Text Size

Pilot Study on the Use of Acupuncture for Postpartum Depression

This study has been completed.
Sponsor:
Collaborators:
Kwong Wah Hospital
Hospital Authority, Hong Kong
Information provided by (Responsible Party):
Dr. Chung Ka-Fai, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01178008
First received: August 1, 2010
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Post-partum Depression
 Procedure: Active acupuncture
Procedure: Placebo acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study on the Use of Acupuncture for Postpartum Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 17-item Hamilton Depression Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    To assess Depressive symptoms


Secondary Outcome Measures:
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To assess depression and anxiety

  • Sheehan Disability Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To assess subjects' functioning in work/study, social life and family

  • Clinical Global Impression Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To assess severity of illness and improvement due to treatment

  • Edinburgh Postnatal Depression Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    To assess subjective Depressive symptoms


Enrollment: 20
Study Start Date: May 2010
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active acupuncture group
Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints.
 Procedure: Active acupuncture
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.
Other Name: Electroacupuncture
Placebo Comparator: Placebo acupuncture group
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
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.
Other Names:
  • Streitberger needles
  • Non-invasive acupuncture

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01178008

Locations
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Kwong Wah Hospital
Hong Kong, Hong Kong
Tsan Yuk Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Kwong Wah Hospital
Hospital Authority, Hong Kong
Investigators
Principal Investigator: Ka-Fai CHUNG, MBBS The University of Hong Kong
  More Information

Publications:

Responsible Party: Dr. Chung Ka-Fai, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01178008     History of Changes
Other Study ID Numbers: Acup-003
Study First Received: August 1, 2010
Last Updated: January 14, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Insomnia
Post-partum Depression
Electroacupuncture
 Acupuncture
Randomized Clinical Trial
Traditional Chinese Medicine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on June 18, 2013