Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care

NCT04978961 | Completed

• 1 other identifier: HSC20160512H
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain; acceptance and commitment therapy; integrated primary care; behavioral health consultant

Outcome Measures

Primary Outcomes (4)

• 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)

• 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

• 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

• 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 Outcomes (4)

• Chronic Pain Acceptance

  Booster (12 weeks from baseline)

• Chronic Pain Acceptance

  6-month follow-up

• Engagement in Valued Activities

  Booster (12 weeks from baseline)

• Engagement in Valued Activities

  6-month follow-up

Study Arms (2)

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.

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.

Behavioral: Enhanced Treatment as Usual (ETAU)

Interventions

Focused Acceptance & Commitment Therapy (FACT) BEHAVIORAL

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.

Focused Acceptance and Commitment Therapy (FACT)

Enhanced Treatment as Usual (ETAU) BEHAVIORAL

This active control intervention included 4 handouts focused on pain management based on cognitive behavioral science.

Enhanced Treatment as Usual (ETAU)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Medical Drive Primary Care

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 35421949 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathryn Kanzler

  University of Texas Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: PI was masked to assessment outcomes during intervention phase
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 27, 2021
• Study Start: October 9, 2017
• Primary Completion: December 10, 2018
• Study Completion: April 22, 2019
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (1)