title: Challenges and Solutions for Depression Prevention Research: Methodology for a Depression Prevention Trial for Older Adults with Knee Arthritis and Emotional Distress.
abstract: To describe the methodology, challenges, and baseline characteristics of a prevention development trial entitled "Reducing Pain, Preventing Depression."
  
  
  
  A sequential multiple assignment randomized trial (SMART) compared sequences of cognitive behavioral therapy (CBT) and physical therapy for knee pain and prevention of depression and anxiety. Participants were randomized to CBT, physical therapy, or enhanced usual care and followed for 12 months for new-episode depression or anxiety. Participants were age ≥ 60 with knee osteoarthritis and subsyndromal depression, defined as 9-item Patient Health Questionnaire (PHQ-9) score ≥1 (which included the endorsement of one of the cardinal symptoms of depression [low mood or anhedonia]) and no diagnosis of major depressive disorder per the Structured Clinical Interview for DSM-IV. Depression and anxiety severity and characterization of new episodes were assessed with the PHQ-9, Generalized Anxiety Disorder-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.
  
  
  
  At baseline there were 99 patients with an average age of 71; 61.62% were women and 81.8% white. The average PHQ-9 was 5.6 and average Generalized Anxiety Disorder-7, was 3.2. Most were satisfied with the interventions and study procedures. The challenges and solutions described here will also be used in a confirmatory clinical trial of efficacy.
  
  
  
  A SMART design for depression and anxiety prevention, using both CBT and physical therapy, appears to be feasible and acceptable to participants. The methodologic innovations of this project may advance the field of late-life depression and anxiety prevention.
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, PA; Veterens Affairs Pittsburgh Health System, Geriatric Research Education and Clinical Center, Pittsburgh, PA.
authors.forename: Jordan F
authors.initials: JF
authors.lastname: Karp
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA; School of Public Health, University of Pittsburgh School of Medicine, Pittsburgh, PA.
authors.forename: Mary Amanda
authors.initials: MA
authors.lastname: Dew
authors.affiliation: Department of Biostatistics, University of Pittsburgh School of Medicine, Pittsburgh, PA.
authors.forename: Abdus S
authors.initials: AS
authors.lastname: Wahed
authors.affiliation: Departmentof Physical Therapy, University of Pittsburgh School of Medicine, Pittsburgh, PA.
authors.forename: Kelley
authors.initials: K
authors.lastname: Fitzgerald
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.
authors.forename: Chloe A
authors.initials: CA
authors.lastname: Bolon
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Medicine, University of Pittsburgh, Pittsburgh, PA; Veterens Affairs Pittsburgh Health System, Geriatric Research Education and Clinical Center, Pittsburgh, PA.
authors.forename: Debra K
authors.initials: DK
authors.lastname: Weiner
authors.affiliation: Department of Psychology, Chatham University, Pittsburgh, PA.
authors.forename: Jennifer Q
authors.initials: JQ
authors.lastname: Morse
authors.affiliation: School of Public Health, University of Pittsburgh School of Medicine, Pittsburgh, PA.
authors.forename: Steve
authors.initials: S
authors.lastname: Albert
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.
authors.forename: Meryl
authors.initials: M
authors.lastname: Butters
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA.
authors.forename: Ariel
authors.initials: A
authors.lastname: Gildengers
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA. Electronic address: reynoldscf@upmc.edu.
authors.forename: Charles F
authors.initials: CF
authors.lastname: Reynolds
mesh_terms: D000368:Aged; D001007:Anxiety / Q000517:prevention & control*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003863:Depression / Q000517:prevention & control*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004644:Emotions; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009864:Ontario; D020370:Osteoarthritis, Knee / Q000523:psychology*; D010146:Pain / Q000523:psychology*; D017060:Patient Satisfaction; D016016:Proportional Hazards Models; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D013315:Stress, Psychological
keywords: anxiety; depression; late life; pain; prevention
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