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RAPID: Reducing Pain; Preventing Depression (RAPID)

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ClinicalTrials.gov Identifier: NCT01530204
Recruitment Status : Completed
First Posted : February 9, 2012
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jordan F. Karp, University of Pittsburgh

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Physical Therapy for knee OA Behavioral: Cognitive Behavioral Therapy for Pain CBT-P Other: Enhanced Treatment as Usual Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: RAPID: Reducing Pain; Preventing Depression
Study Start Date : July 2011
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Patient Global Impression of Change for Knee Pain [ Time Frame: Assessed after the 8-16 week intervention ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530204


Locations
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United States, Pennsylvania
University of Pittsburgh Late Life Depression Program
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Jordan F Karp, MD University of Pittsburgh
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jordan F. Karp, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01530204    
Other Study ID Numbers: MH090333 Sub-Project ID: 8317
First Posted: February 9, 2012    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Keywords provided by Jordan F. Karp, University of Pittsburgh:
knee arthritis
knee osteoarthritis
knee pain
 cognitive behavioral therapy
physical therapy
depression prevention
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Depression
Behavioral Symptoms
 Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases