Acceptance and Commitment TherapyT-PACTNCT03666455
Treating Pain With Acceptance and Commitment Therapy Trial
A study testing Acceptance and Commitment Therapy in people with Acceptance and Commitment Therapy and Chronic Pain, run by University of New Mexico at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Acceptance and Commitment Therapy, Chronic Pain, Opioid Use
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2019to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kentucky
Lexington, Kentucky, 40536
About this study
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.
Read the 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:
- 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.
- 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:
- 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?
- Qualitative research question: How do participants evaluate ACT as an alternative to opioids in their pain management?
- Conditions
- Acceptance and Commitment Therapy, Chronic Pain, Opioid Use
- Being tested
- Acceptance and Commitment Therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | The intervention consists of eight individual (one-on-one) acceptance and commitment therapy sessions approximately one week apart over a 12-week period. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: One year
Secondary outcomes (1)
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Jan 2019
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acceptance and Commitment TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center, University of North Carolina, Chapel Hill, University of Kentucky
- Responsible party
- Principal investigator, Robert L Rhyne, University of New Mexico
- Investigators
- Robert Rhyne, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666455
- Sponsor's protocol ID
- 18-270
- Acronym
- T-PACT
- Status last verified
- May 2023
- First submitted
- 20 Jul 2018
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15042521Keller 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.
PubMed 15322437Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219McCracken 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.
PubMed 16564627
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Pain With Acceptance and Commitment Therapy Trial
- ClinicalTrials.gov ID
- NCT03666455
- Acronym / sponsor ID
- T-PACT / 18-270
- Conditions
- Acceptance and Commitment Therapy, Chronic Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center, University of North Carolina, Chapel Hill, University of Kentucky
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- 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?
- Qualitative research question: How do participants evaluate ACT as an alternative to opioids in their pain management?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyThe intervention consists of eight individual (one-on-one) acceptance and commitment therapy sessions approximately one week apart over a 12-week period. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAcceptance 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. | Behavioural | Acceptance and Commitment Therapy |
Primary outcome
Primary study outcome will be the Success Scale of the Chronic Pain Values Inventory.
Time frame: One year
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."
1 secondary outcome
The secondary study outcome will be the Pain Interference Scale of the Brief Pain Inventory.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 15042521Tan 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.
- Background: PubMed 15322437Keller 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.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background: PubMed 16564627McCracken 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Rhyne, MD principal investigator
University of New Mexico
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Acceptance and Commitment Therapy and Chronic Pain, run by University of New Mexico at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary study outcome will be the Success Scale of the Chronic Pain Values Inventory. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666455, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.