires a waiver of the usual requirement for informed consent prior to random assignment of treatment. The Revised Common Rule includes specific criteria for such a waiver, and those criteria are most often met for evaluation of a low-risk and potentially beneficial intervention added to usual care. Investigators and Institutional Review Boards must also consider whether the scientific or public health benefit of a Zelen design trial outweighs the autonomy interests of potential participants. Analysis of Zelen trials compares outcomes according to original assignment, regardless of any refusal to accept or participate in the assigned treatment.Conclusions: A Zelen design trial assesses the real-world consequences of a specific strategy to prompt or promote uptake of a specific treatment. While such trials are poorly suited to address explanatory or efficacy questions, they are often preferred for addressing pragmatic or policy questions. [ABSTRACT FROM AUTHOR]

Objective To identify factors that influence or interfere with referrals by primary care providers (PCPs) to a pharmacist-led telephone-based program to assist patients undergoing opioid tapering. The Support Team Onsite Resource for Management of Pain (STORM) program provides individualized patient care and supports PCPs in managing opioid tapers. Design Qualitative interviews were conducted with referring PCPs and STORM staff. Interview guides addressed concepts from the RE-AIM framework, focusing on issues affecting referral to the STORM program. Setting An integrated healthcare system (HCS) in the Northwest United States. Subjects Thirty-five interviews were conducted with 20 PCPs and 15 STORM staff. Methods Constant comparative analysis was used to identify key themes from interviews. A codebook was developed based on interview data and a qualitative software program was used for coding, iterative review, and content analysis. Representative quotes illustrate identified themes. Results Use of the STORM opioid tapering program was influenced by PCP, patient, and HCS considerations. Factors motivating use of STORM included lack of PCP time to support chronic pain patients requiring opioid tapering and the perception that STORM is a valued partner in patient care. Impediments to referral included PCP confidence in managing opioid tapering, patient resistance to tapering, forgetting about program availability, and PCP resistance to evolving guidelines regarding opioid tapering goals. Conclusions PCPs recognized that STORM supported patient safety and reduced clinician burden. Utilization of the program could be improved through ongoing PCP education about the service and consistent co-location of STORM pharmacists within primary care clinics. [ABSTRACT FROM AUTHOR]

Background Multisite chronic pain (MSCP) is associated with increased chronic pain impact, but methods for identifying MSCP for epidemiological research have not been evaluated. Objective We assessed the validity of identifying MSCP using electronic health care data compared with survey questionnaires. Methods Stratified random samples of adults served by Kaiser Permanente Northwest and Washington (N = 2,059) were drawn for a survey, oversampling persons with frequent use of health care for pain. MSCP and single-site chronic pain were identified by two methods, with electronic health care data and with self-report of common chronic pain conditions by survey questionnaire. Analyses were weighted to adjust for stratified sampling. Results MSCP was somewhat less common when ascertained by electronic health records (14.7% weighted prevalence) than by survey questionnaire (25.9% weighted prevalence). Agreement of the two MSCP classifications was low (kappa agreement statistic of 0.21). Ascertainment of MSCP with electronic health records was 30.9% sensitive, 91.0% specific, and had a positive predictive value of 54.5% relative to MSCP identified by self-report as the standard. After adjusting for age and gender, patients with MSCP identified by either electronic health records or self-report showed higher levels of pain-related disability, pain severity, depressive symptoms, and long-term opioid use than persons with single-site chronic pain identified by the same method. Conclusions Identification of MSCP with electronic health care data was insufficiently accurate to be used as a surrogate or screener for MSCP identified by self-report, but both methods identified persons with heightened chronic pain impact. [ABSTRACT FROM AUTHOR]

Introduction: Primary care practitioners (PCPs) are concerned about adverse effects and poor outcomes of opioid use but may find opioid tapering difficult because of a lack of pain management training or time constraints limiting patient counseling. In 2010, Kaiser Permanente Northwest implemented a pharmacistled opioid tapering program--Support Team Onsite Resource for Management of Pain (STORM)--to address high rates of opioid use, alleviate PCPs' workload demands, and improve patient outcomes. Objective: To describe the rationale, structure, and delivery of this unique pharmacist-led program, which partners with PCPs and provides individualized care to help patients reduce opioid use, and the Facilitating Lower Opioid Amounts through Tapering study, which examines the program's effectiveness, cost-effectiveness, and implementation. Results: The STORM program includes a pain medicine physician, a social worker or nurse, and pharmacists who have received specialized clinical and communications training. The program has a 2-fold role: 1) to provide PCP education about pain management and opioid use and 2) to offer clinician and patient support with opioid tapering and pain management. After program training, PCPs are equipped to discuss the need for tapering with a patient and to refer to the program. Program pharmacists provide a range of services, including opioid taper plans, nonopioid pain management recommendations, and taper-support outreach to patients. Discussion: The STORM program provides individualized care to assist patients with opioid tapering while reducing the burden on PCPs. Conclusion: The STORM program may be a valuable addition to health care systems and settings seeking options to address their patients' opioid tapering needs. [ABSTRACT FROM AUTHOR]

Background: Chronic pain is a prevalent health concern in the United States (US) and a frequent reason for patients to seek primary care. The challenges associated with developing effective pain management strategies can be perceived as a burden on the patient-provider relationship.Objective: This study explored the relationship between patients' overall satisfaction with their primary care providers (PCPs) and their satisfaction with their chronic pain treatment, as well as the provider behaviors that contributed to chronic pain patients' satisfaction with their PCPs.Design: Concurrent nested mixed-methods design PARTICIPANTS: 97 patients with chronic pain who were assigned to the usual care arm of the Pain Program for Active Coping and Training (PPACT) study.Approach: We analyzed phone interview and survey data (n = 97). Interviews assessed provider behaviors that led to patient satisfaction. Interview transcripts were analyzed based on a content analysis approach. Survey responses assessed patient satisfaction with primary care and pain services. We calculated a Pearson's correlation coefficient using five response categories.Key Results: Interviews revealed that high satisfaction with primary care was driven by five concrete PCP behaviors: (1) listening, (2) maintaining communication with patients, (3) acting as an access point to comprehensive pain care, (4) providing an honest assessment of the possibilities of pain care, and (5) taking time during consultations with patients. In surveys, participants reported higher satisfaction with their primary care services than with the pain services they received; these variables were only moderately correlated (r = 0.586).Conclusions: Results suggest that patients with chronic pain can view the relationship with their PCPs as positive, even in the face of low satisfaction with their pain treatment. The expectations that these patients held of PCPs could be met regardless of providers' ability to successfully relieve chronic pain. [ABSTRACT FROM AUTHOR]

Aims: Despite many reports about complementary and alternative medicine (CAM) use in the general population, little information exists about specific CAM therapies used for particular health conditions. This study examines the use of CAM therapies among patients with temporomandibular disorders (TMD). Methods: We surveyed 192 patients with documented TMD as part of a larger project on the effectiveness of various CAM modalities for TMD patients. The survey asked about use of and attitudes toward specific CAM therapies for treating TMD and other patient-identified health conditions. The survey also measured physical health, health behavior, and psychosocial functioning. Results: Nearly two thirds of the respondents (62.5%; n = 120) reported using CAM therapies for TMD or a related condition. Of all the therapies reported, massage was rated as the most frequent and among the most satisfactory and helpful. In general, respondents who used CAM for their TMD reported being most satisfied with the "hands on" CAM therapies (massage, acupuncture, and chiropractic care). The vast majority of respondents reported using CAM approaches for TMD simultaneously with conventional care (95.6%; 66 of 69). Those using CAM for TMD tended to be older, had a history of multiple medical problems, and reported more positive psychologic functioning. Respondents who most often reported CAM treatment as "very helpful" for their TMD were likely to be healthier (ie, reporting higher levels of exercise and fewer sleep disturbances). Conclusion: Given the frequent use of CAM treatments by our respondents, allopathic providers should inquire about the adjunctive use of CAM among their TMD patients. [ABSTRACT FROM AUTHOR]

Importance: Few studies have examined the relationship between nonmalignant chronic pain (NMCP) and suicide death, and even fewer have specifically explored what role sleep disturbance might play in the association between NMCP and suicide death. Objective: To assess whether sleep disturbance mediates the relationship between NMCP and suicide death. Design: This case‐control study included 2,674 individuals who died by suicide between 2000 and 2013 (cases) and 267,400 matched individuals (controls). Setting: Eight Mental Health Research Network (MHRN)‐affiliated healthcare systems. Participants: All cases and matched controls were health plan members for at least 10 months during the year prior to the index date. Main Outcomes and Measures: Sociodemographic data and diagnosis codes for NMCP and sleep disorders were extracted from the MHRN's Virtual Data Warehouse. Suicide mortality was identified using International Statistical Classification of Diseases and Related Health Problems (ICD)‐10 codes from official government mortality records matched to health system records. Results: After accounting for covariates, there was a significant relationship between NMCP and sleep disturbance; those who were diagnosed with NMCP were more likely to develop subsequent sleep disturbance. Similarly, sleep disturbance was significantly associated with suicide death. Finally, a significant indirect effect of NMCP on suicide death, through sleep disturbance, and a nonsignificant direct effect of NMCP on suicide death provide support for a fully mediated model. Conclusions and Relevance: There is a need for clinicians to screen for both sleep disturbance and suicidal ideation in NMCP patients and for health systems to implement more widespread behavioral treatments that address comorbid sleep problems and NMCP. [ABSTRACT FROM AUTHOR]

Objective: Youth depression can be prevented, yet few programs are offered. Decision makers lack cost information. This study evaluated the cost-effectiveness of a cognitive-behavioral prevention program (CBP) versus usual care.Methods: A cost-effectiveness analysis was conducted with data from a randomized controlled trial of 316 youths, ages 13-17, randomly assigned to CBP or usual care. Youths were at risk of depression because of a prior depressive disorder or subthreshold depressive symptoms, or both, and had parents with a prior or current depressive disorder. Outcomes included depression-free days (DFDs), quality-adjusted life years (QALYs), and costs.Results: Nine months after baseline assessment, youths in CBP experienced 12 more DFDs (p=.020) and .018 more QALYs (p=.007), compared with youths in usual care, with an incremental cost-effectiveness ratio (ICER) of $24,558 per QALY. For youths whose parents were not depressed at baseline, CBP youths had 26 more DFDs (p=.001), compared with those in usual care (ICER=$10,498 per QALY). At 33 months postbaseline, youths in CBP had 40 more DFDs (p=.05) (ICER=$12,787 per QALY). At 33 months, CBP youths whose parents were not depressed at baseline had 91 more DFDs (p=.001) (ICER=$13,620 per QALY). For youths with a currently depressed parent at baseline, CBP was not significantly more effective than usual care at either 9 or 33 months, and costs were higher.Conclusions: CBP produced significantly better outcomes than usual care and was particularly cost-effective for youths whose parents were not depressed at baseline. Depression prevention programs could improve youths' health at a reasonable cost; services to treat depressed parents may also be warranted. [ABSTRACT FROM AUTHOR]

Objectives: The authors employ a Whole Systems framework to explore implementation of new guidelines for back and neck pain in Oregon's Medicaid system. Whole Systems research is useful for understanding the relationship between complementary and integrative health care (CIH) and conventional health care systems in real-world clinical and practice settings. Design: Preliminary results are from an observational study designed to evaluate state-wide implementation of CIH and other non-pharmacological treatments for neck and back pain among Oregon Medicaid patients. This natural experiment, even in early stages, provides insight into the challenges of integrating Whole Systems oriented therapies into Medicaid billing and treatment. Methods: Qualitative data are drawn from: (1) semi-structured interviews with representatives of each of the 16 coordinated care organizations (CCOs) responsible for administering the Oregon's Medicaid insurance through the Oregon Health Plan (OHP); and (2) open-ended survey responses from acupuncturists in all 16 CCO areas. Results: Implementation of the new policy guidelines poses logistical and epistemological challenges. Differences in worldview, inadequate reimbursement, and simple lack of awareness of CIH among medical providers are some of the factors that pose barriers to merging CIH therapies into conventional frameworks. Conclusions: In this article, we explore the potential for a Whole Systems perspective to better explain the complexity of integrating CIH and other non-pharmacological services into a state financed health care system. Oregon's expansion of services for back and neck pain presents an opportunity to explore challenges and successes in melding multiple approaches to health and pain management into a managed system such as the OHP. [ABSTRACT FROM AUTHOR]

Chronic pain is widely prevalent among Veterans and can have serious negative consequences for functional status and quality of life among other domains. The Veterans Health Administration (VHA) convened a state-of-the-art (SOTA) conference to develop research priorities for advancing the science and clinical practice of non-pharmacological management of chronic musculoskeletal pain. In this perspective article, we present the methods and consensus recommendations for research priorities emanating from the SOTA. In the months leading up to the SOTA, a core group of researchers defined four areas of focus: psychological/behavioral therapies; exercise/movement therapies; manual therapies; and models for delivering multi-modal pain care and divided into workgroups. Each workgroup, in their respective areas of focus, identified seminal studies capturing the state of the evidence. Herein, we present consensus recommendations ranging from efficacy to effectiveness to implementation/dissemination research depending on the state of the evidence as assessed by participants, including commentary on common elements across workgroups and future areas of innovation in study design, measurement, and outcome ascertainment. [ABSTRACT FROM AUTHOR]

The article recommends ways of protecting the security of health care system data used in embedded research from potential harm that may be caused by data sharing. Topics discussed include the ways in which health facilities or health care systems may be harmed by careless data sharing practices, the potential structures for data sharing in embedded research and the questions that should be asked before deciding on what technical and governance model will be used for data sharing.

Background: The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped.Methods: To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design.Results: In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs.Conclusion: A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity. [ABSTRACT FROM AUTHOR]

Background: Supporting day-to-day self-care activities has emerged as a best practice when caring for patients with chronic pain, yet providing this support may introduce challenges for both patients and primary care physicians. It is essential to develop tools that help patients identify the issues and outcomes that are most important to them and to communicate this information to primary care physicians at the point of care. Objective: We describe our process to engage patients, primary care physicians, and other stakeholders in the context of a pilot randomized controlled trial of a patient-centered assessment process implemented in an everyday practice setting. We identify lessons on how to engage stakeholders and improve patient-centered care for those with chronic conditions within the primary care setting. Methods: A qualitative analysis of project minutes, interviews, and focus groups was conducted to evaluate stakeholder experiences. Stakeholders included patients, caregivers, clinicians, medical office support staff, health plan administrators, an information technology consultant, and a patient advocate. Results: Our stakeholders included many patients with no prior experience with research. This approach enriched the applicability of feedback but necessitated extra time for stakeholder training and meeting preparation. Types of stakeholders varied over the course of the project, and more involvement of medical assistants and Information Technology staff was required than originally anticipated. Conclusion: Meaningful engagement of patient and physician stakeholders must be solicited in a well-coordinated manner with broad health care system supports in place to ensure full execution of patient-centered processes. [ABSTRACT FROM AUTHOR]

Introduction: Self-reporting by patients though the use of electronic patient-reported outcome (PRO) measures has been shown to use increase patient satisfaction with care, and improve patient-provider communication, symptom management, and health quality. Additionally, PROs are increasingly used in research to expand understanding regarding the relative risks, benefits, and burdens of interventions. While experience embedding patient-reported outcomes (PROs) into registries and clinical workflow is growing, there is little in the literature to guide those interested in incorporating PROs into routine clinical care and for use in research. Case Descriptions: The NIH Health Care Systems Research Collaboratory PRO Core interviewed investigators from seven programs to get their first-hand experiences on the incorporation of PROs for both care and research, and the investigators have contributed to this manuscript as authors. Findings: We use these case studies to present practical approaches to initiating and implementing PROS, including instrument selection, tips for integrating PRO collection systems into clinical workflow, considerations for user experience and data collection, and the methods to assess and monitor quality. Conclusion: Because the decision to initiate and implement PRO collection impacts many different stakeholders, the solution requires collaboration among the involved parties, careful planning, and integration into clinical workflow. [ABSTRACT FROM AUTHOR]

Background: Current literature describes the limits and pitfalls of using opioid pharmacotherapy for chronic pain and the importance of identifying alternatives. The objective of this study was to identify the practical issues patients and providers face when accessing alternatives to opioids, and how multiple parties view these issues. Methods: Qualitative data were gathered to evaluate the outcomes of acupuncture and chiropractic (A/C) services for chronic musculoskeletal pain (CMP) using structured interview guides among patients with CMP (n = 90) and primary care providers (PCPs) (n = 25) purposively sampled from a managed care health care system as well as from contracted community A/C providers (n = 14). Focus groups and interviews were conducted patients with CMP with varying histories of A/C use. Plan PCPs and contracted A/C providers took part in individual interviews. All participants were asked about their experiences managing chronic pain and experience with and/or attitudes about A/C treatment. Audio recordings were transcribed and thematically coded. A summarized version of the focus group/interview guides is included in the Additional file 1. Results: We identified four themes around opioid use: (1) attitudes toward use of opioids to manage chronic pain; (2) the limited alternative options for chronic pain management; (3) the potential of A/C care as a tool to help manage pain; and (4) the complex system around chronic pain management. Despite widespread dissatisfaction with opioid medications for pain management, many practical barriers challenged access to other options. Most of the participants’ perceived A/C care as helpful for short term pain relief. We identified that problems with timing, expectations, and plan coverage limited A/C care potential for pain relief treatment. Conclusions: These results suggest that education about realistic expectations for chronic pain management and therapy options, as well as making A/C care more easily accessible, might lead to more satisfaction for patients and providers, and provide important input to policy makers. [ABSTRACT FROM AUTHOR]

Primary care clinics are an ideal setting for early identification and possibly treatment of adolescent obesity. However, despite practice recommendations promoting preventive screening and monitoring of obesity, implementation has been modest. In this study, we interviewed providers to determine barriers to managing pediatric obesity, perceived skill in obesity interventions, and interest in additional training. The sensitivity of weight-related discussions and time were the 2 most significant barriers reported. We designed a brief training program, implemented it within a larger randomized controlled trial, and surveyed providers regarding its utility. The training was satisfactory to attendees and led to reported changes in practice patterns. Providers who received more complete training reported greater ease working with overweight teens and greater confidence that they could motivate teen patients to make healthy lifestyle changes compared with those who received less training. A fairly modest training intervention could improve patient care in the primary care setting. [ABSTRACT FROM AUTHOR]

Background Traditional recruitment methods for clinical trials, such as telephone, mail, and print media, are often inefficient, costly, and use large amounts of staff time and resources.Purpose This analysis was conducted to determine whether retention, demographics, and outcomes differed between enrolled participants who responded to recruitment outreach using an Internet-based information and registration system and enrollees whose first contact was with study staff via telephone.Methods We identified potentially eligible participants from Kaiser Permanente Northwest (KPNW) databases and mailed brochures inviting them to participate in the Life weight loss maintenance study. We also used employee newsletters, a member-directed website, and messages to employee email distribution lists to publicize the study. All outreach methods contained both a website address and a telephone number through which respondents could register for an information session. The website contained the same information as was provided by staff over the telephone.Results Out of 2122 potential participants who expressed interest in the study, 70% did so through the website. There was no difference in retention rates between enrollees who initiated contact through the website (WEB = 308) and enrollees who contacted the study by telephone (staff = 161). The WEB group was younger (p = 0.01), had higher income (p = 0.01) and education (p < 0.01) levels, and lower body mass index (BMI; p < 0.01). There was a trend toward greater weight loss in the WEB group (p = 0.06).Limitations We did not conduct a formal cost analysis of the two methods. Also, the population for this analysis was mostly Caucasian and middle income; thus, we cannot draw conclusions about the generalizability of our findings to more racially and economically diverse populations.Conclusion Enrolled participants who used a website to register for an initial study information session had similar study retention and outcome performance as enrollees who used a more traditional telephone method. For larger clinical trials, a website may help researchers more efficiently and cost-effectively achieve recruitment, eligibility, and randomization goals. More research is needed to determine whether similar recruitment and retention patterns are observed among racially and economically diverse populations when these and similar methods are compared. [ABSTRACT FROM PUBLISHER]

Objective: We sought to describe meal and snack frequencies of individuals with recurrent binge eating and examine the association between these eating patterns and clinical correlates. Method: Data from 106 women with a minimum diagnosis of recurrent binge eating were used. Meal and snack frequencies were correlated with measures of weight, eating disorder features, and depression. Participants who ate breakfast every day (n 5 25) were compared with those who did not (n 5 81) on the same measures. Results: Breakfast was the least, and dinner the most, commonly consumed meal. Evening snacking was the most common snacking occasion. Meal patterns were not significantly associated with clinical correlates; however, evening snacking was associated with binge eating. Discussion: Our findings largely replicated those reported in earlier research. More research is needed to determine the role of breakfast consumption in binge eating. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to replicate and extend results of a previous blended efficacy and effectiveness trial of a low-intensity, manual-based guided self-help form of cognitive-behavioral therapy (CBT-GSH) for the treatment of binge eating disorders in a large health maintenance organization (HMO) and to compare them with usual care.Methods: To extend previous findings, the investigators modified earlier recruitment and assessment approaches and conducted a randomized clinical trial to better reflect procedures that may be reasonably carried out in real-world practices. The intervention was delivered by master's-level interventionists to 160 female members of a health maintenance organization who met diagnostic criteria for recurrent binge eating. Data collected at baseline, immediately posttreatment, and at six- and 12-month follow-ups were used in intent-to-treat analyses.Results: At the 12-month follow-up, CBT-GSH resulted in greater remission from binge eating (35%, N=26) than usual care (14%, N=10) (number needed to treat=5). The CBT-GSH group also demonstrated greater improvements in dietary restraint (d=.71) and eating, shape, and weight concerns (d=1.10, 1.24, and .98, respectively) but not weight change.Conclusions: Replication of the pattern of previous findings suggests that CBT-GSH is a robust treatment for patients with recurrent binge eating. The magnitude of changes was significantly smaller than in the original study, however, suggesting that patients recruited and assessed with less intensive procedures may respond differently from their counterparts enrolled in trials requiring more comprehensive procedures. [ABSTRACT FROM AUTHOR]

The article discusses a study designed to extend the effectiveness of a guided self-help type of cognitive-behavioral therapy (CBT-GSH) for treatment of binge eating. Methods, results, and conclusions are reported, noting the perceived robustness of the system as demonstrated by the replication of previous findings.

Context: Adolescent offspring of depressed parents are at markedly increased risk of developing depressive disorders. Although some smaller targeted prevention trials have found that depression risk can be reduced, these results have yet to be replicated and extended to large-scale, at-risk populations in different settings.Objective: To determine the effects of a group cognitive behavioral (CB) prevention program compared with usual care in preventing the onset of depression.Design, Setting, and Participants: A multicenter randomized controlled trial conducted in 4 US cities in which 316 adolescent (aged 13-17 years) offspring of parents with current or prior depressive disorders were recruited from August 2003 through February 2006. Adolescents had a past history of depression, current elevated but subdiagnostic depressive symptoms, or both. Assessments were conducted at baseline, after the 8-week intervention, and after the 6-month continuation phase.Intervention: Adolescents were randomly assigned to the CB prevention program consisting of 8 weekly, 90-minute group sessions followed by 6 monthly continuation sessions or assigned to receive usual care alone.Main Outcome Measure: Rate and hazard ratio (HR) of a probable or definite depressive episode (ie, depressive symptom rating score of > or = 4) for at least 2 weeks as diagnosed by clinical interviewers.Results: Through the postcontinuation session follow-up, the rate and HR of incident depressive episodes were lower for those in the CB prevention program than for those in usual care (21.4% vs 32.7%; HR, 0.63; 95% confidence interval [CI], 0.40-0.98). Adolescents in the CB prevention program also showed significantly greater improvement in self-reported depressive symptoms than those in usual care (coefficient, -1.1; z = -2.2; P = .03). Current parental depression at baseline moderated intervention effects (HR, 5.98; 95% CI, 2.29-15.58; P = .001). Among adolescents whose parents were not depressed at baseline, the CB prevention program was more effective in preventing onset of depression than usual care (11.7% vs 40.5%; HR, 0.24; 95% CI, 0.11-0.50), whereas for adolescents with a currently depressed parent, the CB prevention program was not more effective than usual care in preventing incident depression (31.2% vs 24.3%; HR, 1.43; 95% CI, 0.76-2.67).Conclusion: The CB prevention program had a significant prevention effect through the 9-month follow-up period based on both clinical diagnoses and self-reported depressive symptoms, but this effect was not evident for adolescents with a currently depressed parent.Trial Registration: clinicaltrials.gov Identifier: NCT00073671. [ABSTRACT FROM AUTHOR]

The article presents a study on the effects of a cognitive behavioral (CB) prevention program in the prevention of depression onset in adolescents at high risk for depression. The participants were randomly assigned to either a CB prevention program or traditional care. The recruited adolescents had symptoms of depression that were not diagnostic, a history of depression, or both. A baseline assessment was taken, then a reassessment occurred after eight weeks and six months for a total follow-up period of nine months. The study concluded that for adolescents who did not have a parent who was depressed, the CB prevention program was significantly effective.

This article describes website use and behavioral outcomes in a multi-component lifestyle intervention promoting healthy diet and exercise. Methods A 2-year randomized clinical trial to improve bone density in 228 adolescent girls, the intervention included a website designed to enhance intervention adherence, retention of participants, and behavioral,outcomes. Measures included diet and exercise recalls, surveys, and web-usage data. Results Website use was associated with increases in calcium intake (β = 69.72, p = .01, ES = 0.15) and high-impact activity (β = 10.93, p = .04, ES = .13). Use of web pages related to behavioral feedback and communications was not significantly associated with behavioral outcomes. The most visited website pages had content related to incentive points, caption contests, and fun facts. Conclusions Web elements of a multi-component intervention may promote retention and engagement in target behaviors. Such websites may be most acceptable to adolescent participants if they blend fun and behavioral elements, rather than exclusively focusing on behavioral changes. [ABSTRACT FROM AUTHOR]

Objective: The authors sought to identify predictors of self-harm adverse events in treatment-resistant, depressed adolescents during the first 12 weeks of treatment. Method: Depressed adolescents (N=334) who had not responded to a previous trial with an SSRI antidepressant were randomized to a switch, to either another SSRI or venlafaxine, with or without cognitive behavior therapy. Self-harm events, i.e., suicidal and non-suicidal self-injury adverse events were assessed by spontaneous report for the first 181 participants, and by systematic weekly assessment for the last 153 participants. Results: Higher rates of suicidal (20.8% vs. 8.8%) and nonsuicidalself-injury (17.6% vs. 2.2%), but not serious adverse events (8.4% vs. 7.3%) were detected with systematic monitoring. Median time to a suicidal event was 3 weeks, predicted by high baseline suicidal ideation, family conflict, and drug and alcohol use. Median time to nonsuicidal self-injury was 2 weeks, predicted by previous history of nonsuicidal self-injury. While there were no main effects of treatment, venlafaxine treatment was associated with a higher rate of self-harm adverse events in those with higher suicidal ideation. Adjunctive use of benz diazepines, while in a small number of participants (N=10) was associated with higher rate of both suicidal and nonsuicidal self-injury adverse events. Conclusions: Since predictors of suicidal adverse events also predict poor response to treatment, and many of these events occurred early in treatment, improving the speed of response to depression, by targeting of family conflict, suicidal ideation, and drug use may help to reduce their incidence. The relationship of yenlafaxine and of benzodiazepines to selfharm events requires further study and clinical caution. [ABSTRACT FROM AUTHOR]

This study examined healthcare services used by children with attention-deficit/hyperactivity disorder (ADHD), with and without psychiatric comorbidities. The study was conducted in a large health maintenance organization in the Pacific Northwest on all continuously enrolled children aged 5 to 12 from January 1997 through July 1998. The study measured all outpatient medical care, specialty mental health care services, and prescription drug dispensings from computer records. Children with ADHD, with and without other psychiatric comorbidities, use more general medical services than do other groups of children, including outpatient visits, acute care (emergency room [ER] urgent care) visits. ADHD and other psychiatric comorbidities lead to higher use of specialty mental health services and greater use of psychotropic medications. [ABSTRACT FROM AUTHOR]

Background: Recent pharmacoepidemiological reports have contributed to concerns about frequent and perhaps indiscriminate psychopharmacotherapy for very young children. Objective: To examine the diagnoses, symptoms, and health care services associated with preschool children receiving psychotropic medication. Design: Population-based pharmacoepidemiological analysis of electronic medical records, paper medical and mental health charts, and pharmacy records from 1997 and 1998. Setting: A large Pacific Northwest health maintenance organization. Participants: Preschool children receiving psychotropic medication (psychostimulants, antidepressants, neuroleptics, or α[sub 2]-adrenergic agonists). Measures: Physician-reported mental health diagnoses and related symptoms, functional impairment, family and participant characteristics, and the types and level of associated medical and mental health services. Results: Of 743 preschool children who clinicians identified as having behavioral or emotional problems, 120 (16%) received psychotropic medication; 57 children (48%) were prescribed a stimulant medication only, and 60 (50%) received a diagnosis of attention-deficit/hyperactivity disorder. Most children had substantial psychosocial risk factors, including parents with psychiatric or substance abuse problems (71%; n = 85), documented histories of abuse (29%; n = 35), and out-of-home placement (31%; n = 37). Four of 5 children or families (83%; n = 99) received psychosocial services in addition to pharmacotherapy. On average, children received psychotropic medication at least 6 months after initial identification of a behavioral or mental health problem. Conclusions: Despite commentary by the popular media about widespread psychopharmacotherapy for very young children, such treatment was only infrequently received in this health plan. Most children receiving psychopharmacotherapy had substantial additional risk factors and were receiving psychosocial services for... [ABSTRACT FROM AUTHOR]

This study examined the “treated” prevalence, incidence, and pharmacotherapy of child and adolescent mood disorders in a managed care setting. General prevalence patterns across age and sex were similar to those reported in community epidemiology studies, although, not unexpectedly, the overall rates were somewhat lower. Primary care providers identified a substantial proportion of the youth with a mood disorder. Antidepressant medication was used more often by youth identified with a mood disorder in medical care settings than by those youth identified in specialty mental health care settings. These results are valuable in determining if youth with mood disorders receiving medication prescriptions across settings are treated according to current best practice guidelines (such as the adult depression guidelines [U.S. Department of Health and Human Services, 1993]), that is, primarily with SSRI medications. [ABSTRACT FROM AUTHOR]