Abstract
Background:
Chronic pain is common and challenging to treat. Although cognitive behavioral therapy (CBT) is efficacious, its benefit in disadvantaged populations is largely unknown.
Objective:
To evaluate the efficacy of literacy-adapted and simplified group CBT versus group pain education (EDU) versus usual care.
Design:
Randomized controlled trial. (ClinicalTrials.gov: NCT01967342)
Setting:
Community health centers serving low-income patients in Alabama.
Patients:
Adults (aged 19 to 71 years) with mixed chronic pain.
Interventions:
CBT and EDU delivered in 10 weekly 90-minute group sessions.
Measurements:
Self-reported, postintervention pain intensity (primary outcome) and physical function and depression (secondary outcomes).
Results:
290 participants were enrolled (70.7% of whom were women, 66.9% minority group members, 72.4% at or below the poverty level, and 35.8% reading below the fifth grade level); 241 (83.1%) participated in posttreatment assessments. Linear mixed models included all randomly assigned participants. Members of the CBT and EDU groups had larger decreases in pain intensity scores between baseline and posttreatment than participants receiving usual care (estimated differences in change scores—CBT: −0.80 [95% CI −1.48 to −0.11]; P = 0.022; EDU: −0.57 [CI, −1.04 to −0.10]; P = 0.018). At 6-month follow-up, treatment gains were not maintained in the CBT group but were still present in the EDU group. With regard to physical function, participants in the CBT and EDU interventions had greater posttreatment improvement than those receiving usual care, and this progress was maintained at 6-month follow-up. Changes in depression (secondary outcome) did not differ between either the CBT or EDU group and the usual care group.
Limitations:
Participants represented a single health care system. Self-selection bias may have been present.
Conclusion:
Simplified group CBT and EDU interventions delivered at low-income clinics significantly improved pain and physical function compared with usual care.
Primary Funding Source:
Patient-Centered Outcomes Research Institute.
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Author, Article, and Disclosure Information
Beverly E. Thorn,
University of Alabama, Tuscaloosa, Alabama (B.E.T., J.C.E., B.P.V., C.A.T., A.K.N., P.R.B., M.M.M.)
Rush University Medical Center, Chicago, Illinois (J.W.B.)
Ohio State University, Columbus, Ohio (M.K., J.S.C.)
East Carolina University, Greenville, North Carolina (L.C.C.)
University of Alabama, Tuscaloosa, Alabama, and Integrated Psychology Solutions, Little Rock, Arkansas (B.A.)
Arizona Emergency Medicine Research Center, Tucson, Arizona (B.J.B.)
Whatley Health Services, Tuscaloosa, Alabama (R.B., T.T.B., C.S.E., D.H.T.)
University of Alabama, Tuscaloosa, Alabama, and Pacific Rehabilitation Centers, Bellevue, Washington (C.M.D.)
University of Alabama, Tuscaloosa, Alabama, and CHI Franciscan Medical Group, Tacoma, Washington (W.D.D.)
University of California, Los Angeles, Los Angeles, California (M.J.)
University of Alabama, Tuscaloosa, and University of Alabama at Birmingham, Birmingham, Alabama (T.P.)
Virginia Commonwealth University, Richmond, Virginia (L.J.S.)
Disclaimer: The statements presented in this work are solely the responsibility of the authors and do not necessarily represent the views of PCORI, its board of governors, or the methodology committee.
Acknowledgment: The authors thank the many persons who assisted with this study, particularly Madison Anzelc, Jacob Baxter, Julie Cunningham, Laura M. Daniels, Julia Dodd, Courtney Harhay, Tyler Jones, Wesley Korfe, Shweta Kapoor, Megan Lyons, Hylton Molzof, Ian Sherwood, and Bryan Valladares.
Financial Support: Funded partially by a PCORI Research Award (contract 941) and partially by the University of Alabama.
Disclosures: Dr. Thorn reports grants from PCORI and indirect cost recovery for research expenses from the University of Alabama during the conduct of the study and personal fees from Guilford Publications outside the submitted work. Drs. Eyer and Burns, Mr. Van Dyke, Ms. Newman, and Mr. Penn report grants from PCORI during the conduct of the study. Dr. Campbell reports grants from the University of Alabama and PCORI during the conduct of the study. Dr. Cheavens reports personal fees from the University of Alabama during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-0972.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: See Supplement. Statistical code: Not available. Data set: Available from Dr. Thorn (e-mail, bthorn@ua.
Corresponding Author: Beverly E. Thorn, PhD, University of Alabama, 348 Gordon Palmer Hall, Tuscaloosa, AL 35487; e-mail, bthorn@ua.
Current Author Addresses: Dr. Thorn, Mr. Van Dyke, Ms. Torres, Ms. Newman, Ms. Block, and Mr. Mulla: University of Alabama, 348 Gordon Palmer Hall, Tuscaloosa, AL 35487.
Dr. Eyer: University of Alabama, 650 University Boulevard East, Tuscaloosa, AL 35401.
Dr. Burns: Rush University Medical Center, 1645 West Jackson Boulevard, Suite 400, Chicago, IL 60612.
Dr. Kim: Ohio State University, 127 Arps Hall, 1945 North High Street, Columbus, OH 43210.
Dr. Campbell: East Carolina University, Rawl Building Room 104, Greenville, NC 27858.
Dr. Anderson: 1303 Stagecoach Village, Little Rock, AR 72210.
Dr. Bobrow: University of Arizona, Department of Emergency Medicine, 1501 North Campbell Avenue, P.O. Box 245057, Tucson, AZ 85724.
Ms. Brooks, Dr. Burton, Ms. Edwards, and Ms. Tucker: Whatley Health Services, 2731 Martin Luther King Boulevard, Tuscaloosa, AL 35401.
Dr. Cheavens: Ohio State University, 147 Psychology Building, Columbus, OH 43210.
Dr. C.M. DeMonte: Pacific Rehabilitation Centers, 126 15th Street Southeast, Puyallup, WA 98372.
Dr. W.D. DeMonte: Franciscan Medical Pavilion, 16045 1st Avenue South, Burien, WA 98148.
Dr. Jeong: University of California, Los Angeles, 3141 Moore Hall, 457 Portola Avenue, Los Angeles, CA 90024.
Mr. Penn: University of Alabama at Birmingham, 201 Campbell Hall, Birmingham, AL 35294.
Ms. Smith: 806 West Franklin Street, Box 842018, Richmond, VA 23284.
Author Contributions: Conception and design: B.E. Thorn, J.C. Eyer, B.P. Van Dyke, C.A. Torres, J.W. Burns, L.C. Campbell, P.R. Block.
Analysis and interpretation of the data: B.E. Thorn, J.C. Eyer, B.P. Van Dyke, C.A. Torres, J.W. Burns, M. Kim, A.K. Newman, B.J. Bobrow, J.S. Cheavens, M. Jeong.
Drafting of the article: B.E. Thorn, J.C. Eyer, B.P. Van Dyke, C.A. Torres, J.W. Burns, A.K. Newman, L.C. Campbell, J.S. Cheavens.
Critical revision for important intellectual content: B.E. Thorn, J.C. Eyer, B.P. Van Dyke, C. Torres, L.C. Campbell, P.R. Block, T.T. Burton.
Final approval of the article: B.E. Thorn, J.C. Eyer, B.P. Van Dyke, C.A. Torres, J.W. Burns, M. Kim, A.K. Newman, L.C. Campbell, B. Anderson, P.R. Block, B.J. Bobrow, R. Brooks, T.T. Burton, J.S. Cheavens, C.M. DeMonte, W.D. DeMonte, C.S. Edwards, M. Jeong, M.M. Mulla, T. Penn, L.J. Smith, D.H. Tucker.
Provision of study materials or patients: B.E. Thorn, J.C. Eyer, B. Anderson, T.T. Burton.
Statistical expertise: J.C. Eyer, B.P. Van Dyke, M. Kim, M. Jeong.
Obtaining of funding: B.E. Thorn, J.C. Eyer.
Administrative, technical, or logistic support: B.E. Thorn, J.C. Eyer, C.A. Torres, L.C. Campbell, B. Anderson, P.R. Block, T.T. Burton, C.M. DeMonte, W.D. DeMonte, M.M. Mulla, T. Penn, D.H. Tucker.
Collection and assembly of data: B.P. Van Dyke, B. Anderson, P.R. Block, R. Brooks, T.T. Burton, C.M. DeMonte, W.D. DeMonte, C.S. Edwards, L.J. Smith.
This article was published at Annals.org on 27 February 2018.
* Authors listed after Dr. Campbell are in alphabetical order.
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