Clinical trial NCT02437188: Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT
Official title: Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Post-surgical Pain
Acceptance and Commitment Therapy
Substance Use Disorder
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2015-05-07
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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.

Primary outcomes:
measure: Percent of Veterans Willing and Able to Receive the ACT Intervention.
timeFrame: Enrollment to 3 months post surgery
measure: Amount of Pain Intensity on 0-10 Numeric Rating Scale
timeFrame: 3 months post surgery
measure: Amount of Opioid Use
timeFrame: 3 months post surgery
measure: Length of Pain (Days)
timeFrame: 6 months post surgery
measure: Length of Opioid Use (Days)
timeFrame: 6 months post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Iowa City VAMC
state: Iowa
Study officials:
affiliation: University of Iowa
name: Barbara Rakel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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