Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care

The University of Texas System (UT)

Status: Completed

Conditions: Chronic Pain

Treatments: Behavioral: Enhanced Treatment as Usual (ETAU); Behavioral: Focused Acceptance & Commitment Therapy (FACT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04978961

HSC20160512H

Details and patient eligibility

About

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.

Full 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

Enrollment: 26 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Focused Acceptance and Commitment Therapy (FACT)

Experimental group

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.

Treatment:

Behavioral: Focused Acceptance & Commitment Therapy (FACT)

Enhanced Treatment as Usual (ETAU)

Active Comparator group

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.

Treatment:

Behavioral: Enhanced Treatment as Usual (ETAU)