Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02869646 |
| Other study ID # |
CLNA-02-15F |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 5, 2018 |
| Est. completion date |
December 30, 2022 |
Study information
| Verified date |
April 2024 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Current treatments for Veterans with PTSD include medications and therapy where the patient
talks about traumatic events in order to desensitize to them. While these treatments work for
many, a large minority of Veterans do not want medications or exposure therapy. The
investigators developed an acupuncture (ACU) treatment for PTSD in order to broaden treatment
options. The investigators' first study showed that it helped most people. However, the
investigators need better scientific evidence that it works by comparing ACU to a placebo,
such as "sham" acupuncture (fewer needles in non-important sites) and determining if ACU
alters abnormal physiology in PTSD. In this study 90 Veterans will be randomly assigned (like
a coin flip) to receive either ACU or sham. The investigators expect to find that the ACU
treated patients have more improvement in PTSD and in physiology (less startle reaction -
assessed non-invasively using skin sensors) than the patients in the sham group. This study
will provide information to support the use of acupuncture for PTSD at the VA, which will
expand treatment options.
Description:
Posttraumatic Stress Disorder (PTSD) is debilitating and common (up to 30% in Vietnam
Veterans and 16% in Afghanistan and Iraq Veterans). A significant number of Veterans do not
engage in or drop-out from effective trauma-focused therapies due to avoidance from
trauma-related memories. Because of this limitation, and because scientific literature
suggested that acupuncture might be effective for PTSD symptoms, the investigators developed
an acupuncture intervention for PTSD and conducted a clinical trial that showed positive
effects. This remains the only high quality trial of acupuncture for PTSD published, because
of which the current VA/DoD guidelines for PTSD state that acupuncture is a "B"
recommendation (fair evidence, provide service) for PTSD treatment. That civilian study
compared acupuncture to an effective therapy (CBT) and a wait-list control, but did not have
a placebo control. And, research has shown that Veterans may respond differently to therapies
than civilians. More definitive data about the efficacy of acupuncture for PTSD is required
in order to recommend it as an "A" evidence-based intervention for PTSD in Veterans.
Specifically, it is important to show that acupuncture is better than a placebo control and
that it has effects on biological abnormalities of PTSD. The aim of this study is to
demonstrate efficacy of acupuncture for PTSD by showing clinical and biological effects that
are statistically larger and clinically more important than effects of "sham" acupuncture.
Given current knowledge and the need for efficient, ethical and best practices within an
experimental design, the primary aim is best accomplished by a randomized controlled trial
comparing verum acupuncture (ACU) to placebo minimal needling sham acupuncture (MIN). The
goal is to evaluate ACU for a significant positive signal, not to compare ACU to other
interventions or to evaluate treatment durability. Acupuncture is delivered in 24 sessions
over 12 weeks. The primary hypothesis is that efficacy of ACU for PTSD symptom severity will
be large (pre- to post-treatment Cohen's d > 0.8), and significantly better than MIN (between
group Cohen's d > 0.30, with 80% probability of detecting a true group difference at p<0.05
(2-sided). The secondary hypothesis is that compared to MIN, ACU will be associated with a
significantly larger change from pre- to post-treatment in psychophysiological response
(decreased startle by EMG eyeblink during fear conditioning procedure). The study design is a
two-arm, parallel-group, prospective randomized controlled trial (RCT). The sample frame is
Veterans with chronic PTSD with a sample of convenience from those seeking care at the Long
Beach VA. Exclusion criteria are meant to keep out individuals with characteristics that are
known to be PTSD treatment confounds, associated with non-adherence or negative response to
treatment, that may significantly affect biological assessment, or who may be put at risk of
harm. The sample size (90) provides adequate power to test hypotheses. Subjects will be
allocated to intervention group by computer-generated adaptive randomization. General linear
mixed models will be used to evaluate hypothesized effects over time (mid treatment, end of
treatment, 1-month follow-up), controlling for baseline severity of symptoms and demographic
characteristics (e.g., age, gender) using intent-to-treat modeling. Outcome effect size
(Cohen's d) within and between subjects will be calculated. Interaction terms will be
included in the models to evaluate treatment fidelity and treatment expectancy as potential
moderators. Study results will provide clinicians and policy makers with more information to
make decisions about the rational use of acupuncture for PTSD. This is important because
acupuncture is being touted for PTSD by many advocates. It has the potential to reach PTSD
sufferers who are not willing to engage in trauma-focused psychotherapy, or for whom current
therapies are ineffective. The objective of this project is consistent with priority research
areas of specific interest to Clinical Science Research & Development (CSR&D) including PTSD
and complementary medicine, and all participants are Veterans at a VA Hospital.
