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Acupuncture for Post-Traumatic Stress in Combat Veterans

S

Southern California Institute for Research and Education

Status

Unknown

Conditions

PTSD
Acupuncture
Combat

Treatments

Device: Acupuncture

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02871076
PR151974

Details and patient eligibility

About

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

Enrollment

90 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 2 patient groups, including a placebo group

Verum Acupuncture
Experimental group
Description:
Patients will receive verum acupuncture twice weekly for twelve weeks.
Treatment:
Device: Acupuncture
Sham Placebo Acupuncture
Placebo Comparator group
Description:
Patients will receive sham placebo acupuncture twice weekly for twelve weeks.
Treatment:
Device: Acupuncture

Trial contacts and locations

1

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Central trial contact

Andrea Munoz, MS; Kala Carrick, MS

Data sourced from clinicaltrials.gov

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