Challenges and Solutions for Depression Prevention Research: Methodology for a Depression Prevention Trial for Older Adults with Knee Arthritis and Emotional Distress

Abstract

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. HHS Public Access

Psychological Outcomes of Living Liver Donors From a Multicenter Prospective Study: Results From the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2)

“…Alcohol abuse was defined as any endorsement of the following items more than once in the preceding 6 months: drinking alcohol despite health problems, drinking alcohol during responsibilities, missed obligations due to drinking, problems getting along with other people due to drinking, or driving after drinking. The PRIME-MD is a validated tool designed to identify clinically significant mental health problems in primary care, but has also been successfully implemented in other patient populations (22–24). The modules are useful for identifying syndromes likely to meet diagnostic criteria (25–27).…”

Prevention of Depression: A Review of Literature

“…Telephone calls has also been used to deliver these interventions for older patients unable to attend the clinic due to pain [58].…”

“…The cognitive behavioral therapy program was feasible and acceptable [58]. This approach is also offered to a large variety of people attending the hospital for various reasons including pregnant women for antenatal care, post-traumatic or geriatric patients [18,37,78,80,81].…”

Shared genetic liability between major depressive disorder and osteoarthritis

“… 6 OA pain and associated disability may increase the risk for MDD through both biological and psychological mechanisms. 7 Chronic pain leads to decreased brain volume, specifically for mood regulation, 8 and the disability resulting from knee OA may result in psychological changes relevant to depression. According to a report from 2015, approximately 21% of adults with OA coexist with depression.…”