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

NCT01482832 | Completed DMC

• 1 other identifier: R01MH093342
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Conditions

Postpartum Depression

Keywords

Randomized trial; Postpartum depression; Adolescent pregnancy; Interpersonal psychotherapy

Outcome Measures

Primary Outcomes (1)

• Diagnosis of depression

  Outcome assessment using KID-SCID

  within 6 months postpartum

Secondary Outcomes (1)

• Degree of depressive symptoms

  pre-randomization; 34-36 weeks gestation; within 4 days postdelivery; postpartum weeks 6, 12, 24 and 52

Study Arms (2)

Experimental

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.

Behavioral: Interpersonal therapy-based treatment

Control

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.

Behavioral: Interpersonal therapy-based treatment

Interventions

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. (5 weekly sessions with a booster session postpartum)

Also known as: REACH 2

Control; Experimental

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Less than 24 weeks pregnant
• Not currently being treated for depression
• Speaks and reads English fluently

You may not qualify if:

• Currently receiving mental health services from a health care provider
• Meets DSM-IV criteria for an affective disorder, substance use disorder, or psychosis

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• National Institute of Mental Health (NIMH): collaborator
• Pacific Institute for Research and Evaluation: collaborator
• Brown University: collaborator

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• 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.

  PMID: 32769639 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Maureen G Phipps, MD, MPH

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: November 25, 2011
• First Posted: December 1, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: October 30, 2018
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)