Acupuncture for Post-Traumatic Stress in Combat Veterans

Study Overview
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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.

Official Title
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Acupuncture for Post-Traumatic Stress in Combat Veterans

Conditions
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PTSD, Acupuncture, Combat

Intervention / Treatment
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* Device: Acupuncture


Participation Criteria
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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 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum Acupuncture<br>Patients will receive verum acupuncture twice weekly for twelve weeks. | Device: Acupuncture<br>* Patients will be randomized to either treatment arm, verum acupuncture or sham placebo acupuncture.<br>|
| Placebo Comparator: Sham Placebo Acupuncture<br>Patients will receive sham placebo acupuncture twice weekly for twelve weeks. | Device: Acupuncture<br>* Patients will be randomized to either treatment arm, verum acupuncture or sham placebo acupuncture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician Administered PTSD Scale (CAPS-5) PTSD Diagnosis |  | 4 months: Baseline CAPS to post treatment |