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Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers (REACH 2)

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal therapy-based treatment
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring Randomized trial, Postpartum depression, Adolescent pregnancy, Interpersonal psychotherapy

Eligibility Criteria

12 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Women & Infants Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Diagnosis of depression
Outcome assessment using KID-SCID

Secondary Outcome Measures

Degree of depressive symptoms
Outcomes assessment using CDRS

Full Information

First Posted
November 25, 2011
Last Updated
April 23, 2019
Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
National Institute of Mental Health (NIMH), Pacific Institute for Research and Evaluation, Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT01482832
Brief Title
Interpersonal Therapy-Based Treatment to Prevent Postpartum Depression in Adolescent Mothers
Acronym
REACH 2
Official Title
Preventing Postpartum Depression in Adolescent Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
National Institute of Mental Health (NIMH), Pacific Institute for Research and Evaluation, Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Randomized trial, Postpartum depression, Adolescent pregnancy, Interpersonal psychotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal therapy-based treatment
Other Intervention Name(s)
REACH 2
Intervention Description
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 Outcome Measure Information:
Title
Diagnosis of depression
Description
Outcome assessment using KID-SCID
Time Frame
within 6 months postpartum
Secondary Outcome Measure Information:
Title
Degree of depressive symptoms
Description
Outcomes assessment using CDRS
Time Frame
pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen G Phipps, MD, MPH
Organizational Affiliation
Women & Infants Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not at this point.
Citations:
PubMed Identifier
32769639
Citation
Phipps MG, Ware CF, Stout RL, Raker CA, Zlotnick C. Reducing the Risk for Postpartum Depression in Adolescent Mothers: A Randomized Controlled Trial. Obstet Gynecol. 2020 Sep;136(3):613-621. doi: 10.1097/AOG.0000000000004003.
Results Reference
derived

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

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