Acupuncture for Women Victims of Domestic Violence With Psychiatric Sequelae

Study Overview
=================
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.

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.

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

Conditions
-----------------
Depression, Domestic Violence, Psychiatric Disorder

Intervention / Treatment
-----------------
* Procedure: Dense cranial electroacupuncture stimulation (DCEAS)
* Procedure: Transcutaneous electrical acupoint stimulation (TEAS)
* Other: Wait-list control: Routine care


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEAS+DCEAS group<br>Subjects assigned to TEAS+DCEAS group will receive TEAS+DCEAS in addition to routine care. | Procedure: Dense cranial electroacupuncture stimulation (DCEAS)<br>* 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.<br>Procedure: Transcutaneous electrical acupoint stimulation (TEAS)<br>* 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.<br>|
| Other: Wait-list control: Routine care group<br>Subjects assigned to this group will continue their current routine care as usual. | Other: Wait-list control: Routine care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 17-item Hamilton Depression Rating Scale (HAMD-17) | 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. | Baseline, Week 3, Week 6 and Week 12 | 
| Changes in Perceived Stress Scale (PSS) | Stress is measured using PSS. Assessments will be conducted at baseline, week 3, week 6 and week 12. | Baseline, Week 3, Week 6 and Week 12 | 
| Changes in PTSD Check List-Civilian Version (PCL-C) | PTSD symptoms are measured using PCL-C. Assessments will be conducted at baseline, week 3, week 6 and week 12. | Baseline, Week 3, Week 6 and Week 12 | 
| Changes in Insomnia Severity Index (ISI) | Severity of insomnia are measured using ISI. Assessments will be conducted at baseline, week 3, week 6 and week 12. | Baseline, Week 3, Week 6 and Week 12 | 
| Changes in Pittsburgh Sleep Quality Index (PSQI) | Sleep quality is assessed using PSQI. Assessments will be conducted at baseline, week 3, week 6 and week 12. | Baseline, Week 3, Week 6 and Week 12 | 
| Changes in 12-Item Short Form Survey (SF-12) | Quality of life is measured using SF-12. Assessments will be conducted at baseline, week 3, week 6 and week 12. | Baseline, Week 3, Week 6 and Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Domestic Violence, Psychiatric Sequelae, Acupuncture, Transcutaneous Electrical Acupoint Stimulation, TEAS, Dense Cranial Electroacupuncture Stimulation, DCEAS