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Completed Not applicable Interventional Results available

Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT

ClinicalTrials.gov ID: NCT02437188

Public ClinicalTrials.gov record NCT02437188. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

A large number of veterans suffer from distress-based conditions, such as anxiety and depression, putting them at high risk of experiencing persistent pain and prolonged opioid use following surgery. These connections are based on strong and consistent evidence from the literature and our preliminary data. The proposed study adds a 1-day workshop of Acceptance and Commitment Therapy (ACT), followed by an individual "booster" session, to treatment as usual (TAU) to reduce veterans' risk of persistent pain and prolonged opioid use following surgery. ACT has been shown to be effective in reducing chronic pain, anxiety and depression. This pilot study will establish the feasibility and preliminary efficacy of incorporating ACT into treatment as usual (TAU) to preoperatively target distress-based risk factors. Aim 1 is to establish the feasibility of successfully delivering ACT to at-risk veterans before and after surgery. Aim 2 is to test the preliminary efficacy of ACT on the length and/or amount of pain and opioid use after surgery. Veterans who are anxious or depressed before surgery will be randomly assigned to receive ACT plus TAU or TAU. Outcomes between the two groups will be compared. Aim 3 is to see if PROMIS modules, developed by the National Institute of Health, are useful for assessing pain and other symptoms in veterans. Findings from this study will be used to inform the design and implementation of a larger, well controlled, randomized clinical trial that will evaluate the efficacy of ACT plus TAU for at-risk veterans. This study will take place at the Iowa City VA Health Care System (VAMC). Veterans scheduled for orthopedic or open abdominal surgery in 1 to 3 months who score high for anxiety or depression will be randomly assigned to attend a 1-day ACT workshop preoperatively, with an individualize "booster" session postoperatively, or to have TAU. Veterans who receive ACT and trainers who provide the treatment will be interviewed to identify barriers and facilitators to providing ACT to at-risk veterans before and after surgery. Other primarily outcomes are pain and opioid use after surgery. Factors that may affect these outcomes will also be measured, including anxiety, depression, substance use disorder, post-traumatic stress disorder, and use of other pain meds. The investigators expect to gain important knowledge about ways to best include ACT as part of routine care for veterans requiring surgery and about the preliminary efficacy of ACT for the prevention of persistent pain and prolonged opioid use following surgery.

Study identification

NCT ID
NCT02437188
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Barbara A Rakel
Other
Enrollment
88 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2015
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016
Last update posted
Jul 31, 2019

2015 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Iowa City VAMC Iowa City Iowa 52242

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02437188, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 31, 2019 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02437188 live on ClinicalTrials.gov.

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