Acupuncture for Post-Traumatic Stress in Combat Veterans
NCT ID: NCT02871076
Last Updated: 2020-04-08
Study Results
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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UNKNOWN
NA
90 participants
INTERVENTIONAL
2018-05-19
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Verum Acupuncture
Patients will receive verum acupuncture twice weekly for twelve weeks.
Acupuncture
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.
Acupuncture
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Southern California Institute for Research and Education
OTHER
Responsible Party
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Michael Hollifield, MD
Director, Program for Traumatic Stress
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PR151974
Identifier Type: -
Identifier Source: org_study_id
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