ACUPUNCTURE TREATMENT OF DEPRESSION DURING PREGNANCY

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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.