Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

RAPID: Reducing Pain; Preventing Depression (RAPID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 1, 2012
First Posted Date  ICMJE February 9, 2012
Last Update Posted Date July 3, 2018
Study Start Date  ICMJE July 2011
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
Patient Global Impression of Change for Knee Pain [ Time Frame: Assessed after the 8-16 week intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RAPID: Reducing Pain; Preventing Depression
Official Title  ICMJE RAPID: Reducing Pain; Preventing Depression
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Procedure: Physical Therapy for knee OA
    8-12 sessions of knee-focused physical therapy and a home-based conditioning program.
  • Behavioral: Cognitive Behavioral Therapy for Pain CBT-P
    8-12 session pain-focused Cognitive Behavioral Therapy
  • Other: Enhanced Treatment as Usual
    Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.
Study Arms  ICMJE
  • Active Comparator: Physical Therapy
    8-12 sessions of knee-focused physical therapy and a home-based conditioning program.
    Intervention: Procedure: Physical Therapy for knee OA
  • Active Comparator: Cognitive Behavioral Therapy for Pain
    8-12 session pain-focused Cognitive Behavioral Therapy
    Intervention: Behavioral: Cognitive Behavioral Therapy for Pain CBT-P
  • Active Comparator: Enhanced Treatment as Usual
    Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.
    Intervention: Other: Enhanced Treatment as Usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2012)
135
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530204
Other Study ID Numbers  ICMJE MH090333 Sub-Project ID: 8317
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jordan F. Karp, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jordan F Karp, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP