Objectives-To describe the methodology, challenges, and baseline characteristics of a prevention development trial entitled "Reducing Pain, Preventing Depression".Design-Sequential multiple assignment randomized trial (SMART) comparing sequences of cognitive behavioral therapy (CBT) and physical therapy for knee pain and prevention of depression and anxiety. Participants were followed for 12 months for new episode depression or anxiety.
Setting-Late-Life Depression Research Clinic.Participants-Individuals 60 and older with knee osteoarthritis and subsyndromal depression, defined as PHQ-9 score of at least "1" (which included the endorsement of one of the cardinal symptoms of depression [low mood or anhedonia]), and no diagnosis of MDD per SCID.Intervention-Sequential randomization to CBT, physical therapy, or enhanced usual care.Measurements-Depression and anxiety severity and characterization of new episodes were assessed with the PHQ-9, GAD-7, and the PRIME-MD. Knee pain was characterized with the Western Ontario McMaster Arthritis Index. Response was defined as at least "Very Much Better" on a Patient Global Impression of Change.Results-At baseline (n=99), average age=71, 61.62% are female, and 81.8% are Caucasian. The average PHQ-9 = 5.6 and average GAD7= 3.2. The majority were satisfied with the interventions and study procedures. We describe the challenges and our solutions which will be used in a confirmatory clinical trial of efficacy.Please address all correspondence to: Charles F. Reynolds III, MD, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, 758 Bellefield Towers, 3811 O'Hara Street, Pittsburgh, PA 15213, T: 412-246-6440, F: 412-246-5991, ; Email: reynoldscf@upmc.edu Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Conflicts of Interest:Receipt of medication supplies for investigator-initiated studies from Pfizer and Reckitt Benckiser. Dr. Butters served as a consultant for GlaxoSmithKline from whom she received remuneration for participating in cognitive diagnostic consensus conferences for a clinical trial; the remaining authors report no disclosures. Conclusions-A SMART design for depression and anxiety prevention, utilizing both CBT and physical therapy, appears to be feasible and acceptable to participants. The methodological innovations of this project may advance the field of late-life depression and anxiety prevention.
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