Acupuncture is under investigation as a potential treatment for combat-related post-traumatic stress disorder (PTSD) in US Veterans, according to a study protocol published in Trials. The randomized, placebo-controlled clinical trial, taking place at the Long Beach VA Healthcare System, aims to determine the clinical and biological effects of verum acupuncture compared to sham acupuncture.
The study addresses limitations of previous acupuncture trials by including a sham control, utilizing gold-standard clinical assessments, and measuring biological outcomes. Researchers are focusing on both clinical improvements and changes in psychophysiological responses, specifically fear-potentiated startle, to provide a comprehensive evaluation of acupuncture's effectiveness.
Study Design and Methods
The trial employs a two-arm, parallel-group design, randomizing participants to either verum acupuncture (ACU) or sham minimal needling (MIN). Each session lasts one hour and is administered twice weekly for 12 weeks. A total of 90 participants will be enrolled, ensuring adequate statistical power to detect significant differences between the two groups.
Inclusion Criteria:
- Veterans aged 18 to 55
- Diagnosis of chronic PTSD based on DSM-5 criteria
- CAPS-5 score of ≥ 26, indicating at least moderate PTSD
Exclusion Criteria:
- Current or past 6-month psychosis
- Substance dependence within the past 6 months
- Severe depression (Beck Depression Inventory-II score ≥ 30)
- Prior acupuncture treatment within the past year
Intervention Protocols
Participants in the verum acupuncture group receive a standardized acupuncture point prescription based on traditional Chinese medicine (TCM) diagnostic patterns for PTSD. Treatments alternate between front and back sessions to prevent point fatigue. The front treatment involves 11 needles at specific points, while the back treatment uses 14 needles. Acupuncturists aim to elicit DeQi, a characteristic sensation associated with acupuncture.
The control group receives sham minimal needling, where needles are inserted superficially at points not associated with PTSD. A non-functioning stimulator is used to enhance the sham effect. The protocol matches the number and body position of points in the ACU group.
Outcome Measures
TheThe primary outcome is the change in PTSD symptom severity, measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Secondary outcomes include changes in psychophysiological responses, specifically startle by electromyographic (EMG) eyeblink, assessed through fear conditioning paradigms.
Exploratory outcomes include assessments of symptoms comorbid with PTSD, such as depression and anxiety, as well as additional psychophysiological measures like heart rate variability.
Data Analysis
General linear mixed models (GLMM) will be used to evaluate the effects of treatment on clinical and biological outcomes over time. Cohen’s d will be calculated to determine effect sizes within and between groups. The study will also assess treatment fidelity and subject expectancy as potential moderators.
Significance
This study is poised to provide robust evidence regarding the efficacy of acupuncture for combat-related PTSD. By addressing limitations of previous trials and incorporating both clinical and biological outcome measures, the findings could influence PTSD treatment approaches within the VA system and beyond. The results will be communicated to the scientific and lay communities through publications and presentations.
