ACTIVE_NOT_RECRUITING

An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers

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 proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.

Official Title

Feasibility of an Adjunctive Dynamic Neurofeedback Training Program to Enhance Wellness Among Postpartum Mothers With a History of Trauma Exposure

Quick Facts

Study Start:2024-03-03
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06054412

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 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must have clinically concerning symptoms of Post-traumatic Stress Disorder and/or it's dissociative sub-type, as indicated by either a score of 3+ on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) screening measure for PTSD symptoms OR endorsement of 2 or more past-month symptoms of moderate or greater severity on the depersonalization/derealization subscale of the Dissociative Subtype of PTSD Scale (DSPS).
  2. * Must be between 3-24 months postpartum
  3. * Must be receiving regular, primarily in-person psychotherapy from a therapist at a clinic in the Greater Detroit area.
  1. * Are currently pregnant
  2. * Have a lifetime history of significant untreated mental illness (not currently treated schizophrenia, schizoaffective disorder, bipolar disorder, or substance use disorder) or neurological or pervasive developmental disorder
  3. * Have a documented history of epilepsy
  4. * Have ever experienced previous head injury with loss of consciousness
  5. * Are currently experiencing domestic or intimate partner violence or otherwise state that their current living conditions are unsafe
  6. * Are currently experiencing psychosis or have been suicidal within the last six months
  7. * Are currently taking, or in the past month has taken benzodiazepines, narcotic drugs, or cannabis
  8. * Have engaged in self-harming behaviors in the last 3 months requiring medical attention
  9. * Do not have competence to understand or consent to the study procedures
  10. * Do not have fluency in written and spoken English

Contacts and Locations

Study Locations (Sites)

Wayne State University
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Wayne State University

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 Date2024-03-03
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-03-03
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Well-Being, Psychological
  • Dissociation
  • Maternal Care Patterns
  • Maternal Behavior
  • Maternal Distress
  • Mood Disturbance
  • Emotional Regulation
  • Post Traumatic Stress Disorder