Pilot Study on the Use of Acupuncture for Postpartum Depression

NCT01178008 | Completed

• 1 other identifier: Acup-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Post-partum Depression

Keywords

Insomnia; Post-partum Depression; Electroacupuncture; Acupuncture; Randomized Clinical Trial; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 17-item Hamilton Depression Rating Scale

  To assess Depressive symptoms

  8 weeks

Secondary Outcomes (4)

• Hospital Anxiety and Depression Scale (HADS)

  8 weeks

• Sheehan Disability Scale

  8 weeks

• Clinical Global Impression Scale

  8 weeks

• Edinburgh Postnatal Depression Scale

  8 weeks

Study Arms (2)

Active acupuncture group

EXPERIMENTAL

Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints.

Procedure: Active acupuncture

Placebo acupuncture group

PLACEBO COMPARATOR

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

Interventions

Active acupuncture PROCEDURE

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.

Also known as: Electroacupuncture

Active acupuncture group

Placebo acupuncture PROCEDURE

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.

Also known as: Streitberger needles, Non-invasive acupuncture

Placebo acupuncture group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The University of Hong Kong: lead
• Kwong Wah Hospital: collaborator
• Hospital Authority, Hong Kong: collaborator

Study Sites (3)

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Tsan Yuk Hospital

Hong Kong, Hong Kong

Location

Related Publications (3)

• 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.

  PMID: 3651732 BACKGROUND

• 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.

  PMID: 14399272 BACKGROUND

• 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.

  PMID: 22840621 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Sleep Initiation and Maintenance Disorders

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Ka-Fai CHUNG, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 1, 2010
• First Posted: August 9, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: June 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

HK (3)