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.

Efficacy of a Self-Hypnotic Relaxation App on Pain and Anxiety in a Randomized Clinical Trial: Results and Considerations on the Design of Active and Control Apps.

Despite an explosion of mobile app offerings for management of pain and anxiety, the evidence for effectiveness is scarce. Placebo-controlled trials are the most desirable but designing inactive placebo apps can be challenging. For a prospective randomized clinical trial with 72 patients in a craniofacial pain center, we created an app with self-hypnotic relaxation (SHR) for use with iOS and Android systems. A placebo background audio (BA) app was built with the same look and functionality. Both iOS and Android SHR apps alone and in comparison to the BA group significantly reduced pain and anxiety during the waiting-room time. The Android BA app significantly reduced anxiety but not pain. The iOS BA app affected neither pain nor anxiety, functioning as an ideal placebo. Usage analysis revealed that different default approaches of the iOS and Android devices accounted for the difference in results.

Sustainability of Improvements in Adaptive Coping Following Mind-Body and Activity Training for Chronic Pain.

BACKGROUND: The strategies patients use to cope with chronic pain are key determinants of pain-related treatment outcomes and are often targeted in psychosocial interventions for chronic pain. However, improvements in coping often fade after intervention completion. Here, we test whether previously reported improvements in coping following two novel mind-body and activity interventions are maintained 3 months after completion. METHODS: Eighty-two patients with heterogeneous chronic pain were randomized to two identical mind-body and activity interventions, one with the addition of a Fitbit device (GetActive-Fitbit) and one without it (GetActive; n = 41 each). Participants completed measures of pain-catastrophizing, kinesiophobia, mindfulness, adaptive coping, and pain-resilience at baseline, post-intervention, and at 3-month follow-up. RESULTS: At follow-up, participants in both groups exhibited sustained improvements in all five coping measures compared to baseline (significant in both groups for all measures except for p = .05 in kinesiophobia in GetActive and p = .07 in pain resilience in GetActive-Fitbit). CONCLUSIONS: Overall, GetActive and GetcActive-Fitbit are promising interventions to sustainably improve coping with chronic pain. TRIAL REGISTRATION: This trial is registered under ClinicalTrials.gov identifier NCT03412916.

Getting Active Mindfully: Rationale and Case Illustration of a Group Mind-body and Activity Program for Chronic Pain.

Chronic pain is associated with substantial decreases in physical and emotional health. Psychosocial and physical restoration interventions, although potentially helpful, typically show small-to-moderate improvements that are limited to the short term, and often exhibit problematic adherence. Here, we present GetActive-Fitbit, a novel 10-week group program that integrates mind-body skills, pain coping and gradual increases in activity reinforced by a commercially available digital monitoring device (Fitbit). We illustrate the program among a group of 4 adults with heterogeneous chronic pain. We also highlight pre to post-program improvements in physical function (objective, performance-based and self-report), emotional function (depression and anxiety) and other relevant outcomes targeted by the program (e.g., pain intensity, catastrophizing, mindfulness, coping, kinesiophobia, emotional support, social isolation, pain resilience, program satisfaction and impression of change). Group participants' experiences suggest that GetActive-Fitbit is credible, useful, and shows potential to improve physical and emotional function among this challenging population.Clinical trial number: NCT03412916.

Physical functioning and mindfulness skills training in chronic pain: a systematic review.

PURPOSE: The importance of improved physical function as a primary outcome in the treatment of chronic pain is widely accepted. There have been limited attempts to assess the effects mindfulness skills training (MST) has on objective outcomes in chronic pain care. METHODS: This systematic review evaluated published reports of original randomized controlled trials that described physical function outcomes after MST in the chronic pain population and met methodological quality according to a list of predefined criteria. PRISMA criteria were used to identify and select studies, and assess their eligibility for inclusion. The established guidelines for best practice of systematic reviews were followed to report the results. RESULTS: Of the 2,818 articles identified from the original search of four electronic databases, inclusionary criteria were met by 15 studies published as of August 10, 2015, totaling 1,199 patients. All included studies used self-report measures of physical function, and only two studies also employed performance-based measures of function. There were wide variations in how physical function was conceptualized and measured. Although the quality of the studies was rated as high, there was inconclusive evidence for improvement in physical function assessed by self-report due to contradiction in individual study findings and the measures used to assess function. Strong evidence for lack of improvement in physical function assessed via performance-based measures was found. CONCLUSION: This review draws attention to the importance of having a unified approach to how physical function is conceptualized and assessed, as well as the importance of using quality performance-based measures in addition to subjective self-reports that appropriately assess the physical function construct within MSTs for chronic pain.

Cannabis for the Treatment of Chronic Pain in the Era of an Opioid Epidemic: A Symposium-Based Review of Sociomedical Science.

OBJECTIVE: This manuscript reviews medical literature published pertaining to the management of chronic pain with medical marijuana therapy (MMJ), with an emphasis on the social, medical, and legal aspects of therapy. DESIGN: Narrative review of peer-reviewed literature. METHODS: The 3rd Symposium on Controlled Substances and Their Alternatives for the Treatment of Pain was held in Boston on February 27, 2016, with a focus on MMJ for the treatment of chronic pain. Invited speakers had diverse backgrounds, including pain management, addiction psychiatry, neurology, and legal authorities. The purpose of this conference and this subsequent narrative review is to provide a medical, legal, and logistical framework for physicians and other health care providers to refer to when considering the initiation of medical marijuana therapy. RESULTS: The invited speakers each covered a unique aspect of MMJ therapy for the treatment of chronic pain. These presentations highlighted the current data for and against the use of MMJ as a pain therapy. Optimal patient selection and screening, in addition to policy developments, were discussed. CONCLUSIONS: Increasing interest in MMJ for chronic pain underscores a need for primary care and pain physicians to better understand the indications and evidence for its use free from cultural bias. Given a lack of full conclusive clinical utility, continued research is needed to better understand how to best utilize MMJ therapy for the treatment of chronic pain. Policy initiatives, such as enumerated indications, should follow medical science in order to prevent another abused substance epidemic.

The Association Between Cannabis Use and Aberrant Behaviors During Chronic Opioid Therapy for Chronic Pain.

Objective: Health care providers are likely to see an increase in the concomitant use of cannabis and opioids, particularly with the increased liberalization and ongoing research into the possible role of medical marijuana for chronic pain. Recent literature reports a prevalence of concurrent use ranging from 8.9% to 31.8%. The primary aim of this study was to determine the relationship between cannabis use and aberrant drug behaviors in noncancer pain patients receiving chronic opioid therapy. Design: Retrospective chart review. Setting: Community-based, interdisciplinary pain management center. Subjects: Data from 209 patients who were evaluated for a medication management program between October 1, 2011, and January 1, 2014, and met inclusion criteria. Forty-four were positive for cannabis in their initial random urine drug toxicology. Methods: Data from electronic health records, including demographics, urine drug toxicology, disability, opioid dose, opioid risk assessment data, and pain severity were analyzed to examine differences among cannabis users and noncannabis users. Results: Subjects with cannabis in their initial urine drug toxicology were more likely to have a future occurrence of an opioid-related aberrancy (P < 0.001), be male (P = 0.047), have a history of substance abuse (P = 0.013), and be enrolled into a higher level of clinical monitoring of opioid medication use (P = 0.008). No other associations with demographic and clinical variables reached statistical significance. Conclusions: Concurrent use of cannabis and opioids by patients with chronic pain appears to indicate higher risk for opioid misuse. Closer monitoring for opioid-related aberrancy is indicated for this group of patients.

A Randomized Controlled Pilot Study on Mindfulness-Based Cognitive Therapy for Unipolar Depression in Patients With Chronic Pain.

OBJECTIVE: Chronic pain is a disabling illness, often comorbid with depression. We performed a randomized controlled pilot study on mindfulness-based cognitive therapy (MBCT) targeting depression in a chronic pain population. METHOD: Participants with chronic pain lasting ≥ 3 months; DSM-IV major depressive disorder (MDD), dysthymic disorder, or depressive disorder not otherwise specified; and a 16-item Quick Inventory of Depressive Symptomatology-Clinician Rated (QIDS-C16) score ≥ 6 were randomly assigned to MBCT (n = 26) or waitlist (n = 14). We adapted the original MBCT intervention for depression relapse prevention by modifying the psychoeducation and cognitive-behavioral therapy elements to an actively depressed chronic pain population. We analyzed an intent-to-treat (ITT) and a per-protocol sample; the per-protocol sample included participants in the MBCT group who completed at least 4 of 8 sessions. Changes in scores on the QIDS-C16 and 17-item Hamilton Depression Rating Sale (HDRS17) were the primary outcome measures. Pain, quality of life, and anxiety were secondary outcome measures. Data collection took place between January 2012 and July 2013. RESULTS: Nineteen participants (73%) completed the MBCT program. No significant adverse events were reported in either treatment group. ITT analysis (n = 40) revealed no significant differences. Repeated-measures analyses of variance for the per-protocol sample (n = 33) revealed a significant treatment × time interaction (F1,31 = 4.67, P = .039, η²p = 0.13) for QIDS-C16 score, driven by a significant decrease in the MBCT group (t18 = 5.15, P < .001, d = >1.6), but not in the control group (t13 = 2.01, P = .066). The HDRS17 scores did not differ significantly between groups. The study ended before the projected sample size was obtained, which might have prevented effect detection in some outcome measures. CONCLUSIONS: MBCT shows potential as a treatment for depression in individuals with chronic pain, but larger controlled trials are needed. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01473615.