RAPID: Reducing Pain; Preventing Depression
RAPID
1 other identifier
interventional
135
1 country
1
Brief Summary
The primary question addressed by this prevention study is to explore if improving pain and disability reduces episodes of Major Depression among seniors with knee osteoarthritis (OA) and mild depressive symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 knee-osteoarthritis
Started Jul 2011
Longer than P75 for phase_4 knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJuly 3, 2018
July 1, 2018
4.7 years
February 1, 2012
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Global Impression of Change for Knee Pain
Assessed after the 8-16 week intervention
Study Arms (3)
Physical Therapy
ACTIVE COMPARATOR8-12 sessions of knee-focused physical therapy and a home-based conditioning program.
Cognitive Behavioral Therapy for Pain
ACTIVE COMPARATOR8-12 session pain-focused Cognitive Behavioral Therapy
Enhanced Treatment as Usual
ACTIVE COMPARATORInformation about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.
Interventions
8-12 sessions of knee-focused physical therapy and a home-based conditioning program.
8-12 session pain-focused Cognitive Behavioral Therapy
Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.
Eligibility Criteria
You may qualify if:
- \>/= age 60
- meets accepted clinical criteria for knee OA based on the American College of Rheumatology 1986 clinical criteria guidelines.
- Western Ontario and McMaster University Arthritis Index (WOMAC) pain subscale score in the range of 7-15 (to minimize including subjects with knee OA so severe they may be better served by arthroplasty)
- PHQ-9 scores 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed.
- Modified Mini Mental State (3MS) Examination \>/= 80.
- Has or is willing to establish care with a personal physician prior to any experimental procedures.
You may not qualify if:
- Major Depressive Episode or anxiety disorder within the past 1 year
- Currently taking an antidepressant
- History of bipolar or schizophrenia
- Drug or alcohol use disorder within the past 12 months
- Receiving knee-related workers compensation or involved in knee pain-related litigation.
- Currently taking an anti-anxiety medicine \> 4 times/week for the past 4 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh Late Life Depression Program
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (3)
Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.
PMID: 17466815BACKGROUNDBeissner K, Henderson CR Jr, Papaleontiou M, Olkhovskaya Y, Wigglesworth J, Reid MC. Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Phys Ther. 2009 May;89(5):456-69. doi: 10.2522/ptj.20080163. Epub 2009 Mar 6.
PMID: 19270046BACKGROUNDKarp JF, Zhang J, Wahed AS, Anderson S, Dew MA, Fitzgerald GK, Weiner DK, Albert S, Gildengers A, Butters M, Reynolds CF 3rd. Improving Patient Reported Outcomes and Preventing Depression and Anxiety in Older Adults With Knee Osteoarthritis: Results of a Sequenced Multiple Assignment Randomized Trial (SMART) Study. Am J Geriatr Psychiatry. 2019 Oct;27(10):1035-1045. doi: 10.1016/j.jagp.2019.03.011. Epub 2019 Mar 21.
PMID: 31047790DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jordan F Karp, MD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 1, 2012
First Posted
February 9, 2012
Study Start
July 1, 2011
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
July 3, 2018
Record last verified: 2018-07