Treating Pain With Acceptance and Commitment Therapy Trial
NCT ID: NCT03666455
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-01-01
2020-03-23
Brief Summary
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Detailed Description
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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?
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Acceptance and Commitment Therapy
The intervention consists of eight individual (one-on-one) acceptance and commitment therapy sessions approximately one week apart over a 12-week period.
Acceptance and Commitment Therapy
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.
Interventions
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Acceptance and Commitment Therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
65 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
University of North Carolina, Chapel Hill
OTHER
University of Kentucky
OTHER
University of New Mexico
OTHER
Responsible Party
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Robert L Rhyne
Professor & Vice Chair of Research
Principal Investigators
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Robert Rhyne, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Countries
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References
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Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain. 2004 Sep-Oct;20(5):309-18. doi: 10.1097/00002508-200409000-00005.
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
McCracken LM, Yang SY. The role of values in a contextual cognitive-behavioral approach to chronic pain. Pain. 2006 Jul;123(1-2):137-45. doi: 10.1016/j.pain.2006.02.021. Epub 2006 Mar 29.
Other Identifiers
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18-270
Identifier Type: -
Identifier Source: org_study_id
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