Substance Use Disorder Clinical Trial
— PreACTOfficial title:
Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT
NCT number | NCT02437188 |
Other study ID # | 201603778 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | November 2016 |
Verified date | June 2019 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Iowa City VAMC | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
Barbara A Rakel |
United States,
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. — View Citation
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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. — View Citation
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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. Review. — View Citation
McCracken LM, Gutiérrez-Martínez 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. — View Citation
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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. — View Citation
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Rakel BA, Blodgett NP, Bridget Zimmerman M, 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):2192-203. doi: 10.1016/j.pain.2012.06.021. Epub 2012 Jul 25. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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