title: Identifying treatment responders and predictors of improvement after cognitive-behavioral therapy for juvenile fibromyalgia.
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.affiliation: Department of Pediatrics, Emory University School of Medicine, Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Atlanta, GA, USA 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 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.
authors.forename: Soumitri
authors.initials: S
authors.lastname: Sil
authors.forename: Lesley M
authors.initials: LM
authors.lastname: Arnold
authors.forename: Anne
authors.initials: A
authors.lastname: Lynch-Jordan
authors.forename: Tracy V
authors.initials: TV
authors.lastname: Ting
authors.forename: James
authors.initials: J
authors.lastname: Peugh
authors.forename: Natoshia
authors.initials: N
authors.lastname: Cunningham
authors.forename: Scott W
authors.initials: SW
authors.lastname: Powers
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Lovell
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Hashkes
authors.forename: Murray
authors.initials: M
authors.lastname: Passo
authors.forename: Kenneth N
authors.initials: KN
authors.lastname: Schikler
authors.forename: Susmita
authors.initials: S
authors.lastname: Kashikar-Zuck
mesh_terms: D000223:Adaptation, Psychological; D000293:Adolescent; D002648:Child; D015928:Cognitive Behavioral Therapy; D003863:Depression / Q000523:psychology*; D004185:Disability Evaluation; D005260:Female; D005356:Fibromyalgia / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D006801:Humans; D008297:Male; D010147:Pain Measurement; D020377:Self Efficacy; D016896:Treatment Outcome
keywords: Clinical significance; Clinically meaningful change; Cognitive-behavioral therapy; Functional disability; Pain coping efficacy; Treatment responders