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Acupuncture and Massage for Depression During Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186654
First Posted: September 16, 2005
Last Update Posted: September 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
Stanford University
  Purpose
This study evaluates the efficacy of acupuncture and massage for the treatment of depression during pregnancy. The study also examines differential effects of study treatments on delivery outcome and post partum depression.

Condition Intervention Phase
Depression Procedure: Acupuncture Procedure: Perinatal massage Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Acupuncture and Massage for Depression During Pregnancy

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Depression severity and response status after 8 weeks of treatment

Secondary Outcome Measures:
  • Depression severity at 3, 6, & 9 months post partum; delivery outcome

Estimated Enrollment: 180
Detailed Description:
Participants in this study are randomly assigned to one of the three experimental groups that include two types of acupuncture treatment and perinatal massage. The two acupuncture treatments are delivered in a double-blind fashion. Treatments consist of an acute phase during which participants receive 12 treatment sessions over a period of 8 weeks. Responders and partial responders enter a continuation phase during which they receive weekly treatments that end 10 weeks post delivery. At the end of the continuation phase, participants continue to be clinically assessed at 3 and 6 months after the end of treatment to detail the natural course of relapse to the index episode in the three treatment groups.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Meet criteria for a current major depressive episode with an HRSD(17) score of at least 14.

  • Ambulatory women (age³18) with a viable pregnancy,
  • Pregnancy between 22 and 30 weeks of gestation
  • Fluent in English

Exclusion Criteria:- Meeting criteria for a primary Axis I disorder in past 2 months, other than unipolar depression or social phobia

  • Seasonal affective disorder or episode duration of 2 years or more (chronic depression)
  • Abnormal results on a laboratory screen that will include a thyroid panel and a drug screen.
  • Serious uncontrolled medical conditions or conditions that may be a medical basis of a depression.
  • Cluster B personality disorders.
  • Confounding treatments for depression, including any psychotherapy, herbs, or pharmacotherapy.
  • Current use of any prescribed psychotropic medication or any medication that impacts mood.
  • Treatment with ECT or vagal nerve stimulation during the last year.
  • Current active suicidal potential necessitating immediate treatment.
  • Absence of prenatal care from an OBGYN practitioner in the community.
  • Any condition that necessitates bed rest.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186654


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Rachel Manber Stanford University
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00186654     History of Changes
Other Study ID Numbers: HS09988
First Submitted: September 14, 2005
First Posted: September 16, 2005
Last Update Posted: September 25, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders