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Acupuncture for Women Victims of Domestic Violence With Psychiatric Sequelae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05102253
Recruitment Status : Not yet recruiting
First Posted : November 1, 2021
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Zhang Zhang-Jin, The University of Hong Kong

Brief 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. Leukocytes, platelet, and sera will be separated for measurement of telomerase and NALP3, 5-HT1A, and BDNF, TNF, IL-4, IL-6, and IL-10, respectively. 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.

Condition or disease Intervention/treatment Phase
Depression Domestic Violence Psychiatric Disorder Procedure: Dense cranial electroacupuncture stimulation (DCEAS) Procedure: Transcutaneous electrical acupoint stimulation (TEAS) Other: Wait-list control: Routine care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TEAS+DCEAS group
Subjects assigned to TEAS+DCEAS group will receive TEAS+DCEAS in addition to routine care.
Procedure: Dense cranial electroacupuncture stimulation (DCEAS)

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.


Procedure: Transcutaneous electrical acupoint stimulation (TEAS)

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.


Wait-list control: Routine care group
Subjects assigned to this group will continue their current routine care as usual.
Other: Wait-list control: Routine care
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.




Primary Outcome Measures :
  1. Changes in Beck Depression Inventory-II (BDI-II) [ Time Frame: Baseline, Week 3, Week 6 and Week 12 ]
    BDI-II is used to measure the severity of depression. Higher scores indicate greater severity. Assessments will be conducted at baseline, week 3, week 6 and week 12.


Secondary Outcome Measures :
  1. Changes in 17-item Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Baseline, Week 3, Week 6 and Week 12 ]
    HAMD-17 is used to measure the severity of depression. Higher scores indicate greater severity. Assessments will be conducted at baseline, week 3, week 6 and week 12.

  2. Changes in Perceived Stress Scale (PSS) [ Time Frame: Baseline, Week 3, Week 6 and Week 12 ]
    Stress is measured using PSS. Assessments will be conducted at baseline, week 3, week 6 and week 12.

  3. Changes in PTSD Check List-Civilian Version (PCL-C) [ Time Frame: Baseline, Week 3, Week 6 and Week 12 ]
    PTSD symptoms are measured using PCL-C. Assessments will be conducted at baseline, week 3, week 6 and week 12.

  4. Changes in Insomnia Severity Index (ISI) [ Time Frame: Baseline, Week 3, Week 6 and Week 12 ]
    Severity of insomnia are measured using ISI. Assessments will be conducted at baseline, week 3, week 6 and week 12.

  5. Changes in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, Week 3, Week 6 and Week 12 ]
    Sleep quality is assessed using PSQI. Assessments will be conducted at baseline, week 3, week 6 and week 12.

  6. Changes in 12-Item Short Form Survey (SF-12) [ Time Frame: Baseline, Week 3, Week 6 and Week 12 ]
    Quality of life is measured using SF-12. Assessments will be conducted at baseline, week 3, week 6 and week 12.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chinese women aged 18-65 years;
  • have experienced domestic violence in the previous two years, confirmed with the Abuse Assessment Screen (AAS) Screen Questionnaire; and
  • are currently experiencing a major depressive episode according to the criteria defined in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), with a BDI-II score of at least 14.

Exclusion Criteria:

  • have serious medical conditions that may limit their participation in TEAS or DCEAS;
  • have a history of brain injury or surgery;
  • pregnancy or lactation;
  • have investigational drug treatment in the previous 6 months;
  • have heart pacemaker or other metal/electrical devices implanted in the body; or
  • have severe needle phobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05102253


Contacts
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Contact: Zhang-Jin Zhang, MMed, PhD +852 3917 6445 zhangzj@hku.hk
Contact: Sichang YANG +852 65612746 sichang@hku.hk

Locations
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Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong, 999077
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Zhang-Jin Zhang, MMed, PhD School of Chinese Medicine, The University of Hong Kong
Publications:
World Health Organization. Global and regional estimates of violence against women: prevalence and health effects of intimate partner violence and non-partner sexual violence. Geneva: World Health Organization, 2013.
https://www.edb.gov.hk/attachment/tc/teacher/student-guidance-discipline-services/lecture-notes/lecture-notes-201718/20180103_Identification_and_ intervention.pdf

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Responsible Party: Prof. Zhang Zhang-Jin, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT05102253    
Other Study ID Numbers: UW 21-238
First Posted: November 1, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Zhang Zhang-Jin, The University of Hong Kong:
Depression
Domestic Violence
Psychiatric Sequelae
Acupuncture
Transcutaneous Electrical Acupoint Stimulation
TEAS
Dense Cranial Electroacupuncture Stimulation
DCEAS
Additional relevant MeSH terms:
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Depression
Mental Disorders
Problem Behavior
Behavioral Symptoms