A randomized controlled trial of cognitive behavioral therapy compared with diabetes education for diabetic peripheral neuropathic pain.

A randomized controlled trial compared cognitive behavioral therapy (CBT) and diabetes education (ED) as an adjunctive treatment for diabetic peripheral neuropathic pain (DPNP). We examined change from baseline to 12- and 36-week follow-up in overall pain intensity (NRS), neuropathic pain intensity/quality, pain interference, and mental health functioning, among others. Although CBT participants demonstrated improvement in pain intensity NRS, there were no between-condition differences at either follow-up. CBT reduced neuropathic pain intensity at 12-weeks more than ED. At 36-weeks, CBT was superior to ED for improving pain interference and mental health functioning. Results provide evidence of benefit of CBT for DPNP.ClinicalTrials.gov Identifier: NCT00830011.

Cognitive Behavioral Therapy for the Management of Multiple Sclerosis-Related Pain: A Randomized Clinical Trial.

BACKGROUND: Pain is a common and often debilitating symptom in persons with multiple sclerosis (MS). Besides interfering with daily functioning, pain in MS is associated with higher levels of depression and anxiety. Although cognitive behavioral therapy (CBT) for pain has been found to be an effective treatment in other populations, there has been a dearth of research in persons with MS. METHODS: Persons with MS with at least moderate pain severity (N = 20) were randomly assigned to one of two groups: CBT plus standard care or MS-related education plus standard care, each of which met for 12 sessions. Changes in pain severity, pain interference, and depressive symptom severity from baseline to 15-week follow-up were assessed using a 2×2 factorial design. Participants also rated their satisfaction with their treatment and accomplishment of personally meaningful behavioral goals. RESULTS: Both treatment groups rated their treatment satisfaction as very high and their behavioral goals as largely met, although only the CBT plus standard care group's mean goal accomplishment ratings represented significant improvement. Although there were no significant differences between groups after treatment on the three primary outcomes, there was an overall improvement over time for pain severity, pain interference, and depressive symptom severity. CONCLUSIONS: Cognitive behavioral therapy or education-based programs may be helpful adjunctive treatments for persons with MS experiencing pain.

Further Examination of the Pain Stages of Change Questionnaires Among Chronic Low Back Pain Patients: Long-term Predictive Validity of Pretreatment and Posttreatment Change Scores and Stability of Posttreatment Scores.

OBJECTIVES: In order to maximize the therapeutic benefits of cognitive-behavioral therapy (CBT) for chronic pain, individuals need to be motivated to adopt a self-management approach. The Pain Stages of Change Questionnaire (PSOCQ) was developed to measure patients' readiness to adopt a self-management approach to chronic pain. The present study examined whether pretreatment and posttreatment PSOCQ change scores among chronic low back pain patients could predict 6- and 12-month follow-up outcomes, and the stability of posttreatment PSOCQ scores during follow-up. METHODS: Participants were recruited from a VA primary care clinic. Data from 60 participants assigned to either regular CBT or a modified CBT (ie, PRIME CBT) condition were analyzed in the present study. Self-report measures including PSOCQ, pain severity, disability, and depressive symptom severity were administered at pretreatment, 10 weeks posttreatment, 6-month and follow-up assessments. RESULTS: Multiple regression analyses showed that pretreatment and posttreatment changes in the Action/Maintenance scores significantly predicted pain severity at 6 months, and changes in the Precontemplation scores significantly predicted disability at 6 months. None of the PSOCQ change scores significantly predicted depressive symptom severity. Posttreatment Precontemplation and Action/Maintenance scores were quite stable, even at 12-month follow-up. CONCLUSIONS: Changes in patients' attitudes toward adopting a pain self-management approach may serve as one of the therapeutic mechanisms and predict long-term function. This study also revealed that changed attitudes toward chronic pain self-management remain quite stable over time. Adoption of beliefs consistent with chronic pain self-management during treatment may promote sustained benefits.

Developing a typology of patient-generated behavioral goals for cognitive behavioral therapy for chronic pain (CBT-CP): classification and predicting outcomes.

Patient-generated treatment goals describe what patients value, yet the content of these goals, and the relationship among goal types, goal accomplishment, and treatment outcomes has received little examination. We used inductive sorting to categorize patient-generated goals made by 147 adults receiving cognitive-behavioral therapy for chronic pain. The resulting goal categories were: Physical Activity (29.0%), Functional Status (24.6%), Wellness (16.3%), Recreational Activities (11.3%), House/Yard Work (9.7%), Socializing (7.1%), and Work/School (2.0%). Next, we examined associations between number of goals by category, goal accomplishment, and clinically meaningful improvements in pain-related interference, pain intensity and depressive symptoms. Improvement in all outcome domains was related to goal accomplishment. Additionally, depressive symptoms were related to number of Physical Activity, House/Yard Work, Recreational Activities, and Wellness goals, whereas improved pain-intensity was significantly related to House/Yard Work. Classifying patient-generated goals facilitates investigation of the relationships among goal type, goal accomplishment and treatment outcomes.

Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial.

Importance: Recommendations for chronic pain treatment emphasize multimodal approaches, including nonpharmacologic interventions to enhance self-management. Cognitive behavioral therapy (CBT) is an evidence-based treatment that facilitates management of chronic pain and improves outcomes, but access barriers persist. Cognitive behavioral therapy delivery assisted by health technology can obviate the need for in-person visits, but the effectiveness of this alternative to standard therapy is unknown. The Cooperative Pain Education and Self-management (COPES) trial was a randomized, noninferiority trial comparing IVR-CBT to in-person CBT for patients with chronic back pain. Objective: To assess the efficacy of interactive voice response-based CBT (IVR-CBT) relative to in-person CBT for chronic back pain. Design, Setting, and Participants: We conducted a noninferiority randomized trial in 1 Department of Veterans Affairs (VA) health care system. A total of 125 patients with chronic back pain were equally allocated to IVR-CBT (n = 62) or in-person CBT (n = 63). Interventions: Patients treated with IVR-CBT received a self-help manual and weekly prerecorded therapist feedback based on their IVR-reported activity, coping skill practice, and pain outcomes. In-person CBT included weekly, individual CBT sessions with a therapist. Participants in both conditions received IVR monitoring of pain, sleep, activity levels, and pain coping skill practice during treatment. Main Outcomes and Measures: The primary outcome was change from baseline to 3 months in unblinded patient report of average pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes included changes in pain-related interference, physical and emotional functioning, sleep quality, and quality of life at 3, 6, and 9 months. We also examined treatment retention. Results: Of the 125 patients (97 men, 28 women; mean [SD] age, 57.9 [11.6] years), the adjusted average reduction in NRS with IVR-CBT (-0.77) was similar to in-person CBT (-0.84), with the 95% CI for the difference between groups (-0.67 to 0.80) falling below the prespecified noninferiority margin of 1 indicating IVR-CBT is noninferior. Fifty-four patients randomized to IVR-CBT and 50 randomized to in-person CBT were included in the analysis of the primary outcome. Statistically significant improvements in physical functioning, sleep quality, and physical quality of life at 3 months relative to baseline occurred in both treatments, with no advantage for either treatment. Treatment dropout was lower in IVR-CBT with patients completing on average 2.3 (95% CI, 1.0-3.6) more sessions. Conclusions and Relevance: IVR-CBT is a low-burden alternative that can increase access to CBT for chronic pain and shows promise as a nonpharmacologic treatment option for chronic pain, with outcomes that are not inferior to in-person CBT. Trial Registration: clinicaltrials.gov Identifier: NCT01025752.

Pain research using Veterans Health Administration electronic and administrative data sources.

Health services researchers are using Veterans Health Administration (VHA) electronic health record (EHR) data sources to examine the prevalence, treatment, and outcomes of pain among Veterans in VHA care. Little guidance currently exists on using these data; thus, findings may vary depending on the methods, data sources, and definitions used. We sought to identify current practices in order to provide guidance to future pain researchers. We conducted an anonymous survey of VHA-affiliated researchers participating in a monthly national pain research teleconference. Thirty-two researchers (89%) responded: 75% conducted pain-focused research, 78% used pain intensity numeric rating screening scale (NRS) scores to identify pain, 41% used International Classification of Diseases-9th Revision codes, and 57% distinguished between chronic and acute pain using either NRS scores or pharmacy data. The NRS and pharmacy data were rated as the most valid pain data sources. Of respondents, 48% reported the EHR data sources were adequate for pain research, while 45% had published peer-reviewed articles based on the data. Despite limitations, VHA researchers are increasingly using EHR data for pain research, and several common methods were identified. More information on the performance characteristics of these data sources and definitions is needed.

Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain.

BACKGROUND: The Institute of Medicine report "Relieving Pain in America" recommends the promotion of patient self-management of pain for all people with pain. Given the high prevalence of chronic pain in the US, new strategies are needed to enhance access to cognitive behavioral therapy (CBT) and other evidence-based treatments designed to facilitate self-management of chronic pain conditions. Although CBT is efficacious, many patients have limited or no access to CBT. Technology-assisted delivery of CBT may improve access while maintaining efficacy. METHODS/DESIGN: We describe a randomized non-inferiority trial of interactive voice response (IVR)-based CBT for patients with chronic low back pain. This intervention uses daily IVR monitoring and weekly pre-recorded therapist feedback, based on patient-reported information, to provide treatment for patients at home. A total of 230 patients with chronic low back pain are being identified from a single statewide health system serving US military veterans. Participants are randomized to receive either ten weeks of in-person CBT or IVR-based CBT. The primary outcome is pain intensity as measured by the Numeric Rating Scale immediately post-treatment. Secondary outcomes include pain-related interference, emotional functioning, and quality of life measured immediately post treatment, and 6 and 9 months post recruitment. Exploratory objectives of the study are to examine: (1) potential mediators of impact on clinical outcomes (treatment retention, self-reported skill practice ratings, IVR call adherence, and treatment satisfaction); and (2) moderators of treatment engagement, adherence to therapist recommendations for pain coping skill practice, and effects on clinical outcomes. DISCUSSION: This non-inferiority trial may identify an alternative to resource intensive in-person CBT that allows many more patients to receive care while also increasing retention of those enrolled in the program. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01025752 . Registered 3 December 2009.

Does Change Occur for the Reasons We Think It Does? A Test of Specific Therapeutic Operations During Cognitive-Behavioral Treatment of Chronic Pain.

OBJECTIVE: To examine the relative validity of 2 conceptual models-Specific, General-by which therapeutic mechanisms in cognitive-behavioral therapy (CBT) for chronic pain achieve favorable outcomes. METHODS: As part of a clinical trial of enhanced versus standard CBT, people with chronic pain received treatment consisting of 3 pain coping skill modules. In secondary analyses of a subsample (n=56), we examined pretreatment to session 4 (of 10 sessions) changes in Chronic Pain Coping Inventory subscales that corresponded to receipt of one of 3 modules; namely Relaxation, Exercise, and Cognitive Coping modules. RESULTS: Findings indicated that: (1) participants receiving the Relaxation module improved more than other groups in relaxation skills, and improved substantially on other coping skills, as well; (2) participants receiving Exercise and Cognitive Coping modules showed mixed improvements and did not improve more than other groups on exercise use or cognitive coping, respectively; and (3) measures of patient-therapist working alliance and patient expectations of treatment benefit at session three correlated significantly with some coping skills changes. DISCUSSION: Change with CBT may occur both by theory-specified mechanisms and general mechanisms. However, the results provide the most support for a General Mechanism model in which changes on coping skills have spreading effects on the use of other coping skills. Significant relationships between some skill changes and indexes of patient-therapist working alliance and outcome expectations suggest that nonspecific factors also play a role in treatment-related changes in the use of pain coping strategies.

Specific and general therapeutic mechanisms in cognitive behavioral treatment of chronic pain.

OBJECTIVE: Many studies document efficacy of cognitive behavioral therapy (CBT) for chronic pain, but few studies have examined potential treatment mechanisms. In analyses of data from a controlled trial, we examined whether changes in attitudes toward adopting a pain self-management approach-CBT-specific mechanisms-and quality of working alliance and patient expectations-general mechanisms-early in treatment were related to later-treatment changes in outcomes. METHOD: Our sample was composed of 94 adults (primarily White; mean age: 55.3 years, SD = 11.7; 23% female) who participated in enhanced or standard CBT, and completed measures of attitudes toward self-management (mechanisms), pain intensity, pain interference, depressive symptoms and goal accomplishment (outcomes) at pretreatment, 4- and 8-week assessments, and posttreatment. Working alliance was measured at 4 and 8 weeks, and patient expectations at 3 weeks. RESULTS: Because the CBT conditions produced comparable improvements, we combined them. Precontemplation and action attitudes toward pain self-management showed significant quadratic trends over assessments such that 67% and 94.1% (respectively) of total pre-post changes occurred in the first 4 weeks. Outcomes showed only significant linear trends. Cross-lagged regressions revealed that pretreatment-to-4-week changes in action attitudes and 4-week levels of working alliance were related significantly with 4-week-to-posttreatment changes in pain intensity and interference but not vice versa and that 3-week patient expectations were related to 4-week-to-posttreatment changes in interference. Analyses in which mechanism factors were entered simultaneously revealed nonsignificant unique effects on outcomes. CONCLUSIONS: Adopting an action attitude early in treatment may represent a specific CBT mechanism but with effects held largely in common with 2 general mechanisms.

Concussive brain injury from explosive blast.

OBJECTIVE: Explosive blast mild traumatic brain injury (mTBI) is associated with a variety of symptoms including memory impairment and posttraumatic stress disorder (PTSD). Explosive shock waves can cause hippocampal injury in a large animal model. We recently reported a method for detecting brain injury in soldiers with explosive blast mTBI using magnetic resonance spectroscopic imaging (MRSI). This method is applied in the study of veterans exposed to blast. METHODS: The hippocampus of 25 veterans with explosive blast mTBI, 20 controls, and 12 subjects with PTSD but without exposure to explosive blast were studied using MRSI at 7 Tesla. Psychiatric and cognitive assessments were administered to characterize the neuropsychiatric deficits and compare with findings from MRSI. RESULTS: Significant reductions in the ratio of N-acetyl aspartate to choline (NAA/Ch) and N-acetyl aspartate to creatine (NAA/Cr) (P < 0.05) were found in the anterior portions of the hippocampus with explosive blast mTBI in comparison to control subjects and were more pronounced in the right hippocampus, which was 15% smaller in volume (P < 0.05). Decreased NAA/Ch and NAA/Cr were not influenced by comorbidities - PTSD, depression, or anxiety. Subjects with PTSD without blast had lesser injury, which tended to be in the posterior hippocampus. Explosive blast mTBI subjects had a reduction in visual memory compared to PTSD without blast. INTERPRETATION: The region of the hippocampus injured differentiates explosive blast mTBI from PTSD. MRSI is quite sensitive in detecting and localizing regions of neuronal injury from explosive blast associated with memory impairment.

Can we improve cognitive-behavioral therapy for chronic back pain treatment engagement and adherence? A controlled trial of tailored versus standard therapy.

OBJECTIVE: This study evaluated whether tailored cognitive-behavioral therapy (TCBT) that incorporated preferences for learning specific cognitive and/or behavioral skills and used motivational enhancement strategies would improve treatment engagement and participation compared with standard CBT (SCBT). We hypothesized that participants receiving TCBT would show a lower dropout rate, attend more sessions, and report more frequent intersession pain coping skill practice than those receiving SCBT. We also hypothesized that indices of engagement and adherence would correlate with pre- to posttreatment changes in outcome factors. METHOD: One hundred twenty-eight of 161 consenting persons with chronic back pain who completed baseline measures were allocated to either TCBT or SCBT using a modified randomization procedure. Participants completed daily ratings of pain coping skill practice and goal accomplishment during treatment, as well as measures of pain severity, disability, and other key outcomes at the end of treatment. RESULTS: No significant differences between treatment groups were noted on measures of treatment engagement or adherence. However, these factors were significantly related to some pre- to posttreatment improvements in outcomes, regardless of treatment condition. CONCLUSIONS: Participants in this study evidenced a high degree of participation and adherence, but treatment tailored to take into account participant preferences, and that employed motivational enhancement strategies, failed to increase treatment participation over and above SCBT for chronic back pain. Evidence that participation and adherence were associated with positive outcomes supports continued clinical and research efforts focusing on these therapeutic processes.