Acupuncture and Massage for Depression During Pregnancy
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.
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.
Status: Completed (Phase 2).
Enrollment: 180 subjects
Study Type: Interventional
Study Design:
- Randomized
- Double-Blind
- Active Control
- Parallel Assignment
Conditions:
Interventions:
- Procedure: Acupuncture
- Procedure: Perinatal massage
Eligibility
Inclusion Criteria:- Meet criteria for a current major depressive episode with an HRSD(17) score of at least 14.
Ambulatory women (age��18) 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.
- Gender
Female
- Mininum Age
18 Years
- Maximum Age
45 Years
- Healthy Volunteers
No
Resources
Source: Stanford University
Authority: United States: Federal Government
Locations
-
Stanford University School of Medicine
Stanford
California
94305
United States
Officials
Rachel Manber (Principal Investigator, Stanford University)
Sponsors
Stanford University (Lead Sponsor)
Agency for Healthcare Research and Quality (AHRQ) (Collaborator)
References
None.
Links
- Date Verified
- August 1st, 2008
- First Received
- September 22nd, 2008
- Last Changed
- September 22nd, 2008
Information obtained from ClinicalTrials.gov on October 02, 2008. Link to the current ClinicalTrials.gov record.
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