Pilot Study on the Use of Acupuncture for Postpartum Depression

Not Applicable

Completed

• Conditions: Post-partum Depression
• Interventions: Procedure: Placebo acupuncture; Procedure: Active acupuncture

• Registration Number: NCT01178008
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-08-01
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Primary Completion: 2011-12
• Study Completion: 2012-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo acupuncture group	Placebo acupuncture	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.
Active acupuncture group	Active acupuncture	Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints.

Primary Outcome Measures

Name	Time	Method
17-item Hamilton Depression Rating Scale	8 weeks	To assess Depressive symptoms

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Tsan Yuk Hospital; 🇭🇰 Hong Kong, Hong Kong

Kwong Wah Hospital; 🇭🇰 Hong Kong, Hong Kong