RAPID: Reducing Pain; Preventing Depression
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Knee Osteoarthritis |
Procedure: Physical Therapy for knee OA Behavioral: Cognitive Behavioral Therapy for Pain CBT-P Other: Enhanced Treatment as Usual |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | RAPID: Reducing Pain; Preventing Depression |
- Patient Global Impression of Change for Knee Pain [ Time Frame: Assessed after the 8-16 week intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 135 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Physical Therapy
8-12 sessions of knee-focused physical therapy and a home-based conditioning program.
|
Procedure: Physical Therapy for knee OA
8-12 sessions of knee-focused physical therapy and a home-based conditioning program.
|
|
Active Comparator: Cognitive Behavioral Therapy for Pain
8-12 session pain-focused Cognitive Behavioral Therapy
|
Behavioral: Cognitive Behavioral Therapy for Pain CBT-P
8-12 session pain-focused Cognitive Behavioral Therapy
|
|
Active Comparator: Enhanced Treatment as Usual
Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.
|
Other: Enhanced Treatment as Usual
Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- >/= 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.
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Mary C McShea, MS | 412-246-6003 | mcsheamc@upmc.edu |
| Contact: Chloe Bolon, BS | 412-246-6018 | bolonc@upmc.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Late Life Depression Program | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Mary C McShea, MS 412-246-6003 mscheamc@upmc.edu | |
| Contact: Chloe Bolon, BS 412-246-6018 bolonc@upmc.edu | |
| Principal Investigator: Jordan F Karp, MD | |
| Principal Investigator: | Jordan F Karp, MD | University of Pittsburgh |
More Information
Additional Information:
Publications:
| Responsible Party: | Jordan F. Karp, Associate Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01530204 History of Changes |
| Other Study ID Numbers: | MH090333 Sub-Project ID: 8317 |
| Study First Received: | February 1, 2012 |
| Last Updated: | February 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
knee arthritis knee osteoarthritis knee pain |
cognitive behavioral therapy physical therapy depression prevention |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Osteoarthritis Osteoarthritis, Knee Behavioral Symptoms Mood Disorders |
Mental Disorders Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013