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Acceptance and Commitment Therapy for Postoperative Pain After Knee Replacement

Phase 2 & 3

Recruiting

Led By Barbara Rakel, PhD

Research Sponsored by Barbara A Rakel

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for unilateral total knee arthroplasty (TKA)

scheduled for unilateral total knee arthroplasty (TKA)

Must not have

Bipolar or psychotic disorder

ACT therapy within the past year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (preop) to 6 months post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether Acceptance and Commitment Therapy (ACT) is more effective than Attention Control (AC) in reducing postoperative pain and improving functioning in at-risk Veterans undergoing total knee arthroplasty (TKA).

Who is the study for?

This trial is for Veterans scheduled for knee replacement surgery who are 'at-risk' due to severe or moderate pain, anxiety, depression, or high levels of distress about pain. They must be able to complete study forms and attend a workshop before surgery. Those with bipolar/psychotic disorders, cognitive impairment, recent ACT therapy, or brain injury history cannot join.

What is being tested?

The trial tests if Acceptance and Commitment Therapy (ACT) is better than Attention Control (AC) at reducing post-surgery pain and improving functioning in Veterans after knee replacement. It also looks at the impact on anxiety, depression, coping skills over time up to 6 months post-surgery.

What are the potential side effects?

While not medication-based interventions that typically have side effects like drugs do, participants may experience emotional discomfort when engaging in therapy sessions as they confront personal issues related to their pain and recovery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a knee replacement surgery on one knee.

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I am scheduled for a knee replacement surgery on one knee.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with bipolar or psychotic disorder.

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I have not had ACT therapy in the last year.

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I cannot attend the pre-surgery workshop.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (preop) to 6 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (preop) to 6 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (preop) to 6 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Function

Pain Intensity

Secondary study objectives

Anxiety

Depressive Symptoms

Level of Pain Acceptance

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Acceptance and Commitment Therapy (ACT)Experimental Treatment1 Intervention

The ACT intervention will include: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop will also include information on pain and pain control post-TKA.

Group II: Attention Control (AC)Active Control1 Intervention

The primary purpose of this workshop is to provide attention and education to participants. Topics of discussion will include: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies will be taught and a progressive muscle relaxation exercise will be performed in the workshop at strategic times to maintain Veteran engagement.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance and Committment Therapy (ACT)

2015

N/A

~100

0 / 5Eligibility criteria met