Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in Post-9/11 Veterans

Summary

This is a research study of an interdisciplinary pain management program for U.S. military veterans who served during the post-9/11 combat eras (e.g., Operations Iraqi Freedom \[OIF\], Enduring Freedom \[OEF\], New Dawn \[OND\]) presenting with chronic musculoskeletal pain related to military service with comorbid depression and/or posttraumatic stress disorder \[PTSD\] symptoms and/or mild traumatic brain injury. This study will test the efficacy of an interdisciplinary pain program compared to treatment as usual in the Veterans Health Administration on pain-related disability, opioid medication use, and pain coping.

Conditions

• Chronic Pain
• Traumatic Brain Injury
• Posttraumatic Stress Disorder
• Depression
• Opioid Use Disorder

Interventions

BEHAVIORAL

FORT-A

FORT-A is based on a functional restoration paradigm of pain management in which treatment is interdisciplinary and designed to achieve a functional goal (often specified by the patient; e.g., doing more with family, returning to work). FORT-A includes intensive functional rehabilitation, group-based pain management intervention, and individual interventions tailored to the patient's specific needs (e.g., biofeedback for stress, individual psychotherapy for mood or trauma symptoms).

OTHER

VA Treatment as Usual

VA TAU includes referrals for specialty intervention, rehabilitation, and behavioral health intervention within the VA medical system. Some participants may be referred for care outside of the VA system. The South Texas Veterans Health Care System offers a wide range of pain management services.

Sponsors & Collaborators

• South Texas Veterans Health Care System

  collaborator FED

• The University of Texas Health Science Center at San Antonio

  lead OTHER

Principal Investigators

• Donald D McGeary, PhD · University of Texas Health Science Center San Antonio

• Blessen Eapen, MD · South Texas Veterans Health Care System

• Cindy A McGeary, PhD · University of Texas Health Science Center San Antonio

• Carlos Jaramillo, MD, PhD · South Texas Veterans Health Care System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

72 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-04

Primary Completion

2020-02-18

Completion

2020-02-18

Countries

• United States

Study Locations