Medical Drive Primary Care
San Antonio, Texas, 78229, United States
NCT Number: NCT04978961
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.
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
San Antonio, Texas, 78229, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
This active control intervention included 4 handouts focused on pain management based on cognitive behavioral science.
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.
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.
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.
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
Time frame: Booster (12 weeks from baseline)
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
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)
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
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.
The University of Texas Health Science Center at San Antonio
Other
A Novel Treatment Delivery of Acceptance and Commitment Therapy for Chronic Pain in an Integrated Primary Care Setting
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