Acupuncture and Massage for Depression During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Acupuncture

Intervention Type PROCEDURE

Perinatal massage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Ambulatory women (age³18) with a viable pregnancy,
* Pregnancy between 22 and 30 weeks of gestation
* Fluent in English

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Rachel Manber

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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Manber R, Schnyer RN, Lyell D, Chambers AS, Caughey AB, Druzin M, Carlyle E, Celio C, Gress JL, Huang MI, Kalista T, Martin-Okada R, Allen JJB. Acupuncture for depression during pregnancy: a randomized controlled trial. Obstet Gynecol. 2010 Mar;115(3):511-520. doi: 10.1097/AOG.0b013e3181cc0816.

Reference Type DERIVED

PMID: 20177281 (View on PubMed)

Other Identifiers

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HS09988

Identifier Type: -

Identifier Source: org_study_id