Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture for PTSD (PTSD ACU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02869646
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Analydata, Inc
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Procedure: Procedure: Acupuncture Procedure: Procedure: Sham acupuncture Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acupuncture for PTSD in Combat Veterans
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Verum acupuncture
Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites
Procedure: Procedure: Acupuncture
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.
Other Name: Traditional Chinese Medicine

Sham Comparator: Minimal needling
shallow and non-acupoint needles at same number of sites
Procedure: Procedure: Sham acupuncture
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 Name: Placebo acupuncture




Primary Outcome Measures :
  1. Change in PTSD symptom severity on the Clinician Administered PSTD Scale - CAPS 5 from before to after treatment [ Time Frame: Baseline, 6 weeks, 12 weeks, and 13 weeks (1-month after end of treatment) ]
    The Clinician Administered PTSD Scale (CAPS) (Blake et al, 1995) is a structured diagnostic interview for PTSD. The CAPS-5 based on DSM-5 criteria will be used. CAPS-5 has 20 symptom items, each rated from 0 (absent) to 4 (severe). A rating of >2 is considered a positive score for diagnostic purposes. The DSM-5 diagnostic rule requires the presence of least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms in addition to other impairment criteria. A DSM-5 CAPS cutoff score of >26 AND meeting each of the 4 symptom cluster criterion will be used for study inclusion and outcomes.


Secondary Outcome Measures :
  1. Change in EMG eyeblink startle from before to after treatment [ Time Frame: Baseline, 12 weeks ]
    The startle response, measured with electromyography (EMG) of the eyeblink, provides an ideal translational tool to investigate fear conditioning and extinction, since the amygdala is directly connected with the startle circuit. The raw EMG signal will be recorded at a rate of 1000 Hz throughout the experimental session using a 28 Hz high pass and 500 Hz low pass filter (as recommended by guidelines for human eyeblink startle in Blumenthal et al., 2005; Psychophysiology, 42:1-15). Raw signals will be stored and exported for analysis in microvolt ( V) values.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869646


Contacts
Layout table for location contacts
Contact: Kala Harkin, MS (562) 826-8000 ext 7212 kala.harkin@va.gov
Contact: Michael Hollifield, MD (562) 826-8000 Michael.Hollifield@va.gov

Locations
Layout table for location information
United States, California
VA Long Beach Healthcare System, Long Beach, CA Recruiting
Long Beach, California, United States, 90822
Contact: Tamara H Bon, BA    562-826-8000    Tamara.Bon@va.gov   
Contact: Chris Reist, MD MBA    (562) 826-8000 ext 4941    Chris.Reist@va.gov   
Principal Investigator: Michael Hollifield, MD         
Sponsors and Collaborators
VA Office of Research and Development
Analydata, Inc
Investigators
Layout table for investigator information
Principal Investigator: Michael Hollifield, MD VA Long Beach Healthcare System, Long Beach, CA

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02869646     History of Changes
Other Study ID Numbers: CLNA-02-15F
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
PTSD
acupuncture
integrative medicine

Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders