Back to resultsPilot Study on the Use of Acupuncture for Postpartum Depression
Primary Purpose
Post-partum Depression
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Active acupuncture
Placebo acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Post-partum Depression focused on measuring Insomnia, Post-partum Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine
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;
Sites / Locations
- Kwong Wah Hospital
- Queen Mary Hospital
- Tsan Yuk Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active acupuncture group
Placebo acupuncture group
Arm Description
Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints.
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.
Outcomes
Primary Outcome Measures
17-item Hamilton Depression Rating Scale
To assess Depressive symptoms
Secondary Outcome Measures
Hospital Anxiety and Depression Scale (HADS)
To assess depression and anxiety
Sheehan Disability Scale
To assess subjects' functioning in work/study, social life and family
Clinical Global Impression Scale
To assess severity of illness and improvement due to treatment
Edinburgh Postnatal Depression Scale
To assess subjective Depressive symptoms
Full Information
NCT ID
NCT01178008
First Posted
August 1, 2010
Last Updated
January 14, 2013
Sponsor
The University of Hong Kong
Collaborators
Kwong Wah Hospital, Hospital Authority, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01178008
Brief Title
Pilot Study on the Use of Acupuncture for Postpartum Depression
Official Title
Pilot Study on the Use of Acupuncture for Postpartum Depression
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Kwong Wah Hospital, Hospital Authority, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-partum Depression
Keywords
Insomnia, Post-partum Depression, Electroacupuncture, Acupuncture, Randomized Clinical Trial, Traditional Chinese Medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active acupuncture group
Arm Type
Experimental
Arm Description
Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints.
Arm Title
Placebo acupuncture group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Active acupuncture
Other Intervention Name(s)
Electroacupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo acupuncture
Other Intervention Name(s)
Streitberger needles, Non-invasive acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
17-item Hamilton Depression Rating Scale
Description
To assess Depressive symptoms
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
To assess depression and anxiety
Time Frame
8 weeks
Title
Sheehan Disability Scale
Description
To assess subjects' functioning in work/study, social life and family
Time Frame
8 weeks
Title
Clinical Global Impression Scale
Description
To assess severity of illness and improvement due to treatment
Time Frame
8 weeks
Title
Edinburgh Postnatal Depression Scale
Description
To assess subjective Depressive symptoms
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka-Fai CHUNG, MBBS
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwong Wah Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Tsan Yuk Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
3651732
Citation
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
Results Reference
background
PubMed Identifier
14399272
Citation
HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
Results Reference
background
PubMed Identifier
22840621
Citation
Chung KF, Yeung WF, Zhang ZJ, Yung KP, Man SC, Lee CP, Lam SK, Leung TW, Leung KY, Ziea ET, Taam Wong V. Randomized non-invasive sham-controlled pilot trial of electroacupuncture for postpartum depression. J Affect Disord. 2012 Dec 15;142(1-3):115-21. doi: 10.1016/j.jad.2012.04.008. Epub 2012 Jul 26.
Results Reference
derived
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Pilot Study on the Use of Acupuncture for Postpartum Depression
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