(TAKEN FROM APPLICANT): Objective:
The aim of the proposed randomized controlled study is to assess the efficacy and effectiveness of acupuncture treatment of depression during pregnancy. Significance: Depression is, unfortunately common during pregnancy and it has significant deleterious effects on mother and infant, including low birth weight, preterm delivery, and continued depression into postpartum. Few medically acceptable treatments are available for the treatment of depression during pregnancy. Our preliminary work provides evidence that acupuncture may be a safe and acceptable treatment option for depression.
Specific aims : 1) to evaluate the efficacy of brief 8-week treatment with SPEC acupuncture for major depression during pregnancy relative to the two control treatments; 2) to evaluate the efficacy and clinical significance (pregnancy outcome) of continued treatment with SPEC acupuncture relative to the two control treatments; and 3) to evaluate the differential impact of treatment with SPEC acupuncture for major depression on the incidence of postpartum depression. Participants. Design: To test the efficacy of acupuncture designed specifically to address depressive symptomatology during pregnancy (SPEC) it will be compared, using random assignment, to the following 2 control conditions: 1) valid acupuncture that does not directly address depressive symptoms (NSPEC), thus controlling for the belief in the efficacy of the treatment; and 2) prenatal massage (MSSG), thus controlling for attention, physical contact, relaxation and respite from daily stress. The study includes three phases, acute, continuation and follows up. Participants: 180 participants meeting western diagnostic criteria for Major Depression with a score >: 14 on the first 17 items of the 24-item Hamilton Depression Rating Scale (HRSD) will be randomized. The ethnic distribution of the sample will be representative of the ethnic distribution in the San Francisco Bay Area. Treatments: The acute phase of treatment consists of 16 half-hour treatment sessions delivered over 8 weeks. To consolidate treatment gains and to prevent post partum depression, participants who have full or partial response at the end of the acute phase will continue to receive the same, but less frequent, treatment until 10 weeks post partum, and will be followed up for 6 more months. Main Outcome Measure(s): The primary outcome measures are the HRSD and the depression portion of the SCID-IV, to be administered monthly during the treatment phases and at 3 and 6 months follow up. Other important measures include the Beck Depression Inventory (weekly), expectations (of the participants and the providers), and delivery and infant measures.
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