- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02869646
Acupuncture for PTSD (PTSD ACU)
Acupuncture for PTSD in Combat Veterans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Long Beach, California, United States, 90822
- VA Long Beach Healthcare System, Long Beach, CA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion criteria are meant to recruit a relatively homogeneous yet generalizable sample of Veterans with at least moderate chronic PTSD due to combat trauma. Criteria are:
- Veterans age 18 to 55
- DSM-5 criteria for chronic PTSD on the Clinician Administered PTSD Scale (CAPS-5)
- At least moderate PTSD by having a total CAPS-5 score of > 26 and meeting criteria for each of 4 symptom clusters.
Eligible persons will be allowed to have other symptoms that are commonly comorbid with PTSD. This strategy will provide a feasible and generalizable sample of those with chronic PSTD, but these will not be inclusion or exclusion criteria, e.g.,:
- anxiety
- mild to moderate depression
- Women and minorities will be recruited
Exclusion Criteria:
Exclusion criteria are meant to keep out individuals with characteristics that are known to be PTSD treatment confounds, that may significantly affect biological assessment, that indicate past non-adherence or treatment resistance, or who may be put at risk of harm. Criteria are:
- Current and past six-months psychosis
- Substance dependence (evidence of tolerance and/or withdrawal) within the past 6 months
- Thyroid disease
- Decisional incapacity (e.g., dementia)
Centrally acting medications that have a potential effect on biological expression, e.g.:,
- beta-blockers
- opiates
- >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) that is deemed more clinically significant than PTSD, since this may bias accurate PTSD diagnosis and biological measures
- A diagnosed and untreated sleep breathing disorder (SBD) which is a treatment confound
A high risk of a SBD as indicated by snoring >50 of nights plus one of:
- 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 of Prolonged Exposure (PE)
- Cognitive Processing Therapy (CPT)
- or an intensive program
- Treatment non-adherence indicated by stopping treatment or >3 missed appointments in the course of a PTSD Evidenced-Based Treatment (EBT)
- High dissociation as indicated by a score of >25 on the Dissociative Experiences Scale - II (Bernstein & Putnam, 1986)
- Past chronic PTSD prior to military service
- Current active psychotherapy for PTSD
- Having acupuncture in the past year
- Pregnancy
A person who is on a stable dose (8 weeks) of medication for:
- depression
- anxiety
- PTSD
- or for sleep, or any other psychoactive medication that may confound the study, and who meet entering criteria and will continue these medications for the duration of the trial will not be excluded (list in Appendix 5)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Verum acupuncture
Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites
|
Acupuncture is a general term indicating the insertion and stimulation of needles at one or more prescribed points in order to effect the biology of the individual.
Other Names:
|
Sham Comparator: Minimal needling
shallow and non-acupoint needles at same number of sites
|
Sham acupuncture is a general term indicating the use of needles, whether inserted or not, at points on the body that are not expected to have a clinically significant biological effect.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PTSD Symptom Severity on the Clinician Administered PSTD Scale - CAPS 5 From Before to After Treatment
Time Frame: Baseline and 12 weeks
|
The Clinician Administered PTSD Scale (CAPS) (Blake et al, 1995) is a structured diagnostic interview for PTSD.
The CAPS-5 based on DSM-5 criteria will be used.
CAPS-5 has 20 symptom items, each rated from 0 (absent) to 4 (severe).
A rating of >2 is considered a positive score for diagnostic purposes.
The DSM-5 diagnostic rule requires the presence of least one Criterion B symptom, one Criterion C symptom, two Criterion D symptoms, and two Criterion E symptoms in addition to other impairment criteria.
The minimum score is 0; the maximum score is 80.
A higher score is more severe symptoms and a worse outcome.
A DSM-5 CAPS cutoff score of >26 AND meeting each of the 4 symptom cluster criterion will be used for study inclusion and outcomes.
|
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change From Baseline in Eyeblink Startle Potentiation
Time Frame: Baseline, 12 weeks
|
The startle response, measured with electromyography (EMG) of the eyeblink, provides an ideal translational tool to investigate fear conditioning and extinction, since the amygdala is directly connected with the startle circuit.
The raw EMG signal will be recorded at a rate of 1000 Hz throughout the experimental session using a 28 Hz high pass and 500 Hz low pass filter (as recommended by guidelines for human eyeblink startle in Blumenthal et al., 2005; Psychophysiology, 42:1-15).
Raw signals will be stored and exported for analysis in microvolt ( V) values.
|
Baseline, 12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Hollifield, MD, VA Long Beach Healthcare System, Long Beach, CA
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLNA-02-15F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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