Acupuncture for PTSD (PTSD ACU)

  • STATUS
    Recruiting
  • days left to enroll
    53
  • participants needed
    90
  • sponsor
    VA Office of Research and Development
Updated on 1 May 2022
depression
anxiety
exposure therapy
chronic post-traumatic stress disorder

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.

Details
Condition Posttraumatic Stress Disorder
Treatment Procedure: Acupuncture, Procedure: Sham acupuncture
Clinical Study IdentifierNCT02869646
SponsorVA Office of Research and Development
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

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
Current and past six-months psychosis
indicate past non-adherence or treatment resistance, or who may be put at risk of harm
Criteria are
Thyroid disease
Substance dependence (evidence of tolerance and/or withdrawal) within the past 6
Decisional incapacity (e.g., dementia)
months
beta-blockers
opiates
Centrally acting medications that have a potential effect on biological expression
>10mg equivalent of diazepam/day
Pain levels requiring opiate medications
e.g
Known exposure to chemicals or physical trauma that cause neuropsychiatric sequelae
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
Severe depression (Beck Depression Inventory-II score >30) that is deemed more
feeling non-refreshed in the morning >50 of mornings
clinically significant than PTSD, since this may bias accurate PTSD diagnosis and
biological measures
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
High dissociation as indicated by a score of >25 on the Dissociative Experiences Scale
daytime sleepiness indicated by falling asleep with routine tasks such as
II (Bernstein & Putnam, 1986)
watching TV or reading
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
Treatment non-adherence indicated by stopping treatment or >3 missed appointments in
the course of a PTSD Evidenced-Based Treatment (EBT)
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)
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