RAPID: Reducing Pain; Preventing Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Jordan F. Karp, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01530204
First received: February 1, 2012
Last updated: June 21, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530204

Contacts
Contact: Mary C McShea, MS 412-246-6003 mcsheamc@upmc.edu
Contact: Chloe Bolon, BS 412-246-6018 bolonc@upmc.edu

Locations
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         
Sponsors and Collaborators
University of Pittsburgh
Investigators
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: June 21, 2013
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 August 26, 2014