Pain coping skills training for African Americans with osteoarthritis: Results of a randomized controlled trial

African Americans bear a disproportionate burden of osteoarthritis (OA), but they have been underrepresented in trials of behavioral interventions for pain. This trial examined a culturally tailored pain coping skills training (CST) program, compared to a wait list control group, among 248 African Americans with knee or hip OA. The pain CST program involved 11 telephone-based sessions over 3 months. Outcomes were assessed at baseline, 3 months (primary), and 9 months, and included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (primary outcome), WOMAC total score and function subscale, PROMIS Pain Interference, Short-Form 12 Mental and Physical Composite Subscales, Coping Strategies Questionnaire - Total Coping Attempts, Pain Catastrophizing Scale, Patient Health Questionnaire-8, Arthritis Self-Efficacy Scale, and Patient Global Impression of Arthritis Symptom Change. Linear mixed models were fit for all outcomes. There were no significant between-group differences in WOMAC pain score at 3 months (-0.63 [95% confidence interval -1.45, 0.18]; P = 0.128) or 9 months (-0.84 [95% confidence interval -1.73, 0.06]; P = 0.068). Among secondary outcomes, at 3 months, there were significant differences, in favor of the CST group, for Coping Strategies Questionnaire Total Coping Attempts, Pain Catastrophizing Scale, Arthritis Self-Efficacy, and Patient Global Impression of Arthritis Symptom Change (P < 0.01). Coping Strategies Questionnaire Total Coping Attempts, Arthritis Self-Efficacy, and Patient Global Assessment Change were also significantly improved at 9 months in the CST group, compared with wait list (P < 0.01). The culturally tailored pain CST program did not significantly reduce pain severity but did improve key measures of pain coping and perceived ability to manage pain among African Americans with OA

Acceptability of telephone-based pain coping skills training among African Americans with osteoarthritis enrolled in a randomized controlled trial: A mixed methods analysis

Background: Osteoarthritis (OA) disproportionately impacts African Americans compared to Caucasians, including greater pain severity. The Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study examined a culturally enhanced Pain Coping Skills Training (CST) program among African Americans with OA. This mixed methods study evaluated the acceptability of the Pain CST program among STAART participants. Methods: STAART was a randomized controlled trial evaluating the effectiveness of an 11-session, telephone-based pain CST program, compared to a usual care control group. Participants were from the University of North Carolina and Durham Veterans Affairs Healthcare Systems. The present analyses included 93 participants in the CST group who completed a questionnaire about experiences with the program. Descriptive statistics of the questionnaire responses were calculated using SAS software. Thematic analysis was applied to open-response data using Dedoose software. Results: Participants' mean rating of overall helpfulness of the pain CST program for managing arthritis symptoms was 8.0 (SD = 2.2) on a scale of 0-10. A majority of participants reported the program made a positive difference in their experience with arthritis (83.1%). Mean ratings of helpfulness of the specific skills ranged from 7.7 to 8.8 (all scales 0-10). Qualitative analysis of the open-response data identified four prominent themes: Improved Pain Coping, Mood and Emotional Benefits, Improved Physical Functioning, and experiences related to Intervention Delivery. Conclusions: The high ratings of helpfulness demonstrate acceptability of this culturally enhanced pain CST program by African Americans with OA. Increasing access to cognitive-behavioral therapy-based programs may be a promising strategy to address racial disparities in OA-related pain and associated outcomes. Trial registration: NCT02560922, registered September 25, 2015

A qualitative study of patient and provider perspectives on using web-based pain coping skills training to treat persistent cancer pain

Objective: Persistent pain is common and inadequately treated in cancer patients. Behavioral pain interventions are a recommended part of multimodal pain treatments, but they are underused in clinical care due to barriers such as a lack of the resources needed to deliver them in person and difficulties coordinating their use with clinical care. Pain coping skills training (PCST) is an evidence-based behavioral pain intervention traditionally delivered in person. Delivering this training via the web would increase access to it by addressing barriers that currently limit its use. We conducted a patient pilot study of an 8-week web-based PCST program to determine the acceptability of this approach to patients and the program features needed to meet their needs. Focus groups with healthcare providers identified strategies for coordinating the use of web-based PCST in clinical care.Method: Participants included 7 adults with bone pain due to multiple myeloma or metastasized breast or prostate cancer and 12 healthcare providers (4 physicians and 8 advanced practice providers) who treat cancer-related bone pain. Patients completed web-based PCST at home and then took part in an in-depth qualitative interview. Providers attended focus groups led by a trained moderator. Qualitative analyses identified themes in the patient and provider data.Results: Patients reported strongly favorable responses to web-based PCST and described emotional and physical benefits. They offered suggestions for adapting the approach to better fit their needs and to overcome barriers to completion. Focus groups indicated a need to familiarize healthcare providers with PCST and to address concerns about overburdening patients. Providers would recommend the program to patients they felt could benefit. They suggested applying a broad definition of cancer pain and having various types of providers help coordinate program its use with clinical care.Significance of results: Web-based PCST was acceptable to patients and providers. Our findings suggest that patients could benefit from this approach, especially if patient and provider barriers are addressed

Pain coping skills training for African Americans with osteoarthritis study: Baseline participant characteristics and comparison to prior studies 11 Medical and Health Sciences 1103 Clinical Sciences 11 Medical and Health Sciences 1117 Public Health and Health Services

Background: The Pain Coping Skills Training for African Americans with OsteoaRTthritis (STAART) trial is examining the effectiveness of a culturally enhanced pain coping skills training (CST) program for African Americans with osteoarthritis (OA). This disparities-focused trial aimed to reach a population with greater symptom severity and risk factors for poor pain-related outcomes than previous studies. This paper compares characteristics of STAART participants with prior studies of CST or cognitive behavioral therapy (CBT)-informed training in pain coping strategies for OA. Methods: A literature search identified 10 prior trials of pain CST or CBT-informed pain coping training among individuals with OA. We descriptively compared characteristics of STAART participants with other studies, in 3 domains of the National Institutes of Minority Health and Health Disparities' Research Framework: Sociocultural Environment (e.g., age, education, marital status), Biological Vulnerability and Mechanisms (e.g, pain and function, body mass index), and Health Behaviors and Coping (e.g., pain catastrophizing). Means and standard deviations (SDs) or proportions were calculated for STAART participants and extracted from published manuscripts for comparator studies. Results: The mean age of STAART participants, 59 years (SD = 10.3), was lower than 9 of 10 comparator studies; the proportion of individuals with some education beyond high school, 75%, was comparable to comparator studies (61-86%); and the proportion of individuals who are married or living with a partner, 42%, was lower than comparator studies (62-66%). Comparator studies had less than about 1/3 African American participants. Mean scores on the Western Ontario and McMaster Universities Osteoarthritis Index pain and function scales were higher (worse) for STAART participants than for other studies, and mean body mass index of STAART participants, 35.2 kg/m2 (SD = 8.2), was higher than all other studies (30-34 kg/m2). STAART participants' mean score on the Pain Catastrophizing scale, 19.8 (SD = 12.3), was higher (worse) than other studies reporting this measure (7-17). Conclusions: Compared with prior studies with predominantly white samples, STAART participants have worse pain and function and more risk factors for negative pain-related outcomes across several domains. Given STAART participants' high mean pain catastrophizing scores, this sample may particularly benefit from the CST intervention approach. Trial registration: NCT02560922

Report on ISCTM consensus meeting on clinical assessment of response to treatment of cognitive impairment in schizophrenia

Funding for this manuscript was provided by the International Society for CNS Clinical Trials and Methodology.Dr Keefe currently or in the past 3 years has received investigator-initiated research funding support from the Department of Veteran's Affair, Feinstein Institute for Medical Research, GlaxoSmithKline, National Institute of Mental Health, Novartis, Psychogenics, Research Foundation for Mental Hygiene, Inc., and the Singapore National Medical Research Council. He currently or in the past 3 years has received honoraria, served as a consultant, or advisory board member for Abbvie, Akebia, Amgen, Asubio, AviNeuro/ChemRar, BiolineRx, Biogen Idec, Biomarin, Boehringer-Ingelheim, Eli Lilly, EnVivo/FORUM, GW Pharmaceuticals, Janssen, Lundbeck, Merck, Minerva Neurosciences, Inc., Mitsubishi, Novartis, NY State Office of Mental Health, Otsuka, Pfizer, Reviva, Roche, Sanofi/Aventis, Shire, Sunovion, Takeda, Targacept, and the University of Texas South West Medical Center. Dr Keefe receives royalties from the BACS testing battery, the MATRICS battery (BACS Symbol Coding), and the Virtual Reality Functional Capacity Assessment Tool. He is also a shareholder in NeuroCog Trials, Inc. and Sengenix. Dr Haig is a full-time employee of Abbvie. Dr Marder has received consulting fees from Abbvie, Genentech, Roche, Lundbeck, Pfizer, Otsuka, Takeda, and Boeringer Ingelheim. He has received research support from Amgen, Sunovion, and Synchroneuron. Dr Harvey has received consulting fees from Abbvie, Boehringer Ingelheim, Forest Labs, Forum Pharma, Genentech, Otsuka America, Roche Pharma, Sunovion Pharma, and Takeda Pharma during the past year. He also received contract research support from Genentech. Dr Dunayevich for the past 3 years has been a full-time employee and stockholder of Amgen. Dr Medalia in the past 3 years has received research funding support from Sunovion. Dr Medalia has also currently or in the past 3 years received honoraria or served as consultant for Dainippon Sumitomo Pharma Co., Ltd., Otsuka, and Takeda Pharmaceuticals U.S.A., Inc. Dr Davidson has received research grant support and/or travel support and/or speaker fees and/or consultancy fees from Lundbeck, Eli Lilly, Servier, Abbott, Minerva and holds stocks in CTR and BiolineRx. Dr Lombardo is a full-time employee of FORUM Pharmaceuticals. Dr Bowie reports receiving grant support from Pfizer. He has also been a consultant for Lundbeck, Otsuka, Abbvie, and Takeda. Dr Buchanan reports: Advisory Board: Abbvie, Amgen, EnVivo, Roche; Consultant: Abbvie, Amgen, Bristol Myers Squibb, EnVivo, Omeros; DSMB member: Pfizer. Dr Bugarski -Kirola is a full-time employee of Hoffmann-La Roche Ltd. Dr Carpenter in the past 2 years has been a consultant to Roche/Genetech. Dr Dago in the last 3 years has received honoraria from Lundbeck, Forest Pharmaceuticals, Otsuka, Pam Labs, and Astra Zeneca for lectures given in promotion of their psychotropic medications. Dr Durand in the past year has been a consultant and received honoraria from Teva Pharmaceuticals. Dr Gold receives royalty payments from the BACS. He also has served as a consultant for Amgen, Hoffman LaRoche, and Lundbeck. Dr Hooker has served as a consultant and is currently a Co-Investigator on an NIH SBIR grant with PositScience Corporation. Dr Loebel is an employee of Sunovion Pharmaceuticals. Dr McGurk reports receiving consulting fees from Abbvie and EnVivo Pharmaceuticals. Dr Pinkham in the past year has received consulting fees from Otsuka America Pharmaceutical, Inc.The following authors have declared that there are no conflicts of interest in relation to the subject of this study: Drs Csernansky, Frese, Goff, Kopelowic, Opler, and Stern. (International Society for CNS Clinical Trials and Methodology; Department of Veteran's Affair; Feinstein Institute for Medical Research; GlaxoSmithKline; National Institute of Mental Health; Novartis; Psychogenics; Research Foundation for Mental Hygiene, Inc.; Singapore National Medical Research Council; Abbvie; Genentech; Roche; Lundbeck; Pfizer; Otsuka; Takeda; Boeringer Ingelheim; Amgen; Sunovion; Synchroneuron; Boehringer Ingelheim; Forest Labs; Forum Pharma; Otsuka America; Roche Pharma; Sunovion Pharma; Takeda Pharma; Eli Lilly; Servier; Abbott; Minerva; BACS; EnVivo Pharmaceuticals; Otsuka America Pharmaceutical, Inc.)Published versio

Racial differences in osteoarthritis pain and function: potential explanatory factors

SummaryObjectiveThis study examined factors underlying racial differences in pain and function among patients with hip and/or knee osteoarthritis (OA).MethodsParticipants were n=491 African Americans and Caucasians enrolled in a clinical trial of telephone-based OA self-management. Arthritis Impact Measurement Scales-2 (AIMS2) pain and function subscales were obtained at baseline. Potential explanatory variables included arthritis self-efficacy, AIMS2 affect subscale, problem- and emotion-focused pain coping, demographic characteristics, body mass index, self-reported health, joint(s) with OA, symptom duration, pain medication use, current exercise, and AIMS2 pain subscale (in models of function). Variables associated with both race and pain or function, and which reduced the association of race with pain or function by ≥10%, were included in final multivariable models.ResultsIn simple linear regression models, African Americans had worse scores than Caucasians on AIMS2 pain (B=0.65, P=0.001) and function (B=0.59, P<0.001) subscales. In multivariable models race was no longer associated with pain (B=0.03, P=0.874) or function (B=0.07, P=0.509), indicating these associations were accounted for by other covariates. Variables associated with worse AIMS2 pain and function were: worse AIMS2 affect scores, greater emotion-focused coping, lower arthritis self-efficacy, and fair or poor self-reported health. AIMS2 pain scores were also significantly associated with AIMS2 function.ConclusionFactors explaining racial differences in pain and function were largely psychological, including arthritis self-efficacy, affect, and use of emotion-focused coping. Self-management and psychological interventions can influence these factors, and greater dissemination among African Americans may be a key step toward reducing racial disparities in pain and function