Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers

Not Applicable

Completed

• Conditions: Postpartum Depression
• Interventions: Behavioral: Interpersonal therapy-based treatment

• Registration Number: NCT01482832
• Lead Sponsor: Women and Infants Hospital of Rhode Island

Brief Summary

The Specific Aim of this study 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.

Detailed 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, 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.

Study Timeline

• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2011-11-30
• Study Start: 2011-12
• Study First Posted: 2011-12-01
• Primary Completion: 2017-12
• Study Completion: 2018-10-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Interpersonal therapy-based treatment	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.
Control	Interpersonal therapy-based treatment	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.

Primary Outcome Measures

Name	Time	Method
Diagnosis of depression	within 6 months postpartum	Outcome assessment using KID-SCID

Secondary Outcome Measures

Name	Time	Method
Degree of depressive symptoms	pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52	Outcomes assessment using CDRS

Trial Locations

Locations (1)

Women & Infants Hospital; 🇺🇸 Providence, Rhode Island, United States