Acupuncture for PTSD
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Procedure: Acupuncture; Procedure: Sham acupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.; Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
Other intervention name(s): Traditional Chinese Medicine; Placebo acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: PTSD; acupuncture; integrative medicine