Treating Pain With Acceptance and Commitment Therapy Trial
Condition: Acceptance and Commitment Therapy; Chronic Pain; Opioid Use
MeSH terms: Chronic Pain
Study type: Interventional

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.
    

Detailed 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?
    

Intervention name(s): Acceptance and Commitment Therapy
Intervention type(s): Behavioral
Intervention description(s): Acceptance and commitment therapy (ACT) is a type of psychotherapy, or cognitive behavioral therapy, that aims to help patients focus on the present, accept their situation, and find positive coping skills.
Intervention model: Single Group Assignment
Intervention model description: Study Design: Mixed methods, intervention trial, feasibility study, with sequential and concurrent quantitative and qualitative data collection before, during, and after the intervention.
Masking: None (Open Label)
Primary purpose: Treatment