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

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00436150

Purpose

This study will aim to prevent postpartum depression in pregnant teenagers through an interpersonal therapy-based program.

Condition	Intervention
Depression	Behavioral: Interpersonal therapy-based treatment Behavioral: Standard care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	Preventing Postpartum Depression in Adolescent Mothers

Resource links provided by NLM:

MedlinePlus related topics: Depression Postpartum Care Postpartum Depression

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Postpartum depression diagnosis [ Time Frame: Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Degree of depressive symptoms [ Time Frame: Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum ] [ Designated as safety issue: No ]
Prenatal distress [ Time Frame: Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum ] [ Designated as safety issue: No ]
Social support [ Time Frame: Measured at pretreatment; Weeks 34 to 36 during pregnancy; hospital stay after delivery; and Weeks 6, 12, and 24 postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	February 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Participants will receive 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 weekly 1-hour sessions for 5 weeks. Other Name: REACH
Active Comparator: B Participants will receive standard care	Behavioral: Standard care Participants assigned to receive standard care will focus more on the health issues associated with pregnancy and postpartum. Both groups will attend weekly 1-hour sessions for 5 weeks. Other Name: Baby Basics

Arms

Assigned Interventions

Experimental: A

Participants will receive 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 weekly 1-hour sessions for 5 weeks.

Other Name: REACH

Active Comparator: B

Participants will receive standard care

Behavioral: Standard care

Participants assigned to receive standard care will focus more on the health issues associated with pregnancy and postpartum. Both groups will attend weekly 1-hour sessions for 5 weeks.

Other Name: Baby Basics

Detailed Description:

Postpartum depression is believed to be one of the most common complications after pregnancy. This type of depression often occurs within the first year after the baby is born and is most likely caused by dramatic changes in hormone levels after pregnancy. Pregnant teenagers are even more at risk for experiencing complications throughout pregnancy and parenting difficulties after delivery. Minimal research has been done on preventive ways to reduce postpartum depression in teenagers. Therefore, this study will evaluate the effectiveness of an interpersonal therapy-based program at preventing postpartum depression in financially disadvantaged pregnant teenagers.

Participants will first undergo a 15-minute interview about their background and emotions. Participants will undergo a second interview and then be randomly assigned to receive either interpersonal therapy-based treatment or standard care. 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. Participants assigned to receive standard care will focus more on the health issues associated with pregnancy and postpartum. Both groups will attend weekly 1-hour sessions for 5 weeks. Homework may be assigned to review topics discussed, and all participants will receive the book Baby Basics. Following treatment, participants will meet with researchers again when they are 34 to 36 weeks pregnant; in the hospital after the baby is born; and 6, 12, and 24 weeks after the baby is born.

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436150

Locations

United States, Rhode Island
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Maureen Phipps, MD

Women and Infants Hospital of Rhode Island

More Information

No publications provided

Responsible Party:	Maureen Phipps, MD, MPH, Women & Infants Hospital
ClinicalTrials.gov Identifier:	NCT00436150 History of Changes
Other Study ID Numbers:	R34 MH077588, DSIR 84-CTP
Study First Received:	February 14, 2007
Last Updated:	March 10, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Adolescents
Depression, postpartum

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms

Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on February 09, 2012