Acupuncture for Post-Traumatic Stress in Combat Veterans

The objective of this study is to determine if acupuncture is an effective treatment option for treating combat Veterans with PTSD.

Study Overview

• Status: Unknown
• Conditions: PTSD; Acupuncture; Combat
• Intervention / Treatment: Device: Acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822
      • Recruiting
      • Veterans Affairs Long Beach Healthcare System
      • Contact: Kala Carrick, MA; Phone Number: 7212 562-826-8000; Email: kala.harkin@va.gov
      • Principal Investigator: Michael Hollifield, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Veteran Age 18 to 55
• DSM-5 criteria for chronic PTSD on Clinical Administered PTSD Scale (CAPS-5)
• CAPS-5 score of ≥ 26 and meeting criteria for each of 4 symptoms

Exclusion Criteria:

• Current and past six-months psychosis
• Substance dependence within 6 months (evidence of tolerance and/or withdrawal)
• Thyroid disease
• Decisional incapacity (e.g., dementia)
• Centrally acting medications that have a potential effect on biological expression (e.g., beta-blockers, opiates, and ≥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)
• A diagnosed and untreated sleep breathing disorder (SBD)

• High risk of a SBD as indicated by snoring ≥50 of nights plus one of any

  1. Any witnessed apnea
  2. Feeling non-refreshed in the morning ≥50 of mornings
  3. 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 to PE, CPT or an intensive program)
• Treatment non-adherence indicated by stopping treatment or >3 missed appointments in the course of PTSD EBT
• High dissociation as indicated by a score of ≥25 on the Dissociative Experiences Scale - II
• Past chronic PTSD prior to military service
• Current active psychotherapy for PTSD
• Having acupuncture in the past year
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum Acupuncture; Patients will receive verum acupuncture twice weekly for twelve weeks.	Device: Acupuncture; Patients will be randomized to either treatment arm, verum acupuncture or sham placebo acupuncture.
Placebo Comparator: Sham Placebo Acupuncture; Patients will receive sham placebo acupuncture twice weekly for twelve weeks.	Device: Acupuncture; Patients will be randomized to either treatment arm, verum acupuncture or sham placebo acupuncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis	4 months: Baseline CAPS to post treatment

Collaborators and Investigators

• Sponsor: Southern California Institute for Research and Education
• Collaborators: VA Office of Research and Development
• Investigators: Principal Investigator: Michael Hollifield, MD, Tibor Rubin VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2018
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 12, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PR151974

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No