ANF therapy® for pain management, feasibility, satisfaction, perceived symptom reduction and side effects: a real-world multisite observational study.

[Purpose] Non-invasive and drug-free interventions for pain are being developed. One of them is ANF (which stands for "Amino Neuro Frequency") Therapy®, which consists in the application of carbonized metal devices on a patient's skin. We aimed to: 1) test perceived changes in pain intensity after ANF application, 2) record frequency and severity of side effects, 3) assess clinician and patient satisfaction, 4) explore effects on swelling and range of motion (ROM). [Participants and Methods] In this real-world multisite observational study, N=113 physical therapists in 45 countries, applied ANF to N=1,054 patients (Mage=45.2, 56.2% female) with pain complaints. Demographic data, pain intensity (NRS-11), effects of ANF on swelling and ROM, clinician and patient satisfaction and side effects were collected. [Results] Main pain locations were: low back (14.9%), knee (12.4%), neck (10%), and shoulder (9.6%). Pre-treatment pain intensity was high (Mean=7.6, SD=1.9). It significantly decreased post-treatment (Mean=3.1, SD=2.0), t(1053)=7.25, with a large effect size (Cohen's d=2.2). Swelling decreased and ROM increased. Average satisfaction with ANF was 92/100. Patients often experienced mild side effects (42.3%): dry mouth, headache and fatigue. [Conclusion] Results show large effect sizes, high satisfaction, and mild and short-term side effects. This is very promising but should be interpreted with caution considering the study limitations.

Development and Validation of the Adolescent Insomnia Questionnaire.

OBJECTIVE: Insomnia is a highly prevalent sleep disorder that is particularly common among adolescents with health conditions. We aimed to develop and validate a brief screening measure of insomnia in adolescents that can be used across clinical and community samples. We hypothesized that we would identify evidence supporting reliability, convergent/discriminant validity, and that we would determine preliminary clinical cutoff scores. METHODS: A team of experts in behavioral sleep medicine developed a 13-item brief screening measure of insomnia in adolescents (Adolescent Insomnia Questionnaire [AIQ]). We evaluated the psychometric properties of the AIQ in a sample of 315 youth (11-18 years old, Mean = 14.90, SD = 2.02; 64% female) who had chronic pain (n = 37), headache (n = 170), insomnia diagnosed by a sleep specialist (n = 22), or were otherwise healthy (n = 86). RESULTS: Using Exploratory and Confirmatory Factor Analysis, we identified three subscales consistent with major diagnostic criteria of insomnia. As expected, the measure showed strong reliability through high internal consistency (α =.91). We also found strong convergent validity through expected positive relationships between the AIQ and self-report measures of sleep disturbance, and divergent validity via weak relationships with parent-report of snoring. Results of receiver operating characteristic (ROC) identified a clinical cutoff score that may assist in clinical decision making. CONCLUSIONS: We found that the AIQ has sound psychometric properties in a large heterogeneous sample of treatment-seeking youth and youth from the community. The AIQ can quickly screen adolescent insomnia and could address an important clinical need in identifying youth in need of insomnia treatment in pediatric practice settings.

Pain-Related Activity Management Patterns as Predictors of Treatment Outcomes in Patients with Fibromyalgia Syndrome.

OBJECTIVES: This study sought to determine if pre- to post-treatment changes in pain-related activity patterns (i.e., overdoing, avoidance, and pacing) were associated with pre- to post-treatment changes in function (i.e., pain interference, psychological function, and physical function) in patients with fibromyalgia syndrome who participated in either an operant learning- or an energy conservation-based training in activity management. METHODS: Sixty-nine patients with fibromyalgia syndrome participated in an activity management treatment (32 in an operant learning group and 37 in an energy conservation group). Outcomes were assessed at pre- and post-treatment, and patients provided demographic information and completed measures assessing pain intensity, pain interference, psychological function, physical function, and pain management activity patterns. Three linear hierarchical regression analyses predicting changes in pain outcomes from changes in pacing, overdoing, and avoidant activity patterns were performed. RESULTS: Changes in pain-related activity patterns made significant contributions to the prediction of changes in patients' function. Specifically: (a) increases in overdoing predicted reductions in pain interference; (b) decreases in avoidance predicted improvements in psychological function; and (c) increases in pacing predicted improvements in physical function. CONCLUSIONS: This study provides support for a role of activity management treatments in improved adjustment to chronic pain. Research is needed to replicate and extend these findings in order to build an empirical basis for developing more effective chronic pain treatments for facilitating improved physical and psychological function in individuals with chronic pain.

Assessing Digital Health Implementation for a Pediatric Chronic Pain Intervention: Comparing the RE-AIM and BIT Frameworks Against Real-World Trial Data and Recommendations for Future Studies.

BACKGROUND: Digital health interventions have demonstrated efficacy for several conditions including for pediatric chronic pain. However, the process of making interventions available to end users in an efficient and sustained way is challenging and remains a new area of research. To advance this field, comprehensive frameworks have been created. OBJECTIVE: The aim of this study is to compare the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Behavior Interventions using Technology (BIT) frameworks with data collected from the web-based management of adolescent pain (WebMAP Mobile; WMM) randomized controlled trial (RCT). METHODS: We conducted a hybrid effectiveness-implementation cluster RCT with a stepped wedge design in which the intervention was sequentially implemented in 8 clinics, following a usual care period. Participants were 143 youths (mean age 14.5 years, SD 1.9; 117/143, 81.8% female) with chronic pain, from which 73 were randomized to receive the active intervention. Implementation outcomes were assessed using the RE-AIM and BIT frameworks. RESULTS: According to the RE-AIM framework, the WMM showed excellent reach, recruiting a sample 19% larger than the size originally planned and consenting 79.0% (143/181) of eligible referred adolescents. Effectiveness was limited, with only global impression of change showing significantly greater improvements in the treatment group; however, greater treatment engagement was associated with greater reductions in pain and disability. Adoption was excellent (all the invited clinics participated and referred patients). Implementation was acceptable, showing good user engagement and moderate adherence and positive attitudes of providers. Costs were similar to planned, with a 7% increase in funds needed to make the WMM publicly available. Maintenance was evidenced by 56 new patients downloading the app during the maintenance period and by all clinics agreeing to continue making referrals and all, but one, making new referrals. According to the BIT, 82% (60/73) of adolescents considered the treatment acceptable. In terms of adoption, 93% (68/73) downloaded the app, and all of them used it after their first log-in. In terms of appropriateness at the user level, 2 participants were unable to download the app. Perceptions of the appearance, navigation, and theme were positive. Providers perceived the WMM as a good fit for their clinic, beneficial, helpful, and resource efficient. In terms of feasibility, no technical issues were reported. In terms of fidelity, 40% (29/73) completed the treatment. Implementation costs were 7% above the budget. With regard to penetration, 56 new users accessed the app during the maintenance period. In terms of sustainability, 88% (7/8) of clinics continued recommending the WMM after the end of the study. CONCLUSIONS: For the first time, a real-world digital health intervention was used as a proof of concept to test all the domains in the RE-AIM and BIT frameworks, allowing for comparisons. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.cct.2018.10.003.

Committed Action, Disability and Perceived Health in Individuals with Fibromyalgia.

Committed action, one of the components of psychological flexibility, has been shown to be related with measures of pain-relevant function domains in patients with chronic pain. However, the associations between measures of committed action and of physical health and function in individuals with fibromyalgia (FM) have not yet been examined. The aim of the present cross-sectional study was to better understand the role that committed action plays in (1) pain-related disability and (2) mental and physical health in individuals with FM. One hundred twenty-nine adult females with a diagnosis of FM from a rheumatologist were administered measures of committed action, disability, physical health, and mental health. After controlling for age and pain intensity, committed action explained an additional 24% of the variance of pain disability, 39% of the variance of physical health, and 41% of the variance of mental health. This study provides important new information on the associations between a measure of committed action and perceived health and function in a sample of women with FM. The findings are also consistent with the psychological flexibility model for understanding pain and its impact in patients with FM.

The Role of Sleep Quality and Fatigue on the Benefits of an Interdisciplinary Treatment for Adults With Chronic Pain.

BACKGROUND: Interdisciplinary chronic pain treatment is effective for reducing pain intensity and pain-related disability, and for improving psychological function. However, the mechanisms that underlie these treatment-related benefits are not yet well understood. Sleep problems and fatigue are modifiable factors often comorbid with chronic pain. The goal of this study was to evaluate the role that changes in sleep quality and fatigue might have on the benefits of an interdisciplinary chronic pain treatment. METHODS: A total of 125 adults with chronic pain participated in a 4-week interdisciplinary pain management program. Measures of depression, sleep disturbance, fatigue, pain intensity, and physical function were administered at pre- and post-treatment. Three regression analyses were conducted to evaluate the contribution of pre- to post-treatment improvements in fatigue and sleep disturbance to the pre- to post-treatment improvements in pain intensity, disability, and depression, while controlling for demographic characteristics (age and sex) and pain intensity. RESULTS: Changes in fatigue and sleep disturbance made independent and significant contributions to the prediction of treatment-related benefits in pain intensity; improvements in depressive symptoms were predicted by improvements in fatigue, and improvements in disability were only predicted by pre-treatment and pre- to post-treatment decreases in pain intensity (one of the control variables). CONCLUSIONS: In addition to sleep, fatigue emerged as a key potential mechanism of multidisciplinary chronic pain treatment-related improvements, suggesting that interventions including elements that effectively target sleep and fatigue may enhance the efficacy of interdisciplinary chronic pain programs. This possibility should be evaluated in future research.

Chronic pain prevalence and associated factors in adolescents with and without physical disabilities.

AIM: Adolescents with physical disabilities may have co-occurring chronic pain, but the prevalence and specific associated factors are unknown. The aims of this study were to determine (1) the prevalence of chronic pain in adolescents with physical disabilities and (2) whether known correlates of chronic pain in the general population are also present in young people both with physical disability and with chronic pain relative to peers. METHOD: We conducted a secondary analysis of cross-sectional nationally representative data from the National Longitudinal Study of Adolescent to Adult Health. Multivariate linear regression analysis was used to identify demographic and psychosocial factors associated with chronic pain. RESULTS: A total of 989 (4.3%) adolescents reported physical disabilities. They had a significantly higher rate of pain (27.2%) compared with able-bodied peers (15.6%, χ2 =86.3550, p<0.001). There was no significant interaction between physical disability status and chronic pain in relation to depressive symptoms, anxiety, or insomnia. INTERPRETATION: Adolescents with physical disabilities experience chronic pain at a significantly higher rate than able-bodied peers, but the comorbidity of physical disability and chronic pain is not related to depression, anxiety, or insomnia. Evaluation of chronic pain and tailored pain interventions need to be developed for this population. WHAT THIS PAPER ADDS: Chronic pain and its correlates are important problems for adolescents with physical disabilities. These adolescents present with higher rates of chronic pain than other young people. Chronic pain is associated with increased levels of depressive symptoms, anxiety, and insomnia regardless of disability status.

Pain catastrophizing, activity engagement and pain willingness as predictors of the benefits of multidisciplinary cognitive behaviorally-based chronic pain treatment.

Pain catastrophizing and pain acceptance have been shown to be associated with improvements after participation in cognitive behaviorally-based treatment (CBT) for chronic pain. However, it is not yet clear how important each of these factors is relative to the other. Furthermore, it is also not clear if multidisciplinary pain treatment has the same impact on the two primary dimensions of pain acceptance (activity engagement and pain willingness), and whether their role in explaining treatment outcome differs as a function of the outcomes under study. The aim of this study was to examine the relative importance of changes in pain catastrophizing, activity engagement and pain willingness as predictors of the benefits of a multidisciplinary CBT for chronic pain. 186 adults with chronic pain participated. Pain catastrophizing and activity engagement, but not pain willingness, were significantly associated with treatment outcome. Moreover, each one evidenced different patterns of associations with outcomes. Specifically, while changes in both were associated with improvements in depressive symptoms, only catastrophizing was associated with improvements in pain intensity and only activity engagement was associated with improvements in pain-related disability.

Pain Extent, Pain Intensity, and Sleep Quality in Adolescents and Young Adults.

OBJECTIVES: Pain has been shown to be associated with poor sleep quality. The aim of this study was to better understand the role that pain intensity and pain extent (number of painful areas) may play in the sleep quality of young people with acute and chronic pain. DESIGN: Cross-sectional survey. SETTING AND PATIENTS: A convenience sample of adolescents and young adults with acute or chronic pain; 414 individuals ages 12 to 24 (44% with chronic pain). METHODS: We performed a hierarchical regression analysis with sleep as the dependent variable and pain intensity, extent, age and pain chronicity as predictors. RESULTS: Pain extent and pain intensity made significant and independent contributions to the prediction of sleep quality (ßs = 0.23 [P < 0.001] and 0.14 [P < 0.01]). Young adults reported poorer sleep than adolescents (ß = 0.13, P < 0.01). Two significant interactions emerged: age × intensity (ß = 0.39, P < 0.05) and chronicity × intensity (ß = 0.88, P < 0.001). CONCLUSIONS: Sleep quality in young people could be improved by teaching them strategies to better manage pain intensity and pain extent. Clinical trials to evaluate the efficacy of (and best timing for) pain interventions to improve sleep quality are warranted.

AN APP for the Assessment of Pain Intensity: Validity Properties and Agreement of Pain Reports When Used with Young People.

OBJECTIVE: Painometer is a mobile application that includes four pain intensity scales: the Numerical Rating Scale, the Faces Pain Scale-Revised, the mechanical visual analogue scale and the Colored Analogue Scale. The aim of this study was to analyze the validity and agreement of the intensity reports provided by these scales and their traditional counterparts. METHODS: Participants were 180 young people (mean age = 14.88; SD= 1.64; age range: 12-19). They were asked to report the maximum intensity of their most frequent pain in the previous three months using traditional and electronic versions of the scales. They also reported their level of fatigue and pain catastrophizing. Construct validity was evaluated by confirmatory factor analysis (CFA) and by convergent and discriminant validity. Criterion validity was assessed as concurrent validity. Agreement was calculated using the Bland and Altman method. Analyses were conducted for two confidence intervals (CI): 95% and 80%. RESULTS: CFA demonstrated that the four electronic versions of the scales measure a single factor. All the scales showed a) moderate to high convergent validity, b) adequate discriminant validity with fatigue ratings, and c) adequate concurrent validity with pain catastrophizing ratings. Results also show that traditional and electronic versions of the four scales are in agreement, at least at the 80% CI. CONCLUSIONS: Our results demonstrate that pain intensity scores reported with the scales in Painometer are valid, and concordant with their traditional counterparts.

Assessment of pain intensity in clinical trials: individual ratings vs composite scores.

OBJECTIVES: To evaluate the reliability of findings suggesting that composite scores made up of just two ratings of recalled pain may be adequately reliable and valid for assessing outcome in pain clinical trials. DESIGN: Secondary analyses of data from a study where the responsivity of the outcome measures was a critical concern; that is, a study with few subjects testing the effects of a treatment that had only modest effects. Ten adults with spinal cord injury rated four domains of pain intensity (current pain and 24-hour recalled worst, least, and average pain) on four occasions before and after 12 sessions of neurofeedback treatment. We evaluated the reliability and validity of four single ratings and 16 different composite scores. RESULTS: None of the single-item scales performed adequately. However, composite scores made up of two items or more yielded consistent effect size estimates. CONCLUSIONS: The findings provide additional evidence that two-item composite scores may be adequate for assessing the primary outcome of pain intensity in chronic pain clinical trials. Additional research is needed to further establish the generalizability of these findings.

The Number of Ratings Needed for Valid Pain Assessment in Clinical Trials: Replication and Extension.

OBJECTIVES: To provide additional empirical findings regarding the number of pain ratings needed to obtain valid measures for assessing outcomes in pain clinical trials. DESIGN: Secondary analyses of data from a clinical study examining the effects of psychological treatments on pain. Eleven adults with multiple sclerosis and chronic pain reported on four domains of pain intensity (current pain and 24-hour recalled worst, least, and average pain) on four occasions before and after receiving 16 sessions of psychological pain treatments. We evaluated the reliability and validity of four single ratings and 16 different composite scores. RESULTS: Many of the single pain ratings were inadequately reliable while almost all of the composite scores, including the scores created from two ratings, evidenced adequate to excellent reliability. There was a noticeable increase in validity (ability to detect treatment effects) as the number of ratings used increased from one to two. However, there was little change in the validity as the number of items used to create composite scores increased from 2 to 3 or more. The findings also indicated that the scores assessing recalled worst pain were more valid than the scores assessing any of the other pain intensity domains. CONCLUSIONS: Composite pain intensity scores created from two individual ratings of recalled pain appear to be adequately valid for detecting treatment effects. Moreover, the findings indicate that the selection of the pain intensity domain to use as a primary outcome variable may play a more important role than increasing reliability by obtaining more assessments; specifically, ratings of recalled worst pain may be more valid for detecting treatment effects than ratings of average pain.

Optimizing Pain Intensity Assessment in Clinical Trials: How Many Ratings are Needed to Best Balance the Need for Validity and to Minimize Assessment Burden?

Pain intensity is the most commonly used outcome domain in pain clinical trials. To minimize the chances of type II error (ie, concluding that a treatment does not have beneficial effects, when in fact it does), the measure of pain intensity used should be sensitive to changes produced by effective pain treatments. Here we sought to identify the combination of pain intensity ratings that would balance the need for reliability and validity against the need to minimize assessment burden. We conducted secondary analyses using data from a completed 4-arm clinical trial of psychological pain treatments (N = 164 adults). Current, worst, least, and average pain intensity in the past 24 hours were assessed 4 times before and after treatment using 0 to 10 numerical rating scale-11. We created a variety of composite scores using these ratings and evaluated their reliability (Cronbach's alphas) and validity (ie, associations with a gold standard score created by averaging 16 ratings and sensitivity for detecting between-group differences in treatment efficacy). We found that for each measure, reliability increased as the number of ratings used to create the measures increased and that ratings from 3 or more days were needed to have adequately strong associations with the gold standard. Regarding sensitivity, the findings suggest that composite scores made up of ratings from 4 days are needed to maximize the chances of detecting treatment effects, especially with smaller sample sizes. In conclusion, using data from 3 or 4 days of assessment may be the best practice. PERSPECTIVE: Composite scores made up of at least 3 days of pain ratings appear to be needed to maximize reliability and validity while minimizing the assessment burden. TRIAL REGISTRATION: clinicaltrials.gov NCT01800604.

Neuropsychological and biopsychosocial evolution, therapeutic adherence and unmet care needs during paediatric transplantation: study protocol of a mixed-methods design (observational cohort study and focus groups) - the TransplantKIDS mental health project.

The present article describes the protocol of a mixed-methods study (an observational cohort design and focus groups), aimed to examine neuropsychological functioning and other biopsychosocial outcomes, therapeutic adherence and unmet care needs in paediatric population undergoing solid organ or allogeneic hematopoietic transplant during the pre- and post-transplant phases. Following a multi-method/multi-source approach, neuropsychological domains will be comprehensively measured with objective tests (SDMT, K-CPT 2/CPT 3, TAVECI/TAVEC, WISC-V/WAIS-IV Vocabulary and Digit Span subtests, Verbal Fluency tests, Stroop, ROCF, and TONI-4); ecological executive functioning, affective and behavioral domains, pain intensity/interference, sleep quality and therapeutic adherence will be assessed through questionnaires (parent/legal guardians-reported: BRIEF-2 and BASC-3; and self-reported: BASC-3, BPI, PROMIS, AIQ and SMAQ); and blood levels of prescribed drugs will be taken from each patient's medical history. These outcomes will be measured at pre-transplant and at 4-weeks and 6-months post-transplant phases. The estimated sample size was 60 patients (any type of transplant, solid organ, or hematopoietic) from La Paz University Hospital (Madrid, Spain). Finally, three focus group sessions will be organized with patients, parents/guardians, and transplant clinicians (n = 15, with 5 participants per group), in order to qualitatively identify unmet care needs during the pre-, and post-transplant stages of the process. The study protocol was registered at ClinicalTrials.gov (NCT05441436).

Measuring Pain-related Behavioral Inhibition and Behavioral Activation System Responses: Further Validity Evidence for the Pain Responses Scale.

OBJECTIVES: The Pain Responses Scale and its Short Form (PRS-SF) were recently developed to assess the affective, behavioral, and cognitive responses to pain based on the behavioral inhibition system (BIS) and behavioral activation system (BAS) model of chronic pain. The purpose of this study was to provide additional tests of the psychometric properties of the PRS-SF in a new sample of individuals with chronic pain. METHODS: A sample of Spanish adults (N = 190) with chronic non-cancer pain completed a translated version of the PRS-SF and a battery of questionnaires measuring validity criteria hypothesized the be associated with BIS and BAS activation, including measures of sensitivity to punishment, sensitivity to reward, pain intensity, pain interference, catastrophizing, and pain acceptance. RESULTS: Confirmatory factor analysis supported a 4-factor structure for the PRS-SF assessing despondent, escape, approach, and relaxation responses (S-B χ 2 [5] = 1.49, Comparative Fit Index = 0.99, Non-Normed Fit Index = 0.99, root-mean-square error of approximation = 0.051, Akaike Information Criterion = 4113.66), with marginal internal consistency for 1 scale (relaxation) and adequate to good internal consistency for the others. The pattern of associations found between the PRS-SF Scale scores and the validity criterion supports the validity of the instrument. CONCLUSION: The results provide additional support for the validity of the 4 PRS-SF Scale scores, and the reliability of 3 of the scales. If these findings are replicated in future research, investigators may wish to administer more items from the original Relaxation Scale when assessing this domain to ensure adequate reliability for this scale. The other items from the PRS-SF assessing despondent, escape, and approach responses appear to provide at least adequate reliability. When used in this way, the PRS-SF may be used to measure BIS and BAS responses to pain to: (1) provide further tests of the BIS-BAS model of chronic pain and/or (2) understand the potential mediating effects of BIS and BAS responses on the effects of psychological pain treatments to help determine which specific responses are most responsible for the benefits of treatment, and, therefore, which responses should be specifically targeted to enhance treatment response.

Vulnerability Factors, Adjustment, and Opioid Misuse in Chronic Noncancer Pain Individuals.

Several person variables predate injury or pain onset that increase the probability of maladjustment to pain and opioid misuse. The aim of this study was to evaluate the role of 2 diathesis variables (impulsiveness and anxiety sensitivity [AS]) in the adjustment of individuals with chronic noncancer pain and opioid misuse. The sample comprised 187 individuals with chronic noncancer pain. The hypothetical model was tested using correlation and structural equation modeling analyses. The results show a significant association between impulsiveness and AS and all the maladjustment variables, and between impulsiveness and AS and opioid misuse and craving. However, although the correlation analysis showed a significant association between adjustment to pain and opioid misuse, the structural equation modeling analysis showed a nonsignificant association between them (as latent variables). The findings support the hypothesis that both impulsiveness and AS are vulnerability factors for maladaptive adjustment to chronic pain and opioid misuse. PERSPECTIVE: This article adds to the empirical literature by including AS and impulsiveness as antecedent variables in a model of dual vulnerability to chronic pain maladjustment and opioid misuse. The findings suggest the potential utility of assessing both factors in individuals in the first stages of chronic pain.

Mediating Role of Treatment Perceptions in the Relationship Between Individual Characteristics and Engagement With a Digital Psychological Intervention for Pediatric Chronic Pain: Secondary Data Analysis.

BACKGROUND: Engagement predicts benefits from self-managed treatments. However, engagement is an important concern in digital interventions, with over 50% of patients being nonadherent to interventions in chronic conditions such as chronic pain. Little is known about the individual characteristics that contribute to engagement with a digital self-management treatment. OBJECTIVE: This study tested the mediating role of treatment perceptions (difficulty and helpfulness) in the association between individual baseline characteristics (treatment expectancies and readiness to change) and treatment engagement (online and offline) with a digital psychological intervention for adolescents with chronic pain. METHODS: A secondary data analysis of a single-arm trial of Web-based Management of Adolescent Pain, a self-guided internet intervention developed for the management of chronic pain in adolescents, was conducted. Survey data were collected at baseline (T1), midtreatment (ie, 4 weeks after the treatment started; T2), and post treatment (T3). Online engagement was assessed using back-end information on the number of days adolescents accessed the treatment website, while the offline engagement was assessed with the reported frequency of use of skills (ie, pain management strategies) learned at the end of the treatment. Four parallel multiple mediator linear regression models, using ordinary least square regression incorporating the variables were tested. RESULTS: In total, 85 adolescents with chronic pain (12-17 years old, 77% female) participated. Several mediation models were significant in predicting online engagement. A significant indirect effect was found for the path expectancies-helpfulness-online engagement (effect 0.125; SE 0.098; 95% CI 0.013-0.389) and for the path precontemplation-helpfulness-online engagement (effect -1.027; SE 0.650; 95% CI -2.518 to -0.054). Fourteen percent of the variance of online engagement was explained by the model including expectancies as a predictor (F3=3.521; P<.05), whereas 15% was explained by the model where readiness to change was the predictor (F3=3.934; P<.05). Offline engagement was partially explained in the model including readiness to change as the predictor but with marginal significance (F3=2.719; R2=0.111; P=.05). CONCLUSIONS: Treatment perception, specifically, perceived helpfulness, was a mediator of the pathway between both treatment expectancies and readiness to change and online engagement with a digital psychological intervention for chronic pain. Assessing these variables at baseline and midtreatment may help to determine the risk of nonadherence. Further work is needed to confirm these mediation pathways in larger samples. TRIAL REGISTRATION: ClinicalTrials.gov NCT04043962; https://clinicaltrials.gov/ct2/show/NCT04043962.

Physicians' perception about predictors of opioid abuse in patients with chronic non-cancer pain: a Delphi study.

Background: Opioids are being prescribed widely, and increasingly, for the treatment of chronic non-cancer pain (CNCP). However, several side effects are associated with mid- and long-term opioid use and, for certain patients, with the risk of problematic opioid use. The aim of this study is to know the perception of the physicians about which variables could be associated with increased risk of patients with CNCP developing a problem of abuse or misuse of the prescribed opioid medication. Methods: Twenty-nine physicians with experience in CNCP pain management and opioids prescription participated in a two-round Delphi study focused on the risk factors for opioid misuse and abuse. Results: The variables that reached consensus regarding their relationship with the increased risk of suffering a problem of opioid abuse or misuse were: (1) Experiencing pain on a daily basis, (2) previous use of high-dose opioids, (3) generalized anxiety, (4) hopelessness, (5) benzodiazepine intake, (6) use of opioids for reasons other than pain, (7) family problems, family instability or family breakdown, and (8) having access to several opioid prescribers. The only variable that reached consensus regarding it not being associated to a possible risk of abuse or misuse was having mild pain intensity (0-4 on a NRS-11). Conclusions: This study provides useful information that could help make decisions about the use of opioids for CNCP treatment and prevent future difficulties. Prospective studies testing the relationship of the variables that reached consensus with the risk of opioid misuse and abuse are warranted. Significance: This study shows the variables of CNCP that the professional must take into account in order to avoid possible problems when prescribing opioids.

Does pain catastrophizing and distress intolerance mediate the relationship between PTSD and prescribed opioid misuse in people with chronic noncancer pain?

OBJECTIVE: There is an ongoing debate on the use of long-term high-dose medically prescribed opioid analgesics for patients with chronic noncancer pain. Such use is elevated when there is comorbid pain and PTSD, which is quite prevalent. Therefore, it is relevant to investigate the psychological variables that may explain opioid misuse in this population. The purpose of this study was to examine the interaction effect of PTSD severity, distress intolerance, and pain catastrophizing on prescribed opioid misuse in chronic noncancer pain patients. METHOD: A total of 168 participants (M age = 60 years, 74% women) were assessed regarding opioid medication, pain intensity, traumatic psychological events, PTSD, distress intolerance, pain catastrophizing, and current opioid misuse. RESULTS: Groups were formed according to the level of PTSD severity (no symptoms, moderate symptoms, and severe symptoms). Significant differences were found between the groups in pain intensity, catastrophizing, distress intolerance, and opioid misuse. The severe-symptoms group had the highest scores on all variables. There were no between-group differences in the prescribed medication. Mediation analysis showed that the relationship between PTSD severity and opioid misuse was completely and independently mediated by distress intolerance and pain catastrophizing. CONCLUSIONS: Distress intciolerance and pain catastrophizing may be theoretically and clinically relevant constructs in understanding the motivation for opioid misuse in people with concurrent chronic noncancer pain and PTSD. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Protocol for a multi-phase, multi-center, real-world, hybrid effectiveness-implementation study of a digital intervention for pediatric chronic pain co-designed with patients (Digital SPA).

Background: Children and adolescents with chronic pain are a vulnerable population who often lack the resources to manage their condition. Due to high personal, social, and economic consequences, proper management in its early stages is key to reducing disability. The aim of this project is to co-develop a digital intervention for pediatric chronic pain (Digital SPA) with end-users and to evaluate its effectiveness and implementation outcomes in Spain. Methods: (Phase 1) Focus groups with patients, parents, and clinicians (n = 5-6 each) will inform about unmet pain care needs and provide a starting point for co-designing the intervention. (Phase 2) Content creation and usability testing will be based on the results of Phase 1, and the theory-driven development will follow the latest available evidence. The intervention will use validated psychological techniques focused on improving functioning by teaching pain coping skills. (Phase 3) Hybrid effectiveness-implementation trial. Participants (n = 195) will be adolescents aged 12-17 years old with chronic pain and one of their parents. Assessments include physical function, pain, sleep, anxiety, mood, satisfaction and adherence to the treatment, and number of visits to the emergency room. A qualitative framework analysis will be conducted with data from Phase 1. Effects of the intervention will be evaluated using linear multilevel modeling. The Consolidated Framework for Implementation Research (CFIR) and Behavioral Interventions Using Technology (BIT) frameworks will be used to evaluate implementation. Discussion: This study is expected to produce a co-created evidence-based digital intervention for pediatric chronic pain and a roadmap for successful implementation. Trial registration number TRN and date of registration: ClinicalTrials.gov (registered on 26 June 2023: https://clinicaltrials.gov/study/NCT05917626). Contributions to the literature The implementation of digital health interventions has two major gaps: (1) adherence to treatment is suboptimal, and (2) the process of making the interventions available to the end-user in a sustainable way is often unsuccessful.In this study, we expect that assessing users' needs and co-designing an intervention with them will improve adherence.Documenting the implementation process from the project inception and integrating the results into an implementation framework will allow for replication and extension in different contexts.This study will increase the knowledge about implementation in a vulnerable population: adolescents with chronic pain without access to in-person multidisciplinary pain care.