Acupuncture for PTSD

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.

Inclusion Criteria:

Inclusion criteria are meant to recruit a relatively homogeneous yet generalizable sample
of Veterans with at least moderate chronic PTSD due to combat trauma. Criteria are:

- Veterans age 18 to 55

- DSM-5 criteria for chronic PTSD on the Clinician Administered PTSD Scale (CAPS-5)

- At least moderate PTSD by having a total CAPS-5 score of > 26 and meeting criteria for
each of 4 symptom clusters.

- Eligible persons will be allowed to have other symptoms that are commonly comorbid
with PTSD. This strategy will provide a feasible and generalizable sample of those
with chronic PSTD, but these will not be inclusion or exclusion criteria, e.g.,:

- anxiety

- mild to moderate depression

- Women and minorities will be recruited

Exclusion Criteria:

Exclusion criteria are meant to keep out individuals with characteristics that are known to
be PTSD treatment confounds, that may significantly affect biological assessment, that
indicate past non-adherence or treatment resistance, or who may be put at risk of harm.
Criteria are:

- Current and past six-months psychosis

- Substance dependence (evidence of tolerance and/or withdrawal) within the past 6
months

- Thyroid disease

- Decisional incapacity (e.g., dementia)

- Centrally acting medications that have a potential effect on biological expression,
e.g.:,

- beta-blockers

- opiates

- >10mg equivalent of diazepam/day

- Pain levels requiring opiate medications

- Known exposure to chemicals or physical trauma that cause neuropsychiatric sequelae

- Severe depression (Beck Depression Inventory-II score >30) that is deemed more
clinically significant than PTSD, since this may bias accurate PTSD diagnosis and
biological measures

- A diagnosed and untreated sleep breathing disorder (SBD) which is a treatment confound

- A high risk of a SBD as indicated by snoring >50 of nights plus one of:

- any witnessed apnea

- feeling non-refreshed in the morning >50 of mornings

- daytime sleepiness indicated by falling asleep with routine tasks such as
watching TV or reading

- Non-response to >2 evidence-based PTSD treatments

- adequate medication of 12 weeks or completion of Prolonged Exposure (PE)

- Cognitive Processing Therapy (CPT)

- or an intensive program

- Treatment non-adherence indicated by stopping treatment or >3 missed appointments in
the course of a PTSD Evidenced-Based Treatment (EBT)

- High dissociation as indicated by a score of >25 on the Dissociative Experiences Scale
- II (Bernstein & Putnam, 1986)

- Past chronic PTSD prior to military service

- Current active psychotherapy for PTSD

- Having acupuncture in the past year

- Pregnancy

- A person who is on a stable dose (8 weeks) of medication for:

- depression

- anxiety

- PTSD

- or for sleep, or any other psychoactive medication that may confound the study,
and who meet entering criteria and will continue these medications for the
duration of the trial will not be excluded (list in Appendix 5)