Improving multimodal physical function in adults with heterogeneous chronic pain; Protocol for a multisite feasibility RCT.

BACKGROUND: Chronic pain is associated with substantial impairment in physical function, which has been identified as a top concern among persons with pain. GetActive-Fitbit, a mind-body activity program, is feasible, acceptable, and associated with improvement in physical function among primarily White, sedentary individuals with pain. In preparation for a multisite efficacy trial, we must examine feasibility across multiple sites with diverse patient populations. Here we describe the protocol of a multisite, feasibility RCT comparing GetActive-Fitbit with a time- and attention-matched educational comparison (Healthy Living for Pain). We aim to 1) test multisite fidelity of clinician training; 2) evaluate multisite feasibility benchmarks, including recruitment of chronic pain patients taking <5000 steps/day and racial and ethnic minorities; and 3) optimize fidelity and study protocol in preparation for a future multisite efficacy trial. METHODS: Clinician training fidelity was assessed via roleplays and mock group sessions. Feasibility (i.e., recruitment, acceptability, credibility, adherence, satisfaction), multimodal physical function (e.g., self-report, 6-Minute Walk Test, step-count), and other psychosocial outcomes are assessed at baseline, posttest, and 6 months. Protocol optimization will be assessed using exit interviews and cross-site meetings. RESULTS: The trial is ongoing. Clinician training is complete. 87 participants have been recruited. 54 completed baseline assessments and randomization, 44 are mid-intervention, and 9 have completed the intervention and posttest. CONCLUSIONS: This study addresses the critical need for feasible, acceptable mind-body-activity interventions for chronic pain that follow evidence-based guidelines and improve all aspects of physical function across diverse populations. Results will inform a future fully-powered multisite efficacy trial. CLINICAL TRIAL REGISTRATION: NCT05700383.

Perceived discrimination and problematic opioid use among Black individuals with chronic musculoskeletal pain.

OBJECTIVE: Chronic musculoskeletal pain (CMP) is prevalent, burdensome, and associated with an increased risk for opioid use disorder. Evidence suggests that perceived racial/ethnic discrimination is associated with problematic substance use among Black individuals, but studies have not focused on problematic opioid use among Black individuals with CMP specifically or explored the contribution of perceived discrimination, pain intensity, and pain-relevant psychological factors to this association. METHOD: We recruited 401 Black individuals (Mage = 35.98, 51.9% female) with self-reported CMP and prescription opioid use. We tested whether perceived discrimination (a) was associated with self-reported problematic opioid use and (b) explained unique variance in this outcome after accounting for pain intensity, demographic factors, and psychological factors previously implicated in problematic opioid/substance use (distress tolerance and pain avoidance). RESULTS: Hierarchical linear regression analysis revealed that our model as a whole explained significant variance in problematic opioid use, R² = .30, F(6, 394) = 28.66, p < .001. Perceived discrimination specifically was associated with more problematic opioid use (ß = .39, SE = .05, p < .001) and explained unique variance in this outcome even after accounting for pain intensity (ß = .06, SE = .04, p = .20), distress tolerance (ß = -.10, SE = .05, p = .04), pain avoidance (ß = .12, SE = .05, p = .02), age (ß = -.10, SE = .05, p < .05), and employment status (ß = .13, SE = .11, p < .01). CONCLUSIONS: Systemic efforts to combat racism along with individualized therapeutic approaches to process and cope with perceived racial discrimination may be particularly important to prevent and reduce problematic opioid use among Black individuals with CMP. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Improving Health for Older Adults With Pain Through Engagement: Protocol for Tailoring and Open Pilot Testing of a Mind-Body Activity Program Delivered Within Shared Medical Visits in an Underserved Community Clinic.

BACKGROUND: Chronic musculoskeletal pain is prevalent and disabling among older adults in underserved communities. Psychosocial pain management is more effective than pharmacological treatment in older adults. However, underserved community clinics often lack psychosocial treatments, in part because of a lack of trained providers. Shared medical appointments, in which patients undergo brief medical evaluation, monitoring, counseling, and group support, are an efficacious and cost-effective method for chronic disease management in underserved clinics, reducing the need for specialized providers. However, shared medical visits are often ineffective for chronic pain, possibly owing to lack of inclusion of skills most relevant for older adults (eg, pacing to increase engagement in daily activities). OBJECTIVE: We have described the protocol for the development and initial pilot effectiveness testing of the GetActive+ mind-body activity intervention for older adults with chronic pain. GetActive+ was adapted from GetActive, an evidence-based intervention that improved pain outcomes among mostly affluent White adults. We aim to establish the initial feasibility, acceptability, fidelity, and effectiveness of GetActive+ when delivered as part of shared medical appointments in a community clinic. METHODS: We conducted qualitative focus groups and individual interviews with providers (n=25) and English-speaking older adults (aged ≥55 y; n=18) with chronic pain to understand the pain experience in this population, perceptions about intervention content, and barriers to and facilitators of intervention participation and implementation in this setting. Qualitative interviews with Spanish-speaking older adults are in progress and will inform a future open pilot of the intervention in Spanish. We are currently conducting an open pilot study with exit interviews in English (n=30 individuals in total). Primary outcomes are feasibility (≥75% of patients who are approached agree to participate), acceptability (≥75% of patients who enrolled complete 8 out of 10 sessions; qualitative), and fidelity (≥75% of session components are delivered as intended). Secondary outcomes include physical function-self-reported, performance based (6-minute walk test), and objective (step count)-and emotional function (depression and anxiety). Other assessments include putative mechanisms (eg, mindfulness and pain catastrophizing). RESULTS: We began enrolling participants for the qualitative phase in November 2022 and the open pilot phase in May 2023. We completed the qualitative phase with providers and English-speaking patients, and the results are being analyzed using a hybrid, inductive-deductive approach. We conducted rapid analysis of these data to develop GetActive+ before the open pilot in English, including increasing readability and clarity of language, reducing the number of skills taught to increase time for individual check-ins and group participation, and increasing experiential exercises for skill uptake. CONCLUSIONS: We provide a blueprint for the refinement of a mind-body activity intervention for older adults with chronic pain in underserved community clinics and for incorporation within shared medical visits. It will inform a future, fully powered, effectiveness-implementation trial of GetActive+ to help address the chronic pain epidemic among older adults. TRIAL REGISTRATION: ClinicalTrials.gov NCT05782231; https://clinicaltrials.gov/study/NCT05782231. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52117.

Addressing the Chronic Pain-Early Cognitive Decline Comorbidity Among Older Adults: Protocol for the Active Brains Remote Efficacy Trial.

BACKGROUND: Chronic pain and early cognitive decline, which are costly to treat and highly prevalent among older adults, commonly co-occur, exacerbate one another over time, and can accelerate the development and progression of Alzheimer disease and related dementias. We developed the first mind-body activity program (Active Brains [AB]) tailored to the needs of older adults with chronic pain and early cognitive decline. Results from our previous study strongly supported the feasibility of conducting AB remotely and provided evidence for improvements in outcomes. OBJECTIVE: We are conducting a single-blinded, National Institutes of Health stage-2, randomized clinical trial to establish the efficacy of AB versus a time-matched and dose-matched education control (Health Enhancement Program [HEP]) in improving self-reported and objective outcomes of physical, cognitive, and emotional functions in 260 participants. The methodology described in this paper was informed by the lessons learned from the first year of the trial. METHODS: Participants are identified and recruited through multidisciplinary clinician-referred individuals (eg, pain psychologists and geriatricians), the Rally Research platform, social media, and community partnerships. Interested participants complete eligibility screening and electronic informed consent. Baseline assessments include self-report, performance-based measures (eg, 6-min walk test) and objective measures (eg, Repeatable Battery for the Assessment of Neuropsychological Status). Participants are mailed a wrist-worn ActiGraph device (ActiGraph LLC) to passively monitor objective function (eg, steps) during the week between the baseline assessment and the beginning of the programs, which they continue to wear throughout the programs. After baseline assessments, participants are randomized to either AB or HEP and complete 8 weekly, remote, group sessions with a Massachusetts General Hospital psychologist. The AB group receives a Fitbit (Fitbit Inc) to help reinforce increased activity. Assessments are repeated after the intervention and at the 6-month follow-up. Coprimary outcomes include multimodal physical function (self-report, performance based, and objective). Secondary outcomes are cognitive function (self-report and objective), emotional function, and pain. RESULTS: We began recruitment in July 2022 and recruited 37 participants across 4 cohorts. Of them, all (n=37, 100%) have completed the baseline assessment, 26 (70%) have completed the posttest assessment, and 9 (24%) are actively enrolled in the intervention (total dropout: n=2, 5%). In the three cohorts (26/37, 70%) that have completed the AB or HEP, 26 (100%) participants completed all 8 group sessions (including minimal makeups), and watch adherence (1937/2072, 93.48%, average across ActiGraph and Fitbit devices) has been excellent. The fourth cohort is ongoing (9/37, 24%), and we plan to complete enrollment by March 2026. CONCLUSIONS: We aim to establish the efficacy of the AB program over a time-matched and dose-matched control in a live video-based trial and test the mechanisms through theoretically driven mediators and moderators. Findings will inform the development of a future multisite effectiveness-implementation trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05373745; https://classic.clinicaltrials.gov/ct2/show/NCT05373745. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47319.

The impact of a virtual mind-body program on resilience factors among international English-speaking adults with neurofibromatoses: secondary analysis of a randomized clinical trial.

PURPOSE: To test the effects of the Relaxation Response Resiliency Program - Neurofibromatosis (3RP-NF), a mind-body resilience program for people with NF, on resilience factors from baseline to post-treatment and 6- and 12-month follow-up. METHODS: This is a secondary analysis of a fully powered randomized clinical trial (RCT) of 3RP-NF and health education control (HEP-NF). We recruited adults with NF1, NF2, or schwannomatosis who reported stress or difficulty coping with NF symptoms. Both conditions received 8 weekly 90-minute group sessions; 3RP-NF focused on building resilience skills. We measured resilience factors via the Measure of Current Status-A (adaptive coping), Cognitive and Affective Mindfulness Scale-Revised (mindfulness), Gratitude Questionnaire-6 (gratitude), Life Orientation Test Optimism Scale (optimism), and Medical Outcomes Study Social Support Survey (perceived social support) at baseline, post-intervention, and 6- and 12-month follow-up. We used linear mixed models with completely unstructured covariance across up to four repeated measurements (baseline, post-treatment, and 6- and 12-month follow-up) to investigate treatment effects on resilience factors. RESULTS: We enrolled 228 individuals (Mage=42.7, SD = 14.6; 74.5% female; 87.7% White; 72.8% NF1, 14.0% NF2, 13.2% schwannomatosis). Within groups, both 3RP-NF and HEP-NF showed statistically significant improvements in all outcomes across timepoints. 3RP-NF showed significantly greater improvement in adaptive coping compared to HEP-NF from baseline to post-intervention and baseline to 6 months (Mdifference= 0.29; 95% CI 0.13-0.46; p < 0.001; Mdifference= 0.25; 95% CI 0.07-0.33; p = 0.005); there were no other between-group differences amongst the remaining resilience factors. CONCLUSION: 3RP-NF showed promise in sustainably improving coping abilities amongst people with NF. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov Identifier: NCT03406208. Registration submitted December 6, 2017, first patient enrolled October 2017.

Cannabinoid Therapy: Attitudes and Experiences of People With Chronic Pain.

OBJECTIVE: Clinical trials of cannabinoids for chronic pain have mixed and often inconclusive results. In contrast, many prospective observational studies show the analgesic effects of cannabinoids. This survey study aimed to examine the experiences/attitudes of individuals with chronic pain who are currently taking, have previously taken, or never taken cannabinoids for chronic pain to inform future research. METHODS: This study is based on a cross-sectional, web-based survey of individuals with self-reported chronic pain. Participants were invited to participate through an email that was distributed to the listservs of patient advocacy groups and foundations that engage individuals with chronic pain. RESULTS: Of the 969 respondents, 444 (46%) respondents reported currently taking, 213 (22%) previously taken, and 312 (32%) never taken cannabinoids for pain. Participants reported using cannabinoids to treat a wide variety of chronic pain conditions. Those currently taking cannabinoids (vs previously) more frequently reported: (1) large improvements from cannabinoids in all pain types, including particularly difficult-to-treat chronic overlapping pain conditions (eg, pelvic pain), (2) improvements in comorbid symptoms (eg, sleep), and (3) lower interference from side effects. Those currently taking cannabinoids reported more frequent and satisfactory communication with clinicians regarding cannabinoid use. Those never taken cannabinoids reported a lack of suggestion/approval of a clinician (40%), illegality (25%), and lack of FDA regulation (19%) as reasons for never trying cannabinoids. CONCLUSION: These findings underscore the importance of conducting high-quality clinical trials that include diverse pain populations and clinically relevant outcomes that if successful, could support FDA approval of cannabinoid products. Clinicians could then prescribe and monitor these treatments similarly to other chronic pain medications.

Initial Validation of the Intentions to Co-Use Alcohol and Opioids Scale.

Co-use of alcohol and prescription opioid medication increases risk for harmful and potentially fatal health effects (e.g., overdose). Behavioral intentions (i.e., the immediate antecedent of corresponding behavior according to the Theory of Planned Behavior) are important in prediction of substance use, and a valid measure assessing intentions to co-use alcohol and opioids is needed to identify individuals at-risk for harmful substance use. The goal of the current study was to develop and conduct the psychometric validation of a six-item Intentions to Co-Use Alcohol and Opioids (ICAO) scale. Participants included 261 (Mage = 38; 64% male) past-month drinkers with a current opioid prescription and chronic musculoskeletal pain who completed a targeted online survey. Confirmatory factor analysis indicated that a single-factor structure provided good model fit (Bollen-Stine bootstrap p = .121). Moreover, the ICAO demonstrated high internal consistency (α = .96) and was correlated with measures of alcohol and opioid use/co-use. These findings provide support for the single-factor structure, reliability, and concurrent/convergent validity of the ICAO among individuals who endorse alcohol use, opioid use, and chronic musculoskeletal pain. The ICAO may offer clinical utility as a tool to identify individuals at greater risk of potentially fatal co-use of alcohol and opioid medications.

Benzodiazepine Use and Dependence in Relation to Chronic Pain Intensity and Pain Catastrophizing.

Benzodiazepines (BZDs), a class of sedative-hypnotic medications, generated concern as their popularity grew, with particular alarm regarding elevated rates of BZD use among chronic pain populations. Consistent with negative reinforcement/motivational models of substance use, desire for pain alleviation may motivate BZD use. Yet, little is known about relations between pain and addiction-relevant BZD use processes. This cross-sectional survey study aimed to: a) test associations between pain intensity and clinically relevant BZD use patterns, and b) examine the role of pain catastrophizing in hypothesized pain-BZD relations. Participants included 306 adults with chronic musculoskeletal pain and a current BZD prescription who completed an online survey study (Mage = 38.7, 38.9% female). Results indicated that pain intensity was positively associated with past-month BZD use frequency, BZD dependence severity, and likelihood of endorsing BZD misuse behaviors (ps < .05). Pain catastrophizing was positively associated with BZD dependence/likelihood of BZD misuse, covarying for pain intensity (P < .05). These findings build upon an emerging literature by highlighting positive covariation of pain intensity and pain catastrophizing with addiction-relevant BZD use behaviors. Results underscore the need to further investigate high-risk BZD use among individuals with chronic pain, with and without concurrent opioid use, to inform prevention/intervention efforts. PERSPECTIVE: This article presents findings on cross-sectional associations of pain intensity and pain catastrophizing with clinically relevant benzodiazepine (BZD) use outcomes, including dependence and misuse, among individuals with chronic pain. Findings help elucidate the higher burden of BZD misuse/dependence in chronic pain populations and suggest that pain relief may be a common, yet under recognized, self-reported motivation for taking BZDs.

Pain Intensity, Emotion Dysregulation, and Hazardous Drinking Among Adults With Chronic Pain.

OBJECTIVE: Chronic pain and hazardous alcohol use (i.e., a pattern of alcohol consumption that increases risk for harmful consequences) are prevalent and frequently comorbid conditions that have been posited to interact in a bidirectional manner, leading to greater pain and heavier drinking. Despite evidence that emotion dysregulation (i.e., difficulty modulating emotional responses when experiencing negative emotions) is independently associated with both greater pain and greater alcohol consumption, we are not aware of any previous research examining relations between emotion dysregulation, pain intensity, and hazardous alcohol use among individuals with chronic pain. METHOD: Participants included 125 past-month alcohol users with chronic musculoskeletal pain (38.4% female; mean age = 32.97 years; mean drinks/day = 1.62) who were recruited for an online survey study of pain and substance use. RESULTS: As expected, emotion dysregulation was positively associated with increased odds of hazardous alcohol use. We also observed a significant indirect association, such that higher levels of emotion dysregulation were associated with greater pain intensity, which in turn was associated with a greater likelihood of scoring above the Alcohol Use Disorders Identification Test cutoff for hazardous alcohol use. CONCLUSIONS: These findings suggest that emotion dysregulation may contribute to hazardous drinking among individuals with chronic pain, perhaps indirectly via pain amplification. Emotion dysregulation warrants consideration as a potential transdiagnostic vulnerability factor in comorbid chronic pain and hazardous drinking. Future prospective research is needed to examine causal pathways and establish temporal precedence.

Feasibility of Computerized Cognitive-Behavioral Therapy Combined With Bifrontal Transcranial Direct Current Stimulation for Treatment of Major Depression.

BACKGROUND: Cognitive behavioral therapy (CBT) is effective in the treatment of major depressive disorder (MDD). Transcranial Direct Current Stimulation (tDCS) has demonstrated preliminary antidepressant effects and beneficial effects on cognitive function. OBJECTIVE: We investigated the feasibility and acceptability of using tDCS to enhance the effects of computer-based CBT for treatment of MDD. MATERIALS AND METHODS: In a randomized, double-blind, sham-controlled study, 14 patients with MDD on stable or no pharmacotherapy received active or sham bifrontal tDCS for four weeks with concurrent CBT. RESULTS: Ten participants completed the protocol. Three withdrew from the study because of lack of efficacy or dislike of the eCBT program. One was discontinued from the protocol by the investigators. Treatment was well tolerated, and most side-effects were mild and consistent with prior tDCS research. Pooled data from both groups showed significant baseline to endpoint improvement in depression (p = 0.008). Overall percent change on the HAMD-21 was 28.98%. The study was underpowered to detect differences in tDCS treatment groups. CONCLUSIONS: Combining tDCS with computer-based CBT is feasible for MDD. Further work is needed to evaluate potential synergistic effects of combined tDCS and CBT.