N/A
N=92
Acupuncture for PTSD
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02869646 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Change in PTSD Symptom Severity on the Clinician Administered PSTD Scale - CAPS 5 From Before to After Treatment — 22.6; 29.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Procedure: Acupuncture (Procedure); Procedure: Sham acupuncture (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PTSD Symptom Severity on the Clinician Administered PSTD Scale - CAPS 5 From Before to After Treatment |
22.6; 29.1 | — |
| SECONDARY Percentage Change From Baseline in Eyeblink Startle Potentiation |
-55.8; 6.1 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02869646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.