Acupuncture and Massage for Depression During Pregnancy

September 22, 2008 updated by: Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Depression severity and response status after 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Depression severity at 3, 6, & 9 months post partum; delivery outcome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

September 25, 2008

Last Update Submitted That Met QC Criteria

September 22, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS09988

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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