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Completed

NCT Number: NCT00186654

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acupuncture

Procedure

Perinatal massage

Procedure

Primary outcomes

  1. Depression severity and response status after 8 weeks of treatment

Secondary outcomes

  1. Depression severity at 3, 6, & 9 months post partum; delivery outcome

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

First posted
Sep 16, 2005
Registry last updated
Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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