Treating Pain With Acceptance and Commitment Therapy Trial

Chronic Pain Clinical Trial

— T-PACT  

Official title:

Treating Pain With Acceptance and Commitment Therapy Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666455
• Other study ID #: 18-270
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 23, 2020

Study information

• Verified date: May 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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?

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acceptance and Commitment Therapy
• Chronic Pain
• Opioid Use

Intervention

Behavioral:
• 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.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University of New Mexico	University of Kansas Medical Center, University of Kentucky, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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