Recruiting

Acupuncture

Sponsor:

Southern California Institute for Research and Education

Code:

NCT02871076

Conditions

PTSD

Acupuncture

Combat

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Acupuncture

Study Details

Brief summary:

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

Conditions

PTSD

Acupuncture

Combat

Study ID

NCT02871076

Start date

May 19, 2018

Status verified date

Apr, 2020

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Sep 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Verum Acupuncture

Patients will receive verum acupuncture twice weekly for twelve weeks.

placebo comparator: Sham Placebo Acupuncture

Patients will receive sham placebo acupuncture twice weekly for twelve weeks.

Interventions

Acupuncture

Patients will be randomized to either treatment arm, verum acupuncture or sham placebo acupuncture.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Veterans Affairs Long Beach Healthcare System

Recruiting

Long Beach, California, United States, 90822

Contacts

Principal Investigator:

Michael Hollifield, MD

More Information

Sponsor

Southern California Institute for Research and Education

Last update posted

Apr 8, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Southern California Institute for Research and Education on 2020-04-08.