Because few medically acceptable treatments are available for the unfortunately common condition of depression during pregnancy, our long- term goal to assess the efficacy and effectiveness of acupuncture treatment of depression during pregnancy. As a first step, this pilot study focuses on obtaining sufficient data to refine the pilot design of a subsequent Randomized Clinical Trial. Depression during pregnancy has significant deleterious effects including low birth weight, preterm delivery, and continued depression into postpartum. Acupuncture provides an alternative treatment for depression (Allen, Schnyer, and Hitt, 1998), one that is medically acceptable and that could become an ideal treatment option during pregnancy. Our primary objective is to determine if the efficacy of acute (short term) acupuncture treatment for depression during pregnancy is substantial enough to warrant a large-scale clinical trial. We propose to test the efficacy of acupuncture designed specifically to address depressive that are not symptomatology during pregnancy by comparing it to acupuncture designed to address valid symptoms that are not part of the depressive symptom picture, thus controlling for the belief in the efficacy of the treatment. We also propose to compare specific acupuncture to prenatal massage, thus controlling for attention, physical contact, relaxation and respite from daily stress. Seventy five participants meeting western diagnostic criteria for Major Depression will be randomized to receive one of the three treatments, each consisting of 12 treatment sessions delivered over 8 weeks. Because the risk for depression following delivery is high, participants who have full or partial response at the end of acute phase will continue to receive the same, but less frequent, treatment until 8 weeks post partum, and will be followed up for 6 more months.
The specific aims are: a) to evaluate the efficacy (and effect size) of acupuncture treatment for major depression during pregnancy at the end of the acute phase, relative to the two control conditions; b) to evaluate the efficacy (and effect size) of the combined acute/continuation specific acupuncture on the incidence of depression during the post partum period, relative to the two control conditions; and, c) to evaluate the clinical significance of acupuncture treatment for major depression by assessing the differential impact of the treatment conditions on infant outcomes measures. By focusing on these aims we will be able to meet the following stated objectives of this PAS: refine the intervention strategy, refine the control strategy (including success of our double- blind strategy), test the adequacy of recruitment procedures, and establish measures of effectiveness. In addition, by computing attrition rates and effect sizes we will determine the number of participants that will ultimately be needed in a definitive study of the efficacy and effectiveness of acupuncture in the treatment of depression during pregnancy.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
7R01HS009988-02
Application #
6078098
Study Section
Special Emphasis Panel (ZRG7-SSS-9 (16))
Program Officer
Coopey, Margaret
Project Start
1999-09-30
Project End
2001-09-29
Budget Start
1999-09-30
Budget End
2000-09-29
Support Year
2
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Stanford University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
800771545
City
Stanford
State
CA
Country
United States
Zip Code
94305
Lyell, Deirdre J; Chambers, Andrea S; Steidtmann, Dana et al. (2012) Antenatal identification of major depressive disorder: a cohort study. Am J Obstet Gynecol 207:506.e1-6
Manber, Rachel; Schnyer, Rosa N; Lyell, Deirdre et al. (2010) Acupuncture for depression during pregnancy: a randomized controlled trial. Obstet Gynecol 115:511-20
Tikotzky, Liat; Chambers, Andrea S; Gaylor, Erika et al. (2010) Maternal sleep and depressive symptoms: links with infant Negative Affectivity. Infant Behav Dev 33:605-12
Manber, R; Blasey, C; Allen, J J B (2008) Depression symptoms during pregnancy. Arch Womens Ment Health 11:43-8
Manber, Rachel; Schnyer, Rosa N; Allen, John J B et al. (2004) Acupuncture: a promising treatment for depression during pregnancy. J Affect Disord 83:89-95
Manber, Rachel; Chambers, Andrea S; Hitt, Sabrina K et al. (2003) Patients' perception of their depressive illness. J Psychiatr Res 37:335-43
Manber, Rachel; Allen, John J B; Morris, Margaret E et al. (2002) Alternative treatments for depression: empirical support and relevance to women. J Clin Psychiatry 63:628-40
Schnyer, Rosa N; Allen, John J B (2002) Bridging the gap in complementary and alternative medicine research: manualization as a means of promoting standardization and flexibility of treatment in clinical trials of acupuncture. J Altern Complement Med 8:623-34