Treating Pain With Acceptance and Commitment Therapy Trial

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?

Inclusion Criteria:

- Adult patients (21-65 years of age).

- Has a diagnosis of CNCP (> 3 months). We will limit the diagnostic inclusion criteria
to the most common pain diagnoses (excluding headache): low back, multi-site/full body
(e.g., fibromyalgia, and various kinds of arthritis), neck, lower extremity, and
abdomen.

- Being prescribed chronic opioid medications for the pain.

- Mentally and physically able to participate in data collection (namely, completing an
extensive survey at three points in time, attending 8 one-hour therapy sessions, and
participating in an interview by the research staff).

Exclusion Criteria:

- Children under the age of 21 will be excluded from participating because this study is
examining ACT in adults with CNCP. Pregnant women will be excluded because their use
of opioids presents a special therapeutic circumstance out of the scope of this study.
People who are not fluent in English will be excluded because this is a small
feasibility study and we do not have the resources to conduct the intervention or
collect data in other languages.