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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (preop) to 6 months post-surgery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am scheduled for a knee replacement surgery on one knee.
Select...
I am scheduled for a knee replacement surgery on one knee.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Function
Pain Intensity
Secondary outcome measures
Anxiety
Depressive Symptoms
Level of Pain Acceptance
+2 more

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

Find a Location

Who is running the clinical trial?

Barbara A RakelLead Sponsor
2 Previous Clinical Trials
405 Total Patients Enrolled
Baylor College of MedicineOTHER
1,001 Previous Clinical Trials
6,001,822 Total Patients Enrolled
8 Trials studying Pain
1,728 Patients Enrolled for Pain
Barbara Rakel, PhDPrincipal InvestigatorUniversity of Iowa
2 Previous Clinical Trials
131 Total Patients Enrolled

Media Library

Acceptance and Committment Therapy (ACT) Clinical Trial Eligibility Overview. Trial Name: NCT03965897 — Phase 2 & 3
Pain Research Study Groups: Attention Control (AC), Acceptance and Commitment Therapy (ACT)
Pain Clinical Trial 2023: Acceptance and Committment Therapy (ACT) Highlights & Side Effects. Trial Name: NCT03965897 — Phase 2 & 3
Acceptance and Committment Therapy (ACT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03965897 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the positive results that researchers hope to find at the end of this study?

"Over the course of six months, this clinical trial will focus on reducing pain intensity for patients. Additionally, success in values-based behaviour, usage of pain management strategies, and levels of anxiety will be monitored as secondary outcomes."

Answered by AI

Are patients able to still sign up for this trial?

"Yes, the most recent information available on clinicaltrials.gov indicates that this particular trial is still actively recruiting patients. The430 patients are needed from 1 location, and the study was originally posted on 7/29/2019 with the latest update being 10/14/2021."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
Texas
What site did they apply to?
Iowa City VAMC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Preventing Persistent Post-Surgical Pain and Dysfunction
Barbara A Rakel 2019. "Preventing Persistent Post-Surgical Pain and Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03965897.
All > Depression > Pain
~47 spots leftby Nov 2024
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