NCT01744041.

Trial name or title	Mommy‐Baby Treatment for Perinatal Depression
Methods	Allocation: randomised Intervention model: parallel assignment Masking: open label Primary purpose: treatment
Participants	Enrolment: n = 40 Inclusion criteria: Pregnant women Aged ≥ 18 years 12‐30 weeks' gestation Score ≥ 13 on EPDS SCID‐IV diagnosis of MDD, dysthymia or DD‐NOS English speaking Exclusion criteria: Substance abuse or dependence in past 3 months Active suicidal or homicidal ideation Bipolar disorder, psychotic disorder Unstable medical condition or other medical/obstetrical complication Evidence of severe intimate partner violence Ongoing psychosocial or pharmacotherapy for depression
Interventions	Behavioural: dyadic IPT versus other: enhanced treatment‐as‐usual Experimental: Brief IPT during pregnancy, followed by dyadic mother‐infant psychotherapy for 1‐year postpartum intervention Active comparator: Enhanced treatment‐as‐usual personalised referral to community resources for depression treatment
Outcomes	Change in EPDS from baseline: Time frame: change from baseline at end of pregnancy (37‐39 weeks' gestation); change from baseline at 3 months' postpartum; change from baseline at 6 months' postpartum; change from baseline at 9 months' postpartum; change from baseline at 12 months' postpartum Designated as safety issue: no
Starting date	Study start date: November 2012 Study completion date: completing October 2015 (final data collection date for primary outcome measure)
Contact information	Principal investigator: Shannon Lenze, PhD Washington University and National Institute of Mental Health (NIMH), USA
Notes	Perinatal depression is a major public health problem, affecting 15% of women during pregnancy through the postpartum period, with adverse consequences for the mother, fetus, infant, and family. Despite increasing evidence of the importance of this critical risk interval, little research has investigated the effects of depression treatment during pregnancy on infant outcomes. The purpose of this study is to test the feasibility, acceptability, and effectiveness of a new intervention: IPT for the mother‐infant dyad (IPT‐Dyad). This intervention begins during pregnancy and continues with the mother and infant until 1‐year postpartum. The investigators hypothesise that IPT‐Dyad will be better than treatment‐as‐usual in reducing depressive symptoms, improving psychosocial functioning, increasing parenting self efficacy, improving infant emotional development, and enhancing mother‐infant relationship quality