The long term goal is to develop an efficient, economical intervention to prevent or shorten severe bereavement reactions following miscarriage and fetal death. Miscarriage/fetal death occur in 10-20 percent of clinically recognized pregnancies. In our previous observational studies we found that such losses are associated with a 2-5 fold increase in levels of depressive symptoms and depressive disorder in the subsequent 6 months-findings that are consistent with other reports. These observations, as well as lay publications emphasizing the psychological impact of miscarriage, have prompted the widespread adoption of supportive counseling and therapy programs in various medical settings. However, these programs have not been evaluated for safety and efficacy. This proposal serves as the first step in developing a fully standardized counseling protocol focused primarily on miscarriage/early fetal loss and in evaluating its safety, acceptability, and efficacy. This proposal seeks 1) to pilot a manualized, 1-6 session, telephone administered program of interpersonal counseling for women with miscarriage/fetal death, the latter defined as an involuntary intrauterine loss before 28 weeks gestation; 2) to evaluate the feasibility and acceptability of the counseling and field procedures for a two armed randomized controlled intervention trial of this program among women seeking care for a miscarriage/fetal death. Women symptomatic at baseline (Beck depression scores greater than = 9) are allocated either to interpersonal counseling (n=40) or standard care (n=40). 3) To test for preliminary evidence of intervention safety and efficacy by comparing the level of depressive symptoms and functioning at 10 weeks after loss among women assigned to interpersonal counseling with that among women assigned to standard care. 4) Assuming the field procedures prove feasible, acceptable and offer preliminary evidence of efficacy, to finalize the counseling intervention manual. The project will draw on women seeking care for a miscarriage or fetal death at one New York City medical center serving a multi-ethnic, socio-economically diverse population.
Neugebauer, Richard; Kline, Jennie; Bleiberg, Kathryn et al. (2007) Preliminary open trial of interpersonal counseling for subsyndromal depression following miscarriage. Depress Anxiety 24:219-22 |
Neugebauer, Richard; Kline, Jennie; Markowitz, John C et al. (2006) Pilot randomized controlled trial of interpersonal counseling for subsyndromal depression following miscarriage. J Clin Psychiatry 67:1299-304 |