Chronic Pain Clinical Trial
— T-PACTOfficial title:
Treating Pain With Acceptance and Commitment Therapy Trial
NCT number | NCT03666455 |
Other study ID # | 18-270 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | March 23, 2020 |
Verified date | May 2023 |
Source | University of New Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 23, 2020 |
Est. primary completion date | March 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of New Mexico | University of Kansas Medical Center, University of Kentucky, University of North Carolina, Chapel Hill |
United States,
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary study outcome will be the Success Scale of the Chronic Pain Values Inventory. | Primary study outcome will be the Success Scale of the Chronic Pain Values Inventory (CPVI). Based on an in-progress meta-analysis of unidisciplinary Acceptance and Commitment Therapy for chronic pain, we expect a post-treatment effect size of d = .80 (95% CI: .41 - 1.20).
Construct: The CPVI has 12 items that measure, "which values are important to an individual and to assess the degree of success they are having in following their values" and "has supported its use in a contextual analysis of pain and as part of a treatment for chronic pain." Scale ranges: 0 to 5. First sore is mean success rating; second score is mean discrepancy rating. Outcome measures: "Low success in living in accordance to an important value is presumed to entail greater suffering than low success in living in accordance to a value that is relatively unimportant." |
One year | |
Secondary | The secondary study outcome will be the Pain Interference Scale of the Brief Pain Inventory. | The secondary study outcome will be the Pain Interference Scale of the Brief Pain Inventory (BPI). Based on an in-progress meta-analysis of unidisciplinary Acceptance and Commitment Therapy for chronic pain, we expect a post-treatment effect size of d = .40 (95% CI: .17 - .64).
Construct: The BPI measures chronic cancer- and noncancer-related pain. Scale ranges: Scale of 0 to 10; patients rate current pain intensity, pain in the last 24 hours, and pain interference in quality of life. Higher scores equal greater pain and/or greater interference. Outcome measures: A decrease in scores over time indicates an improvement of pain and less interference of pain on quality of life. |
One year |
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