Acupuncture and Massage for Depression During Pregnancy

Depression Clinical Trial

Official title:

Acupuncture and Massage for Depression During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186654
• Other study ID #: HS09988
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2005
• Last updated: September 22, 2008

Study information

• Verified date: August 2008
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Procedure:
• Acupuncture

• Perinatal massage

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression severity and response status after 8 weeks of treatment
Secondary	Depression severity at 3, 6, & 9 months post partum; delivery outcome

External Links

•   Link