Acupuncture and Massage for Depression During Pregnancy

Phase 2

Completed

• Conditions: Depression

• Registration Number: NCT00186654
• Lead Sponsor: Stanford University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-16
• Status Verified: 2008-08
• Last Update Submitted: 2008-09-22
• Last Update Posted: 2008-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression severity and response status after 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Depression severity at 3, 6, & 9 months post partum; delivery outcome

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States