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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Barbara A Rakel

  lead OTHER

Principal Investigators

• Barbara Rakel, PhD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2016-11-30

Completion

2016-11-30

Countries

• United States

Study Locations