Acupuncture and Massage for Depression During Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186654
First received: September 14, 2005
Last updated: September 22, 2008
Last verified: August 2008
  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-Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Rachel Manber Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00186654     History of Changes
Other Study ID Numbers: HS09988
Study First Received: September 14, 2005
Last Updated: September 22, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 14, 2014