RAPID: Reducing Pain; Preventing Depression

Knee Osteoarthritis Clinical Trial

— RAPID  

Official title:

RAPID: Reducing Pain; Preventing Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530204
• Other study ID #: MH090333 Sub-Project ID: 8317
• Status: Completed
• Phase: Phase 4
• Start date: July 2011
• Est. completion date: March 2016

Study information

• Verified date: July 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Late Life Depression Program	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (2)

Beissner K, Henderson CR Jr, Papaleontiou M, Olkhovskaya Y, Wigglesworth J, Reid MC. Physical therapists' use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Phys Ther. 2009 May;89(5):456-69. doi: 10.2522/ptj.20080163. Epub 2009 Mar 6. — View Citation

Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Impression of Change for Knee Pain		Assessed after the 8-16 week intervention

External Links

•   Description of clinical trial for older adults with low back pain and depression
•   University of Pittsburgh Institute on Aging