Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT
NCT ID: NCT02437188
Last Updated: 2019-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
88 participants
INTERVENTIONAL
2015-02-28
2016-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Bipolar or psychotic disorder;
* History of brain injury;
* Complication(s) following surgery requiring reoperation or revision.
18 Years
ALL
No
Sponsors
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Barbara A Rakel
OTHER
Responsible Party
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Barbara A Rakel
Professor
Principal Investigators
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Barbara Rakel, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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Iowa City VAMC
Iowa City, Iowa, United States
Countries
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References
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Caffo O, Amichetti M, Ferro A, Lucenti A, Valduga F, Galligioni E. Pain and quality of life after surgery for breast cancer. Breast Cancer Res Treat. 2003 Jul;80(1):39-48. doi: 10.1023/A:1024435101619.
Abyholm AS, Hjortdahl P. [The pain takes hold of life. A qualitative study of how patients with chronic back pain experience and cope with their life situation]. Tidsskr Nor Laegeforen. 1999 Apr 30;119(11):1624-9. Norwegian.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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201603778
Identifier Type: -
Identifier Source: org_study_id
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