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A randomized controlled trial to evaluate a behavioral economic strategy for improving mobility in veterans with chronic pain.

ABSTRACT: Rates of chronic pain and daily opioid use are higher among veterans relative to civilian populations. Increasing physical activity can reduce pain severity and decrease opioid use among patients with chronic pain. Behavioral economic strategies can improve physical activity levels but have been undertested in veterans with chronic pain. The objective of this study was to evaluate if a financial incentive combined with a loss aversion component-a "regret lottery" in which veterans could win money if they met a set goal or told how much they could have won had they met their goal-would increase physical activity levels among veterans with chronic pain. A 12-week single-blinded randomized controlled trial (ClinicalTrials.gov: NCT04013529) was designed. Veterans with chronic pain (N = 40) receiving care at a specialty pain clinic were eligible for participation, and were randomly assigned (1:1) to either (a) activity trackers and daily text message reminders to increase physical activity ("control arm"), or (b) the same plus a weekly regret lottery ("intervention arm"). For those in the intervention arm, participants who met their activity goal, had a chance to win a small ($30) or large ($100) gift card incentive; those who did not meet their goals were informed of what they would have won had they met their goal. The primary outcome, physical activity, was measured using self-reported physical activity and step counts using activity trackers. Secondary outcomes included changes in physical function, chronic pain severity, depression and opioid use. The sample was primarily white, male and disabled, with an average age of 57 years. No between-arm differences were noted for physical activity, physical function, chronic pain severity, depression or opioid use. Regret lottery-based approaches may be ineffective at increasing physical activity levels in veterans with chronic pain. Trial Registry: NCT04013529.

SUBMITTER: Compton P

PROVIDER: S-EPMC8504760 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Opioid prescription in the treatment of chronic pain is frequent and carries a risk of increased morbidity and mortality in a clinically significant number of patients, particularly those who are using opioids in a hazardous manner. Few treatment options are available that target both pain-related interference and hazardous opioid use among patients with chronic pain. In military Veterans, this issue is of particular importance as numerous reports indicate continued high rates of opioid prescription for chronic pain, as well as significant opioid-related problems. The overall aim of the present study was to determine the feasibility of an integrated psychosocial treatment in Veterans with chronic pain, who also have evidence of hazardous opioid use. To examine this aim, a random design was used to assess the feasibility and initial efficacy of integrating 2 empirically supported interventions: Acceptance and Commitment Therapy for chronic pain and Mindfulness Based Relapse Prevention for opioid misuse. Half of participants were randomized to the integrated treatment group and all participants received usual care through a Veteran's Administration co-occurring disorders medical clinic to treat chronic pain and opioid misuse. In total, 37 participants were randomized and included in intent-to-treat analyses and 32 individuals were included in per protocol analyses with 6-month follow-up serving as the primary study endpoint. Feasibility indicators included recruitment, retention, and treatment completion rates. Recruitment fell short of targeted enrollment, although retention and completion were excellent. Primary outcome measures were opioid misuse, pain interference, and pain behavior. Simultaneous multiple regression analyses controlled for pain duration, baseline opioid dose, and baseline value for outcome measures. Results of both the intent-to-treat and per protocol indicated a significant effect in favor of the integrated intervention for opioid misuse, pain interference, and pain behavior. Results support the feasibility of providing an integrated treatment for both opioid risk and pain interference. PERSPECTIVE: Opioid misuse occurs in some opioid-prescribed individuals with chronic pain. Few treatment options exist that target both pain interference and opioid misuse. This study examined feasibility and initial efficacy of an integrated behavioral treatment for Veterans. Feasibility was supported, except recruitment. Efficacy was supported compared to usual care.

Project description:IntroductionOver the last two decades, the use of opioids for the treatment of chronic pain in England has steadily increased despite lack of evidence of both long-term effectiveness in pain relief and significant, well-documented physical and mental adverse events. Guidelines recommend tapering when harms outweigh benefits, but the addictive nature of opioids hinders simple dose-reduction strategies. Improving the Well-being of people with Opioid Treated CHronic pain (I-WOTCH) trial tests a multicomponent self-management intervention aimed to help patients with chronic non-malignant pain taper opioid doses. This paper outlines the methods to be used for the economic analysis of the I-WOTCH intervention compared with the best usual care.Methods and analysisEconomic evaluation alongside the I-WOTCH study, prospectively designed to identify, measure and value key healthcare resource use and outcomes arising from the treatment strategies being compared. A within-trial cost-consequences analysis and a model-based long-term cost-effectiveness analysis will be conducted from the National Health Service and Personal Social Service perspective in England. The former will quantify key parameters to populate a Markov model designed to estimate the long-term cost and quality-adjusted life years of the I-WOTCH intervention against best usual care. Regression equations will be used to estimate parameters such as transition probabilities, utilities, and costs associated with the model's states and events. Probabilistic sensitivity analysis will be used to assess the impact of parameter uncertainty onto the predicted costs and health outcomes, and the resulting value for money assessment of the I-WOTCH intervention.Ethics and disseminationFull ethics approval was granted by Yorkshire & The Humber-South Yorkshire Research Ethics Committee on 13 September 2016 (16/YH/0325). Current protocol: V.1.7, date 31 July 2019. Findings will be disseminated in peer-reviewed journals, scientific conferences, newsletters and websites.Trial registration numberInternational Standard Randomised Controlled Trial Number (49 470 934); Pre-result.

Project description:BackgroundPatients with chronic pain often experience insomnia symptoms. Pain initiates, maintains, and exacerbates insomnia symptoms, and vice versa, indicating a complex situation with an additional burden for these patients. Hence, the evaluation of insomnia-related interventions for patients with chronic pain is important.ObjectiveThis randomized controlled trial examined the effectiveness of internet-based cognitive behavioral therapy for insomnia (ICBT-i) for reducing insomnia severity and other sleep- and pain-related parameters in patients with chronic pain. Participants were recruited from the Swedish Quality Registry for Pain Rehabilitation.MethodsWe included 54 patients (mean age 49.3, SD 12.3 years) who were randomly assigned to the ICBT-i condition and 24 to an active control condition (applied relaxation). Both treatment conditions were delivered via the internet. The Insomnia Severity Index (ISI), a sleep diary, and a battery of anxiety, depression, and pain-related parameter measurements were assessed at baseline, after treatment, and at a 6-month follow-up (only ISI, anxiety, depression, and pain-related parameters). For the ISI and sleep diary, we also recorded weekly measurements during the 5-week treatment. Negative effects were also monitored and reported.ResultsResults showed a significant immediate interaction effect (time by treatment) on the ISI and other sleep parameters, namely, sleep efficiency, sleep onset latency, early morning awakenings, and wake time after sleep onset. Participants in the applied relaxation group reported no significant immediate improvements, but both groups exhibited a time effect for anxiety and depression at the 6-month follow-up. No significant improvements on pain-related parameters were found. At the 6-month follow-up, both the ICBT-i and applied relaxation groups had similar sleep parameters. For both treatment arms, increased stress was the most frequently reported negative effect.ConclusionsIn patients with chronic pain, brief ICBT-i leads to a more rapid decline in insomnia symptoms than does applied relaxation. As these results are unique, further research is needed to investigate the effect of ICBT-i on a larger sample size of people with chronic pain. Using both treatments might lead to an even better outcome in patients with comorbid insomnia and chronic pain.Trial registrationClinicalTrials.gov NCT03425942; https://clinicaltrials.gov/ct2/show/NCT03425942.

Project description:BackgroundChronic pain is a highly prevalent health condition among veterans. Traditional pharmacological interventions present unique challenges for chronic pain management including prescription opioid addiction and overdose. In alignment with the 2016 Comprehensive Addiction and Recovery Act and VA's Stepped Care Model to meet veterans' pain management needs, the Offices of Rural Health and Pain Management, Opioid Safety, and Prescription Drug Monitoring Program (PMOP) funded an enterprise-wide initiative to implement a Step 3 integrated tele-pain program: Empower Veterans Program (EVP). EVP provides veterans with chronic pain self-care skills using a whole health driven approach to pain management.ObjectivesThe Comprehensive Addiction and Recovery Act prompted the strategic approach to offer non-pharmacological options to meet veterans' pain management needs. EVP, a 10-week interdisciplinary group medical appointment, leverages Acceptance and Commitment Therapy, Mindful Movement, and Whole Health to provide veterans with chronic pain self-care skills. This evaluation was conducted to describe participant characteristics, graduation, and satisfaction rates; and assess pre-post patient-reported outcomes (PRO) associated with EVP participation.MethodsA sample of 639 veterans enrolled in EVP between May, 2015 and December, 2017 provided data to conduct descriptive analyses to assess participant demographics, graduation, and satisfaction rates. PRO data were analyzed using a within-participants pre-post design, and linear mixed-effects models were used to examine pre-post changes in PRO.ResultsOf 639 participants, 444 (69.48%) graduated EVP. Participant median program satisfaction rating was 8.41 (Interquartile Range: 8.20-9.20). Results indicate pre-post EVP improvements (Bonferroni-adjusted p < .003) in the three primary pain outcomes (intensity, interference, catastrophizing), and 12 of 17 secondary outcomes, including physical, psychological, health-related quality of life (HRQoL), acceptance, and mindfulness measures.DiscussionData suggest that EVP has significant positive outcomes in pain, psychological, physical, HRQoL, acceptance, and mindfulness measures for veterans with chronic pain through non-pharmacological means. Future evaluations of intervention dosing effect and long-term effectiveness of the program is needed.

Project description:BackgroundChronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations.Methods/designThis study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records.DiscussionThis study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities.Trial registrationClinicalTrials.gov: NCT02224183.

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A randomized controlled trial to evaluate a behavioral economic strategy for improving mobility in veterans with chronic pain.

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