Purpose: In its 3rd strategic plan, NCCAM identified goals for future research, including ‘‘better understanding of the contri- butions of both specific and nonspecific effects influencing outcomes.’’ We present progress to date on our NCCAM-funded project, The Healing Context in CAM: Instrument Development and Initial Validation, which will measure nonspecific factors from the patient’s perspective. Methods: We used PROMISÒ methodology to develop pa- tient-report measures of nonspecific factors that may influence healing, such as perceptions of the provider and healthcare environment, treatment expectations, and spirituality and op- timism. We conducted 6 focus groups of CAM and conven- tional medicine patients, interviewed 22 CAM experts, and evaluated existing questionnaires. Through an iterative ap- proach involving writing, rewriting, and revising items based on feedback from patients, we developed a set of item banks containing a total of 296 items. The items were tested on an Internet sample of 1400 adults who had experienced CAM or conventional treatments, and on a Pittsburgh sample of 257 patients who had started a CAM or conventional treatment for any non-acute condition within the previous 4 months. Data analysis included exploratory factor analysis (EFA), confir- matory factor analysis (CFA), and item response theory (IRT). Additionally, 221/257 of the Pittsburgh sample rated their Clinical Global Impression (CGI) of improvement 6 weeks after completing the item banks. Results: EFA and CFA retained 250 items and identified 5 factors: 1) Patient-Provider Relationship + Healthcare Environ- ment, 2) Optimism, 3) Spirituality, 4) Pro-CAM Attitudes, and 5) Treatment Expectations. IRT analyses resulted in retaining Healthcare Environment as a separate construct. Patients’ IRT theta scores for all factors except Spirituality were significantly but modestly correlated with CGI, with Treatment Expecta- tions showing the highest correlation with CGI (Spearman’s Rho = .358, p < 0.01). Conclusion: The project has successfully created item banks to measure nonspecific factors in healing, with most item banks exhibiting significant associations with patient reports of im- provement. Further validity studies are forthcoming. Contact: Carol Greco, grecocm@upmc.edu OA08.04 Determinants of Responders in a Dose-Response Trial of Spinal Manipulation for the Care of Chronic Low Back Pain Darcy Vavrek (1), Mitchell Haas (1), David Peterson (1), Moni Neradilek (2), Nayak Polissar (2) (1) University of Western States, Portland, OR, USA (2) The Mountain-Whisper-Light Statistics, Seattle, WA, USA Purpose: The aim of this secondary analysis is to identify de- terminants of success of spinal manipulation (SMT) for the treatment of chronic low back pain (cLBP). Methods: We randomized 400 cLBP patients to receive 18 sessions of lumbar SMT or a light massage control scheduled over 6-weeks; with SMT at 0, 6, 12, or 18 of the visits. Patients were followed for 52-weeks. Successful response to treatment is defined as a 50% improvement in pain measured with the 100- point modified Von Korff Pain Scale. Three-quarters of the data-set is used to develop the predictive models with stepwise logistic regression. Investigated determinants of successful re- sponse are baseline measures of pain, disability, outside care, health status, age, gender, relative confidence in SMT/massage, any previous SMT/massage care, and time-point. Secondarily, models are validated on the remaining data with sensitivity and specificity. Results: Determinants associated with improvement across all time points included number of weeks since baseline, dose, number of comorbidities, number of treatment visits, confidence in physician’s ability to treat cLBP, and the EuroQol question about self-care at baseline with p-values of 0.048, < 0.001, 0.020, 0.080, 0.100, and 0.046 respectively. 50%-improvement in pain, across all time points, was predicted best, using forward stepwise selection, by treatment and lower number of co- morbidities. An increase in dose increased successful recovery with an OR per increase of 6 treatments of 1.32 95%CI[1.11, 1.57, p = 0.002]. And an increased count of the number of co- morbidities prevented recovery at an OR per 1 comorbidity of 0.82 95%CI[0.69, 0.97; p = 0.025]. Conclusion: These findings will assist with developing models for predicting which cLBP patients would especially benefit from SMT. Contact: Darcy Vavrek, dvavrek@uws.edu Oral Abstract Session 09: Clinical Trials OA09.01 LB Mindfulness Training Versus Sleep Hygiene for Insomnia Symptoms in Older Adults: A Randomized Controlled Comparison Trial Gillian O’Reilly (1), David Black (1), Eileen Luders (1), Elizabeth Breen (1), Richard Olmstead (2), Irwin Michael (2) (1) University of Southern California, Los Angeles, CA, USA (2) Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience & Human Behavior, University of California, Los Angeles, CA, USA Purpose: Adequate sleep is vital to our survival, yet sleep problems grow common with age. About 50% of people aged 55 + years experience insomnia weekly. Given that sleep problems often go untreated in older adults, and untreated sleep problems increase the risk for morbidity and all-cause mortality, effective treatments for sleep problems are a priority to improve the health of our aging population. This randomized controlled comparison trial examined the relative efficacy of two 6-week interventions (mindfulness meditation training, MT vs. sleep hygiene, SH) on sleep, inflammatory markers, and brain mor- phology. Methods: Participants (N = 49) were ages 55–90 (M = 66.27, SD = 7.43). Inclusion criteria: currently active insomnia symp- toms, age in years > 55, and agreeing to randomization. Exclu- sion criteria: current inflammatory disorder, illness, or infection, current practice of mediation, depression, cognitive impairment, class II or greater obesity, current sleep apnea diagnosis, inability to speak English, and current smoking and/or substance depen- dence. The UCLA IRB approved study procedures. Measures included self-reported sleep, fatigue, and peripheral blood mono- nuclear cell levels of Nuclear Factor-kappa B. Brain images were acquired on a 1.5T Siemens Sonata scanner using an 8-channel head coil and a T1-weighted MPRAGE sequence. Results: Forty-three (88%) participants completed the trial. ITT analyses showed that both groups reported improved sleep and NF-kB levels post-intervention. Sleep improvements in the MT condition were significantly greater than SH (p < .02). Fatigue symptoms improved only in the MT group (p < .01). Significant A14