Post-traumatic Stress Disorders
Conditions
Keywords
Post-traumatic stress disorders, Acupuncture, Quality of life, sleep disorder
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.
Interventions
OTHERAcupuncture treatment
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
Sponsors
Samueli Institute for Information Biology
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 | baseline, 6 or 12 weeks (latest available is used) | 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
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Index | baseline, 6 or 12 weeks (latest available is used) | subscales range from 0 to 3 with higher being worse. |
Countries
United States
Participant flow
Pre-assignment details
34 subjects were interviewed for consent. 15 were assigned to immediate treatment. 15 were assigned to wait list treatment. 2 did not meet inclusion criteria. 2 were assigned to case study.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 24 semi-individualized acupuncture treatments over 12 weeks. 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 | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 5 |
| Overall Study | Withdrawal by Subject | 5 | 5 |
Baseline characteristics
| Characteristic | Arm 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: baseline, 6 or 12 weeks (latest available is used)
Population: due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | SF-36 | mcs pre treatment | 35.2 units on a scale | Standard Deviation 10.7 |
| Arm 1 | SF-36 | mcs post treatment | 39.0 units on a scale | Standard Deviation 12.6 |
| Arm 1 | SF-36 | pcs pre treatment | 41.2 units on a scale | Standard Deviation 9.9 |
| Arm 1 | SF-36 | pcs post treatment | 44.5 units on a scale | Standard Deviation 9.5 |
Comparison: for mcsp-value: 0.15t-test, 2 sided
Comparison: for pcsp-value: 0.28t-test, 2 sided
Secondary
Pittsburgh Sleep Index
subscales range from 0 to 3 with higher being worse.
Time frame: baseline, 6 or 12 weeks (latest available is used)
Population: due to very small numbers of completers in the acupuncture and the wait list control, the data from the wait list group who completed at least 6 weeks of treatment were combined with those initially assigned to treatment for a single group pre/post analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Pittsburgh Sleep Index | sleep duration pre | 2.4 units on a scale | Standard Deviation 0.7 |
| Arm 1 | Pittsburgh Sleep Index | sleep duration post | 2.1 units on a scale | Standard Deviation 0.7 |
| Arm 1 | Pittsburgh Sleep Index | sleep disturbance pre | 2.4 units on a scale | Standard Deviation 0.5 |
| Arm 1 | Pittsburgh Sleep Index | sleep distubance post | 1.7 units on a scale | Standard Deviation 0.7 |
| Arm 1 | Pittsburgh Sleep Index | sleep latency pre | 2.6 units on a scale | Standard Deviation 0.5 |
| Arm 1 | Pittsburgh Sleep Index | sleep latency post | 1.7 units on a scale | Standard Deviation 1.2 |
Comparison: for sleep durationp-value: 0.34t-test, 2 sided
Comparison: for sleep disturbancep-value: 0.001t-test, 2 sided
Comparison: for sleep latencyp-value: 0.015t-test, 2 sided