Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment.

BACKGROUND: Chronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to their increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high-quality, clinician-delivered, empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap. OBJECTIVE: This study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback, compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD. METHODS: Adult participants (n=160) receiving MOUD and reporting bothersome or high-impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut (United States) and randomized 1:1 to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant-reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected through digital surveys. Outcomes will be assessed at 3, 6, and 9 months post randomization. The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semistructured qualitative interviews with study participants (n=34) randomized to IMPACT (completers and noncompleters) will be conducted to evaluate the usability and quality of the program and its outcomes. RESULTS: The study has received institutional review board approval and began recruitment at 1 site in July 2022. Recruitment at a second site started in January 2023, with a third and final site anticipated to begin recruitment in January 2024. Data collection is expected to continue through June 2025. CONCLUSIONS: Establishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD, which reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates or modifications to improve engagement and efficacy. TRIAL REGISTRATION: ClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54342.

Pre-implementation formative evaluation of cooperative pain education and self-management expanding treatment for real-world access: A pragmatic pain trial.

OBJECTIVE: Cognitive behavioral therapy for chronic pain (CBT-CP) is an evidence-based treatment for improving functioning and pain intensity for people with chronic pain with extensive evidence of effectiveness. However, there has been relatively little investigation of the factors associated with successful implementation and uptake of CBT-CP, particularly clinician and system level factors. This formative evaluation examined barriers and facilitators to the successful implementation and uptake of CBT-CP from the perspective of CBT-CP clinicians and referring primary care clinicians. METHODS: Qualitative interviews guided by the Consolidated Framework for Implementation Research were conducted at nine geographically diverse Veterans Affairs sites as part of a pragmatic clinical trial comparing synchronous, clinician-delivered CBT-CP and remotely delivered, technology-assisted CBT-CP. Analysis was informed by a grounded theory approach. RESULTS: Twenty-six clinicians (CBT-CP clinicians = 17, primary care clinicians = 9) from nine VA medical centers participated in individual qualitative interviews conducted by telephone from April 2019 to August 2020. Four themes emerged in the qualitative interviews: (1) the complexity and variability of referral pathways across sites, (2) referring clinician's lack of knowledge about CBT-CP, (3) referring clinician's difficulty identifying suitable candidates for CBT-CP, and (4) preference for interventions that can be completed from home. CONCLUSIONS: This formative evaluation identified clinician and system barriers to widespread implementation of CBT-CP and allowed for refinement of the subsequent implementation of two forms of CBT-CP in an ongoing pragmatic trial. Identification of relative difference in barriers and facilitators in the two forms of CBT-CP may emerge more clearly in a pragmatic trial that evaluates how treatments perform in real-world settings and may provide important information to guide future system-wide implementation efforts.

Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial.

BACKGROUND: Cognitive behavioral therapy for chronic pain (CBT-CP) has a strong evidence base, but little is known about when treatment benefits are achieved. The present study is a secondary analysis of individuals with chronic back pain recruited for a noninferiority trial comparing interactive voice response (IVR) CBT-CP with in-person CBT-CP. METHODS: On the basis of data from daily IVR surveys, a clinically meaningful change was defined as a 30% reduction in pain intensity (n = 108) or a 45% increase in daily steps (n = 104) compared with the baseline week. We identified individuals who achieved a meaningful change at any point during treatment, and then we compared those who maintained a meaningful change in their final treatment week (i.e., responders) with those who did not or who achieved a meaningful change but lapsed (i.e., nonresponders). RESULTS: During treatment, 46% of participants achieved a clinically meaningful decrease in pain intensity, and 66% achieved a clinically significant increase in number of steps per day. A total of 54% of patients were classified as responders in terms of decreases in pain intensity, and 70% were responders in terms of increases in step count. Survival analyses found that 50% of responders first achieved a clinically meaningful change by week 4 for pain intensity and week 2 for daily steps. Dropout and demographic variables were unrelated to responder status, and there was low agreement between the two measures of treatment response. CONCLUSIONS: Collectively, results suggest that most responders improve within 4 weeks. Evaluating treatment response is highly specific to the outcome measure, with little correlation across outcomes.

Results from the blood donor competence, autonomy, and relatedness enhancement (blood donor CARE) randomized trial.

BACKGROUND: This study aimed to promote competence, autonomy, and relatedness among first-time whole blood donors to enhance intrinsic motivation and increase retention. STUDY DESIGN AND METHODS: Using a full factorial design, first-time donors (N = 2002) were randomly assigned to a no-treatment control condition or to one of seven intervention conditions designed to promote donation competence, autonomy, relatedness, a combination of two (e.g., competence and autonomy), or all three constructs. Participants completed donor motivation measures before the intervention and 6 weeks later, and subsequent donation attempts were assessed for 1 year. RESULTS: There was no significant group difference in the frequency of donation attempts or in the number of days to return. Significant effects of group were observed for 10 of the 12 motivation measures, although follow-up analyses revealed significant differences from the control group were restricted to interventions that included an autonomy component. Path analyses confirmed direct associations between interventions involving autonomy and donor motivation, and indirect mediation of donation attempts via stronger donation intentions and lower donation anxiety. CONCLUSION: Among young, first-time, whole blood donors, brief interventions that include support for donor autonomy were associated with direct effects on donor motivation and indirect, but small, effects on subsequent donation behavior.

Co-Operative Pain Education and Self-management (COPES) Expanding Treatment for Real-World Access (ExTRA): Pragmatic Trial Protocol.

BACKGROUND: Given access barriers to cognitive behavioral therapy for chronic pain (CBT-CP), this pragmatic superiority trial will determine whether a remotely delivered CBT-CP intervention that addresses these barriers outperforms in-person and other synchronous forms of CBT-CP for veterans with musculoskeletal pain. DESIGN: This pragmatic trial compares an asynchronous form of CBT-CP that uses interactive voice response (IVR) to allow patients to participate from their home (IVR CBT-CP) with synchronous CBT-CP delivered by a Department of Veterans Affairs (VA) clinician. Veterans (n=764; 50% male) with chronic musculoskeletal pain throughout nine VA medical centers will participate. The primary outcome is pain interference after treatment (4 months). Secondary outcomes, including pain intensity, depression symptom severity, sleep, self-efficacy, and global impression of change, are also measured after treatment. Where possible, outcomes are collected via electronic health record extraction, with remaining measures collected via IVR calls to maintain blinding. Quantitative and qualitative process evaluation metrics will be collected to evaluate factors related to implementation. A budget impact analysis will be performed. SUMMARY: This pragmatic trial compares the outcomes, cost, and implementation of two forms of CBT-CP as delivered in the real-world setting. Findings from the trial can be used to guide future policy and implementation efforts related to these interventions and their use in the health system. If one of the interventions emerges as superior, resources can be directed to this modality. If both treatments are effective, patient preferences and health care system factors will take precedence when making referrals. Implications of COVID-19 on treatment provision and trial outcomes are discussed.

Pain Acceptance Partially Mediates the Relationship Between Perceived Injustice and Pain Outcomes Over 3 Months.

OBJECTIVES: Perceived injustice is a maladaptive cognitive appraisal of pain or injury, characterized by attributions of blame, unfairness, severity of loss, and irreparability of loss. Research suggests that perceived injustice may negatively affect pain outcomes by inhibiting the development of pain-related acceptance. The current study aimed to extend cross-sectional research by testing whether pain acceptance mediates the effects of perceived injustice on pain-related outcomes longitudinally. MATERIALS AND METHODS: Data was analyzed from a prospective study to examine the potential mediating role of pain acceptance on recovery 3 months after an episode of low back pain. Using Mechanical Turk, we recruited participants who experienced an episode of back pain within the preceding 2 weeks, 343 of whom completed measures of perceived injustice, pain acceptance, pain ratings, and quality of life at each of 3 timepoints (recruitment, 1 mo later, and 3 mo later). Path analyses were conducted to examine pain acceptance at 1 month as a potential mediator of the relationship between perceived injustice at recruitment and pain intensity, disability, and depressive symptoms at 3 months. RESULTS: Results indicated that perceived injustice at recruitment was directly related to pain intensity, disability, and depressive symptoms 3 months later, and that pain acceptance partially mediated these relationships. DISCUSSION: Although these findings provide further support for pain acceptance as a buffer for the deleterious effects of perceived injustice, they also highlight that adjunctive mechanisms should be investigated to provide more comprehensive clinical insight.

The Effect of Pain Resilience on Experimental Pain Experience Across Different Stimuli.

OBJECTIVE: Pain resilience, one's ability to maintain behavioral engagement and adaptively regulate cognitions and emotions despite intense or prolonged pain, has been shown to protect against negative pain-related outcomes in experimental settings. A weakness of this research, and much of experimental pain research in general, has been the lack of rationale behind the selection of noxious stimuli, which can activate different nociceptive fibers. The present study sought to determine if the relationship between pain resilience and pain ratings differed across stimuli based on the stimulated nociceptors. METHODS: Healthy undergraduate students (N = 100; mean [SD] age = 19.4 [1.2] years; 60% female) completed the Pain Resilience Scale and provided continuous pain ratings during exposure to three different tasks, each selected based on their ability to stimulate specific combinations of nociceptive fibers: pinprick (Aδ fibers), cold water immersion (Aδ and C fibers), and ischemic tourniquet (C fibers). RESULTS: Participants with high pain resilience reported lower pain ratings over time during cold water immersion than did those with low pain resilience (F(1, 39) = 8.526, p = .006); however, there was no relationship between pain resilience and pain ratings during either of the pinprick or ischemic tourniquet stimuli. CONCLUSIONS: This study provides further support for the use of multiple pain stimuli for pain assessment given their unique characteristics and concludes that outcome variables aside from pain ratings may provide additional insight into the role of resilience on pain adaptation.

Longitudinal Analysis Supports a Fear-Avoidance Model That Incorporates Pain Resilience Alongside Pain Catastrophizing.

BACKGROUND: The fear-avoidance model of chronic pain holds that individuals who catastrophize in response to injury are at risk for pain-related fear and avoidance behavior, and ultimately prolonged pain and disability. PURPOSE: Based on the hypothesis that the predictive power of the fear-avoidance model would be enhanced by consideration of positive psychological constructs, the present study examined inclusion of pain resilience and self-efficacy in the model. METHODS: Men and women (N = 343) who experienced a recent episode of back pain were recruited in a longitudinal online survey study. Over a 3-month interval, participants repeated the Pain Resilience Scale, Pain Catastrophizing Scale, Tampa Scale of Kinesiophobia, Pain Self-Efficacy Questionnaire, the McGill Pain Questionnaire, and NIH-recommended measures of pain, depressive symptoms, and physical dysfunction. Structural equation modeling assessed the combined contribution of pain resilience and pain catastrophizing to 3-month outcomes through the simultaneous combination of kinesiophobia and self-efficacy. RESULTS: An expanded fear-avoidance model that incorporated pain resilience and self-efficacy provided a good fit to the data, Χ2 (df = 14, N = 343) = 42.09, p = .0001, RMSEA = 0.076 (90% CI: 0.05, 0.10), CFI = 0.97, SRMR = 0.03, with higher levels of pain resilience associated with improved 3-month outcomes on measures of pain intensity, physical dysfunction, and depression symptoms. CONCLUSIONS: This study supports the notion that the predictive power of the fear-avoidance model of pain is enhanced when individual differences in both pain-related vulnerability (e.g., catastrophizing) and pain-related protective resources (e.g., resilience) are considered.

Enhancing Motivation for Change in the Management of Chronic Painful Conditions: a Review of Recent Literature.

PURPOSE OF REVIEW: The purpose of this review is to evaluate and summarize recent empirical research investigating motivational factors for management of chronic pain and headache disorders. RECENT FINDINGS: Research on motivation for non-pharmacological treatment of chronic pain and headache disorders has identified factors that influence initiation of and adherence to treatment. To address common factors that inhibit initiation of treatment (i.e., cost, time commitment), several electronic treatments have been developed. Self-efficacy is the most commonly studied psychosocial influence on treatment adherence, with evidence that it is positively correlated with adherence. Other studies have sought to improve adherence to treatment using motivational interviewing interventions. There is currently limited research on how to enhance motivation for initial adherence to non-pharmacological treatment for chronic pain and headache disorders. Instead of enhancing motivation, researchers have looked to reduce barriers to treatment with electronic health treatments; however, many of these studies have focused on intervention feasibility, rather than efficacy or effectiveness. Numerous studies have identified a relationship between self-efficacy and treatment adherence. Although motivational interviewing interventions have been shown to improve adherence to treatment, there is little evidence that they improve treatment outcomes. Recommendations for further investigation include improving interventions to enhance accessibility and adherence to treatment with the goal of improving outcomes, as well as identifying ways to improve treatment initiation and adherence in patients who are currently engaged in long-term opioid therapy.

An automated motivational interview promotes donation intention and self-efficacy among experienced whole blood donors.

BACKGROUND: Interventions intended to motivate donors to return can be costly and time consuming. The current study examined the effect of a Web-based automated interview, informed by motivational interviewing and self-determination theory, on donor intention, motivation, and behavior in a sample of highly experienced donors. STUDY DESIGN AND METHODS: Approximately 1 week after donating, 1177 highly experienced whole blood donors (mean prior donations, 35.5; mean age, 46.9 years; 66.3% female) participated in a study in which they were randomly assigned to either a donor motivational interview (n = 544) or knowledge interview (n = 633). Measures of donor motivation and psychological need support were obtained before the interviews, and again at postinterview assessments conducted approximately 2 days later and 7 weeks later. Blood center records were used to assess repeat donation attempts for 1 year after the interviews. RESULTS: Relative to the knowledge interview, participants in the motivational interview had larger increases in donation intention and self-efficacy from preinterview to the first follow-up. Among women only, the motivational interview was associated with greater competence and relatedness increases at both follow-up assessments. CONCLUSION: An automated motivational interview appears to be a feasible way to promote donation intention and self-efficacy. Although the observed effects were small among highly experienced donors, we are currently assessing the potential effect of this intervention among less experienced donors.

The working alliance and Clinician-assisted Emotional Disclosure for rheumatoid arthritis.

OBJECTIVES: The working alliance predicts improvement following general psychotherapy, but how it operates in brief interventions conducted with medically ill patients is unknown. Also, the role of the working alliance may differ in emotion-focused versus educational interventions. METHODS: We report secondary analyses of a randomized clinical trial (Keefe et al.) [35], in which patients with rheumatoid arthritis (RA) received four nurse-provided sessions of either a) Clinician-assisted Emotional Disclosure (CAED), which emphasized the disclosure, expression, and processing of emotions related to stressful events; or b) Arthritis Education (AE), which provided basic education about RA. The Working Alliance Inventory was completed by both patient and nurse after each session. Patients were evaluated on multiple health measures at baseline and 1, 3, and 12months post-treatment. RESULTS: Analyses compared the alliance between interventions and related the alliance to outcomes within interventions. Patients in CAED reported a lower alliance than patients in AE. Interestingly, in CAED, lower alliance ratings predicted better outcomes (improved functioning, lower pain behaviors, lower inflammation, lower daily stress), whereas in AE, the working alliance was largely not predictive of outcomes. CONCLUSION: Having nurses encourage emotional disclosure among patients with RA reduced the patients' working alliance, but a lower alliance nonetheless predicted better patient outcomes, perhaps reflecting successful engagement in an intervention that is emotionally and relationally challenging. The level and predictive validity of the working alliance likely depends on patient, provider, and intervention factors, and further study of the working alliance in psychosocial interventions in the medical context is needed.

A motivational interview promotes retention of blood donors with high internal motivation.

BACKGROUND: Based on the hypothesis that self-determined motivation is associated with an increased likelihood of future behavior, the present study examined the ability of a motivational interview to promote internal motivation for giving blood and future donation attempts. STUDY DESIGN AND METHODS: A sample of 484 recent whole-blood and double red blood cell donors (62.4% female; age = 30.2 ± 11.8 years) were randomly assigned to either a telephone-delivered motivational interview or a control call approximately 6 weeks after donating. Several weeks before the call and again 1 week after the call, participants completed the Blood Donor Identity Survey, a multidimensional measure of donor motivation, to derive indices of amotivation, external motivation, and internal motivation to give blood. Repeat donation attempts were tracked using blood center records. RESULTS: Relative to controls, participants in the motivational interview group showed a shift toward more self-determined motivation, as indicated by significant decreases in amotivation (p = 0.01) and significant increases in external (p = 0.009) and internal (p = 0.002) motivation. Furthermore, those with initially high levels of autonomous motivation were more likely to make a donation attempt in the subsequent year if they completed the motivational interview (71.1%) versus the control call (55.1%). CONCLUSION: Motivational interviewing is a potentially useful strategy to enhance retention of existing blood donors, particularly among those who express a greater sense of internal motivation for giving.

Validation of the Pain Resilience Scale in a Chronic Pain Sample.

Psychosocial factors that protect against negative outcomes for individuals with chronic pain have received increased attention in recent years. Pain resilience, or the ability to maintain behavioral engagement and regulate emotions as well as cognitions despite prolonged or intense pain, is one such factor. A measure of pain-specific resilience, the Pain Resilience Scale, was previously identified as a better predictor of acute pain tolerance than general resilience. The present study sought to validate this measure in a chronic pain sample, while also furthering understanding of the role of pain resilience compared with other protective factors. Participants with chronic pain completed online questionnaires to assess factors related to positive pain outcomes, pain vulnerability, pain intensity, and quality of life. A confirmatory factor analysis confirmed the 2-factor structure of the Pain Resilience Scale previously observed among respondents without chronic pain, although one item from each subscale was dropped in the final version. For this chronic pain sample, structural equation modeling showed that pain resilience contributes unique variance to a model including pain acceptance and pain self-efficacy in predicting quality of life and pain intensity. Further, pain resilience was a better fit in this model than general resilience, strengthening the argument for assessing pain resilience over general resilience. PERSPECTIVE: A modified version of the Pain Resilience Scale retained the original factor structure when tested in a chronic pain sample. Construct validity was supported by expected relationships with pain-related protective and vulnerability measures. Further, a model including positive pain constructs showed that pain resilience accounts for unique variability when predicting quality of life and pain intensity.

A brief motivational interview with action and coping planning components enhances motivational autonomy among volunteer blood donors.

BACKGROUND: In contrast to standard donor retention strategies (e.g., mailings, phone calls, text messages), we developed a brief telephone interview, based on motivational interviewing principles, that encourages blood donors to reflect upon their unique motivators and barriers for giving. This study examined the effect of this motivational interview, combined with action and coping plan components, on blood donor motivations. STUDY DESIGN AND METHODS: The design was to randomly assign blood donors to receive either a telephone-delivered motivational interview with action and coping plan components or a control call approximately 6 weeks after their most recent donation. Participants completed a series of surveys related to donation motivation approximately 3 weeks before telephone contact (precall baseline) and then repeated these surveys approximately 1 week after telephone contact (postcall). RESULTS: The sample was 63% female, included a majority (52.6%) of first-time blood donors, and had a mean age of 30.0 years (SD, 11.7 years). A series of analyses of variance revealed that, relative to controls (n = 244), donors in the motivational interview group (n = 254) had significantly larger increases in motivational autonomy (p = 0.001), affective attitude (p = 0.004), self-efficacy (p = 0.03), anticipated regret (p = 0.001), and intention (p = < 0.001), as well as larger decreases in donation anxiety (p = 0.01), from precall baseline to postcall assessment. CONCLUSION: This study supports motivational interviewing with action and coping planning as a novel strategy to promote key contributors to donor motivation.

Development and Initial Validation of the Pain Resilience Scale.

UNLABELLED: Over the past decade, the role of positive psychology in pain experience has gained increasing attention. One such positive factor, identified as resilience, has been defined as the ability to maintain positive emotional and physical functioning despite physical or psychological adversity. Although cross-situational measures of resilience have been shown to be related to pain, it was hypothesized that a pain-specific resilience measure would serve as a stronger predictor of acute pain experience. To test this hypothesis, we conducted a series of studies to develop and validate the Pain Resilience Scale. Study 1 described exploratory and confirmatory factor analyses that support a scale with 2 distinct factors, Cognitive/Affective Positivity and Behavioral Perseverance. Study 2 showed test-retest reliability and construct validity of this new scale, including moderate positive relationships with measures of positive psychological functioning and small to moderate negative relationships with vulnerability measures such as pain catastrophizing. Finally, consistent with our initial hypothesis, study 3 showed that the Pain Resilience Scale is more strongly related to ischemic pain responses than existing measures of general resilience. Together, these studies support the predictive utility of this new pain-specific measure of resilience in the context of acute experimental pain. PERSPECTIVE: The Pain Resilience Scale represents a novel measure of Cognitive/Affective Positivity and Behavioral Perseverance during exposure to noxious stimuli. Construct validity is supported by expected relationships with existing pain-coping measures, and predictive validity is shown by individual differences in response to acute experimental pain.