← Back to Search

Adapted Cognitive-Behavioral Therapy + Support for Prenatal Stress & Perinatal Anxiety & Depression

N/A

Recruiting

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-45

Be between 18 and 65 years old

Must not have

age <18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2nd obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trialwill study how to help pregnant Black/African-Descent women dealing with stress, anxiety and depression. Patient navigation, adapted therapies & peer support groups are being tested.

Who is the study for?

This trial is for low-income Black/African Descent pregnant women under 45 years old, who are less than 28 weeks pregnant, speak English, and are experiencing stress or depression. They must be on Medicaid and able to consent. Women actively suicidal, using substances, planning to deliver outside DC, or not of the specified descent cannot join.

What is being tested?

The study tests if patient navigation combined with culturally adapted cognitive-behavioral therapy and peer support can help manage stress, anxiety, and depression in eligible participants. It's a randomized controlled trial meaning people will be randomly assigned to different treatment groups.

What are the potential side effects?

Since this trial involves behavioral interventions like therapy rather than medications, side effects may include emotional discomfort during discussions but typically do not involve physical risks associated with drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2nd obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2nd obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2nd obstetrics visit (assessed 24-28 weeks gestation) through 12 months postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Anxiety at 24 weeks of pregnancy to 12 months postpartum

Change in Depression at 24 weeks of pregnancy to 12 months postpartum

Change in Stress at 24 weeks of pregnancy to 12 months postpartum

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Patient Navigation and treatmentExperimental Treatment2 Interventions

In the patient navigation arm, women who do not meet diagnostic criteria (Group 2a) can participate in: (1) group-based CBT preventative intervention; (2) peer support group (virtual); or (3) both. Women in the threshold risk group, meeting diagnostic criteria for depression/anxiety (Group 2b) at baseline can participate in: (1) individual CBT treatment (2) peer support group (virtual) (3) both Prevention group includes 8 sessions based on culturally adapted CBT for Black/ of African descent populations facilitated by mental health professionals. Individual treatment includes 12 sessions based on culturally adapted CBT for Black/ of African descent populations.

Group II: Usual CareActive Control1 Intervention

Participants will participate in usual prenatal care throughout the duration of study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Patient Navigation

2017

Completed Phase 2

~38910

0 / 2Eligibility criteria met