Acupuncture for Post-Traumatic Stress in Combat Veterans

NCT ID: NCT02871076

Last Updated: 2020-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-19

Study Completion Date

2022-03-31

Brief Summary

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

Detailed Description

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Conditions

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PTSD Acupuncture Combat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Verum Acupuncture

Patients will receive verum acupuncture twice weekly for twelve weeks.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type DEVICE

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

Sham Placebo Acupuncture

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

Group Type PLACEBO_COMPARATOR

Acupuncture

Intervention Type DEVICE

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

Interventions

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Acupuncture

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role collaborator

Southern California Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Michael Hollifield, MD

Director, Program for Traumatic Stress

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Hollifield, MD

Role: PRINCIPAL_INVESTIGATOR

Tibor Rubin VA Medical Center

Locations

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Veterans Affairs Long Beach Healthcare System

Long Beach, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kala Carrick, MS

Role: CONTACT

562-826-8000 ext. 7212

Andrea Munoz, MS

Role: CONTACT

562-826-8000 ext. 3590

Facility Contacts

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Kala Carrick, MA

Role: primary

562-826-8000 ext. 7212

Other Identifiers

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PR151974

Identifier Type: -

Identifier Source: org_study_id

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