Acupuncture and Massage for Depression During Pregnancy - Full Text View

Sponsors and Collaborators:	Stanford University Agency for Healthcare Research and Quality (AHRQ)
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00186654

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 II

MedlinePlus related topics: Acupuncture Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:	Acupuncture and Massage for Depression During Pregnancy

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

Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	HS09988
Study First Received:	September 14, 2005
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00186654
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 15, 2009