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

June 5, 2019 updated by: Barbara A Rakel

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A large number of veterans suffer from distress-based conditions, such as anxiety and depression, putting them at risk of experiencing persistent pain and prolonged opioid use following surgery. Preventing these problems (our long term goal) for the thousands of veterans who undergo surgery each year can have a dramatic impact on quality of life and productivity, including positive effects on mood, daily activities, sleep, cognitive functions, social life and decreased risk of suicide (1, 2). In addition to these benefits for individual veterans, prevention of these problems can significantly reduce the estimated billions of dollars associated with veterans' utilization of the healthcare system as well as costs associated with lost work productivity, including unemployment and disability benefits (3).

Building on strong and consistent evidence showing that high anxiety and depression put veterans at risk for persistent pain and prolonged opioid use following surgery (4, 5), this proposal tests the feasibility and preliminary efficacy of implementing a 1-day training session with Acceptance and Commitment Therapy (ACT) in veterans identified to be at-risk prior to surgery. ACT has been shown to significantly lower distress and disability in patients with chronic pain (6-8) and is particularly valuable intervention for the 80% of veterans who experience some level of psychological distress prior to surgery (9) and the 50% of veterans who report they experience pain on a regular basis (10, 11). Current practice does not include psychological interventions specifically aimed at addressing distress-based conditions prior to surgery. This study is a necessary first step in evaluating the efficacy of this novel intervention during a critical juncture in care to benefit veterans and prevent the devastating consequences of persistent pain and prolonged opioid use following surgery.

This project is based on our interdisciplinary team's research on psychological factors predicting persistent pain after total knee replacement (12) and the effect of ACT on depression and pain in depressed migraine sufferers (13). The design of this 1-day workshop was developed based on feedback given by patients who received ACT during co-I Dindo's preliminary study. The rationale for this research is that, once we determine the feasibility and preliminary efficacy of incorporating this 1-day workshop into treatment as usual (TAU) to preoperatively target distress-based risk conditions, 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 (ACT + TAU) for at-risk veterans. The following specific aims will be achieved:

  • Aim #1: The primary aim of this pilot study is to determine the feasibility of successfully delivering a 1-day ACT intervention with at-risk veterans prior to surgery and an individualized "booster" session after surgery. The following aspects of the intervention will be assessed: 1) the number of at-risk veterans who are willing and able to receive the ACT workshops and individual "booster" sessions; 2) veteran identification of barriers and facilitators to receiving the ACT intervention and utilizing the skills taught; 3) trainer identification of barriers and facilitators to providing the ACT intervention with at-risk veterans before and after surgery; and 4) veteran and trainer suggestions about ways to improve the intervention. These aspects will be assessed primarily through guided open-ended interviews after the ACT workshop and 3 months postoperatively.
  • Aim #2: To determine if a 1-day preoperative ACT workshop with an individualized "booster" session postoperatively reduces the length and/or amount of pain and opioid use following surgery when compared to treatment as usual (TAU). Participants will be randomized to ACT + TAU or TAU and record pain and opioid use daily after surgery.
  • Aim #3: A secondary, exploratory aim is to determine the usability and utility of the Patient Reported Outcomes Measurement Information System (PROMIS) modules for assessing pain and associated symptoms in veterans. We will compare modules to the Brief Pain Inventory (Pain Interference), the State/Trait Anxiety Inventory (Anxiety), and the Patient Health Questionnaire (PHQ)-9 (Depression).

This project has the potential to infuse what is known about effective treatment of chronic pain into the acute care environment to benefit veterans and improve surgical outcomes. It incorporates an interdisciplinary approach to the care of veterans that attends to the psychology of pain.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Iowa City VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Scheduled for orthopedic surgery at the Iowa City VAMC at least 1 month in the future.
  • Movement or resting pain ≥ 3 on a 0-10 NRS.
  • Score on the Hamilton Anxiety Rating Scale (HAM-A) ≥ 14; OR
  • Score on the Hamilton Depression Rating Scale (HAMD) ≥ 17.

Exclusion Criteria:

  • Inability to complete study forms because of either mental incapacity or a language barrier;
  • Bipolar or psychotic disorder;
  • History of brain injury;
  • Complication(s) following surgery requiring reoperation or revision.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT plus TAU
Participants randomized to receive ACT will be scheduled to attend a 1-day training session before their preoperative clinic visit. The intervention will incorporate both experiential learning and didactic content, will include a summary of the main concepts at the end of the day, and a manual of the main concepts will be sent home with participants so they can practice the exercises prior to and after surgery. Participants will also receive an individualized phone call "booster" intervention 2 weeks after surgery to address any issues and reinforce the information that was given during the workshop. This will be done to facilitate the participant's use of the skills during the postoperative period.
Behavioral: ACT (Acceptance and Commitment Therapy)
The 1-day training session with ACT proposed for this study is designed to reduce behavioral avoidance and to enhance acceptance-based coping. The intervention includes: 1) Behavioral Change Training (2.5 hours) 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; 2) Acceptance and Mindfulness Training (2.5 hours) emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts and learning how to willingly face experiences that cannot be changed.
No Intervention: TAU
Current pre-surgery treatment includes a nurse-led patient education class covering the post-operative course and what to expect for pain control and recovery. Patients may be taking analgesia (i.e. opioids and/or non-opioids) preoperatively for a chronic pain condition and are prescribed analgesics, sedatives and/ or anxiolytics immediately prior to surgery. Intraoperatively, regional (i.e., spinal and femoral) anesthesia and analgesia is given and patients receive opioids, non-opioids, anticonvulsants and/or anxiolytics during the immediate postoperative period. Other pain treatments may be used, such as cryotherapy, music therapy, relaxation, imagery, etc. Patients are sent home with analgesia (often a combination medication of an opioid and acetaminophen) for breakthrough pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Veterans Willing and Able to Receive the ACT Intervention.
Time Frame: Enrollment to 3 months post surgery
The percent of veterans randomized to the ACT intervention who did receive the ACT intervention will be collected.
Enrollment to 3 months post surgery
Amount of Pain Intensity on 0-10 Numeric Rating Scale
Time Frame: 3 months post surgery
Participants will be asked to rate the intensity of their maximum pain on a vertical, 0-10 numeric rating scale (0-10 NRS) with 0.5 increments at 3 months after surgery. Participants will be asked to provide a number that represents their highest pain intensity during the day if 0 is no pain and 10 is the most intense pain imaginable.
3 months post surgery
Amount of Opioid Use
Time Frame: 3 months post surgery
Participants will be asked total daily dose of opioid medications at 3 months after surgery. All opioid doses converted to oral morphine equivalents.
3 months post surgery
Length of Pain (Days)
Time Frame: 6 months post surgery
Participants will record their pain daily after surgery via an electronic (REDCap) or hardcopy log. When pain < 3 has been recorded for 5 consecutive days, the first date in the series will be used as the point of cessation and the length of time from surgery to this date will be calculated as the length of pain.
6 months post surgery
Length of Opioid Use (Days)
Time Frame: 6 months post surgery
Participants will record all pain medications (i.e. opioids and non-opioids) taken on a computerized pain medication form (or hardcopy log if participant does not have computer access available) until 3 months after surgery. The computerized pain medication form will list the drug name, route, dose, number taken, and date/time of each dose. When 0 doses of opioids have been recorded for 5 consecutive days, the first date in the series will be used as the point of cessation and the length of time from surgery to this date will be calculated as the length of opioid use.
6 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbara A Rakel

Investigators

  • Principal Investigator: Barbara Rakel, PhD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

May 4, 2015

First Posted (Estimate)

May 7, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201603778

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Substance Use Disorder

Clinical Trials on ACT (Acceptance and Commitment Therapy)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe