Browsing by Subject "randomized clinical trial"

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    Design and methods of the Care Management for the Effective Use of Opioids (CAMEO) trial
    (Elsevier, 2021-07) Bushey, Michael A.; Slaven, James; Outcalt, Samantha D.; Kroenke, Kurt; Kempf, Carol; Froman, Amanda; Sargent, Christy; Baecher, Brad; Zillich, Alan; Damush, Teresa M.; Saha, Chandan; French, Dustin D.; Bair, Matthew J.; Medicine, School of Medicine
    Low back pain is the most common pain condition seen in primary care, with the most common treatment being analgesic medications, including opioids. A dramatic increase in opioid prescriptions for low back pain over the past few decades has led to increased non-medical use and opioid overdose deaths. Cognitive behavioral therapy (CBT) for chronic pain is an evidence-based non-pharmacological treatment for pain with demonstrated efficacy when delivered using collaborative care models. No previous studies have tested CBT compared to analgesic optimization that includes opioid management in primary care. This paper describes the study design and methods of the CAre Management for the Effective use of Opioids (CAMEO) trial, a 2-arm, randomized comparative effectiveness trial in seven primary care clinics. CAMEO enrolled 261 primary care veterans with chronic (6 months or longer) low back pain of at least moderate severity who were receiving long-term opioid therapy and randomized them to either nurse care management focused on analgesic treatment and optimization (MED) or cognitive behavioral therapy (CBT). All subjects undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months by interviewers blinded to treatment assignment. The primary outcome is pain severity and interference, measured by the Brief Pain Inventory (BPI) total score. Secondary outcomes include health-related quality of life, fatigue, sleep, functional improvement, pain disability, pain beliefs, alcohol and opioid problems, depression, anxiety, and stress.
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    Symptoms Improve After a Yoga Program Designed for PTSD in a Randomized Controlled Trial With Veterans and Civilians
    (APA, 2020) Davis, Louanne W.; Schmid, Arlene A.; Daggy, Joanne K.; Yang, Ziyi; O'Connor, Caitlin E.; Schalk, Nancy; Do, Ai-Nghia L.; Maric, Danka; Lazarick, Donna; Knock, Heidi; Biostatistics, School of Public Health
    Objective: Although yoga shows promise as a treatment for posttraumatic stress disorder (PTSD), there are few randomized controlled trials that demonstrate significant benefits for individuals with PTSD. The present study addresses this need by comparing the effects of a holistic yoga program (HYP) to that of a wellness lifestyle program (WLP) on PTSD symptom severity with a randomized clinical trial. Method: The sample consisted of 209 participants (91.4% veterans; 66% male; 61.7% White) who met diagnostic criteria for PTSD at baseline. Participants were randomly assigned to attend one of the 2 weekly interventions for 16 weeks. The HYP consisted of yoga instruction, while the WLP consisted of didactics, discussions, and walking. PTSD severity was measured using the Clinician Administered PTSD Scale (CAPS-5) and the PTSD Checklist (PCL-5). Results: Analyses revealed that the HYP reduced PTSD severity measured by the CAPS-5 significantly more than the WLP at treatment end (mean difference = −5.4, effect size = 0.46, p < .001), but not at 7-month follow up (mean difference = −0.9, p = .603). Similarly, the HYP reduced PTSD severity measured by the PCL-5 significantly more than the WLP at treatment end (difference = −6.0, p = .001), but not at 7-month follow up (mean difference = −1.0, p = .682). Conclusion: Yoga may be an effective intervention for PTSD in addition to standard treatments. Future yoga trials should consider adding a social component to interventions or booster classes to maintain effects long term.