Acupuncture for Post-Traumatic Stress in Combat Veterans

Not Applicable

• Conditions: PTSD; Combat; Acupuncture
• Interventions: Device: Acupuncture

• Registration Number: NCT02871076
• Lead Sponsor: Southern California Institute for Research and Education

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-18
• Study Start: 2018-05-19
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-06
• Last Update Posted: 2020-04-08
• Primary Completion: 2021-09-30
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum Acupuncture	Acupuncture	Patients will receive verum acupuncture twice weekly for twelve weeks.
Sham Placebo Acupuncture	Acupuncture	Patients will receive sham placebo acupuncture twice weekly for twelve weeks.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Veterans Affairs Long Beach Healthcare System; 🇺🇸 Long Beach, California, United States