Clinical trial NCT04978961: Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care
Official title: A Novel Treatment Delivery of Acceptance and Commitment Therapy for Chronic Pain in an Integrated Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
acceptance and commitment therapy
integrated primary care
behavioral health consultant
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Self-reported physical disability
timeFrame: Booster (12 weeks from baseline)
measure: Self-reported physical disability
timeFrame: 6-month follow-up
measure: Feasibility of intervention and study (attrition and satisfaction ratings)
timeFrame: 6-month follow-up
measure: Acceptability of the FACT intervention
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Chronic Pain Acceptance
timeFrame: Booster (12 weeks from baseline)
measure: Chronic Pain Acceptance
timeFrame: 6-month follow-up
measure: Engagement in Valued Activities
timeFrame: Booster (12 weeks from baseline)
measure: Engagement in Valued Activities
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Medical Drive Primary Care
state: Texas
Study officials:
affiliation: University of Texas Health San Antonio
name: Kathryn Kanzler
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.