At a glance
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Transcutaneous Electrical Acupoint Stimulation (TEAS) and Dense Cranial Electroacupuncture Stimulation (DCEAS) for Psychiatric Sequelae and Related Biomarkers in Women Victims of Domestic Violence: a Randomized Controlled Trial
In Brief
A clinical study evaluating Dense cranial electroacupuncture stimulation (DCEAS), Transcutaneous electrical acupoint stimulation (TEAS), and 1 other intervention for Depression and 2 related conditions. Completed, enrolled 110 participants across 1 site.
Detailed Summary
This is an assessor-blinded, randomized controlled trial. A total of 110 women victims of domestic violence aged 18-65 years will be recruited from local community centers and domestic violence shelters (refugee centers). They will be randomly assigned to routine care combined with (n = 55) and without (n = 55) additional acupuncture (TEAS+DCEAS) for 12 weeks. Acupuncture therapy will be conducted with 2 DCEAS sessions at clinics and 3 TEAS sessions at home each week. The primary outcome is the Beck Depression Inventory II (BDI-II) for depression. Secondary outcomes include the 17-item Hamilton Depression Rating Scale (HAMD-17) for depression, Perceived Stress Scale (PSS) for stress, PTSD Check List-Civilian Version (PCL-C) for PTSD symptoms, Insomnia Severity Index (ISI) for sleep and 12-Item Short Form Survey (SF-12) for quality of life. Two 10-ml blood samples will be drawn respectively at baseline and at the end of 12-week study. A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the two groups and linear regression will be conducted to examine inter-correlations among clinical improvement and changes in biomarker levels.
Study Details
Timeline
Interventions
DCEAS will be conducted for 2 sessions per week for 12 consecutive weeks. Electrical stimulation will be conducted on six pairs of forehead acupoints located on the frontal, parietal, and temporal scalp areas. The acupoints includes: Bai-Hui (GV20), Yin-Tang (EX-HN3), left and right Si-Shen-Cong (EX-HN1), Tou-Lin-Qi (GB15), Shuai-Gu (GB8), Tai-Yang (EX-HN5) and Tou-Wei (ST8). Disposable acupuncture needles will be inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation will be carried out for all acupoints to evoke needling sensation, followed by electrical stimulation. The stimulation intensity will be adjusted to a level at which patients felt most comfortable. Each session of treatment will last 30 min.
TEAS will be done for 3 times per week for 12 consecutive weeks by participants at home. A training workshop will be conducted to instruct participants how to use TEAS stimulator. Briefly, TEAS will be delivered on the bilateral Nei-Guan (PC6), which is located on the anterior forearm, between the tendons of the palmaris longus and flexor carpi radialis, at the junction of the distal sixth and proximal five sixths of the line connecting the middle points of the wrist and elbow crease. Constant current electrical impulses will be produced from a TEAS apparatus. Two electrode pads will be adhered onto the acupoint skin. The pulse amplitude will be adjusted to a level at which the perception of 'strong but comfortable' is achieved. Each session of treatment will last 30 min.
The routine care may include medications, advocacy intervention, and CBT. Post-trial treatment of TEAS+DCEAS will be offered to serve as a compensation for their participation.