Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT04978961
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
Study:
NCT04978961
Study Brief:
Protocol Section:
NCT04978961