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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

207,457 Total Patients Enrolled

George Washington UniversityOTHER

243 Previous Clinical Trials

453,074 Total Patients Enrolled

1 Trials studying Postpartum Depression

120 Patients Enrolled for Postpartum Depression

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,996,748 Total Patients Enrolled

2 Trials studying Postpartum Depression

9,675 Patients Enrolled for Postpartum Depression

Media Library

Adapted Cognitive-Behavioral Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05345834 — N/A

Postpartum Depression Research Study Groups: Usual Care, Patient Navigation and treatment

Postpartum Depression Clinical Trial 2023: Adapted Cognitive-Behavioral Therapy Highlights & Side Effects. Trial Name: NCT05345834 — N/A

Adapted Cognitive-Behavioral Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05345834 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor seek to involve elderly individuals?

"In alignment with the established prerequisites for this clinical trial, only individuals between 18 and 45 years of age can be enrolled."

Answered by AI

What is the participant enrollment for this experiment?

"Affirmative. The information available on clinicaltrials.gov confirms that this investigation, which was made public on August 22nd 2022, is presently looking for volunteers. Approximately 700 participants are required from one medical centre."

Answered by AI

Are there still slots available for this trial?

"Affirmative. Clinicaltrials.gov specifies that this experiment is currently accepting participants and was initially posted on August 22nd 2022, with its most recent update occurring on February 6th 2023. A total of 700 patients need to be recruited from 1 sites for the study's completion."

Answered by AI

Does my medical history and current condition meet the criteria to partake in this experiment?

"This clinical trial seeks 700 participants who are Black/of African Descent, below 28 weeks gestation, aged 18-45 and proficient in English. Furthermore, they must be receiving Medicaid benefits and have either subthreshold or threshold risk of maternal distress (stress, depression, and anxiety). Consent is also required at one of the four study sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The DC Mother-Infant Behavioral Wellness Program

Catherine Limperopoulos 2022. "The DC Mother-Infant Behavioral Wellness Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05345834.

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