The Psychological Functioning in the COVID-19 Pandemic and Its Association With Psychological Flexibility and Broader Functioning in People With Chronic Pain

Aims: People with chronic pain may be particularly vulnerable to the impact of the pandemic COVID-19, and psychological flexibility may protect them. This study investigates psychological functioning in the context of COVID-19, including fear and avoidance in the context of COVID-19, specifically its association with daily functioning, and the role of psychological flexibility, among people with chronic pain. Methods: Responses from 555 adults with chronic pain were collected through a cross-sectional online survey and analyzed. Results: Eight out of 10 participants reported significant depression and nearly 9 out of 10 reported significant functional impairment. COVID-19-related fear and avoidance significantly correlated with pain, pain-related disability, depression, and work and social adjustment (r = 18–.32), as well as psychological flexibility processes, including pain acceptance, self-as-context, and committed action, |r|=.13–.30. COVID-19-related fear and avoidance and COVID-19-related interference were significant predictors of some measures of daily functioning beyond demographics and pain, β = .09–.14. However, these associations weakened when psychological flexibility processes were factored into the models, with fear of COVID-19 no longer being a significant predictor of pain-related disability or depression, and COVID-19 avoidance no longer a significant predictor of depression. Conclusions: The psychological functioning in the context of COVID-19 appears to be negatively associated with daily functioning in people with chronic pain, and is statistically significant in this regard. Psychological flexibility may have a role in these associations for people with chronic pain in the pandemic.PerspectiveThis article demonstrates the psychological implication of COVID-19 and its association with broader emotional and daily functioning in people with chronic pain. It also demonstrates that Psychological flexibility may have a role in these associations for people with chronic pain in the pandemic.     

Committed Action: An Application of the Psychological Flexibility Model to Activity Patterns in Chronic Pain

Whether a person with chronic pain avoids activity, persists with activity, or overexerts himself or herself is considered important to the quality of his or her daily functioning. However, results from studies of these activity patterns have not always yielded clear and consistent findings. It is suggested that applying the psychological flexibility model to activity patterns may clarify and integrate research in this area. Psychological flexibility is defined as the ability to persist or to change behavior in a setting of competing psychological influences, guided by goals and dependent on what the situation at hand affords. One aspect of psychological flexibility that appears pertinent to chronic pain is called committed action. Committed action is essentially goal-directed, flexible persistence. The purpose of the current study was to develop a measure of committed action, the committed action questionnaire (CAQ), in people seeking treatment for chronic pain (N = 216), to examine preliminary reliability and validity, and to test how well a summary score from the measure is able to predict patient health and functioning. Results generally support the internal consistency of the CAQ and show that it is correlated with another established component of psychological flexibility. In regression analyses the CAQ was able to account for significant variance in depression, social functioning, mental health, vitality, and general health, beyond the contributions of pain and acceptance of pain.PerspectiveThe psychological flexibility model may be useful for understanding patterns of behavior in relation to chronic pain. It appears possible to assess a process in this model called committed action, and this process appears related to important aspects of functioning.     

Telephone interventions for co-morbid insomnia and osteoarthritis pain: The OsteoArthritis and Therapy for Sleep (OATS) randomized trial design

The OsteoArthritis and Therapy for Sleep (OATS) study is a population-based randomized controlled trial of cognitive behavioral therapy for insomnia (CBTI) with four innovative methodological aims. These are to: (1) Enroll representative participants across Washington state, including those from medically underserved communities; (2) Enroll persons with persistent insomnia and chronic osteoarthritis (OA) pain; (3) Test a scalable CBT-I intervention; and (4) Evaluate patient-reported outcomes (insomnia, pain severity, fatigue, depression) and cost-effectiveness over one year. This paper describes progress towards achieving these aims. The target population was persons age 60+ who had received OA care within the Kaiser Permanente Washington (KPW) health care system. We employed a two-phase screening via mail survey and telephone follow-up, with a 3-week interval between screens to exclude persons with spontaneous improvement in sleep or pain symptoms. Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC). Blinded outcome assessments (completed online or on mailed paper forms) included primary and secondary sleep and pain outcome measures and quality of life measures. We obtained healthcare utilization from administrative claims data. Intent to treat analyses, including all participants randomized when they scheduled the first telephone session, will be conducted to compare CBT-I and EOC outcomes. The trial will be the largest experimental evaluation of telephone CBT-I to date, and the first to evaluate its cost-effectiveness.Trial registration: ClinicalTrials.gov identifier: NCT02946957.     

Telephone-delivered cognitive behavioral therapy for veterans with chronic pain following traumatic brain injury: Rationale and study protocol for a randomized controlled trial study

Background and objectivesChronic pain is a highly prevalent and potentially disabling condition in Veterans who have had a traumatic brain injury (TBI) and access to non-pharmacological pain treatments such as cognitive behavioral therapy is limited and variable. The purpose of this randomized controlled trial (RCT) is to evaluate the efficacy of a telephone-delivered cognitive behavioral therapy (T-CBT) for pain in Veterans with a history of TBI.MethodsVeterans with a history of TBI and chronic pain of at least six months duration (N = 160) will be randomized to either T-CBT or a telephone-delivered pain psychoeducational active control condition (T-Ed). The eight-week T-CBT intervention builds on other efficacious CBT interventions for chronic pain in the general population but is novel in that it is conducted via telephone and adapted for Veterans with a history of TBI. Outcome variables will be collected pre, mid-, and post-treatment, and 6 months following randomization (follow-up).Projected outcomesIn addition to evaluating the effects of the interventions on pain intensity (primary outcome), this study will determine their effects on pain interference, sleep, depression, and life satisfaction. We will also examine potential moderators of treatment outcomes such as cognition, PTSD, and alcohol and drug use. This non-pharmacologic one-on-one therapeutic intervention has the potential to reduce pain and pain-related dysfunction, improve access to care, and reduce barriers associated with geography, finances, and stigma, without the negative effects on physical and cognitive performance and potential for addiction as seen with some pharmacologic treatments for pain.This trial is registered at ClinicalTrials.gov, protocol NCT01768650     

A randomized trial to examine the mechanisms of cognitive,behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol

This randomized trial will evaluate the mechanisms of three chronic pain treatments: cognitive therapy (CT), mindfulness meditation (MM), and activation skills (AS). We will determine the extent to which late-treatment improvement in primary outcome (pain interference) is predicted by early-treatment changes in cognitive content, cognitive process, and/or activity level. The shared versus specific role of these mechanisms across the three treatments will be evaluated during treatment (Primary Aim), and immediately post-treatment to examine relapse mechanisms (Secondary Aim).We will enroll 300 individuals with chronic pain (with low back pain as a primary or secondary condition), with 240 projected to complete the study. Participants will be randomly assigned to eight, 1.5 h telehealth group sessions of CT, MM, or AS. Mechanisms and outcomes will be assessed twice daily during 2-week baseline, 4-week treatment period, and 4-week post-treatment epoch via random cue-elicited ecological momentary assessment (EMA); activity level will be monitored during these time epochs via daily monitoring with ActiGraph technology. The primary outcome will be measured by the PROMIS 5-item Pain Interference scale. Structural equation modeling (SEM) will be used to test the primary aims. This study is pre-registered on clinicaltrials.gov (Identifier: NCT03687762).This study will determine the temporal sequence of lagged mediation effects to evaluate rates of change in outcome as a function of change in mediators. The findings will provide an empirical basis for enhancing and streamlining psychosocial chronic pain interventions. Further, results will guide future efforts towards optimizing maintenance of gains to effectively reduce relapse risk.     

Athletes for life: Rationale and methodology of a community- and family-based randomized controlled trial to promote cardiovascular fitness among primarily Latino families

BackgroundCommunity-based programs have had modest success in combating obesity in Latino populations. Latino families' norms and beliefs about weight often hold larger body sizes to be normal, leading to lower engagement in weight-focused programs. Because improvements in cardiorespiratory fitness confer health benefits, regardless of weight, they offer an alternative to obesity-focused approaches. We describe the rationale and design of Athletes for Life (AFL), a community- and family-based intervention for Latino families.Methods/DesignThis two-group randomized controlled trial will test the efficacy of AFL for improving cardiorespiratory fitness and diet in 6- to 11-year-old children (N = 160) and their parents, relative to a wait-list control group. Children will participate in 12 weeks of semiweekly sports skill programing and nutrition sessions. Concurrently, parents will participate in sports-focused activity and behavior change sessions that focus on nutrition, chronic disease prevention, and healthy eating. Cardiovascular fitness will be measured by the 1-mile run and 3-min step-test for both parents and children. Secondary outcomes include changes in objectively measured physical activity, dietary measures, body composition, and cardiometabolic risk (waist circumference, blood pressure, blood lipids, glucose, insulin, and C-reactive protein).DiscussionAFL, implemented with a strong community partnership, will provide a test of the efficacy of culturally tailored intervention programming to promote positive health behaviors and improve health outcomes in Latino families. Intervention content, structure, and messaging will provide guidance for future methods to engage Latino families in health promotion programs that highlight their cultural norms, and beliefs.Trial registrationClinicaltrials.gov Identifier NCT03761589 (12/3/2018).     

Testing the effectiveness of physical activity advice delivered via text messaging vs. human phone advisors in a Latino population: The On The Move randomized controlled trial design and methods

Physical inactivity is a key risk factor for a range of chronic diseases and conditions, yet, approximately 50% of U.S. adults fall below recommended levels of regular aerobic physical activity (PA). This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. Text messaging (SMS) represents a convenient and accessible communication channel for delivering targeted PA information and support, but has not been rigorously evaluated against standard telehealth advising programs. The objective of the On The Move randomized controlled trial is to test the effectiveness of a linguistically and culturally targeted SMS PA intervention (SMS PA Advisor) versus two comparison conditions: a) a standard, staff-delivered phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention to promote a healthy diet (SMS Nutrition Advisor). The study sample (N = 350) consists of generally healthy, insufficiently active Latino adults ages 35 years and older living in five northern California counties. Study assessments occur at baseline, 6, and 12 months, with a subset of participants completing 18-month assessments. The primary outcome is 12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables. Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yields.Trial Registration: clinicaltrial.gov Identifier = NCT02385591     

Interim monitoring in a treatment strategy trial with a composite primary endpoint

When a clinical trial has a composite endpoint and a comparison of treatment strategies with multiple intervention components, interim data reviews by a data safety and monitoring board (DSMB) can be challenging as the data evolve on multiple fronts. We illustrate with a study in the treatment of Kaposi sarcoma (KS), an HIV-associated cancer with a multi-faceted disease presentation. The study, ACTG-A5264/AMC-067, was a 1:1 randomized trial to compare two strategies: immediate initiation of etoposide with antiretroviral therapy (ART), or ART with delayed etoposide upon disease progression. The outcome was a composite endpoint that included the following events, ordered from worst to best in the following three categories: (1) KS progression at 48 weeks, death, initiation of alternate KS treatment, loss to study follow-up; (2) stable KS; and (3) partial or complete KS response at 48 weeks. We present the interim results on the composite endpoint and the individual components, where components favored different study arms at an interim review. To facilitate interim data monitoring for complex trials, we recommend clear communications between the study team and the DSMB prior to the initiation of the trial on the need for a composite endpoint, the intentions behind the defined strategies, and relative importance of individual components of the composite endpoint. We also recommend flexibility in the timing of data reviews by the DSMB to interpret emerging data in multiple dimensions.Clinicaltrials.gov NCT01352117     

Long-term outcome of perioperative low cardiac output syndrome in cardiac surgery: 1-year results of a multicenter randomized trial

PurposePerioperative myocardial dysfunction occurs frequently in cardiac surgery, and is a risk factor for morbidity and mortality. Levosimendan has been suggested to reduce mortality of patients with perioperative myocardial dysfunction. However, long-term outcome data on its efficacy in cardiac surgery are lacking.Materials and methodsCardiac surgery patients with perioperative myocardial dysfunction were randomized to levosimendan or placebo, in addition to standard inotropic care. One-year mortality data were collected.ResultsWe randomized 506 patients (248 to levosimendan 258 to placebo). At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference −1.8; 95% CI −8.4 to 4.9; P = .60). Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass were independently associated with 1-year mortality.ConclusionsLevosimendan administration does not improve 1-year survival in cardiac surgery patients with perioperative myocardial dysfunction. One-year mortality in these patients is 17%. Six predictive factors for long-term mortality were identified.Study registration numberNCT00994825 (ClinicalTrials.gov).     

Study protocol for targeted interventions to prevent chronic low back pain in high-risk patients: A multi-site pragmatic cluster randomized controlled trial (TARGET Trial)

BackgroundLow back pain (LBP) is one of the most prevalent and potentially disabling conditions for which people seek health care. Patients, providers, and payers agree that greater effort is needed to prevent acute LBP from transitioning to chronic LBP.Methods and study designThe TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial is a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute LBP and identified as high risk for persistent disabling symptoms. Study sites include primary care clinics within each of five geographical regions in the United States, with clinics randomized to either GBC or GBC + PIPT. Acute LBP patients at all clinics are risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes are the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes are LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records. Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1860 high-risk patients in the randomized controlled trial cohort. A prospective observational cohort of approximately 6900 low and medium-risk acute LBP patients was enrolled concurrently.DiscussionThe TARGET pragmatic trial aims to establish the effectiveness of the stratified approach to acute LBP intervention targeting high-risk patients with GBC and PIPT.Trial Registration: ClinicalTrials.gov NCT02647658 Registered Jan. 6, 2016.     

Comparative effectiveness of proprioceptive neuromuscular facilitation and passive vertebral mobilization for neck disability in patients with mechanical neck pain: A randomized controlled trial

ObjectiveTo compare the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF) and Passive Vertebral Mobilization (PVM), both when given in adjunct to routine physical therapy (RPT), on neck disability in patients with mechanical neck pain (MNP).MethodsA single-blinded randomized controlled trial was conducted on 90 patients with MNP at the National Institute of Rehabilitation Medicine, Islamabad, Pakistan, from September 2015 to March 2018. The participants aged between 18 and 65 years were recruited through a simple random sampling technique and randomly divided into three groups i.e. PNF + RPT, PVM + RPT, and RPT. Each participant was evaluated pre and post-intervention (after four weeks) through neck disability index (NDI). The data were analyzed by using SPSS version 21.ResultsThe MANOVA was run on the pre-post mean differences of the variables to determine the changes within the groups which showed that the participants improved significantly in all the groups in terms of the NDI components and overall NDI score (p < 0.05). Univariate analysis with the post-hoc comparison and Tuckey HSD correction was used to determine the differences between the groups which showed that there was a significant difference between the interventional groups in the overall pain intensity, as well as pain experienced while performing personal care activities, reading, doing work, driving, sleeping, recreation and in the total NDI score (p < 0.05).ConclusionPVM (in adjunct to RPT) was more effective than PNF (in adjunct to RPT) for the patients with MNP to manage themselves in daily activities.Clinical trial registrationNCT03813680 (at clinicaltrials.gov) (https://clinicaltrials.gov/ct2/show/NCT03813680)     

The Psychological Inflexibility in Pain Scale (PIPS) – Statistical properties and model fit of an instrument to assess change processes in pain related disability

Recent developments within CBT have emphasized acceptance rather than control of pain and distress in treatments aimed at improving functioning and life quality, but there is still a lack of reliable and valid instruments to assess relevant processes in such interventions. The Psychological Inflexibility in Pain Scale (PIPS) was developed to assess target variables in exposure and acceptance oriented treatments. A preliminary validation study resulted in a two‐factor solution with subscales for avoidance and cognitive fusion related to pain, showing satisfactory psychometric properties. This study sought to evaluate the instrument with 611 participants with whiplash associated disorders. Exploratory and confirmatory factor analyses supported a two‐factor solution with 12 items which showed an acceptable model fit, adequate internal consistencies, and strong relations with criteria variables (e.g. disability and life satisfaction). The construct validity of the instrument was supported by high correlations with subscales from the Chronic Pain Acceptance Questionnaire (CPAQ) and the Tampa Scale of Kinesiophobia (TSK). Notably, hierarchical regression analyses illustrated that PIPS explained more variance than TSK in pain, disability, life satisfaction and depression. Furthermore, PIPS was found to mediate the relationship between e.g. pain and disability, suggesting the usefulness of PIPS as a process measure in treatments of people with chronic pain. Thus, it is argued that this 12‐item version of PIPS may be used to explore the importance of psychological in/flexibility in chronic pain and to analyse processes of change in exposure based interventions, as well as for clinicians in tailoring interventions for patients with chronic debilitating pain.     

Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS) to increase evidence based psychotherapy in military behavioral health clinics: Design of a cluster-randomized stepped-wedge implementation study

BackgroundDespite efforts by the U.S. Department of Defense to train behavioral health (BH) providers in evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), numerous barriers limit EBP implementation. A context-tailored implementation approach called TACTICS (Targeted Assessment and Context-Tailored Implementation of Change Strategies) holds promise for increasing the use of EBPs such as prolonged exposure therapy (PE) in military treatment facilities. TACTICS combines a needs assessment, a rubric for selecting implementation strategies based on local barriers, an implementation toolkit, and external facilitation to support local champions and their implementation teams in enacting changes. This paper describes the rationale for and design of a study that will evaluate whether TACTICS can increase implementation of PE for PTSD and improve patient outcomes in military BH clinics relative to provider training in PE alone.MethodsThe study is a multi-site, cluster randomized, stepped-wedge trial, with the military treatment facility as the unit of analysis. Eight facilities undergo a provider-training phase, followed by 5 months of TACTICS implementation. The timing of TACTICS at each facility is randomly assigned to begin 9, 14, or 19 months after beginning the provider-training phase. Primary analyses will compare the proportion of PTSD patients receiving PE and patients' mean improvement in PTSD symptoms before and after the onset of TACTICS.DiscussionTACTICS endeavors to balance standardization of empirically-supported implementation strategies with the flexibility of application necessary for success across varied clinical settings. If successful, TACTICS may represent a systematic and scalable method of promoting and supporting EBP implementation.Trial registrationClinicaltrials.gov Identifier: NCT03663452     

Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol

BackgroundFunctional gastrointestinal disorders (FGIDs) are the commonest reason for gastroenterological consultation, with patients usually seen by a specialist working in isolation. There is a wealth of evidence testifying to the benefit provided by dieticians, behavioral therapists, hypnotherapists and psychotherapists in treating these conditions, yet they rarely form a part of the therapeutic team, and these treatment modalities are rarely offered as part of the therapeutic management. There has been little examination of different models of care for FGIDs. We hypothesize that multi-disciplinary integrated care is superior to standard specialist-based care in the treatment of functional gut disorders.MethodsThe “MANTRA” (Multidisciplinary Treatment for Functional Gut Disorders) study compares comprehensive multi-disciplinary outpatient care with standard hospital outpatient care. Consecutive new referrals to the gastroenterology and colorectal outpatient clinics of a single secondary and tertiary care hospital of patients with an FGID, defined by the Rome IV criteria, will be included. Patients will be prospectively randomized 2:1 to multi-disciplinary (gastroenterologist, gut-hypnotherapist, psychiatrist, behavioral therapist (‘biofeedback’) and dietician) or standard care (gastroenterologist or colorectal surgeon). Patients are assessed up to 12 months after completing treatment. The primary outcome is an improvement on a global assessment scale at the end of treatment. Symptoms, quality of life, psychological well-being, and healthcare costs are secondary outcome measures.DiscussionThere have been few studies examining how best to deliver care for functional gut disorders. The MANTRA study will define the clinical and cost benefits of two different models of care for these highly prevalent disorders.TRIAL REGISTRATION Number: Clinicaltrials.gov NCT03078634Registered on Clinicaltrials.gov, completed recruitment, registered on March 13th 2017.Ethics and Dissemination:Ethical approval has been received by the St Vincent's Hospital Melbourne human research ethics committee (HREC-A 138/16). The results will be disseminated in peer-reviewed journals and presented at international conferences.Protocol version 1.2     

Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial

Posttraumatic stress disorder (PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. Prolonged Exposure (PE) therapy is one of the most widely used evidence-based treatments for PTSD, but there is substantial room for improvement in outcomes and retention rates. Accumulating data suggest that oxytocin offers a promising pharmacological approach towards achieving this goal. Therefore, the primary objective of this two-site Phase II study is to examine the ability of oxytocin (vs. placebo) administration combined with PE therapy to (1) reduce PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates. To accomplish these objectives, we will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up). Intranasal oxytocin (40 IU) will be administered directly prior to each PE therapy session. Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response. ClinicalTrials.gov Identifier: NCT04228289     

Effects of milrinone on renal perfusion,filtration and oxygenation in patients with acute heart failure and low cardiac output early after cardiac surgery

PurposeEarly postoperative heart failure is common after cardiac surgery, and inotrope treatment may impact renal perfusion and oxygenation. We aimed to study the renal effects of the inodilator milrinone when used for the treatment of heart failure after weaning from cardiopulmonary bypass (CPB).Material and methodsIn 26 patients undergoing cardiac surgery with CPB, we used renal vein catheterization to prospectively measure renal blood flow (RBF), glomerular filtration rate (GFR), and renal oxygenation. Patients who developed acute heart failure and low cardiac output (cardiac index <2.1 L/min/m²) at 30 min after weaning from CPB (n = 7) were given milrinone, and the remaining patients (n = 19) served as controls. Additional measurements were made at 60 min after CPB.ResultsIn patients with acute postoperative heart failure, before receiving milrinone, renal blood flow was lower (−33%, p < .05) while renal oxygen extraction was higher (41%, p < .05) compared to the control group. Milrinone increased cardiac index (21%, p < .001), RBF (36%, p < .01) and renal oxygen delivery (35%, p < .01), with no significant change in GFR and oxygen consumption compared to the control group.ConclusionsIn patients with acute heart failure after weaning from CPB, the milrinone-induced increase in cardiac output was accompanied by improved renal oxygenation.Trial registrationClinicalTrials.gov; identifier NCT02405195, date of registration; March 27, 2015, and NCT02549066, date of registration; 9 September 2015.     

Transversus abdominis activation does not alter gait impairments in patients with and without knee osteoarthritis

BackgroundKnee osteoarthritis accounts for more years of disability than all other forms of osteoarthritis combined. Gait kinetic and kinematic changes, in addition to reduced gait speed, are commonly observed. This study investigates whether core activation, which modifies lower extremity movement in young, active populations, can alter the gait and baseline core activation of those with knee osteoarthritis as compared to controls, and alter osteoarthritic knee pain.MethodsForty-four participants (22 controls and 22 with knee osteoarthritis) underwent biomechanical gait assessment, examining kinetic and kinematic variables, in addition to gait speed, with and without volitional transversus abdominis activation. Surface electromyography was used to measure baseline transversus abdominis activation under both conditions. Knee pain ratings were examined for those with knee osteoarthritis.FindingsNo significant biomechanical differences were observed within groups, or in the time/group interaction. Between-groups kinetic (time to first peak ground reaction force and amplitude of second peak ground reaction force) and gait speed differences were observed under both conditions. There were no differences in baseline electromyography activation between or within-groups, or within-group for self-reported pain for the osteoarthritic group.InterpretationAlthough previous studies have shown the benefit of core activation in correcting lower extremity movement patterns and kinetic loading in young, athletic populations, this study is the first to show this is not the case for persons with knee osteoarthritis. Future studies should examine the value of a progressive core stabilization program, of sufficient dose and mode, in correcting the observed gait differences in those with knee osteoarthritis.Clinical Trial Registration Number: NCT03776981     

Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial

ImportanceExtant treatments for youth depression are only modestly effective. Alternative approaches are needed to improve health outcomes. A novel approach to improve depression outcomes is suggested by epidemiological studies finding that insomnia often predates and may contribute to depression risk. We test whether treating insomnia among youth starting a new course of SSRI antidepressants improves depression outcomes. This paper describes our study design.Design2-arm randomized controlled efficacy-effectiveness trial.SettingA large non-profit health maintenance organization.Participants165 adolescents aged 12–19 with research-confirmed depression and insomnia diagnoses, starting a new episode of selective serotonin reuptake inhibitor (SSRI) antidepressant treatment prescribed by their usual care provider.InterventionsTwo sleep interventions, each 6–7 sessions, both overlaying “treatment as usual” (TAU) SSRIs: a sleep hygiene (SH) attention control condition, and cognitive-behavioral therapy for insomnia (CBTI).Conclusions and relevanceIf CBT-I improved sleep is shown to improve depression-related outcomes, this may provide an additional, easily tolerated intervention for an important public health target.Trial Registration: clinicaltrials.gov, NCT02290496, https://clinicaltrials.gov/ct2/show/NCT02290496.     

Willing and Able: A Closer Look at Pain Willingness and Activity Engagement on the Chronic Pain Acceptance Questionnaire (CPAQ-8)

An 8-item version of the Chronic Pain Acceptance Questionnaire (CPAQ-8) has recently been proposed and validated. The aims of this study were to further investigate the reliability and validity of the CPAQ-8 in a new sample. Questionnaires were completed by 550 people with chronic pain (478 online survey, 72 paper survey). A demographic and pain history questionnaire was administered along with the CPAQ-8 and measures of pain self-efficacy, pain catastrophizing, psychological flexibility in pain, anxiety, and mood. In addition, 105 respondents completed the CPAQ-8 within 6 weeks to provide test-retest reliability data. The 2-factor structure of the CPAQ-8 (Activity Engagement [AE] and Pain Willingness [PW]) was confirmed and had reasonable-to-good scale score reliability and test-retest reliability. Pain acceptance as measured by the CPAQ-8 was associated with less depression, anxiety, pain interference, fear of reinjury, pain catastrophizing, and psychological inflexibility in pain, and higher levels of satisfaction with life, pain self-efficacy, and general acceptance. Furthermore, pain acceptance fully mediated the relationship between reported pain severity and emotional distress (anxiety and depression) and partially mediated the relationship between pain severity and pain interference in a structural equation model. The test-retest reliability after 4 to 6 weeks ranged from .68 for PW to .86 for AE; the overall score correlation was .81. We conclude that the CPAQ-8 is a reliable and valid measure of pain acceptance and that the 2 subscales of the measure each make an individual contribution to the prediction of adjustment in people with chronic pain.PerspectiveThe present study provides further evidence for the reliability and validity of the CPAQ-8. Support was found for the 2 related subscales, PW and AE, which appear to work in synergy to influence levels of pain interference and emotional distress in people living with chronic pain.     

Design and recruitment of the randomized order safety trial evaluating resident-physician schedules (ROSTERS) study

IntroductionWhile the Accreditation Council for Graduate Medical Education limited first year resident-physicians to 16 consecutive work hours from 2011 to 2017, resident-physicians in their second year or higher were permitted to work up to 28 h consecutively. This paper describes the Randomized Order Safety Trial Evaluating Resident-physician Schedules (ROSTERS) study, a clustered-randomized crossover clinical trial designed to evaluate the effectiveness of eliminating traditional shifts of 24 h or longer for second year or higher resident-physicians in pediatric intensive care units (PICUs).MethodsROSTERS was a multi-center non-blinded trial in 6 PICUs at US academic medical centers. The primary aim was to compare patient safety between the extended duration work roster (EDWR), which included shifts ≥24 h, and a rapidly cycling work roster (RCWR), where shifts were limited to a maximum of 16 h. Information on potential medical errors was gathered and used for classification by centrally trained physician reviewers who were blinded to the study arm. Secondary aims were to assess the relationship of the study arm to resident-physician sleep duration, work hours and neurobehavioral performance.ResultsThe study involved 6577 patients with a total of 38,821 patient days (n = 18,749 EDWR, n = 20,072 RCWR). There were 413 resident-physician rotations included in the study (n = 203 EDWR, n = 210 RCWR). Resident-physician questionnaire data were over 95% complete.ConclusionsResults from data collected in the ROSTERS study will be evaluated for the impact of resident-physician schedule roster on patient safety outcomes in PICUs, and will allow for examination of a number of secondary outcome measures.ClinicalTrials.gov Identifier: NCT02134847