Depression Prevention Program for American Indian Adolescents During and After Pregnancy

Depression Clinical Trial

Official title:

Depression Prevention in Pregnant American Indian Teens Using CBT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183547
• Other study ID #: R34MH071300
• Secondary ID: R34MH071300DSIR
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: May 28, 2013
• Start date: January 2005
• Est. completion date: September 2007

Study information

• Verified date: December 2008
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will determine the effectiveness of the "Living in Harmony" depression prevention program in preventing depressive symptoms among pregnant American Indian adolescents during pregnancy and after giving birth.

Description:

Pregnancy among reservation-based American Indian adolescents has become increasingly common. Numerous psychosocial and environmental factors have put this population at high risk for pregnancy-related depression. Depression during pregnancy and after giving birth is associated with reduced quality of life for both young mothers and their children. Many reservations lack mental health services; therefore, an inexpensive intervention is needed to prevent depressive symptoms among pregnant adolescents who live on reservations.

The duration of this study will vary for each participant, depending on the time of study entry. Participants will be randomly assigned to receive weekly sessions of either the "Living in Harmony" program, consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support; or general depression-prevention education and support. Participants' depressive symptoms will be assessed at study entry, at 4, 12, and 24 weeks after giving birth, and study completion. Interviews and self-report scales will be used to assess participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

• At 28th week or earlier of pregnancy

• Center for Epidemiologic Studies-Depression Scale (CES-D) score of 16 or higher

• Identified (by others and by self) as an American Indian

• Currently live on an American Indian reservation

• Parent or guardian willing to give consent, if applicable

• Willing and able to comply with all study requirements

Exclusion Criteria:

• Diagnosis of major depressive disorder

• Current psychiatric disorder or condition requiring intervention or treatment

• Current participation in another mental or behavioral health study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Pregnancy

Intervention

Behavioral:
• "Living in Harmony" depression prevention program
Weekly therapy sessions consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support
• Depression-prevention education and support
Weekly therapy sessions offering general depression-prevention education and support

Locations

Country	Name	City	State
United States	Johns Hopkins Center for American Indian Health	Baltimore	Maryland
United States	Johns Hopkins Center for American Indian Health	Whiteriver	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum depression		up to 24 weeks postpartum	No