RECRUITING

DBT-P Treatment Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to find out if improving emotion regulation skills use during pregnancy reduces maternal stress and improves heart rate. The main questions it aims to answer are: * Does improving emotion regulation skills during pregnancy reduce stress and improve the ability to cope? * How is a participant's heart rate affected by their ability to control their emotions during pregnancy? Researchers will test the hypothesis that dialectical behavior therapy skills groups (DBT-P) will improve emotion regulation skills use as well as heart rate. Participants will: * Visit the clinic for 3 sessions at the beginning, middle and end of their pregnancy. * Compete surveys and interviews asking about their thoughts, feelings and how they cope with emotions. * Have their heart rate taken. * If assigned to the investigational group, they will complete weekly remote emotion regulation skills groups for 10 weeks and complete daily diary cards that ask about mood and any thoughts of self-harm.

Official Title

Developing Pregnancy-specific Dialectical Behavior Therapy Skills to Promote Multigenerational Mental Health

Quick Facts

Study Start:2025-06-06
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06963801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Emotion dysregulation score of 88 or above
  2. * At least 12 weeks pregnant
  3. * Singleton Pregnancy
  4. * Fluent in English
  1. * Active psychosis
  2. * Drug or alcohol use disorder during pregnancy
  3. * High risk of an imminent suicide attempt
  4. * Significant health complications (e.g., cancer)
  5. * Illiterate and/or unable to independently complete and comprehend written measures

Contacts and Locations

Study Contact

Janea Cato
CONTACT
(919) 684-3251
janea.cato@duke.edu
Alicia Holloway
CONTACT
(919) 684-1333
adh60@duke.edu

Principal Investigator

Elisabeth Conradt, PhD
PRINCIPAL_INVESTIGATOR
Duke University
Andrada Neacsiu, PhD
PRINCIPAL_INVESTIGATOR
Duke University
Sheila Crowell, PhD
PRINCIPAL_INVESTIGATOR
University of Oregon

Study Locations (Sites)

Duke University
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

  • Elisabeth Conradt, PhD, PRINCIPAL_INVESTIGATOR, Duke University
  • Andrada Neacsiu, PhD, PRINCIPAL_INVESTIGATOR, Duke University
  • Sheila Crowell, PhD, PRINCIPAL_INVESTIGATOR, University of Oregon

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-06
Study Completion Date2027-01

Study Record Updates

Study Start Date2025-06-06
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Emotion dysregulation
  • Pregnancy
  • Maternal health
  • RSA
  • Coping
  • Stress
  • DBT-P
  • Moms2B

Additional Relevant MeSH Terms

  • Emotion Dysregulation