Chronic PainNCT04978961
Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care
A study testing Focused Acceptance & Commitment Therapy (FACT) and Enhanced Treatment as Usual (ETAU) in people with Chronic Pain, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This mixed-methods pilot randomized controlled trial sought to: 1) evaluate implementation of a brief Acceptance and Commitment Therapy treatment for chronic pain delivered by an integrated behavioral health consultant in primary care; and to 2) explore treatment outcomes and their associated mechanisms of change. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Focused Acceptance & Commitment Therapy (FACT) and Enhanced Treatment as Usual (ETAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 22 Apr 2019
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 and older
- at least one non-cancer pain condition persisting for 12 weeks or more
- a current primary care clinician at the study clinic
- ongoing treatment for a non-cancer chronic pain condition
Who cannot join
- social anxiety or unwillingness to participate in a class setting
- presence of symptoms of psychosis and/or delirium
- a medical condition or life circumstance that would contraindicate or prevent participating (e.g. upcoming surgery)
- inability to comprehend the informed consent process or study instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Drive Primary Care
San Antonio, Texas, 78229
About this study
Official title: A Novel Treatment Delivery of Acceptance and Commitment Therapy for Chronic Pain in an Integrated Primary Care Setting
This mixed-methods pilot randomized controlled trial sought to: 1) evaluate implementation of a brief Acceptance and Commitment Therapy treatment for chronic pain delivered by an integrated behavioral health consultant in primary care; and to 2) explore treatment outcomes and their associated mechanisms of change.
Read the detailed description
Background: Most patients with chronic pain obtain their treatment in primary care settings, where evidence-based behavioral interventions are not typically provided, despite robust evidence for treatments like Acceptance and Commitment Therapy.
Objective: This mixed-methods pilot randomized controlled trial sought to: 1) evaluate implementation of a brief Acceptance and Commitment Therapy treatment for chronic pain delivered by an integrated behavioral health consultant in primary care; and to 2) explore treatment outcomes and their associated mechanisms of change.
Design: Mixed-methods pilot randomized controlled trial. Active participants completed one 30-minute individual Focused Acceptance and Commitment Therapy (FACT) visit followed by 3 weekly 60-minute group visits and a booster visit 2 months later. An enhanced treatment as usual (ETAU) control group received 4 handouts about pain management based on cognitive behavioral science. Follow-up research visits occurred during and after treatment, at 12 weeks (booster visit), and at 6 months. Semi-structured interviews were conducted after the last research visit.
Setting: A small integrated primary care clinic in southwestern U.S. affiliated with an academic medical center
- Conditions
- Chronic Pain
- Being tested
- Focused Acceptance & Commitment Therapy (FACT), Enhanced Treatment as Usual (ETAU)
- Keywords
- chronic pain, acceptance and commitment therapy, integrated primary care, behavioral health consultant
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Acceptance & Commitment Therapy (FACT)Behavioural
FACT is a brief form of Acceptance and Commitment Therapy and in this study, FACT focused on increasing patient functioning through connection with valued activities and increased acceptance.
Enhanced Treatment as Usual (ETAU)Behavioural
This active control intervention included 4 handouts focused on pain management based on cognitive behavioral science.
| Study group | Role | What they receive |
|---|---|---|
| Focused Acceptance and Commitment Therapy (FACT) | Experimental | Focused Acceptance \& Commitment Therapy (FACT): FACT is a brief type of cognitive behavioral therapy that helps patients reduce disability through increased acceptance, reconnection with values, and reduced unhelpful control/coping strategies. Patients randomized to the intervention group received FACT per the study manual, delivered by an integrated Behavioral Health Consultant (BHC). Patients had one individual visit (30 minutes) and three consecutive weekly group visits (one hour) followed by a booster visit two months later. These classes (group visits) were rolling, not cohort-driven, meaning new and returning patients will be attending together. After the individual BHC visit and each class, patients had behavioral "homework" to complete. Receives: Behavioral: Focused Acceptance & Commitment Therapy (FACT) |
| Enhanced Treatment as Usual (ETAU) | Active comparator | Patients randomized to the Enhanced-Treatment As Usual (ETAU) group received "enhancement" of usual primary care via 1-page (2-sided) educational handouts on four topic areas: Sleep, Pacing, Relaxation and Goal Setting. All topics have an evidence base in standard Cognitive Behavioral Therapy treatment of pain. One handout per assessment visit was given to each patient. Patients will continue to see their primary care clinicians and have access to all routine clinical services throughout the study. Receives: Behavioral: Enhanced Treatment as Usual (ETAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported physical disability
The Oswestry Disability Index (ODI) is a 10-item self-report scale that assesses perceived disability and functional impairment across a range of daily activities, with higher scores indicating greater perceived disability. Although originally developed as a measure of back pain, we used an established modified version that asked about "pain" rather than "back pain." The ODI uses a 6-point Likert scale for each item, which is summed to create a total score (maximum 50) that is then divided by highest possible score based on items skipped, and doubled to provide a percentage of patient perceived disability. The ODI and has been validated across a wide range of populations as a reliable and useful indicator of overall disability. Scores range from 0-100.
Measured: Booster (12 weeks from baseline)
Self-reported physical disability
The Oswestry Disability Index (ODI) is a 10-item self-report scale that assesses perceived disability and functional impairment across a range of daily activities, with higher scores indicating greater perceived disability. Although originally developed as a measure of back pain, we used an established modified version that asked about "pain" rather than "back pain." The ODI uses a 6-point Likert scale for each item, which is summed to create a total score (maximum 50) that is then divided by highest possible score based on items skipped, and doubled to provide a percentage of patient perceived disability. The ODI and has been validated across a wide range of populations as a reliable and useful indicator of overall disability. Scores range from 0 - 100.
Measured: 6-month follow-up
Feasibility of intervention and study (attrition and satisfaction ratings)
Feasibility was evaluated using a priori established benchmarks: (a) < 25% participant attrition; (b) at least 80% of participants rating the FACT program as satisfactory as measured by response of at least 5 on a 7-point Likert-scale (1= Not Satisfied at All, 7 = Very Satisfied). The satisfaction question was asked in the context of an "exit interview": all participants who completed the 6-month follow-up assessment were contacted by the PI to provide feedback on their experiences in the study.
Measured: 6-month follow-up
Acceptability of the FACT intervention
Acceptability of the FACT intervention from the participants' perspective was measured via 3 Likert-scale questions gathered during the semi-structured interview focused on: perceived benefit, ease of learning about pain management, and whether the participant would recommend the FACT treatment to a friend or family member
Measured: 6-month follow-up
Secondary outcomes (4)
Chronic Pain Acceptance
The 20-item Chronic Pain Acceptance Questionnaire (CPAQ) assesses the degree to which activities are done in the presence of chronic pain and pain-related experiences (Activities Engagement), and the degree of effort put in to controlling pain (Willingness). Each of the 20 items uses a 6-point numerical rating scale. The CPAQ has acceptable psychometrics in many studies and each item uses a 6-point numerical rating scale. There are no established cut-points, although higher scores on the CPAQ indicate greater acceptance of chronic pain. Scores range from 0 - 120.
Measured: Booster (12 weeks from baseline)
Chronic Pain Acceptance
The 20-item Chronic Pain Acceptance Questionnaire (CPAQ) assesses the degree to which activities are done in the presence of chronic pain and pain-related experiences (Activities Engagement), and the degree of effort put in to controlling pain (Willingness). Each of the 20 items uses a 6-point numerical rating scale. The CPAQ has acceptable psychometrics in many studies and each item uses a 6-point numerical rating scale. There are no established cut-points, although higher scores on the CPAQ indicate greater acceptance of chronic pain. Scores range from 0 - 120.
Measured: 6-month follow-up
Engagement in Valued Activities
The Chronic Pain Values Inventory (CPVI) identifies which values are important to a person with chronic pain, and assesses the degree of success they are having in following their values. The valued domains are family, intimate relations, friends, work, health, and growth or learning. The 12-item CPVI uses 6-point Likert scale questions to measure the discrepancy between ratings of importance of valued life areas and success in engaging in those life areas; lower scores reflect greater alignment (i.e., less discrepancy) between values and actions in one's life. Scores range from 0-6.
Measured: Booster (12 weeks from baseline)
Engagement in Valued Activities
The Chronic Pain Values Inventory (CPVI) identifies which values are important to a person with chronic pain, and assesses the degree of success they are having in following their values. The valued domains are family, intimate relations, friends, work, health, and growth or learning. The 12-item CPVI uses 6-point Likert scale questions to measure the discrepancy between ratings of importance of valued life areas and success in engaging in those life areas; lower scores reflect greater alignment (i.e., less discrepancy) between values and actions in one's life. Scores range from 0-6.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start9 Oct 2017
- Primary completion10 Dec 2018
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn Kanzler, Principal investigator, University of Texas Health San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978961
- Sponsor's protocol ID
- HSC20160512H
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author, \[author initials\], upon reasonable request
Publications
Kanzler KE, Robinson PJ, McGeary DD, Mintz J, Kilpela LS, Finley EP, McGeary C, Lopez EJ, Velligan D, Munante M, Tsevat J, Houston B, Mathias CW, Potter JS, Pugh J. Addressing chronic pain with Focused Acceptance and Commitment Therapy in integrated primary care: findings from a mixed methods pilot randomized controlled trial. BMC Prim Care. 2022 Apr 14;23(1):77. doi: 10.1186/s12875-022-01690-2.
PubMed 35421949
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Treatment Delivery of Acceptance and Commitment Therapy for Chronic Pain in an Integrated Primary Care Setting
- ClinicalTrials.gov ID
- NCT04978961
- Acronym / sponsor ID
- HSC20160512H
- Conditions
- Chronic Pain
- Keywords
- chronic pain, acceptance and commitment therapy, integrated primary care, behavioral health consultant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 27 Jul 2021 (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.
This mixed-methods pilot randomized controlled trial sought to: 1) evaluate implementation of a brief Acceptance and Commitment Therapy treatment for chronic pain delivered by an integrated behavioral health consultant in primary care; and to 2) explore treatment outcomes and their associated mechanisms of change.
Detailed description
Background: Most patients with chronic pain obtain their treatment in primary care settings, where evidence-based behavioral interventions are not typically provided, despite robust evidence for treatments like Acceptance and Commitment Therapy.
Objective: This mixed-methods pilot randomized controlled trial sought to: 1) evaluate implementation of a brief Acceptance and Commitment Therapy treatment for chronic pain delivered by an integrated behavioral health consultant in primary care; and to 2) explore treatment outcomes and their associated mechanisms of change.
Design: Mixed-methods pilot randomized controlled trial. Active participants completed one 30-minute individual Focused Acceptance and Commitment Therapy (FACT) visit followed by 3 weekly 60-minute group visits and a booster visit 2 months later. An enhanced treatment as usual (ETAU) control group received 4 handouts about pain management based on cognitive behavioral science. Follow-up research visits occurred during and after treatment, at 12 weeks (booster visit), and at 6 months. Semi-structured interviews were conducted after the last research visit.
Setting: A small integrated primary care clinic in southwestern U.S. affiliated with an academic medical center
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused Acceptance and Commitment Therapy (FACT) | Experimental | Behavioral: Focused Acceptance & Commitment Therapy (FACT)Focused Acceptance \& Commitment Therapy (FACT): FACT is a brief type of cognitive behavioral therapy that helps patients reduce disability through increased acceptance, reconnection with values, and reduced unhelpful control/coping strategies. Patients randomized to the intervention group received FACT per the study manual, delivered by an integrated Behavioral Health Consultant (BHC). Patients had one individual visit (30 minutes) and three consecutive weekly group visits (one hour) followed by a booster visit two months later. These classes (group visits) were rolling, not cohort-driven, meaning new and returning patients will be attending together. After the individual BHC visit and each class, patients had behavioral "homework" to complete. |
| Enhanced Treatment as Usual (ETAU) | Active comparator | Behavioral: Enhanced Treatment as Usual (ETAU)Patients randomized to the Enhanced-Treatment As Usual (ETAU) group received "enhancement" of usual primary care via 1-page (2-sided) educational handouts on four topic areas: Sleep, Pacing, Relaxation and Goal Setting. All topics have an evidence base in standard Cognitive Behavioral Therapy treatment of pain. One handout per assessment visit was given to each patient. Patients will continue to see their primary care clinicians and have access to all routine clinical services throughout the study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 and older
- at least one non-cancer pain condition persisting for 12 weeks or more
- a current primary care clinician at the study clinic
- ongoing treatment for a non-cancer chronic pain condition
Key exclusion criteria (4 listed)
- social anxiety or unwillingness to participate in a class setting
- presence of symptoms of psychosis and/or delirium
- a medical condition or life circumstance that would contraindicate or prevent participating (e.g. upcoming surgery)
- inability to comprehend the informed consent process or study instructions.
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 |
|---|---|---|
| Focused Acceptance & Commitment Therapy (FACT)FACT is a brief form of Acceptance and Commitment Therapy and in this study, FACT focused on increasing patient functioning through connection with valued activities and increased acceptance. | Behavioural | Focused Acceptance and Commitment Therapy (FACT) |
| Enhanced Treatment as Usual (ETAU)This active control intervention included 4 handouts focused on pain management based on cognitive behavioral science. | Behavioural | Enhanced Treatment as Usual (ETAU) |
Primary outcome
Self-reported physical disability
Time frame: Booster (12 weeks from baseline)
The Oswestry Disability Index (ODI) is a 10-item self-report scale that assesses perceived disability and functional impairment across a range of daily activities, with higher scores indicating greater perceived disability. Although originally developed as a measure of back pain, we used an established modified version that asked about "pain" rather than "back pain." The ODI uses a 6-point Likert scale for each item, which is summed to create a total score (maximum 50) that is then divided by highest possible score based on items skipped, and doubled to provide a percentage of patient perceived disability. The ODI and has been validated across a wide range of populations as a reliable and useful indicator of overall disability. Scores range from 0-100.
Self-reported physical disability
Time frame: 6-month follow-up
The Oswestry Disability Index (ODI) is a 10-item self-report scale that assesses perceived disability and functional impairment across a range of daily activities, with higher scores indicating greater perceived disability. Although originally developed as a measure of back pain, we used an established modified version that asked about "pain" rather than "back pain." The ODI uses a 6-point Likert scale for each item, which is summed to create a total score (maximum 50) that is then divided by highest possible score based on items skipped, and doubled to provide a percentage of patient perceived disability. The ODI and has been validated across a wide range of populations as a reliable and useful indicator of overall disability. Scores range from 0 - 100.
Feasibility of intervention and study (attrition and satisfaction ratings)
Time frame: 6-month follow-up
Feasibility was evaluated using a priori established benchmarks: (a) < 25% participant attrition; (b) at least 80% of participants rating the FACT program as satisfactory as measured by response of at least 5 on a 7-point Likert-scale (1= Not Satisfied at All, 7 = Very Satisfied). The satisfaction question was asked in the context of an "exit interview": all participants who completed the 6-month follow-up assessment were contacted by the PI to provide feedback on their experiences in the study.
Acceptability of the FACT intervention
Time frame: 6-month follow-up
Acceptability of the FACT intervention from the participants' perspective was measured via 3 Likert-scale questions gathered during the semi-structured interview focused on: perceived benefit, ease of learning about pain management, and whether the participant would recommend the FACT treatment to a friend or family member
4 secondary outcomes
Chronic Pain Acceptance
Time frame: Booster (12 weeks from baseline)
Chronic Pain Acceptance
Time frame: 6-month follow-up
Engagement in Valued Activities
Time frame: Booster (12 weeks from baseline)
Engagement in Valued Activities
Time frame: 6-month follow-up
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 27 Jul 2021.
- Derived from this study: PubMed 35421949Kanzler KE, Robinson PJ, McGeary DD, Mintz J, Kilpela LS, Finley EP, McGeary C, Lopez EJ, Velligan D, Munante M, Tsevat J, Houston B, Mathias CW, Potter JS, Pugh J. Addressing chronic pain with Focused Acceptance and Commitment Therapy in integrated primary care: findings from a mixed methods pilot randomized controlled trial. BMC Prim Care. 2022 Apr 14;23(1):77. doi: 10.1186/s12875-022-01690-2.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author, [author initials], upon reasonable request
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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.
Kathryn Kanzler principal investigator
University of Texas Health San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Acceptance & Commitment Therapy (FACT) and Enhanced Treatment as Usual (ETAU) in people with Chronic Pain, run by The University of Texas Health Science Center at San Antonio at 1 site 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 4 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 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Self-reported physical disability (time frame: Booster (12 weeks from baseline)). The study lists 4 primary outcomes in all. 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 NCT04978961, which also lists 1 linked publication.
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 27 Jul 2021.