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

Sponsor
Barbara A Rakel (Other)
Overall Status
Completed
CT.gov ID
NCT02437188
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
21
Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ACT (Acceptance and Commitment Therapy)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Preventing Persistent Post-Surgical Pain and Opioid Use In At-Risk Veterans: Effect of ACT
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Percent of Veterans Willing and Able to Receive the ACT Intervention. [Enrollment to 3 months post surgery]

    The percent of veterans randomized to the ACT intervention who did receive the ACT intervention will be collected.

  2. Amount of Pain Intensity on 0-10 Numeric Rating Scale [3 months post surgery]

    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. Amount of Opioid Use [3 months post surgery]

    Participants will be asked total daily dose of opioid medications at 3 months after surgery. All opioid doses converted to oral morphine equivalents.

  4. Length of Pain (Days) [6 months post surgery]

    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.

  5. Length of Opioid Use (Days) [6 months post surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Iowa City VAMC Iowa City Iowa United States 52242

Sponsors and Collaborators

  • Barbara A Rakel

Investigators

  • Principal Investigator: Barbara Rakel, PhD, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Barbara A Rakel, Professor, University of Iowa
ClinicalTrials.gov Identifier:
NCT02437188
Other Study ID Numbers:
  • 201603778
First Posted:
May 7, 2015
Last Update Posted:
Aug 1, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative
Substance-Related Disorders

Study Results

Participant Flow

Recruitment Details Veterans indicated for orthopedic surgery and identified to be at-risk for poor outcomes were recruited following their indication clinic visit at the VAMC orthopedic clinic.
Pre-assignment Detail Eligible participants were randomized at their enrollment visit following phone screening. They were excluded if imminent risk of suicide. Active treatment groups received both ACT and TAU.
Arm/Group Title ACT + TAU Treatment as Usual (TAU)
Arm/Group Description Acceptance and Commitment Therapy plus Treatment as Usual Treatment as Usual
Period Title: Overall Study
STARTED 44 44
COMPLETED 40 35
NOT COMPLETED 4 9

Baseline Characteristics

Arm/Group Title ACT + TAU Treatment as Usual Total
Arm/Group Description Acceptance and Commitment Therapy plus Treatment as Usual Treatment as usual - preoperative education and perioperative analgesia Total of all reporting groups
Overall Participants 40 34 74
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
62.2
(10.1)
63
(10.7)
62.6
(10.4)
Sex: Female, Male (Count of Participants)
Female
5
12.5%
0
0%
5
6.8%
Male
35
87.5%
34
100%
69
93.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
3
8.8%
3
4.1%
Not Hispanic or Latino
35
87.5%
28
82.4%
63
85.1%
Unknown or Not Reported
5
12.5%
3
8.8%
8
10.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
1
2.9%
1
1.4%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
4
10%
1
2.9%
5
6.8%
White
34
85%
27
79.4%
61
82.4%
More than one race
0
0%
1
2.9%
1
1.4%
Unknown or Not Reported
2
5%
4
11.8%
6
8.1%
Region of Enrollment (participants) [Number]
United States
40
100%
35
102.9%
75
101.4%

Outcome Measures

1. Primary Outcome
Title Percent of Veterans Willing and Able to Receive the ACT Intervention.
Description The percent of veterans randomized to the ACT intervention who did receive the ACT intervention will be collected.
Time Frame Enrollment to 3 months post surgery

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title ACT + TAU Treatment as Usual (TAU)
Arm/Group Description Acceptance and Commitment Therapy plus treatment as usual Treatment as Usual
Measure Participants 32 35
Number [percent]
80
100
2. Primary Outcome
Title Amount of Pain Intensity on 0-10 Numeric Rating Scale
Description 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.
Time Frame 3 months post surgery

Outcome Measure Data

Analysis Population Description
Intent-to-treat - with randomized participants who received surgery
Arm/Group Title ACT + TAU Treatment as Usual
Arm/Group Description Acceptance and Commitment Therapy plus treatment as usual Treatment as usual - preoperative education and perioperative analgesia
Measure Participants 40 35
Median (Inter-Quartile Range) [score on a scale]
7.5
8
3. Primary Outcome
Title Amount of Opioid Use
Description Participants will be asked total daily dose of opioid medications at 3 months after surgery. All opioid doses converted to oral morphine equivalents.
Time Frame 3 months post surgery

Outcome Measure Data

Analysis Population Description
Intent-to-treat - for participants who received surgery
Arm/Group Title ACT + TAU Treatment as Usual
Arm/Group Description Acceptance and Commitment Therapy plus treatment as usual Treatment as usual - preoperative education and peri-operative analgesia
Measure Participants 40 35
Median (Full Range) [mg oral morphine]
0
0
4. Primary Outcome
Title Length of Pain (Days)
Description 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.
Time Frame 6 months post surgery

Outcome Measure Data

Analysis Population Description
Intent-to-treat - with participants who received surgery
Arm/Group Title ACT + TAU Treatment as Usual
Arm/Group Description Acceptance and Commitment Therapy plus Treatment as Usual Treatment as usual - preoperative education and perioperative analgesia
Measure Participants 40 35
Median (Inter-Quartile Range) [days]
66
74
5. Primary Outcome
Title Length of Opioid Use (Days)
Description 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.
Time Frame 6 months post surgery

Outcome Measure Data

Analysis Population Description
Intent-to-treat - with participants who received surgery
Arm/Group Title ACT + TAU Treatment as Usual
Arm/Group Description Acceptance and Commitment Therapy plus Treatment as Usual Treatment as usual - preoperative education and perioperative analgesia
Measure Participants 40 35
Median (Inter-Quartile Range) [days]
42.5
51

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title ACT + TAU Treatment as Usual
Arm/Group Description
All Cause Mortality
ACT + TAU Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
ACT + TAU Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/40 (0%) 0/34 (0%)
Other (Not Including Serious) Adverse Events
ACT + TAU Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/40 (5%) 6/34 (17.6%)
Nervous system disorders
Pain increase 1/40 (2.5%) 1 1/34 (2.9%) 1
Psychiatric disorders
Distress-based symptom increase 1/40 (2.5%) 1 5/34 (14.7%) 5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Lilian Dindo, Assistant Professor
Organization Baylor College of Medicine
Phone 713-440-4637
Email lilian.dindo@bcm.edu
Responsible Party:
Barbara A Rakel, Professor, University of Iowa
ClinicalTrials.gov Identifier:
NCT02437188
Other Study ID Numbers:
  • 201603778
First Posted:
May 7, 2015
Last Update Posted:
Aug 1, 2019
Last Verified:
Jun 1, 2019