Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care

Chronic Pain Clinical Trial

Official title:

A Novel Treatment Delivery of Acceptance and Commitment Therapy for Chronic Pain in an Integrated Primary Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04978961
• Other study ID #: HSC20160512H
• Status: Completed
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: April 22, 2019

Study information

• Verified date: July 2021
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 22, 2019
• Est. primary completion date: December 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 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.
• Enhanced Treatment as Usual (ETAU)
This active control intervention included 4 handouts focused on pain management based on cognitive behavioral science.

Locations

Country	Name	City	State
United States	Medical Drive Primary Care	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Booster (12 weeks from baseline)
Primary	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.	6-month follow-up
Primary	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.	6-month follow-up
Primary	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	6-month follow-up
Secondary	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.	Booster (12 weeks from baseline)
Secondary	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.	6-month follow-up
Secondary	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.	Booster (12 weeks from baseline)
Secondary	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.	6-month follow-up