Charles Elder

Impact of sleep, screen time, depression and stress on weight change in the intensive weight loss phase of the LIFE study.

Background:The LIFE study is a two-phase randomized clinical trial comparing two approaches to maintaining weight loss following guided weight loss. Phase I provided a nonrandomized intensive 6-month behavioral weight loss intervention to 472 obese (body mass index 30–50) adult participants. Phase II is the randomized weight loss maintenance portion of the study. This paper focuses on Phase I measures of sleep, screen time, depression and stress.Methods:The Phase I intervention consisted of 22 group sessions led over 26 weeks by behavioral counselors. Recommendations included reducing dietary intake by 500 calories per day, adopting the Dietary Approaches to Stop Hypertension (DASH) dietary pattern and increasing physical exercise to at least 180 min per week. Measures reported here are sleep time, insomnia, screen time, depression and stress at entry and post-weight loss intervention follow-up.Results:The mean weight loss for all participants over the intensive Phase I weight loss intervention was 6.3 kg (s.d. 7.1). Sixty percent (N=285) of participants lost at least 4.5 kg (10 lbs) and were randomized into Phase II. Participants (N=472) attended a mean of 73.1% (s.d. 26.7) of sessions, completed 5.1 (s.d. 1.9) daily food records/week, and reported 195.1 min (s.d. 123.1) of exercise per week. Using logistic regression, sleep time (quadratic trend, P=0.030) and lower stress (P=0.024) at entry predicted success in the weight loss program, and lower stress predicted greater weight loss during Phase I (P=0.021). In addition, weight loss was significantly correlated with declines in stress (P=0.048) and depression (P=0.035).Conclusion:Results suggest that clinicians and investigators might consider targeting sleep, depression and stress as part of a behavioral weight loss intervention.

A Pilot Whole Systems Clinical Trial of Traditional Chinese Medicine and Naturopathic Medicine for the Treatment of Temporomandibular Disorders

OBJECTIVES To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research. DESIGN A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC). SETTING/LOCATION Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon. SUBJECTS One hundred and sixty (160) women 25-55 years of age attending a KPNW TMD specialty clinic. INTERVENTIONS Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided. OUTCOME MEASURES TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0-10 where 10 is worst). RESULTS Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = -1.11 +/- 0.43, p = 0.010 and -1.02 +/- 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (-1.07 +/- 0.51, p = 0.037 and -1.27 +/- 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference. CONCLUSIONS These alternative medicine approaches each resulted in significantly greater reduction of pain and psychosocial interference than SC. Further research on the potential benefits of traditional whole systems of medicine for TMD appears warranted.

Effect of Transcendental Meditation on Employee Stress, Depression, and Burnout: A Randomized Controlled Study

CONTEXT Workplace stress and burnout are pervasive problems, affecting employee performance and personal health. OBJECTIVE To evaluate the effects of the Transcendental Meditation program on psychological distress and burnout among staff at a residential therapeutic school for students with severe behavioral problems. DESIGN A total of 40 secondary schoolteachers and support staff at the Bennington School in Vermont, a therapeutic school for children with behavioral problems, were randomly assigned to either practice of the Transcendental Meditation program or a wait-list control group. The Transcendental Meditation course was provided by certified instructors. MAIN OUTCOME MEASURES Outcome measures were assessed at baseline and four months, and included perceived stress, depression, and burnout. A multivariate analysis of covariance was used to determine overall effects. RESULTS Analysis of the 4-month intervention data indicated a significant improvement in the main outcomes of the study resulting from practice of the Transcendental Meditation program compared with controls (Wilks Λ [3,28] = 0.695; p = 0.019). Results of univariate F tests indicated a significant reduction of all main outcome measures: perceived stress (F[1,32] = 13.42; p = < 0.001); depression (F[1,32] = 6.92; p = 0.013); and overall teacher burnout (F[1,32] = 6.18; p = 0.018). Effect sizes ranged from 0.40 to 0.94. CONCLUSIONS The Transcendental Meditation program was effective in reducing psychological distress in teachers and support staff working in a therapeutic school for students with behavioral problems. These findings have important implications for employees’ job performance as well as their mental and physical health.

Comparative effectiveness of traditional Chinese medicine and psychosocial care in the treatment of temporomandibular disorders-associated chronic facial pain.

UNLABELLED This dual-site study sought to identify the appropriate role for traditional Chinese medicine (TCM; acupuncture and herbs) in conjunction with a validated psychosocial self-care (SC) intervention for treating chronic temporomandibular disorders (TMD)-associated pain. Participants with Research Diagnostic Criteria for Temporomandibular Disorders-confirmed TMD (n = 168) entered a stepped-care protocol that began with a basic TMD class. At weeks 2 and 10, patients receiving SC whose worst facial pain was above predetermined levels were reallocated by minimization to SC or TCM with experienced practitioners. Characteristic facial pain (CFP: mean of worst pain, average pain when having pain, and current pain; each visual analog scale [VAS] 0-10) was the primary outcome. Social activity interference (VAS 0-10) was a secondary outcome. Patients were monitored for safety. TCM provided significantly greater short-term (8-week) relief than SC (CFP reduction difference, -.60 [standard deviation of the estimate .26], P = .020) and greater reduction in interference with social activities (-.81 [standard deviation of the estimate .33], P = .016). In 2 of 5 treatment trajectory groups, more than two thirds of participants demonstrated clinically meaningful responses (≥30% improvement) in pain interference over 16 weeks. This study provides evidence that TMD patients referred for TCM in a community-based model will receive safe treatment that is likely to provide some short-term pain relief and improved quality of life. Similar designs may also apply to evaluations of other kinds of chronic pain. (ClinicalTrials.gov number NCT00856167). PERSPECTIVE This short-term comparative effectiveness study of chronic facial pain suggests that TCM is safe and frequently efficacious alone or subsequent to standard psychosocial interventions. TCM is widely available throughout North America and may provide clinicians and patients with a reasonable addition or alternative to other forms of therapy.

Primary care physicians, acupuncture and chiropractic clinicians, and chronic pain patients: a qualitative analysis of communication and care coordination patterns

BackgroundA variety of people, with multiple perspectives, make up the system comprising chronic musculoskeletal pain (CMP) treatment. While there are frequently problems in communication and coordination of care within conventional health systems, more opportunities for communicative disruptions seem possible when providers use different explanatory models and are not within the same health management system. We sought to describe the communication system surrounding the management of chronic pain from the perspectives of allopathic providers, acupuncture and chiropractor (A/C) providers, and CMP patients.MethodsWe collected qualitative data from CMP patients (n = 90) and primary care physicians (PCPs) (n = 25) in a managed care system, and community acupuncture and chiropractic care providers (n = 14) who received high levels of referrals from the system, in the context of a longitudinal study of CMP patients’ experience.ResultsMultiple points of divergence and communicative barriers were identified among the main stakeholders in the system. Those that were most frequently mentioned included issues surrounding the referral process (requesting, approving) and lack of consistent information flow back to providers that impairs overall management of patient care. We found that because of these problems, CMP patients were frequently tasked and sometimes overwhelmed with integrating and coordinating their own care, with little help from the system.ConclusionsPatients, PCPs, and A/C providers desire more communication; thus systems need to be created to facilitate more open communication which could positively benefit patient outcomes.

An HMO-based prospective pilot study of energy medicine for chronic headaches: whole-person outcomes point to the need for new instrumentation.

OBJECTIVES The purpose of this study was to evaluate an energy healing treatment for possible inclusion as a Kaiser Permanente Northwest (KPNW) Pain Clinic provided therapy, and to identify the appropriate number of treatment sessions for a Pain Clinic protocol, should the intervention prove successful. In addition, our intent was to document the full range of outcomes experienced by patients undergoing energy healing, including whole-person and transformative outcomes should they occur. SETTING The setting for this study was Kaiser Permanente Northwest Pain Clinic. PARTICIPANTS Thirteen (13) patients with chronic headache who were members of the KPNW Health Plan were recruited through flyers or mailings. METHODS Thirteen (13) participants received at least three energy healing sessions at approximately weekly intervals. Assessments were based on pre- and post-treatment qualitative interviews. INTERVENTION The treatment consisted of three Healing Touch sessions provided by a Certified Healing Touch Practitioner. Treatments contained elements common to all sessions, and elements that were tailored to the individual subject. RESULTS Twelve (12) of 13 participants experienced improvement in frequency, intensity, or duration of pain after three treatments. In addition, 11 of 13 participants experienced profound shifts in their view of themselves, their lives, and their potential for healing and transformation. These changes lasted from 24 hours to more than 6 months at follow-up. CONCLUSIONS Energy healing can be an important addition to pain management services. More in-depth qualitative research is needed to explore the diversity of outcomes facilitated by energy healing treatments. Furthermore, the development of new instrumentation is warranted to capture outcomes that reflect transformative change and changes at the level of the whole person.

Effectiveness guidance document (EGD) for Chinese medicine trials: A consensus document

BackgroundThere is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making.MethodsThe Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document.ResultsRecommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.ConclusionThe present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design.

Randomized trial of Tapas Acupressure Technique for weight loss maintenance: rationale and study design.

OBJECTIVES The aim of this article is to present the rationale, study design, and methods of an ongoing randomized controlled trial assessing the efficacy of an energy psychology intervention, Tapas Acupressure Technique (TAT), to prevent weight regain following successful weight loss. DESIGN This is a randomized controlled trial. SETTINGS/LOCATION The study is being conducted at a large group-model health maintenance organization (HMO). SUBJECTS The study subjects are adult members of an HMO. INTERVENTIONS TAT is being compared to a self-directed social support comparison intervention. OUTCOME MEASURES The primary outcome measure is weight-loss maintenance at 6 and 12 months post-randomization. CONCLUSIONS This randomized controlled trial will test the efficacy of an energy psychology intervention, TAT, by comparing it with a self-directed social support group intervention. This is, to our knowledge, the largest randomized controlled study to date of an energy psychology intervention. Positive findings would support the use of TAT as a tool to prevent weight regain following successful weight loss.

Randomized trial of tapas acupressure technique for weight loss maintenance

BackgroundObesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance.MethodsParticipants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®), or a control intervention comprised of social-support group meetings (SS) led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation.ResultsAmong 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd) = 11), mean BMI at randomization was 34 (sd = 5), and mean initial weight loss was 9.8 kg (sd = 5). In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85) weight regain for TAT and 2.96 kg (se 0.96) weight regain for SS, p < 0.097) Tests of between- arm differences for secondary outcomes were also not significant. A secondary analysis showed a significant interaction between treatment and initial weight loss (p < .036), with exploratory post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT.ConclusionsThe primary analysis showed no significant difference in weight regain between TAT and SS, while secondary and post hoc analyses indicate direction for future research.Trial RegistrationClinicalTrials.gov: NCT00526565

Provider and patient perspectives on opioids and alternative treatments for managing chronic pain: a qualitative study

BackgroundCurrent 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.MethodsQualitative 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.ResultsWe 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.ConclusionsThese 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.Trial registrationClinicalTrials.gov NCT01345409, date of registration 28/4/2011