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

Postpartum Depression Clinical Trial

— REACH 2  

Official title:

Preventing Postpartum Depression in Adolescent Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482832
• Other study ID #: R01MH093342
• Secondary ID: R01MH093342
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: October 30, 2018

Study information

• Verified date: April 2019
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 30, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Behavioral:
• Interpersonal therapy-based treatment
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)

Locations

Country	Name	City	State
United States	Women & Infants Hospital	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	Brown University, National Institute of Mental Health (NIMH), Pacific Institute for Research and Evaluation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of depression	Outcome assessment using KID-SCID	within 6 months postpartum
Secondary	Degree of depressive symptoms	Outcomes assessment using CDRS	pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52