Overview

This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments physical therapy for knee oa, cognitive behavioral therapy for pain cbt-p, enhanced treatment as usual
Phase phase 4
Sponsor University of Pittsburgh
Start date July 2011
End date June 2016
Trial size 135 participants
Trial identifier NCT01530204, MH090333 Sub-Project ID: 8317

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
8-12 sessions of knee-focused physical therapy and a home-based conditioning program.
physical therapy for knee oa
8-12 sessions of knee-focused physical therapy and a home-based conditioning program.
(Active Comparator)
8-12 session pain-focused Cognitive Behavioral Therapy
cognitive behavioral therapy for pain cbt-p
8-12 session pain-focused Cognitive Behavioral Therapy
(Active Comparator)
Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.
enhanced treatment as usual
Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.

Primary Outcomes

Measure
Patient Global Impression of Change for Knee Pain
time frame: Assessed after the 8-16 week intervention

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: 1. >/= age 60 2. meets accepted clinical criteria for knee OA based on the American College of Rheumatology 1986 clinical criteria guidelines. 3. 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) 4. PHQ-9 scores 1-9, with at least one of the cardinal symptoms of depression (low mood or anhedonia) endorsed. 5. Modified Mini Mental State (3MS) Examination >/= 80. 6. Has or is willing to establish care with a personal physician prior to any experimental procedures. Exclusion Criteria: 1. Major Depressive Episode or anxiety disorder within the past 1 year 2. Currently taking an antidepressant 3. History of bipolar or schizophrenia 4. Drug or alcohol use disorder within the past 12 months 5. Receiving knee-related workers compensation or involved in knee pain-related litigation. 6. Currently taking an anti-anxiety medicine > 4 times/week for the past 4 weeks.

Additional Information

Official title RAPID: Reducing Pain; Preventing Depression
Principal investigator Jordan F Karp, MD
Description In this Sequential Multiple Assignment Randomized (SMART) Trial, the investigators care comparing Cognitive Behavioral Therapy for Pain (CBT-P) with EXERCISE (knee-specific Physical Therapy) delivered individually and sequentially. A subset of participants will receive enhanced care as usual in which their primary care physicians will receive information about pharmacological management of knee osteoarthritis. The active phase of the study may be up to 16 weeks, and the follow-up period lasts 12 months. Stage 1, Specific Aim 1: To test if Cognitive Behavioral Therapy for Pain (CBT-P) results in more improvement in pain and disability than those receiving knee-specific Physical Therapy (EXERCISE). Stage 1, Hypothesis 1: At week 8, subjects randomized to CBT-P will have more improvement in pain and disability than those randomized to EXERCISE. Stage 2, Specific Aim 2: For non-responders to Stage 1, to explore which sequence of interventions leads to greater improvement in pain and disability. Stage 2, Hypothesis 2: Compared to the other sequenced interventions (see Figure), subjects randomized to CBT-P and then EXERCISE will have the most improvement in pain and disability. Follow-up, Specific Aim 3: To explore if improvement in pain and disability is associated with incident major depressive episode (MDE) over 12 months. Follow-up, Hypothesis 3: More pain and disability improvement will be associated with lower rates of incident (MDE) over 12 months. Exploratory AIM 1: To compare "legacy" assessments of functioning and psychological health with Computer Adaptive Testing (CAT) assessments of these domains for level of agreement. Exploratory AIM 2: To assess candidate genetic polymorphisms, peripheral mRNA biosignatures, and candidate cytokine and growth factor levels using both multiplex assays and individual ELISAs. The investigators are exploring if these biomarkers are associated with pain improvement and risk for developing MDE.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.