Randomized controlled trial of an Internet-delivered family cognitive–behavioral therapy intervention for children and adolescents with chronic pain

Cognitive–behavioral therapy (CBT) interventions show promise for decreasing chronic pain in youth. However, the availability of CBT is limited by many factors including distance to major treatment centers and expense. This study evaluates a more accessible treatment approach for chronic pediatric pain using an Internet-delivered family CBT intervention. Participants included 48 children, aged 11–17 years, with chronic headache, abdominal, or musculoskeletal pain and associated functional disability, and their parents. Children were randomly assigned to a wait-list control group or an Internet treatment group. Primary treatment outcomes were pain intensity ratings (0–10 NRS) and activity limitations on the Child Activity Limitations Interview, both completed via an online daily diary. In addition to their medical care, the Internet treatment group completed 8 weeks of online modules including relaxation training, cognitive strategies, parent operant techniques, communication strategies, and sleep and activity interventions. Youth randomized to the wait-list control group continued with the current medical care only. Findings demonstrated significantly greater reduction in activity limitations and pain intensity at post-treatment for the Internet treatment group and these effects were maintained at the three-month follow-up. Rate of clinically significant improvement in pain was also greater for the Internet treatment group than for the wait-list control group. There were no significant group differences in parental protectiveness or child depressive symptoms post-treatment. Internet treatment was rated as acceptable by all children and parents. Findings support the efficacy and acceptability of Internet delivery of family CBT for reducing pain and improving function among children and adolescents with chronic pain.     

Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain

Chronic pain is a common and costly experience. Cognitive behavioral therapies (CBT) are efficacious for an array of chronic pain conditions. However, the literature is based primarily on urban (white) samples. It is unknown whether CBT works in low-socioeconomic status (SES) minority and nonminority groups. To address this question, we conducted a randomized controlled trial within a low-SES, rural chronic pain population. Specifically, we examined the feasibility, tolerability, acceptability, and efficacy of group CBT compared with a group education intervention (EDU). We hypothesized that although both interventions would elicit short- and long-term improvement across pain-related outcomes, the cognitively-focused CBT protocol would uniquely influence pain catastrophizing. Mixed design analyses of variance were conducted on the sample of eligible participants who did not commence treatment (N = 26), the intention-to-treat sample (ITT; N = 83), and the completer sample (N = 61). Factors associated with treatment completion were examined. Results indicated significantly more drop-outs occurred in CBT. ITT analyses showed that participants in both conditions reported significant improvement across pain-related outcomes, and a nonsignificant trend was found for depressed mood to improve more in CBT than EDU. Results of the completer analyses produced a similar pattern of findings; however, CBT produced greater gains on cognitive and affect variables than EDU. Treatment gains were maintained at 6-month follow-up (N = 54). Clinical significance of the findings and the number of treatment responders is reported. Overall, these findings indicate that CBT and EDU are viable treatment options in low-SES minority and nonminority groups. Further research should target disseminating and sustaining psychosocial treatment options within underserved populations.     

Producing Clinically Meaningful Reductions in Disability: A Causal Mediation Analysis of a Patient Education Intervention

Patient education is recommended as first-line care for low back pain (LBP), although its efficacy for providing clinically meaningful reductions in disability has been questioned. One way to improve treatment effects is to identify and improve targeting of treatment mechanisms. We conducted a pre-planned causal mediation analysis of a randomized, placebo-controlled trial investigating the effectiveness of patient education for patients with acute LBP. 202 patients who had fewer than six-weeks’ duration of LBP and were at high-risk of developing chronic LBP completed two, one-hour treatment sessions of either intensive patient education, or placebo patient education. 189 participants provided data for the outcome self-reported disability at three-months and the mediators, pain self-efficacy, pain catastrophizing, and back beliefs at one-week post treatment. This causal mediation analysis found that pain catastrophizing (mediated effect, -0.64; 95% Confidence Interval [CI], -1.31 to -0.15) and back beliefs (mediated effect, -0.51; 95% CI, -1.15 to -0.02) partly explained the effect of patient education on disability but pain self-efficacy did not (mediated effect, -0.40; 95% CI -1.13 to 0.28). Considering the mediator-outcome relationship, patient education would need to induce an 8 point difference on the pain self-efficacy questionnaire (0-60); an 11 point difference on the back beliefs questionnaire (9-45); and a 21 point difference on the pain catastrophizing scale (0-52) to achieve a minimally clinically important difference of 2 points on the Roland Morris Disability Questionnaire (0-24).PerspectiveUnderstanding the mechanisms of patient education can inform how this treatment can be adapted to provide clinically meaningful reductions in disability. Our findings suggest that adapting patient education to better target back beliefs and pain self-efficacy could result in clinically meaningful reductions in disability whereas the role of pain catastrophizing in acute LBP is less clear.     

Mediators, moderators, and predictors of therapeutic change in cognitive-behavioral therapy for chronic pain

Although cognitive-behavioral therapies (CBT) have been demonstrated to be effective for a variety of chronic pain problems, patients vary in their response and little is known about patient characteristics that predict or moderate treatment effects. Furthermore, although cognitive-behavioral theory posits that changes in patient beliefs and coping mediate the effects of CBT on patient outcomes, little research has systematically tested this. Therefore, we examined mediators, moderators, and predictors of treatment effects in a randomized controlled trial of CBT for chronic temporomandibular disorder (TMD) pain. Pre- to post-treatment changes in pain beliefs (control over pain, disability, and pain signals harm), catastrophizing, and self-efficacy for managing pain mediated the effects of CBT on pain, activity interference, and jaw use limitations at one year. In individual mediator analyses, change in perceived pain control was the mediator that explained the greatest proportion of the total treatment effect on each outcome. Analyzing the mediators as a group, self-efficacy had unique mediating effects beyond those of control and the other mediators. Patients who reported more pain sites, depressive symptoms, non-specific physical problems, rumination, catastrophizing, and stress before treatment had higher activity interference at one year. The effects of CBT generally did not vary according to patient baseline characteristics, suggesting that all patients potentially may be helped by this therapy. The results provide further support for cognitive-behavioral models of chronic pain and point to the potential benefits of interventions to modify specific pain-related beliefs in CBT and in other health care encounters.     

Changes in Pain Coping,Catastrophizing, and Coping Efficacy After Cognitive-Behavioral Therapy in Children and Adolescents With Juvenile Fibromyalgia

A recent randomized multisite clinical trial found that cognitive-behavioral therapy (CBT) was significantly more effective than fibromyalgia education (FE) in reducing functional disability in adolescents with juvenile fibromyalgia (JFM). The primary objective of this study was to examine the psychological processes of CBT effectiveness by evaluating changes in pain coping, catastrophizing, and coping efficacy and to test these changes as mediators of continued improvements in functional disability and depressive symptoms at 6-month follow-up. One hundred adolescents (11–18 years old) with JFM completed the clinical trial. Coping, catastrophizing, and coping efficacy (Pain Coping Questionnaire) and the outcomes of functional disability (Functional Disability Inventory) and depressive symptoms (Children's Depression Inventory) were measured at baseline, posttreatment, and 6-month follow-up. Participants in both conditions showed significant improvement in coping, catastrophizing, and efficacy by the end of the study, but significantly greater improvements were found immediately following treatment for those who received CBT. Treatment gains were maintained at follow-up. Baseline to posttreatment changes in coping, catastrophizing, and efficacy were not found to mediate improvements in functional disability or depressive symptoms from posttreatment to follow-up. Future directions for understanding mechanisms of CBT effectiveness in adolescents with chronic pain are discussed.PerspectiveCBT led to significant improvements in pain coping, catastrophizing, and efficacy that were sustained over time in adolescents with juvenile fibromyalgia. Clinicians treating adolescents with JFM should focus on teaching a variety of adaptive coping strategies to help patients simultaneously regain functioning and improve mood.     

Reduction of pain catastrophizing mediates the outcome of both physical and cognitive-behavioral treatment in chronic low back pain.

The aim of this study was to examine whether treatments based on different theories change pain catastrophizing and internal control of pain, and whether changes in these factors mediate treatment outcome. Participants were 211 patients with nonspecific chronic low back pain (CLBP) participating in a randomized controlled trial, attending active physical treatment (APT, n = 52), cognitive-behavioral treatment (CBT, n = 55), treatment combining the APT and CBT (CT, n = 55), or waiting list (WL, n = 49). Pain catastrophizing decreased in all 3 active treatment groups and not in the WL. There was no difference in the change in internal control across all 4 groups. In all the active treatment groups, patients improved regarding perceived disability, main complaints, and current pain at post-treatment, and no changes were observed in the WL group. Depression only changed significantly in the APT group. Change in pain catastrophizing mediated the reduction of disability, main complaints, and pain intensity. In the APT condition, pain catastrophizing also mediated the reduction of depression. Not only cognitive-behavioral treatments but also a physical treatment produced changes in pain catastrophizing that seemed to mediate the outcome of the treatment significantly. The implications and limitations of these results are discussed. PERSPECTIVE: This article shows that treatment elements that do not deliberately target cognitive factors can reduce pain catastrophizing. Reduction in pain catastrophizing seemed to mediate the improvement of functioning in patients with chronic low back pain. The results might contribute to the development of more effective interventions.     

Evaluating the efficacy of graded in vivo exposure for the treatment of fear in patients with chronic back pain: a randomized controlled clinical trial

Psychological treatments for chronic pain, particularly those based upon cognitive behavioural principles, have generally been shown to be efficacious. Recently, a treatment has been developed based upon the fear-avoidance model of chronic musculoskeletal pain, which suggests chronic pain can be relieved by exposing the individual to movements and tasks that have been avoided due to fear of (re)injury. This graded in vivo exposure treatment has been found to be beneficial in case studies. The present investigation utilized a randomized controlled trial method to assess the effectiveness of graded in vivo exposure relative to other conditions. Forty-four chronic low back pain patients were randomly assigned to graded in vivo exposure, graded activity, or a wait-list condition. While only trend differences were observed for pain-related disability, patients in the graded in vivo exposure condition demonstrated (a) significantly greater improvements on measures of fear of pain/movement, fear avoidance beliefs, pain-related anxiety, and pain self-efficacy when compared to those in the graded activity condition, and (b) significantly greater improvements on measures of fear-avoidance beliefs, fear of pain/movement, pain-related anxiety, pain catastrophising, pain experience, and anxiety and depression when compared to those in the wait-list control condition. Additionally, patients in the graded in vivo exposure condition maintained improvements in these areas at one month follow-up. Implications of these findings for the treatment of individuals with chronic low back and other pain conditions are discussed.     

Estimating the clinical effectiveness of cognitive behavioural therapy in the clinic: evaluation of a CBT informed pain management programme

Randomized controlled trials and meta-analyses provide evidence for the efficacy of cognitive-behaviourally informed treatment (CBT) programmes for chronic pain. The current study aims to provide practice-based evidence for the effectiveness of CBT in routine clinical settings. Over a 10-year period 1013 pain patients were accepted into a 4 week in-patient pain management programme. Data from more than 800 patients was available at pre-treatment and at one month post-treatment and for around 600 patients at pre-treatment and at 9 months follow-up. Measures reported in this analysis were pain experience and interference, psychological distress (depression and anxiety), self-efficacy, catastrophizing, and walking. Change from pre-treatment to post-treatment and follow-up was assessed with conventional statistical tests, the computation of effect sizes and by the reliable change index (RCI) and clinically significant change (CSC) methodology. These analyses provide evidence of statistical improvement at post-treatment and follow-up and the RCI/CSC methodology suggested that between 1 in 3 and 1 in 7 (depending on the outcome measure) achieved clinically significant gains. There was also evidence that a small percentage of patients (1–2%) reliably deteriorated during the period of treatment. The limitations in the inferences that can be drawn from this study and of the methodology are discussed. A case is made for the application of benchmarking methods using data from RCTs in order to more fully evaluate practice and to generate better quality practice based evidence.     

Nurse-led pain management program: Effect on self-efficacy, pain intensity, pain-related disability, and depressive symptoms in chronic pain patients

Nurses routinely use a variety of nonpharmacologic and patient education interventions designed to reduce pain and promote independence. Research on group programs that combine these nursing strategies in a systematic approach provides evidence that chronic pain patients can realize an enhanced confidence in their ability to manage pain (improved self-efficacy) in addition to reductions in pain, emotional distress, and disability. The purpose of this study was to investigate the effect of participating in a nurse-led cognitive-behavioral treatment (CBT) pain management program on self-efficacy, pain intensity, pain-related disability, and depressive symptoms among patients with chronic pain. Pre- and postprogram data from 154 participants were examined to identify changes in pain intensity, self-efficacy, disability, and depressive symptoms. Mean differences, effect sizes, and 95% confidence intervals were computed for the study variables and paired t-tests were done to determine if changes were significant. Z-scores were then calculated. Pearson product moment correlations were examined to test the association between changes in self-efficacy and changes in the other variables of interest. Patients in this study reported significant improvements in all scores postprogram. Self-efficacy, pain-intensity, pain-related disability, and symptoms of depression can be changed through participation in a nurse-led outpatient CBT program. In concert with results from other research on CBT pain programs this study provides further evidence that reduction in suffering and improved sense of well-being is possible even for people who have experienced pain for many years.     

Group membership and staff turnover affect outcomes in group CBT for persistent pain

The effects of two contextual factors, group membership and staff turnover, on the outcome of group cognitive behavioral therapy (CBT) for persistent pain were investigated. The data came from end of treatment and 1 month follow-up assessments of 3050 individuals who attended an intensive group programme over 16 years. Intraclass correlations (ICC) showed significant intragroup effects on self-efficacy (ICC = 0.16 at end of treatment; 0.12 at 1 month), catastrophizing (ICC = 0.06; 0.13) and distance walked (ICC = 0.20; 0.19). This underlines the importance of modelling group membership when analyzing data from group interventions. Linear regression showed that high periods of staff turnover were significantly related to poorer outcomes on self-efficacy and distance walked at end of treatment, with the effect on self-efficacy persisting to 1 month follow-up. Having demonstrated significant contextual effects in an existing data set, further research is needed to explore the mechanisms by which these effects operate.