Acupuncture for PTSD

NCT02869646 | Completed Results DMC

• 1 other identifier: CLNA-02-15F
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Current treatments for Veterans with PTSD include medications and therapy where the patient talks about traumatic events in order to desensitize to them. While these treatments work for many, a large minority of Veterans do not want medications or exposure therapy. The investigators developed an acupuncture (ACU) treatment for PTSD in order to broaden treatment options. The investigators' first study showed that it helped most people. However, the investigators need better scientific evidence that it works by comparing ACU to a placebo, such as "sham" acupuncture (fewer needles in non-important sites) and determining if ACU alters abnormal physiology in PTSD. In this study 90 Veterans will be randomly assigned (like a coin flip) to receive either ACU or sham. The investigators expect to find that the ACU treated patients have more improvement in PTSD and in physiology (less startle reaction - assessed non-invasively using skin sensors) than the patients in the sham group. This study will provide information to support the use of acupuncture for PTSD at the VA, which will expand treatment options.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; acupuncture; integrative medicine

Outcome Measures

Primary Outcomes (1)

• Change in PTSD Symptom Severity on the Clinician Administered PSTD Scale - CAPS 5 From Before to After Treatment

  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 Outcomes (1)

• Percentage Change From Baseline in Eyeblink Startle Potentiation

  Baseline, 12 weeks

Study Arms (2)

Verum acupuncture

EXPERIMENTAL

Traditional Chinese Medicine (TCM) based acupuncture at prescribed sites

Procedure: Procedure: Acupuncture

Minimal needling

SHAM COMPARATOR

shallow and non-acupoint needles at same number of sites

Procedure: Procedure: Sham acupuncture

Interventions

Procedure: Acupuncture PROCEDURE

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.

Also known as: Traditional Chinese Medicine

Verum acupuncture

Procedure: Sham acupuncture PROCEDURE

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.

Also known as: Placebo acupuncture

Minimal needling

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• anxiety
• mild to moderate depression
• Women and minorities will be recruited
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Analydata, Inc.: collaborator

Study Sites (1)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

Related Publications (2)

• Hollifield M, Hsiao AF, Smith T, Calloway T, Jovanovic T, Smith B, Carrick K, Norrholm SD, Munoz A, Alpert R, Caicedo B, Frousakis N, Cocozza K. Acupuncture for Combat-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Jun 1;81(6):545-554. doi: 10.1001/jamapsychiatry.2023.5651.

  PMID: 38381417 DERIVED

• Hollifield M, Hsiao AF, Carrick K, Gory Munoz A, Calloway T, Cocozza K, Smith B, Smith T, Jovanovic T, Norrholm S, Sokhadze E, Reist C. Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial. Trials. 2021 Sep 6;22(1):594. doi: 10.1186/s13063-021-05394-3.

  PMID: 34488824 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Michael Hollifield, M.D.
• Organization: Tibor Rubin VA Medical Center

michael.hollifield@va.gov

562 826-8000

Study Officials

• Michael Hollifield, MD

  VA Long Beach Healthcare System, Long Beach, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 17, 2016
• Study Start: April 5, 2018
• Primary Completion: June 15, 2022
• Study Completion: December 30, 2022
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)