Acupuncture for Women Victims of Domestic Violence With Psychiatric Sequelae

NCT05102253 | Completed

• 1 other identifier: UW 21-238
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Depression; Domestic Violence; Psychiatric Disorder

Keywords

Depression; Domestic Violence; Psychiatric Sequelae; Acupuncture; Transcutaneous Electrical Acupoint Stimulation; TEAS; Dense Cranial Electroacupuncture Stimulation; DCEAS

Outcome Measures

Primary Outcomes (1)

• Changes in Beck Depression Inventory-II (BDI-II)

  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.

  Baseline, Week 3, Week 6 and Week 12

Secondary Outcomes (6)

• Changes in 17-item Hamilton Depression Rating Scale (HAMD-17)

  Baseline, Week 3, Week 6 and Week 12

• Changes in Perceived Stress Scale (PSS)

  Baseline, Week 3, Week 6 and Week 12

• Changes in PTSD Check List-Civilian Version (PCL-C)

  Baseline, Week 3, Week 6 and Week 12

• Changes in Insomnia Severity Index (ISI)

  Baseline, Week 3, Week 6 and Week 12

• Changes in Pittsburgh Sleep Quality Index (PSQI)

  Baseline, Week 3, Week 6 and Week 12

Study Arms (2)

TEAS+DCEAS group

EXPERIMENTAL

Subjects assigned to TEAS+DCEAS group will receive TEAS+DCEAS in addition to routine care.

Procedure: Dense cranial electroacupuncture stimulation (DCEAS); Procedure: Transcutaneous electrical acupoint stimulation (TEAS)

Wait-list control: Routine care group

OTHER

Subjects assigned to this group will continue their current routine care as usual.

Other: Wait-list control: Routine care

Interventions

Dense cranial electroacupuncture stimulation (DCEAS) PROCEDURE

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+DCEAS group

Transcutaneous electrical acupoint stimulation (TEAS) PROCEDURE

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.

TEAS+DCEAS group

Wait-list control: Routine care OTHER

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.

Wait-list control: Routine care group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong, 999077, Hong Kong

Location

Related Publications (20)

• 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.

  PMID: 20682933 BACKGROUND

• 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.

  PMID: 30646209 BACKGROUND

• 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.

  PMID: 25612799 BACKGROUND

• 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.

  PMID: 31423927 BACKGROUND

• 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.

  PMID: 29705474 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29502347 BACKGROUND

• 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.

  PMID: 30565342 BACKGROUND

• 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.

  PMID: 27281260 BACKGROUND

• 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.

  PMID: 31428190 BACKGROUND

• 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.

  PMID: 26796779 BACKGROUND

• 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.

  PMID: 22474503 BACKGROUND

• 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.

  PMID: 22238631 BACKGROUND

• 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.

  PMID: 31747095 BACKGROUND

• 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.

  PMID: 19684500 BACKGROUND

• 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.

  PMID: 25038733 BACKGROUND

• 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.

  PMID: 24657886 BACKGROUND

• 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.

  PMID: 24886127 BACKGROUND

• https://www.edb.gov.hk/attachment/tc/teacher/student-guidance-discipline-services/lecture-notes/lecture-notes-201718/20180103_Identification_and_ intervention.pdf

  BACKGROUND

• Yang S, Tiwari A, Cheung DST, Cheng CPW, Chan MY, Chen H, Zhang ZJ. Electrical acupoint stimulation for psychiatric sequelae in women victims of domestic violence: study protocol for an assessor-blind randomized controlled trial. BMC Complement Med Ther. 2025 Sep 1;25(1):316. doi: 10.1186/s12906-025-05033-3.

  PMID: 40890795 DERIVED

MeSH Terms

Conditions

Depression; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Zhang-Jin Zhang, MMed, PhD

  School of Chinese Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: November 1, 2021
• Study Start: July 13, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)