Preoperative Cognitive Therapy for Improving Health Outcomes After TKA in High-risk Catastrophizing Subjects (CT_TKA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Rush University Medical Center
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Asokumar Buvanendran, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01772329
First received: January 17, 2013
Last updated: April 26, 2016
Last verified: April 2016
  Purpose
The investigators propose a randomized controlled trial to evaluate the effects of treatment intended to reduce pain catastrophizing among patients reporting high pain catastrophizing prior to total knee replacement(TKR), total hip replacement(THR), or shoulder surgery in an effort to thereby reduce the incidence of persistent post-surgical pain (PPP) and enhance physical function at 3-months post-surgery. Preemptive treatment aimed at a known predictor of PPP following total knee replacement is highly innovative and have potentially high impact for public health. Cognitive therapy is a well-tolerated modality among chronic pain patients with few if any side effects. Cognitive therapy (CT) represents an inexpensive method that could greatly reduce suffering and costly post-surgical pain management for high risk TKR patients.

Condition Intervention
Catastrophization
Other: Cognitive Therapy
Other: Routine Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Preoperative Cognitive Therapy for Improving Health Outcomes After Total Knee Replacement in High-risk Catastrophizing Subjects

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Pain Catastrophizing Scale (PCS) [ Time Frame: 4 or 8 weeks after start of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Health Questionnaire (PHQ-8) [ Time Frame: 4 and 8 weeks after start of treatment ] [ Designated as safety issue: No ]
    Patient Health Questionnaire (PHQ-8): The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders

  • Generalized anxiety disorder (GAD-7) [ Time Frame: 4 and 8 weeks after start of treatment ] [ Designated as safety issue: No ]
    Generalized anxiety disorder (GAD-7): The seven-item Generalized Anxiety Disorder Scale (GAD-7) is a practical self-report anxiety questionnaire.


Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4 weekly CT sessions - in person
4 weekly CT sessions; all will be 1-hr individual cognitive therapy sessions with the psychology staff (under the supervision of John Burns, PhD).
Other: Cognitive Therapy
CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.
Experimental: 8 weekly CT sessions
8 weekly CT sessions; 1st and 8th will be 1-hr individual cognitive therapy session with the psychology staff (under the supervision of John Burns, PhD). The intermediate CT sessions will be by telephone call or video/"Skype". Our group will purchase and setup a web camera and headphone/microphone for the subjects in the CT groups that use "Skype". The 1-hr CT protocol was adapted from Dr. Beverly E. Thorn's CT manual (Cognitive Therapy for Chronic Pain: A Step-by-Step Guide; Thorn, 2004; with the Client and Therapy Workbooks.
Other: Cognitive Therapy
CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.
Experimental: 4 weekly CT sessions - Tele-video
4 weekly CT sessions; 1st and 4th will be 1-hr individual cognitive therapy session with the psychology staff. The intermediate CT sessions will be by telephone call or video/"Skype".
Other: Cognitive Therapy
CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.
Placebo Comparator: Routine care
Routine care; no CT sessions
Other: Routine Care
Routine Care. No Cognitive Therapy Intervention

Detailed Description:
Aim 1 is to determine which CT protocol is most effective in reducing Pain Catastrophizing Scale (PCS) and Coping Strategies Questionnaire Catastrophizing Subscale (CSQ-CAT) scores in high-risk TKR candidates. CT will consist of four-to-eight weekly 1-hr individual cognitive therapy sessions prior to surgery.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. undergoing standard primary TKR; THR or Shoulder Surgery
  2. 18- 85 yrs of age;
  3. Surgical joint is the primary source of patient's pain;
  4. Patient agrees to preoperative visits and treatment, follow-up visits and treatment, and to comply with the assessment tests;
  5. Patient consents to standard anesthetic and analgesic protocol, with medical care as deemed necessary by the anesthesiologist, and has no contraindications.
  6. Patient has been diagnosed with osteoarthritis.

Exclusion Criteria:

  1. Currently using antidepressant medication or undergoing cognitive therapy;
  2. chronic opioid use ≥ 10 mg/day of morphine equivalents within one wk prior to the surgery, and duration of use > 4 wks;
  3. history of opioid abuse;
  4. inability to understand and communicate with the investigators to complete the study related questionnaires
  5. patient currently enrolled in another study;
  6. patient is planning to undergo another elective joint procedure during the 6-mo period of participation;
  7. any co-morbidity which results in severe systemic disease limiting function {as defined by the American Society of Anesthesiology (ASA) physical status classification > 3}.
  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: NCT01772329

Contacts
Contact: Mario Moric 312-942-2806 mario_moric@rush.edu
Contact: Sherry J Robison, MBA (312) 942-2985 Sherry_J_Robison@rush.edu

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Andrea Embrechts, RN    312-942-2741    Andrea_Embrechts@rush.edu   
Principal Investigator: Asokumar Buvanendran, MD         
Sponsors and Collaborators
Rush University Medical Center
Pfizer
Investigators
Principal Investigator: Asokumar Buvanendran, MD Rush UMC
  More Information

Responsible Party: Asokumar Buvanendran, Profesor Anesthesiology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01772329     History of Changes
Other Study ID Numbers: 12031901 
Study First Received: January 17, 2013
Last Updated: April 26, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: No plan to share data as of yet but may be willing to.

ClinicalTrials.gov processed this record on July 27, 2016