Overview

This trial is active, not recruiting.

Condition postpartum depression
Treatment interpersonal therapy-based treatment
Sponsor Women and Infants Hospital of Rhode Island
Collaborator National Institute of Mental Health (NIMH)
Start date December 2011
End date December 2017
Trial size 250 participants
Trial identifier NCT01482832, R01MH093342

Summary

The Specific Aim of this proposal is to conduct a randomized controlled trial to evaluate whether Project REACH (an interpersonal psychotherapy-based intervention) compared with a didactic attention-control program reduces the risk of PPD in adolescent mothers.

Primary Hypothesis:

1. The intervention (Project REACH) will be significantly more efficacious than the control program in reducing the risk of PPD up to six months postpartum in adolescent mothers.

Secondary Hypotheses:

2. The decreased rate of major depression in the Project REACH group compared to the control program group will be sustained through one year postpartum.

3. Adolescent mothers in Project REACH compared to the control program group will have higher levels of maternal-child bonding.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Behavioral: Interpersonal therapy-based treatment Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. Both groups will attend 5 weekly sessions and have a brief booster session postpartum.
interpersonal therapy-based treatment REACH 2
Interpersonal therapy-based treatment Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. (5 weekly sessions with a booster session postpartum)
(Active Comparator)
Behavioral: Standard care Participants assigned to receive standard care will focus on prenatal education including issues associated with pregnancy and postpartum. Both groups will attend 5 weekly sessions and have a brief booster session postpartum.
interpersonal therapy-based treatment REACH 2
Interpersonal therapy-based treatment Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. (5 weekly sessions with a booster session postpartum)

Primary Outcomes

Measure
Diagnosis of depression
time frame: within 6 months postpartum

Secondary Outcomes

Measure
Degree of depressive symptoms
time frame: pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52

Eligibility Criteria

Female participants from 12 years up to 19 years old.

Inclusion Criteria: - Less than 24 weeks pregnant - Not currently being treated for depression - Speaks and reads English fluently Exclusion Criteria: - Currently receiving mental health services from a health care provider - Meets DSM-IV criteria for an affective disorder, substance use disorder, or psychosis

Additional Information

Official title Preventing Postpartum Depression in Adolescent Mothers
Principal investigator Maureen G Phipps, MD, MPH
Description Each year, more than 400,000 births in the United States are to mothers less than 20 years old. Alarmingly, approximately 25-36% of teen mothers experience postpartum depression (PPD), a condition associated with significant social and health morbidity. PPD places teen mothers and their children at great risk during an already challenging time in their lives. Preventing PPD in this vulnerable population is essential to improving overall health. Project REACH is a randomized controlled trial, conducted over five years, to evaluate whether our novel preventive intervention compared to a didactic attention control reduces the risk of PPD in adolescent mothers. The intervention, REACH (Relax, Encourage, Appreciate, Communicate, Help), is based on Interpersonal Psychotherapy (IPT) and targets those factors that may play a significant role in the development of PPD in adolescent mothers (i.e., poor social support, role transitions and life stressors). The control condition includes didactic prenatal education sessions. Project REACH builds on the foundation of our NIMH-funded treatment development project and pilot study (R34 MH077588). The pilot study demonstrated feasibility, acceptability and initial efficacy in a small sample. The current R01 proposal aims to evaluate the efficacy of the Project REACH intervention in reducing the risk of PPD.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island.