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Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD

Primary Purpose

Post-traumatic Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture treatment
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorders focused on measuring Post-traumatic stress disorders, Acupuncture, Quality of life, sleep disorder

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1

wait list control

Arm Description

The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen

subjects were put on a wait list control. due to small numbers completing in both groups, the data from the wait list who completed acupuncture are combined with the experimental treatment group for analysis.

Outcomes

Primary Outcome Measures

SF-36
global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.

Secondary Outcome Measures

Pittsburgh Sleep Index
subscales range from 0 to 3 with higher being worse.

Full Information

First Posted
January 29, 2010
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
Collaborators
Samueli Institute for Information Biology
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1. Study Identification

Unique Protocol Identification Number
NCT01060553
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Samueli Institute for Information Biology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorders
Keywords
Post-traumatic stress disorders, Acupuncture, Quality of life, sleep disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
Arm Title
wait list control
Arm Type
No Intervention
Arm Description
subjects were put on a wait list control. due to small numbers completing in both groups, the data from the wait list who completed acupuncture are combined with the experimental treatment group for analysis.
Intervention Type
Other
Intervention Name(s)
Acupuncture treatment
Intervention Description
This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment. Due to the very small number of subjects in the wait list control, the ones who completed 6 or 12 weeks of acupuncture after the wait list were combined with the few who completed the initial acupuncture for a pre-post single group analysis. for those who completed both the 6 and 12 week measures, the latest one was selected for analysis
Primary Outcome Measure Information:
Title
SF-36
Description
global health functioning Mental component (MCS) and Physical component (PCS) subscales range from 0 to 100 with 100 being better; 50 is expected population average.
Time Frame
baseline, 6 or 12 weeks (latest available is used)
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Index
Description
subscales range from 0 to 3 with higher being worse.
Time Frame
baseline, 6 or 12 weeks (latest available is used)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas W Findley, MD PhD
Organizational Affiliation
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States

12. IPD Sharing Statement

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Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD

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