Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care

NCT ID: NCT04978961

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2019-04-22

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

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Focused Acceptance and 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.

Group Type: EXPERIMENTAL

Focused Acceptance & Commitment Therapy (FACT)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Treatment as Usual (ETAU)

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Enhanced Treatment as Usual (ETAU)

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn Kanzler

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health San Antonio

Locations

Medical Drive Primary Care

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35421949 (View on PubMed)

Other Identifiers

HSC20160512H

Identifier Type: -

Identifier Source: org_study_id