Acupuncture for Post-Traumatic Stress in Combat Veterans

NCT02871076 | Unknown DMC

• 1 other identifier: PR151974
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis

  4 months: Baseline CAPS to post treatment

Study Arms (2)

Verum Acupuncture

EXPERIMENTAL

Patients will receive verum acupuncture twice weekly for twelve weeks.

Device: Acupuncture

Sham Placebo Acupuncture

PLACEBO COMPARATOR

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

Device: Acupuncture

Interventions

Acupuncture DEVICE

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

Sham Placebo Acupuncture; Verum Acupuncture

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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 to PE, CPT or an intensive program)
• Treatment non-adherence indicated by stopping treatment or \>3 missed appointments in the course of PTSD EBT

Sponsors & Collaborators

• Southern California Institute for Research and Education: lead
• VA Office of Research and Development: collaborator

Study Sites (1)

Veterans Affairs Long Beach Healthcare System

Long Beach, California, 90822, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Michael Hollifield, MD

  Tibor Rubin VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kala Carrick, MS

CONTACT

562-826-8000; kala.harkin@va.gov

Andrea Munoz, MS

CONTACT

562-826-8000; andrea.gory@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Program for Traumatic Stress

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 18, 2016
• Study Start: May 19, 2018
• Primary Completion: September 30, 2021
• Study Completion: March 31, 2022
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

US (1)