Child and Parent Risk and Resilience Factors as Predictors of Long-term Recovery in Youth Undergoing Spinal Fusion Surgery.

OBJECTIVES: Undertreated pediatric postsurgical pain negatively affects health-related quality of life (HRQOL) and functioning and may lead to chronic postsurgical pain (CPSP). Predictors of recovery have been identified but more research is needed, particularly regarding resilience, social factors, and long-term effects. The aim of the present study was to investigate child and parent risk and resilience factors as predictors of long-term postsurgical recovery for adolescents. METHODS: Participants were patients with Adolescent Idiopathic Scoliosis (AIS), 12 to 18 years old, undergoing spinal fusion, and their parents. Recruitment occurred at the orthopedic units at 4 hospitals in Belgium. Data were collected before surgery (T0), at 3 (T1) and 6 weeks (T2), 6 months (T3), and 1 year (T4) post surgery. Multiple regression models were used to evaluate the predictive effect of pain intensity, pain catastrophizing, psychological flexibility, and pain acceptance on long-term functioning, HRQOL, and pain. RESULTS: The sample comprised 100 adolescents and 61 parents. Pain at T0, T1, and T3 and adolescent pain catastrophizing (T0) predicted health-related quality of life, functioning, and pain at T4 (while pain at T2 predicted HRQOL and pain). Parent pain catastrophizing predicted pain at T4. Adolescent and parental psychological flexibility predicted HRQOL, and parent psychological flexibility also predicted pain at T4. Adolescent acceptance at T1 predicted pain, and acceptance at T2 predicted HRQOL, at T4. DISCUSSION: The study identified pain and adolescent pain catastrophizing as risk factors, and adolescent and parental psychological flexibility and adolescent pain acceptance as resilience factors, for long-term recovery in youths undergoing spinal fusion. Postsurgical pain management targeting these factors may therefore promote recovery for these adolescents.

A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain.

ABSTRACT: Graded exposure treatment (GET) is a theory-driven pain treatment that aims to improve functioning by exposing patients to activities previously feared and avoided. Combining key elements of GET with acceptance-based exposure, GET Living (GL) was developed for adolescents with chronic pain (GL). Based on robust treatment effects observed in our single-case experimental design pilot trial of GL (NCT01974791), we conducted a 2-arm randomized clinical trial comparing GL with multidisciplinary pain management (MPM) comprised of cognitive behavioral therapy and physical therapy for pain management (NCT03699007). A cohort of 68 youth with chronic musculoskeletal pain (M age 14.2 years; 81% female) were randomized to GL or MPM. Owing to COVID-19 restrictions, 54% of participants received zoom video delivered care. Assessments were collected at baseline, discharge, as well as at 3-month and 6-month follow-up. Primary outcomes were self-reported pain-related fear and avoidance. Secondary outcomes were child functional disability and parent protective responses to child pain. As hypothesized, GL improved in primary and secondary outcomes at 3-month follow-up. Contrary to our superiority hypothesis, there was no significant difference between GL and MPM. Patients reported both GL and MPM (in person and video) as credible and were highly satisfied with the treatment experience. Next steps will involve examining the single-case experimental design data embedded in this trial to facilitate an understanding of individual differences in treatment responses (eg, when effects occurred, what processes changed during treatment within the treatment arm). The current findings support GET Living and MPM for youth with chronic pain.

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.

Internet-delivered cognitive behavioral therapy for adolescents with insomnia: Feasibility and preliminary efficacy.

BACKGROUND: Insomnia is common in adolescents. This study evaluated feasibility and preliminary efficacy of a six-week internet-delivered cognitive-behavioral therapy for insomnia (ICBT-I) in adolescents. METHODS: In this uncontrolled pilot study, participants (n = 27, 78% female) completed assessments pre- and post intervention. Data on recruitment, adherence to treatment, treatment activity, satisfaction and credibility was collected to assess feasibility. Self-reported insomnia symptoms, sleep parameters as well as depression, anxiety and daytime function were also assessed. RESULTS: Participants showed good adherence to treatment and found the intervention overall credible and satisfactory. From pre- to post-assessment, statistically significant improvements were found for insomnia symptoms (p < .001; d = 1.02), sleep onset latency (p < .001; d = .39), wake after sleep onset (p = .001; d = .34), sleep efficiency (p < .001; d = .5) and depression (p = .01, d = .37). Changes in scores of total sleep time, generalized anxiety, daytime sleepiness and functional disability were not significant. CONCLUSIONS: The present study indicates that ICBT-I is well accepted by adolescents, that insomnia symptoms and sleep parameters can improve following the intervention, and that co-morbid symptoms of depression can be reduced. Due to the limited sample size and the uncontrolled design, the suggested results need to be replicated in well-powered controlled clinical trials.

Using Personas in the development of eHealth interventions for chronic pain: A scoping review and narrative synthesis.

Objectives: Behavioral eHealth interventions can enhance self-management and improve well-being in people with chronic pain. The development of these interventions calls for a user-centered approach to ensure that patient needs are appreciated. However, it may be challenging to involve patients; particularly during the early stages of the process. Fictional user profiles, known as Personas, can represent needs and guide designing eHealth interventions. This article provides a comprehensive overview of the use of Personas in the development of behavioral eHealth interventions for people with chronic pain with the aim to identify benefits and challenges. Methods: Bibliographic databases (Medline, Web of Science Core Collection, PsycInfo, CINAHL) and registries (PubMed Central, medaRxiv) were systematically searched. In a double-reviewing process, n = 6830 hits and n = 351 full-texts were screened and read. Ten peer-reviewed studies published between 2017 and 2022 were included in the narrative synthesis. Findings: Ten studies reported using "Pain Personas" in the development of eHealth interventions for such purposes as to gain a shared understanding of the user and to discuss solutions in team meetings, or for patients to identify with (if Personas are included in the intervention). Personas were based on qualitative and/or quantitative data. However, the procedure for creating Personas was only described in half of the included studies (n = 5). These five studies provided descriptive details of the Personas (i.e., picture, name, narrative of their pain behavior, technological skills, and motivation). Conclusions: Although Personas have been used by pain researchers in recent projects and were highlighted as an important ingredient in the development process, available design guidelines for the creation and use of Personas are not followed or communicated transparently. Benefits and challenges when using Personas in the development of eHealth interventions for people with chronic pain are discussed to support future eHealth efforts and to improve the quality of eHealth innovation in the field of pain.

Examining predictors of treatment effect in digital Acceptance and Commitment Therapy for chronic pain.

Digitally delivered behavioral interventions for chronic pain have been encouraging with effects similar to face-to-face treatment. Although many chronic pain patients benefit from behavioral treatment, a substantial proportion do not improve. To contribute to more knowledge about factors that predict treatment effects in digitally delivered behavioral interventions for chronic pain, the present study analyzed pooled data (N = 130) from three different studies on digitally delivered Acceptance and Commitment Therapy (ACT) for chronic pain. Longitudinal linear mixed-effects models for repeated measures were used to identify variables with significant influence on the rate of improvement in the main treatment outcome pain interference from pre- to post-treatment. The variables were sorted into six domains (demographics, pain variables, psychological flexibility, baseline severity, comorbid symptoms and early adherence) and analysed in a stepwise manner. The study found that shorter pain duration and higher degree of insomnia symptoms at baseline predicted larger treatment effects. The original trials from which data was pooled are registered at clinicaltrials.gov (registration number: NCT03105908 and NCT03344926).

Inflammatory Blood Signature Related to Common Psychological Comorbidity in Chronic Pain.

Chronic pain is characterized by high psychological comorbidity, and diagnoses are symptom-based due to a lack of clear pathophysiological factors and valid biomarkers. We investigate if inflammatory blood biomarker signatures are associated with pain intensity and psychological comorbidity in a mixed chronic pain population. Eighty-one patients (72% women) with chronic pain (>6 months) were included. Patient reported outcomes were collected, and blood was analyzed with the Proseek Multiplex Olink Inflammation Panel (Bioscience Uppsala, Uppsala, Sweden), resulting in 77 inflammatory markers included for multivariate data analysis. Three subgroups of chronic pain patients were identified using an unsupervised principal component analysis. No difference between the subgroups was seen in pain intensity, but differences were seen in mental health and inflammatory profiles. Ten inflammatory proteins were significantly associated with anxiety and depression (using the Generalized Anxiety Disorder 7-item scale (GAD-7) and the Patient Health Questionnaire (PHQ-9): STAMBP, SIRT2, AXIN1, CASP-8, ADA, IL-7, CD40, CXCL1, CXCL5, and CD244. No markers were related to pain intensity. Fifteen proteins could differentiate between patients with moderate/high (GAD-7/PHQ-9 > 10) or mild/no (GAD-7/PHQ-9 < 10) psychological comorbidity. This study further contributes to the increasing knowledge of the importance of inflammation in chronic pain conditions and indicates that specific inflammatory proteins may be related to psychological comorbidity.

Pain acceptance and psychological inflexibility predict pain interference outcomes for persons with chronic pain receiving pain psychology.

OBJECTIVES: Awareness (being present), acceptance, and engagement (committed action) are three dimensions of psychological flexibility. Understanding these in the context of chronic pain may identify treatment targets to help refine individual treatment. Our objective was to test the predictive capacity of three dimensions within the psychological flexibility model on the longitudinal trajectory of pain interference. METHODS: Patients receiving pain psychology treatment at a pain management center participated in this pragmatic clinical longitudinal study (n=86 with at least three assessments; Mean age=51 years; Gender=60 females, 26 males). Measures included the Five Facet Mindfulness Questionnaire (FFMQ-SF); Chronic Pain Acceptance Questionnaire (CPAQ-8); Psychological Inflexibility in Pain Scale (PIPS-12); and Committed Action Questionnaire (CAQ-8). The dependent variable was the Patient Reported Outcomes Information System (PROMIS) Pain Interference (PI). We used latent growth modelling to analyze scores assessed within 180 days of patient care. RESULTS: Psychological inflexibility (PIPS-12) and pain acceptance (CPAQ-8) measured at baseline predicted PI outcomes (n=86). PIPS-12 showed a direct relationship with pain interference (PI), where higher PIPS-12 scores predicted significantly higher PI mean scores on average across the study period (ρ=0.422, r2=0.382) but also predicted significantly greater decreases in PI across time (ρ=-0.489, r2=0.123). Higher CPAQ-8 scores predicted significantly lower PI mean scores on average across the study period (ρ=-0.478, r2=0.453) but also significantly smaller decreases in PI across time (ρ=0.495, r2=0.076). Awareness (FFMQ-SF) and engagement (CAQ-8) were not predictive of PI outcomes. CONCLUSIONS: Patients who entered pain psychology treatment with lower pain acceptance and higher psychological inflexibility showed the largest reductions in pain interference across time. These results contribute towards a novel prognostic understanding of the predictive roles of an enhancing dimension and limiting dimension of psychological flexibility.

Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy.

INTRODUCTION: Chronic pain affects a significant number of children and impacts multiple domains including social, emotional and behavioural functioning, and negatively impacts family functioning. Roughly 5% of youth with chronic pain experience moderate to severe pain-related disability, with pain-related fear and avoidance of activities being identified as substantial barriers to treatment engagement. Evidence supports targeted psychological and physical interventions to address these barriers (eg, graded-exposure treatment), but accessibility to intervention is undermined by a shortage of services outside of urban areas, high treatment-related costs, and long provider waitlists; highlighting the need to develop digitally delivered behavioural intervention, using agile and iterative study designs that support rapid development and timely dissemination. METHODS AND ANALYSIS: This study seeks to develop an effective and scalable intervention for youth with chronic pain and their caregivers. This paper presents a user-centred protocol for the development and refinement of a digital exposure treatment for youth and caregivers, as well as the study design to examine feasibility and preliminary efficacy of the treatment using single-case experimental design (SCED). Assessments include daily diaries, completed from baseline and daily throughout the intervention (~6 weeks), and at 3-month follow-up, as well as self-report measures completed at baseline, end of intervention and 3-month follow-up. Primary outcomes include treatment satisfaction, treatment expectancy, adherence to daily dairies and functional disability. Secondary outcomes are pain-related fear and avoidance of activities, pain catastrophising and pain acceptance. We will present descriptive and model-based inference analyses, based on SCED reporting guidelines. We will calculate effect sizes for each individual on each outcome. We will examine mean treatment expectancy, credibility and satisfaction scores, and patient drop-out percentage. ETHICS AND DISSEMINATION: This study is approved by the Institutional Review Board at Stanford University (protocol #53323). Findings will be actively disseminated through peer-reviewed journals, conference presentations and social media. TRIAL REGISTRATION NUMBER: NCT05079984.

Baseline Pro-Inflammatory Cytokine Levels Moderate Psychological Inflexibility in Behavioral Treatment for Chronic Pain.

Background: The medical and scientific communities struggle to understand chronic pain and find effective treatments. Multimodal approaches are encouraging but show significant individual differences. Methods: Seventy-eight persons (56 women) with chronic pain received Acceptance and Commitment Therapy and provided blood samples before and after treatment. The participants completed surveys with the blood sampling. Blood plasma was analyzed for IL-6 and TNF-α levels with the Olink Inflammation Panel (Olink Bioscience Uppsala, Sweden). The treatment effects and moderating effects of low-grade inflammation on changes in outcomes were analyzed using linear mixed models. Results: Pain interference (p < 0.001) and psychological inflexibility (p < 0.001) improved significantly during treatment, but pain intensity did not (p = 0.078). Cytokine levels did not change over the course of the treatment (IL-6/TNF-α p = 0.086/0.672). Mean baseline levels of IL-6 and TNF-α moderated improvement in psychological inflexibility during the course of treatment (p = 0.044), but cytokine levels did not moderate changes in pain interference (p = 0.205) or pain intensity (p = 0.536). Conclusions: Higher baseline inflammation levels were related to less improvement in psychological inflexibility. Low-grade inflammation may be one factor underlying the variability in behavioral treatment in chronic pain.

Development, evaluation and implementation of a digital behavioural health treatment for chronic pain: study protocol of the multiphase DAHLIA project.

INTRODUCTION: Chronic pain affects about 20%-40% of the population and is linked to mental health outcomes and impaired daily functioning. Pharmacological interventions are commonly insufficient for producing relief and recovery of functioning. Behavioural health treatment is key to generate lasting benefits across outcome domains. However, most people with chronic pain cannot easily access evidence-based behavioural interventions. The overall aim of the DAHLIA project is to develop, evaluate and implement a widely accessible digital behavioural health treatment to improve well-being in individuals with chronic pain. METHODS AND ANALYSIS: The project follows the four phases of the mHealth Agile Development and Evaluation Lifecycle: (1) development and pre-implementation surveillance using focus groups, stakeholder interviews and a business model; (2) iterative optimisation studies applying single case experimental design (SCED) method in 4-6 iterations with n=10 patients and their healthcare professionals per iteration; (3) a two-armed clinical randomised controlled trial enhanced with SCED (n=180 patients per arm) and (4) interview-based post-market surveillance. Data analyses include multilevel modelling, cost-utility and indicative analyses.In October 2021, inter-sectorial partners are engaged and funding is secured for four years. The treatment content is compiled and the first treatment prototype is in preparation. Clinical sites in three Swedish regions are informed and recruitment for phase 1 will start in autumn 2021. To facilitate long-term impact and accessibility, the treatment will be integrated into a Swedish health platform (www.1177.se), which is used on a national level as a hub for advice, information, guidance and e-services for health and healthcare. ETHICS AND DISSEMINATION: The study plan has been reviewed and approved by Swedish ethical review authorities. Findings will be actively disseminated through peer-reviewed journals, conference presentations, social media and outreach activities for the wider public. TRIAL REGISTRATION NUMBER: NCT05066087.

Autistic Traits and Attention-Deficit Hyperactivity Disorder Symptoms Associated With Greater Pain Interference and Depression, and Reduced Health-Related Quality of Life in Children With Chronic Pain.

Previous research indicates elevated levels of clinically significant traits and symptoms of autism spectrum disorder and attention-deficit hyperactivity disorder (ADHD) in children with chronic pain, but associations with functioning and depression are yet unclear. The current study examined the relationships of autistic traits and ADHD symptoms with pain interference, depression, and health-related quality of life, as well as the mediating roles of insomnia and psychological inflexibility, in children with chronic pain (n = 146, 8-17 years, 102 girls) presenting at a tertiary pain clinic. Children completed measures of pain intensity, depression, pain interference, health-related quality of life, insomnia, and psychological inflexibility. Parents (n = 146, 111 mothers) completed measures to assess autistic traits and ADHD symptoms in their children. Children with clinically significant autistic traits and ADHD symptoms presented with significantly higher levels of depressive symptoms and pain interference, and significantly lower health-related quality of life, than did the other children. Autistic traits and ADHD symptoms contributed significantly to the prediction of pain interference and depressive symptoms, as well as health-related quality of life. Psychological inflexibility mediated the relationships between ADHD symptoms and autistic traits on the one hand and depression, pain interference, and health-related quality of life on the other, while insomnia mediated the relationships between ADHD symptoms and depression, pain interference, and health-related quality of life. All analyses were adjusted for demographics and pain intensity. Results suggest the utility of screening for neurodevelopmental disorders in children with chronic pain. Furthermore, the findings may indicate insomnia and skills related to psychological flexibility as potential treatment targets in interventions aiming at improving functioning and health-related quality of life in children with chronic pain and co-occurring symptoms of neurodevelopmental disorders.

The Rapid Implementation of a Psychological Support Model for Frontline Healthcare Workers During the COVID-19 Pandemic: A Case Study and Process Evaluation.

The COVID-19 pandemic highlighted the need for psychological support initiatives directed toward frontline healthcare workers, which can be rapidly and sustainably implemented during an infectious disease outbreak. The current case study presents a comprehensive model of psychological support that was implemented at an intensive care unit (ICU) during the first wave of the COVID-19 pandemic. The psychological support model aimed at promoting a resilient stress reaction among frontline staff by protecting physical, social, and psychological resources. The initiatives, targeting different groups of workers, included education and training, peer support, psychologist-supervised and unsupervised group sessions, on-boarding for transferred staff, manager support, and individual sessions for workers experiencing strong stress reactions. The results of the process evaluation of this rapid implementation suggest that peer support initiatives as well as daily group sessions were the most appreciated forms of psychological support. Psychologists involved in organizing and providing the support highlighted several aspects of a successful implementation of the support model: offering support during work hours (preferably after shift), positive attitude of line managers that framed support initiatives as a team effort, and involvement of experienced psychologists able to quickly adjust the content of the support according to the current needs. The study also identified two main problems of the current implementation: the lack of efficient planning due to the use of volunteer work and the need for more structural resources on the organizational level to ensure long-term sustainability of the support model and its implementation among all groups of healthcare staff. The current case study highlights the importance of establishing permanent structural resources and routines for psychological support integrated in clinical practice by healthcare organizations to improve both rapid and sustainable response to future crises.

Establishment of an International Collaborative Network for N-of-1 Trials and Single-Case Designs.

In this article we briefly examine the unique features of Single-Case Designs (SCDs) (studies in a single participant), their history and current trends, and real-world clinical applications. The International Collaborative Network for N-of-1 Trials and Single-Case Designs (ICN) is a formal collaborative network for individuals with an interest in SCDs. The ICN was established in 2017 to support the SCD scientific community and provide opportunities for collaboration, a global communication channel, resource sharing and knowledge exchange. In May 2021, there were more than 420 members in 31 countries. A member survey was undertaken in 2019 to identify priorities for the ICN for the following few years. This article outlines the key priorities identified and the ICN's progress to date in these key areas including network activities (developing a communications strategy to increase awareness, collecting/sharing a comprehensive set of resources, guidelines and tips, and incorporating the consumer perspective) and scientific activities (writing position papers and guest editing special journal issues, exploring key stakeholder perspectives about SCDs, and working to streamline ethical approval processes for SCDs). The ICN provides a practical means to engage with this methodology through membership. We encourage clinicians, researchers, industry, and healthcare consumers to learn more about and conduct SCDs, and to join us in our mission of using SCDs to improve health outcomes for individuals and populations.

Neuropsychiatric Symptoms in Pediatric Chronic Pain and Outcome of Acceptance and Commitment Therapy.

Considerable heterogeneity among pediatric chronic pain patients may at least partially explain the variability seen in the response to behavioral therapies. The current study tested whether autistic traits and attention-deficit/hyperactivity disorder (ADHD) symptoms in a clinical sample of children and adolescents with chronic pain are associated with socioemotional and functional impairments and response to acceptance and commitment therapy (ACT) treatment, which has increased psychological flexibility as its core target for coping with pain and pain-related distress. Children and adolescents aged 8-18 years (N = 47) were recruited. Patients and their parents completed questionnaires pre- and post-ACT of 17 sessions. Correlational analyses and mixed-effects models were used to assess the role of autistic traits and ADHD symptoms in pretreatment functioning and ACT-treatment response. Outcome variables were degree to which pain interfered with daily activities (i.e., pain interference, sleep, and physical and school functioning), socioemotional functioning (i.e., depressive symptoms, emotional, and social functioning), psychological inflexibility, and pain intensity. Autistic traits and ADHD symptoms, pain frequency, and pain duration were measured at pretreatment only. Higher autistic traits were associated with greater pain interference, higher depression, and greater psychological inflexibility. Higher ADHD symptomatology was associated with greater pretreatment pain interference, lower emotional functioning, greater depression, and longer duration of pain. Across patients, all outcome variables, except for sleep disturbances and school functioning, significantly improved from pre- to post-ACT. Higher autistic traits were associated with greater pre- to post-ACT improvements in emotional functioning and sleep disturbance and non-significant improvements in pain interference. ADHD symptomatology was not associated with treatment outcome. The current results showed that neuropsychiatric symptoms in pediatric chronic pain patients are associated with lower functioning, particularly pain interfering with daily life and lower socioemotional functioning. The results suggest that not only pediatric chronic pain patients low in neuropsychiatric symptoms may benefit from ACT, but also those high in autism traits and ADHD symptoms. With the present results in mind, pediatric chronic pain patients higher in autistic traits may actually derive extra benefit from ACT. Future research could assess whether increased psychological flexibility, the core focus of ACT, enabled those higher in autism traits to cope relatively better with pain-related distress and thus to gain more from the treatment, as compared to those lower in autism traits. Moreover, to address specific effects of ACT, inclusion of an appropriate control group is key.

The Psychological Inflexibility in Pain Scale (PIPS): Validity and Reliability of the Japanese Version for Chronic Low Back Pain and Knee Pain.

PURPOSE: The aim of this study was to translate the Psychological Inflexibility in Pain Scale Japanese version (PIPS-J) and inspect its validity and reliability in older patients with chronic low back pain and knee pain. MATERIALS AND METHODS: The PIPS was translated into Japanese by a bilingual linguistic expert and three researchers and administered to 120 outpatients with low back pain and knee pain (61.7% women, age 73.8±7.8 years). Construct validity and criterion validity were evaluated using confirmatory factor analysis and the correlations with the Acceptance and Action Questionnaire-II Japanese version (AAQ-II-J) and the Cognitive Fusion Questionnaire Japanese version (CFQ-J), respectively. Internal consistency using Cronbach's alpha and test-retest reliability (n=43) were also examined. RESULTS: Of all, 78.3% had low back pain, 55.6% had knee pain, and 44.2% both. The confirmatory factor analysis reproduced the original PIPS structure with two factors and indicated good model fit (GFI = 0.915, CFI = 0.970, RMSEA = 0.060). All items' standardized regression weights ranged from 0.35 to 0.80. Criterion validity was shown by correlations of r = 0.58 for PIPS-J pain avoidance with the AAQ-II-J, and r = 0.45 between PIPS-J cognitive fusion and the CFQ-J. Cronbach's alpha for the PIPS-J total score was α=0.85 (pain avoidance: 0.87; cognitive fusion: 0.68). The test-retest correlation for all 12 items was r = 0.54 (pain avoidance: 0.48; cognitive fusion: 0.54). CONCLUSION: Although a less relevant item was found on each of subscales, the PIPS-J appear to be fairly valid and reliable to evaluate psychological inflexibility in chronic pain among Japanese older adults.

Internet-delivered acceptance and commitment therapy as microlearning for chronic pain: A randomized controlled trial with 1-year follow-up.

BACKGROUND: Studies of Internet-delivered acceptance and commitment therapy (ACT) for chronic pain have shown small to moderate positive effects for pain interference and pain acceptance. Effects on pain intensity, depression, anxiety and quality of life (QoL) have been less favourable, and improvements for values and sleep are lacking. In this randomized controlled trial iACT - a novel format of Internet-ACT using daily microlearning exercises - was examined for efficacy compared to a waitlist condition. METHODS: Adult participants (mean age 49.5 years, pain duration 18.1 years) with diverse chronic pain conditions were recruited via self-referral, and randomized to iACT (n = 57) or waitlist (n = 56). The primary outcome was pain interference. The secondary outcomes were QoL, depression, anxiety, insomnia and pain intensity. The process variables included psychological inflexibility and values. Post-assessments were completed by 88% (n = 100) of participants. Twelve-month follow-up assessments were completed by 65% (iACT only, n = 37). Treatment efficacy was analysed using linear mixed models and an intention-to-treat-approach. RESULTS: Significant improvements in favour of iACT were seen for pain interference, depression, anxiety, pain intensity and insomnia, as well as process variables psychological inflexibility and values. Between-group effect sizes were large for pain interference (d = 0.99) and pain intensity (d = 1.2), moderate for anxiety and depressive symptoms and small for QoL and insomnia. For the process variables, the between-group effect size was large for psychological inflexibility (d = 1.0) and moderate for values. All improvements were maintained at 1-year follow-up. CONCLUSIONS: Internet-ACT as microlearning may improve a broad range of outcomes in chronic pain. SIGNIFICANCE: The study evaluates a novel behavioral treatment with positive results on pain interference, mood as well as pain intensity for longtime chronic pain sufferers. The innovative format of a digital ACT intervention delivered in short and experiential daily learnings may be a promising way forward.

Group-based Acceptance and Commitment Therapy (AHEAD) for adolescents with multiple functional somatic syndromes: A randomised trial.

Background: Evidence for treatment of adolescents with multiple functional somatic syndromes (FSS) is sparse. This study examined the efficacy of 'Acceptance and Commitment Therapy for Health in Adolescents' (AHEAD), a generic group-based treatment for adolescents with co-occurrence of multiple FSS. Methods: A randomized trial was conducted at a specialized university hospital clinic. Adolescents (15-19 years) with multiple FSS of at least 1 year's duration were randomly assigned to AHEAD or enhanced usual care (EUC). AHEAD consisted of nine modules (i.e., 27 h) and one follow-up meeting. Primary outcome was physical health (SF-36). Various secondary outcomes and treatment targets were included (e.g., symptom severity, symptom impact, and illness perception). A linear mixed-effects model was used for analysis. Trial-registration: ClinicalTrials.gov NCT02346071. Results: Ninety-one patients were included. At 12 months, no significant difference in physical health was identified between groups (mean adjusted difference 1.2 [95% CI -1.6 to 4.0], p = .404). However, different developments over time were seen with an interaction effect between intervention arm and time (χ2(5) = 14.1, p = .0148). AHEAD patients (n = 44) reported a clinically relevant improvement at end of treatment and at 8 and 12 months, while EUC patients (n = 47) displayed a clinically relevant improvement at 12 months. Furthermore, AHEAD patients showed a faster improvement on symptom severity, symptom impact and illness perception. EUC patients received more psychological treatment outside the trial (p ≤ .001) than AHEAD patients. Treatment satisfaction with AHEAD was high in contrast to EUC. Conclusions: Compared with EUC, AHEAD had no additional advantage on the improvement of physical health at the primary endpoint of 12 months. However, a faster improvement of physical health was seen in AHEAD and considerably more psychological treatment was received outside the trial in EUC with clinically meaningful improvements in both groups. The results underpin the importance of an organised and systematic treatment offer for the most severely affected youth.