- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05102253
Acupuncture for Women Victims of Domestic Violence With Psychiatric Sequelae
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
Study Overview
Status
Conditions
Detailed Description
Domestic violence, also referred to as intimate partner violence which overwhelmingly targets women of marriage and cohabitation, is a serious global public health issue with nearly 30% of women who have experienced physical or sexual abuse by their intimate partners. In Hong Kong, there were 4.5%-10% of women who experienced a physical violence and approximately 14,000 domestic violence cases reported to police offices each year. Depression is the most common psychiatric sequela of domestic violence, with an average prevalence of 47.6% among women victims. Recent study has shown that 65.2% women survivors of intimate partner violence had mild to severe depression. Abused women also often experienced post-traumatic stress disorder (PTSD), anxiety, substance abuse, and even suicidal thoughts. Although multiple psychological therapies, such as advocacy, cognitive behavioral therapy (CBT), and empowerment are a mainstay of domestic violence victim interventions, a large portion of the victims could not achieve satisfactory response and have low acceptability for psychological interventions; this seems to be particularly apparent in Asian women. Psychological interventions may be limited to patients with mild symptoms with long-term engagement of professionals. The development of non-psychological therapies is therefore highly desired.
Acupuncture has been widely introduced into local clinics and hospitals of Hong Kong. Numerous studies have shown benefits and efficacy of acupuncture in the treatment of various psychiatric disorders, including depression and anxiety. In addition to traditional invasive acupuncture in which needles are inserted into acupoints on the body, a non-invasive acupuncture mode called transcutaneous electrical acupoint stimulation (TEAS) also has been used in the treatment of postoperative anxiety, depression, autism, smoking cessation, and drug dependence. Compared to invasive acupuncture, obviously, TEAS is more acceptable to patients and physicians as it is non-invasive, safer, and time-saving, without causing pain and needle phobia. Furthermore, TEAS can be performed by patients themselves at home. These suggest that a combination of invasive acupuncture and TEAS could serve as an effective and more acceptable intervention for the victims.
Over the past decade, the effectiveness of advocacy and Qigong interventions in domestic violence women victims has been evaluated. Also, investigators have completed a series of epidemiological and methodological studies on women victims of domestic violence in local and international communities, with over 30 related papers published. On the other hand, a novel acupuncture stimulation called dense cranial electroacupuncture stimulation (DCEAS) based on neuroanatomical rationales has been developed. In this mode, electrical stimulation is delivered on dense acupoints located on the forehead innervated by the trigeminal nerve. Several clinical trials have confirmed the benefits and efficacy of DCEAS in patients with depression, obsessive-compulsive disorder (OCD), and neuropsychiatric sequelae of stroke. Moreover, two large-scale clinical trials have shown that patients with OCD and PTSD achieved an approximately 20% higher clinical remission rate on TEAS combined with CBT and/or antidepressants than those without TEAS. These results provide a solid foundation for further evaluation of the effectiveness of combining TEAS and DCEAS.
Besides, preliminary study has shown that several blood biomarkers were significantly correlated with the severity of depression and stress trauma. Determining relationships between potential biomarkers and the severity of psychiatric symptoms will lead people to better understand the pathogenesis of stress trauma and biochemical mechanisms of acupuncture effects.
These studies have led us to hypothesize that additional therapy with a combination of TEAS and DCEAS produces better outcomes than routine care alone in improving depression and other psychiatric sequelae of domestic violence; the therapeutic effects of acupuncture may be associated with the change of related biomarkers.
To test this hypothesis, an assessor-blinded, randomized controlled trial will be conducted to pursue the following two aims: (1) to compare the effectiveness of routine care with and without additional acupuncture in treating depression, stress, PTSD, insomnia symptoms, and quality of life of domestic violence women victims; and (2) to determine baseline-to-endpoint changes in levels of different blood biomarkers and their correlations with clinical outcomes.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zhang-Jin Zhang, MMed, PhD
- Phone Number: +852 3917 6445
- Email: zhangzj@hku.hk
Study Contact Backup
- Name: Sichang YANG
- Phone Number: +852 65612746
- Email: sichang@hku.hk
Study Locations
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-
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Hong Kong, Hong Kong, 999077
- Recruiting
- The University of Hong Kong
-
Contact:
- Zhang-Jin Zhang, MMed, PhD
- Phone Number: +852 3917 6445
- Email: zhangzj@hku.hk
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TEAS+DCEAS group
Subjects assigned to TEAS+DCEAS group will receive TEAS+DCEAS in addition to routine care.
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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. |
Other: Wait-list control: Routine care group
Subjects assigned to this group will continue their current routine care as usual.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Beck Depression Inventory-II (BDI-II)
Time Frame: Baseline, Week 3, Week 6 and Week 12
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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.
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Baseline, Week 3, Week 6 and Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, Week 3, Week 6 and Week 12
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Changes in Perceived Stress Scale (PSS)
Time Frame: Baseline, Week 3, Week 6 and Week 12
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Stress is measured using PSS.
Assessments will be conducted at baseline, week 3, week 6 and week 12.
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Baseline, Week 3, Week 6 and Week 12
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Changes in PTSD Check List-Civilian Version (PCL-C)
Time Frame: Baseline, Week 3, Week 6 and Week 12
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PTSD symptoms are measured using PCL-C.
Assessments will be conducted at baseline, week 3, week 6 and week 12.
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Baseline, Week 3, Week 6 and Week 12
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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.
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Baseline, Week 3, Week 6 and Week 12
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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.
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Baseline, Week 3, Week 6 and Week 12
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Changes in 12-Item Short Form Survey (SF-12)
Time Frame: Baseline, Week 3, Week 6 and Week 12
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Quality of life is measured using SF-12.
Assessments will be conducted at baseline, week 3, week 6 and week 12.
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Baseline, Week 3, Week 6 and Week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zhang-Jin Zhang, MMed, PhD, School of Chinese Medicine, The University of Hong Kong
Publications and helpful links
General Publications
- Zhang ZJ, Wang XM, McAlonan GM. Neural acupuncture unit: a new concept for interpreting effects and mechanisms of acupuncture. Evid Based Complement Alternat Med. 2012;2012:429412. doi: 10.1155/2012/429412. Epub 2012 Mar 8.
- Zhang ZJ, Ng R, Man SC, Li TY, Wong W, Tan QR, Wong HK, Chung KF, Wong MT, Tsang WK, Yip KC, Ziea E, Wong VT. Dense cranial electroacupuncture stimulation for major depressive disorder--a single-blind, randomized, controlled study. PLoS One. 2012;7(1):e29651. doi: 10.1371/journal.pone.0029651. Epub 2012 Jan 6. Erratum In: PLoS One. 2012 Feb 21;78(8). doi: 10.1371/annotation/b27d20b4-f41c-47af-b19f-a0278c993a2d.
- Zhang ZJ, Wang XY, Tan QR, Jin GX, Yao SM. Electroacupuncture for refractory obsessive-compulsive disorder: a pilot waitlist-controlled trial. J Nerv Ment Dis. 2009 Aug;197(8):619-22. doi: 10.1097/NMD.0b013e3181b05fd1.
- Man SC, Hung BH, Ng RM, Yu XC, Cheung H, Fung MP, Li LS, Leung KP, Leung KP, Tsang KW, Ziea E, Wong VT, Zhang ZJ. A pilot controlled trial of a combination of dense cranial electroacupuncture stimulation and body acupuncture for post-stroke depression. BMC Complement Altern Med. 2014 Jul 19;14:255. doi: 10.1186/1472-6882-14-255.
- Zhang ZJ, Zhao H, Jin GX, Man SC, Wang YS, Wang Y, Wang HR, Li MH, Yam LL, Qin ZS, Yu KT, Wu J, Ng FB, Ziea TE, Rong PJ. Assessor- and participant-blinded, randomized controlled trial of dense cranial electroacupuncture stimulation plus body acupuncture for neuropsychiatric sequelae of stroke. Psychiatry Clin Neurosci. 2020 Mar;74(3):183-190. doi: 10.1111/pcn.12959. Epub 2019 Dec 20.
- Feng B, Zhang Y, Luo LY, Wu JY, Yang SJ, Zhang N, Tan QR, Wang HN, Ge N, Ning F, Zheng ZL, Zhu RM, Qian MC, Chen ZY, Zhang ZJ. Transcutaneous electrical acupoint stimulation for post-traumatic stress disorder: Assessor-blinded, randomized controlled study. Psychiatry Clin Neurosci. 2019 Apr;73(4):179-186. doi: 10.1111/pcn.12810. Epub 2019 Jan 22.
- Tiwari A, Fong DY, Yuen KH, Yuk H, Pang P, Humphreys J, Bullock L. Effect of an advocacy intervention on mental health in Chinese women survivors of intimate partner violence: a randomized controlled trial. JAMA. 2010 Aug 4;304(5):536-43. doi: 10.1001/jama.2010.1052.
- Cheung DST, Deng W, Tsao SW, Ho RTH, Chan CLW, Fong DYT, Chau PH, Hong AWL, Fung HYKY, Ma JLC, Tiwari AFY. Effect of a Qigong Intervention on Telomerase Activity and Mental Health in Chinese Women Survivors of Intimate Partner Violence: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186967. doi: 10.1001/jamanetworkopen.2018.6967.
- Hackett S, McWhirter PT, Lesher S. The Therapeutic Efficacy of Domestic Violence Victim Interventions. Trauma Violence Abuse. 2016 Apr;17(2):123-32. doi: 10.1177/1524838014566720. Epub 2015 Jan 22.
- Sun KS, Lam TP, Piterman L, Lam KF, Tang WS, Kwok KW, Chan HY, Wu D, Tiwari A. Management of Domestic Violence by Primary Care Physicians in Hong Kong: Association With Barriers, Attitudes, Training, and Practice Background. J Interpers Violence. 2021 Oct;36(19-20):9623-9647. doi: 10.1177/0886260519869067. Epub 2019 Aug 17.
- Amorim D, Amado J, Brito I, Fiuza SM, Amorim N, Costeira C, Machado J. Acupuncture and electroacupuncture for anxiety disorders: A systematic review of the clinical research. Complement Ther Clin Pract. 2018 May;31:31-37. doi: 10.1016/j.ctcp.2018.01.008. Epub 2018 Jan 31.
- 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.
- Smith CA, Armour M, Lee MS, Wang LQ, Hay PJ. Acupuncture for depression. Cochrane Database Syst Rev. 2018 Mar 4;3(3):CD004046. doi: 10.1002/14651858.CD004046.pub4.
- Feng B, Zhang ZJ, Zhu RM, Yuan GZ, Luo LY, McAlonan GM, Xu FZ, Chen J, Liu LY, Lv YY, Wong HK, Zhang Y, Zhu LX. Transcutaneous electrical acupoint stimulation as an adjunct therapy for obsessive-compulsive disorder: A randomized controlled study. J Psychiatr Res. 2016 Sep;80:30-37. doi: 10.1016/j.jpsychires.2016.05.015. Epub 2016 May 28.
- Greene MC, Rees S, Likindikoki S, Bonz AG, Joscelyne A, Kaysen D, Nixon RDV, Njau T, Tankink MTA, Tiwari A, Ventevogel P, Mbwambo JKK, Tol WA. Developing an integrated intervention to address intimate partner violence and psychological distress in Congolese refugee women in Tanzania. Confl Health. 2019 Aug 17;13:38. doi: 10.1186/s13031-019-0222-0. eCollection 2019.
- Wong JY, Tiwari A, Fong DY, Bullock L. A Cross-Cultural Understanding of Depression Among Abused Women. Violence Against Women. 2016 Oct;22(11):1371-96. doi: 10.1177/1077801215624791. Epub 2016 Jan 21.
- Zhang ZJ, Wang D, Man SC, Ng R, McAlonan GM, Wong HK, Wong W, Lee J, Tan QR. Platelet 5-HT(1A) receptor correlates with major depressive disorder in drug-free patients. Prog Neuropsychopharmacol Biol Psychiatry. 2014 Aug 4;53:74-9. doi: 10.1016/j.pnpbp.2014.03.004. Epub 2014 Mar 20.
- Malki K, Keers R, Tosto MG, Lourdusamy A, Carboni L, Domenici E, Uher R, McGuffin P, Schalkwyk LC. The endogenous and reactive depression subtypes revisited: integrative animal and human studies implicate multiple distinct molecular mechanisms underlying major depressive disorder. BMC Med. 2014 May 7;12:73. doi: 10.1186/1741-7015-12-73.
- https://www.edb.gov.hk/attachment/tc/teacher/student-guidance-discipline-services/lecture-notes/lecture-notes-201718/20180103_Identification_and_ intervention.pdf
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 21-238
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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