Clinical trial NCT01060553: Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD
Official title: Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorders
Keywords: Post-traumatic stress disorders
Acupuncture
Quality of life
sleep disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Samueli Institute for Information Biology
First posted: 2010-02-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if acupuncture improves Post-Traumatic Stress Disorder symptoms among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study will also examine the degree of veteran acceptance for acupuncture.

Detailed description: Project Background: Acupuncture can be effective for many of the specific co-morbidities that make up war-related Trauma Spectrum Disorder in both TBI and PTSD patients, including pain, stress and anxiety, insomnia, somatic and post-operative pain. Recent studies find very large effect sizes (Cohen's D .85 to 1.4). Thus, there is good reason to believe that acupuncture will induce recovery across a number of trauma spectrum dysfunctions in patients with TBI and PTSD, at low cost and with little risk.

Project Objectives: The overall objective of this application is to determine the efficacy of adjunctive acupuncture for improving quality of life and function and alleviating co-morbidities associated with TBI and PTSD in service members injured in the current wars. The primary hypothesis of this study is: OIF/OEF veterans who screen positive for TBI or PTSD and are treated with a 12 week standard individualized acupuncture method will experience improved HRQL (as measured by the Veteran's SF-36) at 6, 12 and 24 week follow-up, compared to veterans randomly assigned to standard care alone.

Project Methods: This is a pilot study on veterans who screen positive for TBI or PTSD in the VA healthcare record, which is being submitted to obtain additional pilot data, confirmation of recruitment strategies, and information on non-participants . Frequency distribution and summary statistics for demographics and baseline variables will be presented by intervention group and for all subjects combined. Key demographic variables to be summarized are: age, gender, time to deployment, number of deployments, and diagnosis. Key baseline variables are: PTSD CAPS score, VSF-36, and ANAM score.

Eligibility criteria: Inclusion Criteria:

* Diagnosis or positive screen test for PTSD.
* Combat veterans of Operation Iraqi Freedom or Operation Enduring Freedom conflicts.

Exclusion Criteria:

* Unable to travel to East Orange VA for 12 consecutive weeks, biweekly for treatment.
* Does not speak English.
* Acupuncture or CBT treatment within the previous six months.

Primary outcomes:
measure: SF-36
timeFrame: baseline, 6 or 12 weeks (latest available is used)
Secondary outcomes:
measure: Pittsburgh Sleep Index
timeFrame: baseline, 6 or 12 weeks (latest available is used)
Other outcomes:
Locations:
city: East Orange
country: United States
facility: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
state: New Jersey
Study officials:
affiliation: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
name: Thomas W Findley, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: