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Identifying treatment responders and predictors of improvement after cognitive-behavioral therapy for juvenile fibromyalgia.
Pain. 2014 Jul; 155(7):1206-12.PAIN

Abstract

The primary objective of this study was to estimate a clinically significant and quantifiable change in functional disability to identify treatment responders in a clinical trial of cognitive-behavioral therapy (CBT) for youth with juvenile fibromyalgia (JFM). The second objective was to examine whether baseline functional disability (Functional Disability Inventory), pain intensity, depressive symptoms (Children's Depression Inventory), coping self-efficacy (Pain Coping Questionnaire), and parental pain history predicted treatment response in disability at 6-month follow-up. Participants were 100 adolescents (11-18 years of age) with JFM enrolled in a recently published clinical trial comparing CBT to a fibromyalgia education (FE) intervention. Patients were identified as achieving a clinically significant change in disability (i.e., were considered treatment responders) if they achieved both a reliable magnitude of change (estimated as a > or = 7.8-point reduction on the FDI) using the Reliable Change Index, and a reduction in FDI disability grade based on established clinical reference points. Using this rigorous standard, 40% of patients who received CBT (20 of 50) were identified as treatment responders, compared to 28% who received FE (14 of 50). For CBT, patients with greater initial disability and higher coping efficacy were significantly more likely to achieve a clinically significant improvement in functioning. Pain intensity, depressive symptoms, and parent pain history did not significantly predict treatment response. Estimating clinically significant change for outcome measures in behavioral trials sets a high bar but is a potentially valuable approach to improve the quality of clinical trials, to enhance interpretability of treatment effects, and to challenge researchers to develop more potent and tailored interventions.

Authors+Show Affiliations

Department of Pediatrics, Emory University School of Medicine, Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Atlanta, GA, USA. Electronic address: Soumitri.Sil@emory.edu.Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; William S. Rowe Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; William S. Rowe Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.Pediatric Rheumatology Unit, Shaare Zedek Medical Center, Shaare Zedek, Jerusalem, Israel.Division of Rheumatology and Immunology, Medical University of South Carolina, Charleston, SC, USA.Division of Pediatric Rheumatology, University of Louisville School of Medicine, Louisville, KY, USA.Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

24650858

Citation

Sil, Soumitri, et al. "Identifying Treatment Responders and Predictors of Improvement After Cognitive-behavioral Therapy for Juvenile Fibromyalgia." Pain, vol. 155, no. 7, 2014, pp. 1206-12.
Sil S, Arnold LM, Lynch-Jordan A, et al. Identifying treatment responders and predictors of improvement after cognitive-behavioral therapy for juvenile fibromyalgia. Pain. 2014;155(7):1206-12.
Sil, S., Arnold, L. M., Lynch-Jordan, A., Ting, T. V., Peugh, J., Cunningham, N., Powers, S. W., Lovell, D. J., Hashkes, P. J., Passo, M., Schikler, K. N., & Kashikar-Zuck, S. (2014). Identifying treatment responders and predictors of improvement after cognitive-behavioral therapy for juvenile fibromyalgia. Pain, 155(7), 1206-12. https://doi.org/10.1016/j.pain.2014.03.005
Sil S, et al. Identifying Treatment Responders and Predictors of Improvement After Cognitive-behavioral Therapy for Juvenile Fibromyalgia. Pain. 2014;155(7):1206-12. PubMed PMID: 24650858.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Identifying treatment responders and predictors of improvement after cognitive-behavioral therapy for juvenile fibromyalgia. AU - Sil,Soumitri, AU - Arnold,Lesley M, AU - Lynch-Jordan,Anne, AU - Ting,Tracy V, AU - Peugh,James, AU - Cunningham,Natoshia, AU - Powers,Scott W, AU - Lovell,Daniel J, AU - Hashkes,Philip J, AU - Passo,Murray, AU - Schikler,Kenneth N, AU - Kashikar-Zuck,Susmita, Y1 - 2014/03/17/ PY - 2013/07/29/received PY - 2014/02/20/revised PY - 2014/03/06/accepted PY - 2014/3/22/entrez PY - 2014/3/22/pubmed PY - 2015/2/13/medline KW - Clinical significance KW - Clinically meaningful change KW - Cognitive-behavioral therapy KW - Functional disability KW - Pain coping efficacy KW - Treatment responders SP - 1206 EP - 12 JF - Pain JO - Pain VL - 155 IS - 7 N2 - The primary objective of this study was to estimate a clinically significant and quantifiable change in functional disability to identify treatment responders in a clinical trial of cognitive-behavioral therapy (CBT) for youth with juvenile fibromyalgia (JFM). The second objective was to examine whether baseline functional disability (Functional Disability Inventory), pain intensity, depressive symptoms (Children's Depression Inventory), coping self-efficacy (Pain Coping Questionnaire), and parental pain history predicted treatment response in disability at 6-month follow-up. Participants were 100 adolescents (11-18 years of age) with JFM enrolled in a recently published clinical trial comparing CBT to a fibromyalgia education (FE) intervention. Patients were identified as achieving a clinically significant change in disability (i.e., were considered treatment responders) if they achieved both a reliable magnitude of change (estimated as a > or = 7.8-point reduction on the FDI) using the Reliable Change Index, and a reduction in FDI disability grade based on established clinical reference points. Using this rigorous standard, 40% of patients who received CBT (20 of 50) were identified as treatment responders, compared to 28% who received FE (14 of 50). For CBT, patients with greater initial disability and higher coping efficacy were significantly more likely to achieve a clinically significant improvement in functioning. Pain intensity, depressive symptoms, and parent pain history did not significantly predict treatment response. Estimating clinically significant change for outcome measures in behavioral trials sets a high bar but is a potentially valuable approach to improve the quality of clinical trials, to enhance interpretability of treatment effects, and to challenge researchers to develop more potent and tailored interventions. SN - 1872-6623 UR - https://www.unboundmedicine.com/medline/citation/24650858/Identifying_treatment_responders_and_predictors_of_improvement_after_cognitive_behavioral_therapy_for_juvenile_fibromyalgia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0304-3959(14)00104-3 DB - PRIME DP - Unbound Medicine ER -