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

NCT02437188 | Completed Results DMC

• 1 other identifier: 201603778
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Persistent Post-surgical Pain; Acceptance and Commitment Therapy; Substance Use Disorder

Outcome Measures

Primary Outcomes (5)

• Percent of Veterans Willing and Able to Receive the ACT Intervention.

  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

  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

  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)

  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)

  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

Study Arms (2)

ACT plus TAU

EXPERIMENTAL

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)

TAU

NO INTERVENTION

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.

Interventions

ACT (Acceptance and Commitment Therapy) BEHAVIORAL

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.

ACT plus TAU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barbara A Rakel: lead

Study Sites (1)

Iowa City VAMC

Iowa City, Iowa, 52242, United States

Location

Related Publications (15)

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  PMID: 12889597 BACKGROUND

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  PMID: 10385806 BACKGROUND

• Kerns RD, Sellinger J, Goodin BR. Psychological treatment of chronic pain. Annu Rev Clin Psychol. 2011;7:411-34. doi: 10.1146/annurev-clinpsy-090310-120430.

  PMID: 21128783 BACKGROUND

• Carroll I, Hah J, Mackey S, Ottestad E, Kong JT, Lahidji S, Tawfik V, Younger J, Curtin C. Perioperative interventions to reduce chronic postsurgical pain. J Reconstr Microsurg. 2013 May;29(4):213-22. doi: 10.1055/s-0032-1329921. Epub 2013 Mar 5.

  PMID: 23463498 BACKGROUND

• Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.

  PMID: 19672167 BACKGROUND

• McCracken LM, Gutierrez-Martinez O. Processes of change in psychological flexibility in an interdisciplinary group-based treatment for chronic pain based on Acceptance and Commitment Therapy. Behav Res Ther. 2011 Apr;49(4):267-74. doi: 10.1016/j.brat.2011.02.004. Epub 2011 Feb 15.

  PMID: 21377652 BACKGROUND

• McCracken LM, Velleman SC. Psychological flexibility in adults with chronic pain: a study of acceptance, mindfulness, and values-based action in primary care. Pain. 2010 Jan;148(1):141-147. doi: 10.1016/j.pain.2009.10.034. Epub 2009 Nov 28.

  PMID: 19945795 BACKGROUND

• McCracken LM, Vowles KE. A prospective analysis of acceptance of pain and values-based action in patients with chronic pain. Health Psychol. 2008 Mar;27(2):215-20. doi: 10.1037/0278-6133.27.2.215.

  PMID: 18377140 BACKGROUND

• Patton CM, Hung M, Lawrence BD, Patel AA, Woodbury AM, Brodke DS, Daubs MD. Psychological distress in a Department of Veterans Affairs spine patient population. Spine J. 2012 Sep;12(9):798-803. doi: 10.1016/j.spinee.2011.10.008. Epub 2011 Nov 16.

  PMID: 22088603 BACKGROUND

• Otis JD, Keane TM, Kerns RD, Monson C, Scioli E. The development of an integrated treatment for veterans with comorbid chronic pain and posttraumatic stress disorder. Pain Med. 2009 Oct;10(7):1300-11. doi: 10.1111/j.1526-4637.2009.00715.x.

  PMID: 19818040 BACKGROUND

• Kerns RD, Otis J, Rosenberg R, Reid MC. Veterans' reports of pain and associations with ratings of health, health-risk behaviors, affective distress, and use of the healthcare system. J Rehabil Res Dev. 2003 Sep-Oct;40(5):371-9. doi: 10.1682/jrrd.2003.09.0371.

  PMID: 15080222 BACKGROUND

• Rakel BA, Blodgett NP, Zimmerman BM, Logsden-Sackett N, Clark C, Noiseux N, Callaghan J, Herr K, Geasland K, Yang X, Sluka KA. Predictors of postoperative movement and resting pain following total knee replacement. Pain. 2012 Nov;153(11):2192-2203. doi: 10.1016/j.pain.2012.06.021. Epub 2012 Jul 25.

  PMID: 22840570 BACKGROUND

• Dindo L, Recober A, Marchman JN, Turvey C, O'Hara MW. One-day behavioral treatment for patients with comorbid depression and migraine: a pilot study. Behav Res Ther. 2012 Sep;50(9):537-43. doi: 10.1016/j.brat.2012.05.007. Epub 2012 May 27.

  PMID: 22728646 BACKGROUND

• Dindo L, Zimmerman MB, Hadlandsmyth K, StMarie B, Embree J, Marchman J, Tripp-Reimer T, Rakel B. Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study. J Pain. 2018 Oct;19(10):1211-1221. doi: 10.1016/j.jpain.2018.04.016. Epub 2018 May 17.

  PMID: 29777950 RESULT

• Liu W, Dindo L, Hadlandsmyth K, Unick GJ, Zimmerman MB, St Marie B, Embree J, Tripp-Reimer T, Rakel B. Item Response Theory Analysis: PROMIS(R) Anxiety Form and Generalized Anxiety Disorder Scale. West J Nurs Res. 2022 Aug;44(8):765-772. doi: 10.1177/01939459211015985. Epub 2021 May 17.

  PMID: 33998340 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Lilian Dindo, Assistant Professor
• Organization: Baylor College of Medicine

lilian.dindo@bcm.edu

713-440-4637

Study Officials

• Barbara Rakel, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 7, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 1, 2019
• Results First Posted: August 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)