Pilot Study on the Use of Acupuncture for Postpartum Depression

Study Overview
=================
Brief Summary
-----------------
The proposed study is a randomized controlled trial to examine the efficacy and safety of active acupuncture versus placebo acupuncture for the treatment of postpartum depression. The investigators hypothesis is that active acupuncture would be superior to placebo acupuncture in the short-term treatment of postpartum depression.

Detailed Description
-----------------
This study will be a randomized, controlled, subject- and assessor-blind trial in patients with postpartum depression. Eligible subjects will be randomly assigned to active acupuncture or placebo acupuncture. The subjects will receive acupuncture treatment twice per week for 4 consecutive weeks. The acupuncturist of this trial will not participate in data collection and data entry. The trial assessor will be blind to the subjects' treatment allocation.

Official Title
-----------------
Pilot Study on the Use of Acupuncture for Postpartum Depression

Conditions
-----------------
Post-partum Depression

Intervention / Treatment
-----------------
* Procedure: Active acupuncture
* Procedure: Placebo acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ethnic Hong Kong Chinese aged 18 years or above; Within 6 months of giving birth; Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987) score higher than or equal to 12 or being diagnosed as depressed by their obstetrician; Meeting the Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis criteria for major depressive disorder; 17-item Hamilton Depression Rating Scale (HDRS17) (Hamilton, 1960) score of between 12 and 19 at screening and baseline assessment; Willingness to give informed consent and comply with trial protocol. Exclusion Criteria: Suffering from other psychiatric disorders such as schizophrenia, other psychotic disorders, bipolar disorder or substance use disorder; Serious physical illnesses or mental disorders due to a general medical condition which are judged by the investigator to render unsafe; A significant risk of suicide according to the rating of HDRS17 item 3 (score higher than 2), i.e., presence of ideas or gesture of suicide; A presence of idea of self-harming according to the rating of EPDS item 10 (score higher than 0); A significant risk of infanticide according to the investigator assessment; Any acupuncture treatment during the previous 12 months prior to baseline; Valvular heart defects, bleeding disorders or taking anticoagulant drugs; Infection or abscess close to the site of selected acupoints; Herbal remedies or psychotropic drugs that are intended for depression are taken within the last 2 weeks prior to baseline or during the study. Receiving counseling or psychological therapies at baseline or during the study; Participation in any clinical trial within the previous 3 months prior to baseline;

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active acupuncture group<br>Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints. | Procedure: Active acupuncture<br>* Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints which are empirical for treating depression in term of traditional Chinese medicine theory. It is done by a registered Chinese medicine practitioner with at least 3 years experience of providing acupuncture treatment. An electric-stimulator is connected to these needles to give an electric-stimulation in a continuous wave The needles will be left for 30 min and then removed. Acupuncture treatment will consist of two sessions per week for 4 consecutive weeks.<br>* Other names: Electroacupuncture;|
| Placebo Comparator: Placebo acupuncture group<br>Streitberger's non-invasive acupuncture needles will be applied to serve as placebo control at the same acupoints and the same stimulation modality, except that the needles only affixed on the skin with adhesive tapes instead of insertion. Since all the points used are beyond patients' vision as they lay on bed, they could not visualize the acupuncture procedure. The acupuncturist, setting, treatment frequency, and duration of the treatment course are the same as the active acupuncture group. | Procedure: Placebo acupuncture<br>* Streitberger's non-invasive acupuncture needles will be applied to serve as placebo control at the same acupoints and the same stimulation modality, except that the needles only affixed on the skin with adhesive tapes instead of insertion. Since all the points used are beyond patients' vision as they lay on bed, they could not visualize the acupuncture procedure. The acupuncturist, setting, treatment frequency, and duration of the treatment course are the same as the active acupuncture group.<br>* Other names: Non-invasive acupuncture;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 17-item Hamilton Depression Rating Scale | To assess Depressive symptoms | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | To assess depression and anxiety | 8 weeks | 
| Sheehan Disability Scale | To assess subjects' functioning in work/study, social life and family | 8 weeks | 
| Clinical Global Impression Scale | To assess severity of illness and improvement due to treatment | 8 weeks | 
| Edinburgh Postnatal Depression Scale | To assess subjective Depressive symptoms | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insomnia, Post-partum Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine