Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2015 |
| End Date: | August 2016 |
| Contact: | Barbara Rakel, PhD |
| Email: | barbara-rakel@uiowa.edu |
| Phone: | 319-335-7036 |
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.
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.
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.
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.
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.
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