NCT03965897: PrePARE

Preventing Persistent Post-Surgical Pain and Dysfunction

Completed Phase 2 Last updated 13 December 2024

What this trial tests

Phase 2 trial testing Acceptance and Committment Therapy (ACT) in Pain in 487 participants. Completed in 30 January 2024.

Timeline

29 July 2019

Primary endpoint
30 July 2023

30 January 2024

Quick facts

Lead sponsor	Barbara A Rakel
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	487
Start date	29 July 2019
Primary completion	30 July 2023
Estimated completion	30 January 2024
Sites	1 location across United States

Drugs / interventions tested

• Acceptance and Committment Therapy (ACT)
• Attention Control (AC)

Conditions studied

• Pain — all drugs for Pain →
• Function — all drugs for Function →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →

Sponsor

Barbara A Rakel

Who can join

18 and older, any sex, with Pain or Function. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Aim: To examine the superior efficacy of ACT versus Attention Control (AC) on postoperative pain intensity and functioning in at-risk Veterans undergoing TKA. Changes in pain intensity and functioning from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Level of pain intensity will be measured using the BPI Pain Severity Subscale and level of functioning will be measured using the KOOS Activities of Daily Living and Quality Of Life Subscales.

Secondary Aims: A) To examine the superior efficacy of ACT versus AC on the severity of anxiety and depressive symptoms and improvements in coping skills. Changes from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Anxiety and depressive symptoms will be measured with the Hamilton Rating Scales (Ham-A and Ham-D, respectively). Coping skills (i.e. Pain Acceptance and Engagement in Values-Based Behavior) will be measured with the Chronic Pain Acceptance Questionnaire and the Chronic Pain Values Inventory. B) To evaluate whether decreases in distress-based symptoms and increases in coping skills mediate changes in pain and functioning at 6 months in Veterans receiving ACT. Changes in anxiety symptoms, depressive symptoms, pain acceptance and engagement in values-based behavior from baseline to 6 weeks and 3 months will be used as potential mediators for changes in pain and functioning at 6 months.

Exploratory Aim: Describe the pharmacological and non-pharmacological strategies Veterans are using to manage pain and their perceived helpfulness. This will provide insights into the effects of the current opioid restrictions on pain management strategies. These strategies \& their perceived helpfulness will be assessed using the Pain Management Strategies Survey at baseline, 6 weeks, 3, and 6 months.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intersectional pain disparities and resilience in veterans with chronic pain.
   Shanahan ML, Zimmerman B, Rodrigues M, Green D, et al · · 2026 · PMID 41396638 · DOI 10.1037/hea0001555
2. ACT for postsurgical pain and dysfunction in at-risk veterans: Multisite, double-blind, cluster RCT.
   Dindo L, Hadlandsmyth K, Garvin L, Marchman J, et al · · 2025 · PMID 41032959 · DOI 10.1016/j.jpsychores.2025.112393