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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2020-10-31

Brief Summary

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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.

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Detailed Description

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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.

Aim 2 is to compare the most efficient treatment from Aim 1 with a control group to evaluate pain relief at 3 months.

Conditions

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Catastrophization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

n=80 Subjects for Aim 1 and another n=80 Subjects for Aim 2

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

Cognitive Therapy

Intervention Type OTHER

CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.

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.

Group Type EXPERIMENTAL

Cognitive Therapy

Intervention Type OTHER

CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.

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".

Group Type EXPERIMENTAL

Cognitive Therapy

Intervention Type OTHER

CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.

Routine care

Routine care; no CT sessions

Group Type PLACEBO_COMPARATOR

Routine Care

Intervention Type OTHER

Routine Care. No Cognitive Therapy Intervention

Interventions

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Cognitive Therapy

CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.

Intervention Type OTHER

Routine Care

Routine Care. No Cognitive Therapy Intervention

Intervention Type OTHER

Eligibility Criteria

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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 is planning to undergo another elective joint procedure during the 6-mo period of participation;
6. any co-morbidity which results in severe systemic disease limiting function {as defined by the American Society of Anesthesiology (ASA) physical status classification \> 3}.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes