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Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focused Acceptance & Commitment Therapy (FACT)
Enhanced Treatment as Usual (ETAU)
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, acceptance and commitment therapy, integrated primary care, behavioral health consultant

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Medical Drive Primary Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Focused Acceptance and Commitment Therapy (FACT)

Enhanced Treatment as Usual (ETAU)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 15, 2021
Last Updated
July 24, 2021
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT04978961
Brief Title
Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care
Official Title
A Novel Treatment Delivery of Acceptance and Commitment Therapy for Chronic Pain in an Integrated Primary Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
December 10, 2018 (Actual)
Study Completion Date
April 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, acceptance and commitment therapy, integrated primary care, behavioral health consultant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
PI was masked to assessment outcomes during intervention phase
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Focused Acceptance and Commitment Therapy (FACT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Treatment as Usual (ETAU)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Focused Acceptance & Commitment Therapy (FACT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment as Usual (ETAU)
Intervention Description
This active control intervention included 4 handouts focused on pain management based on cognitive behavioral science.
Primary Outcome Measure Information:
Title
Self-reported physical disability
Description
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.
Time Frame
Booster (12 weeks from baseline)
Title
Self-reported physical disability
Description
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.
Time Frame
6-month follow-up
Title
Feasibility of intervention and study (attrition and satisfaction ratings)
Description
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.
Time Frame
6-month follow-up
Title
Acceptability of the FACT intervention
Description
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
Time Frame
6-month follow-up
Secondary Outcome Measure Information:
Title
Chronic Pain Acceptance
Description
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.
Time Frame
Booster (12 weeks from baseline)
Title
Chronic Pain Acceptance
Description
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.
Time Frame
6-month follow-up
Title
Engagement in Valued Activities
Description
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.
Time Frame
Booster (12 weeks from baseline)
Title
Engagement in Valued Activities
Description
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.
Time Frame
6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn Kanzler
Organizational Affiliation
University of Texas Health San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Drive Primary Care
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data that support the findings of this study are available from the corresponding author, [author initials], upon reasonable request
Citations:
PubMed Identifier
35421949
Citation
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.
Results Reference
derived

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Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care

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