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N/A N=88 Randomized Single-blind Prevention

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

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

Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Percent of Veterans Willing and Able to Receive the ACT Intervention. — 80; 100 percent

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ACT (Acceptance and Commitment Therapy) (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Barbara A Rakel
Primary completion
Nov 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent of Veterans Willing and Able to Receive the ACT Intervention.
80; 100
PRIMARY
Amount of Pain Intensity on 0-10 Numeric Rating Scale
7.5; 8
PRIMARY
Amount of Opioid Use
0; 0
PRIMARY
Length of Pain (Days)
66; 74
PRIMARY
Length of Opioid Use (Days)
42.5; 51

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02437188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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