Treating Pain With Acceptance and Commitment Therapy Trial — T-PACT  

Chronic Pain Clinical Trial

Official title: Treating Pain With Acceptance and Commitment Therapy Trial

Status Completed

Clinical Trial Summary

The long-term goal is to define best practices for diminishing the risk of high opioid doses used to treat chronic non-cancer pain (CNCP) patients while optimizing pain outcomes and functional levels of activity, emotional functioning, and quality of life. The short-term goal is to assess the feasibility of multiple Clinical and Translational Research Award (CTSA) sites working together to perform and study the effects of a cognitive behavioral therapy intervention in a future randomized controlled trial (RCT) among CNCP patients in rural primary care practices in each CTSA state.

Clinical Trial Description

The long-term goal is to define best practices for diminishing the risk of high opioid doses used to treat chronic non-cancer pain (CNCP) patients while optimizing pain outcomes and functional levels of activity, emotional functioning, and quality of life. The short-term goal is to assess the feasibility of multiple Clinical and Translational Research Award (CTSA) sites working together to perform and study the effects of a cognitive behavioral therapy intervention in a future randomized controlled trial (RCT) among CNCP patients in rural primary care practices in each CTSA state.

The current feasibility study uses a multi-site, pragmatic, community-based, mixed methods design to assess the feasibility of multiple CTSA locations working together to administer the evidence-based intervention, Acceptance and Commitment Therapy (ACT), to reduce harmful opioid use among CNCP patients. This mixed methods study will have a quantitative arm and a qualitative arm. Following this feasibility study, the team will use the resulting preliminary data to apply for a larger grant to implement a larger multi-site RCT at the same sites.

The specific aims of this feasibility study are:

1. To conduct a multi-site, mixed methods study to demonstrate the feasibility of performing a future pragmatic RCT on the effectiveness of treating CNCP with Acceptance and Commitment Therapy (ACT), delivered in rural primary healthcare practices, with the goal of decreasing chronic, harmful opioid use among rural populations.

2. To generate preliminary data that will be used to apply for a larger multi-site RCT study that would test the effectiveness of ACT in the same population of rural pain patients.

The feasibility study hypothesis is that the study team can demonstrate the ability for multiple CTSA sites to work together on a small research project in rural primary care practices, among rural patients with chronic non-cancer pain on long-term opioid therapy. The team will show that it is feasible to implement the intervention ACT in a future larger RCT study, which would test its effectiveness at reducing or eliminating opioid use while managing chronic pain.

The hypothesis for preliminary data collection and a larger RCT is that ACT, which has been shown to be an effective treatment for chronic pain, will be effective at reducing or eliminating opioid use for CNCP patients in rural primary care practices.

Research questions:

1. Quantitative research questions: Is ACT delivered in a rural primary care practices an effective alternative to opioids in managing chronic pain? How does ACT impact chronic pain in rural primary healthcare patients?

2. Qualitative research question: How do participants evaluate ACT as an alternative to opioids in their pain management? ;

Related Conditions & MeSH terms

• Acceptance and Commitment Therapy
• Chronic Pain
• Opioid Use

• NCT number: NCT03666455
• Study type: Interventional
• Source: University of New Mexico
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Completion date: March 23, 2020