Clinical trial NCT06054412: An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers
Official title: Feasibility of an Adjunctive Dynamic Neurofeedback Training Program to Enhance Wellness Among Postpartum Mothers With a History of Trauma Exposure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-Being, Psychological
Dissociation
Maternal Care Patterns
Maternal Behavior
Maternal Distress
Mood Disturbance
Emotional Regulation
Post Traumatic Stress Disorder
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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).
* Must be between 3-24 months postpartum
* Must be receiving regular, primarily in-person psychotherapy from a therapist at a clinic in the Greater Detroit area.

Exclusion Criteria:

* Are currently pregnant
* 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
* Have a documented history of epilepsy
* Have ever experienced previous head injury with loss of consciousness
* Are currently experiencing domestic or intimate partner violence or otherwise state that their current living conditions are unsafe
* Are currently experiencing psychosis or have been suicidal within the last six months
* Are currently taking, or in the past month has taken benzodiazepines, narcotic drugs, or cannabis
* Have engaged in self-harming behaviors in the last 3 months requiring medical attention
* Do not have competence to understand or consent to the study procedures
* Do not have fluency in written and spoken English

Primary outcomes:
measure: Neuro-QoL Item Bank v1.0 - Positive Affect and Well-Being - Short Form
timeFrame: Weekly, throughout the course of the 3-month training phase
measure: Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard)
timeFrame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
measure: Dissociative Experiences Scale II
timeFrame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
measure: Patient Health Questionnaire 8
timeFrame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
measure: The State Trait Anger Expression Inventory
timeFrame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
measure: Brief Child Abuse Potential screener, an abbreviated version of the Child Abuse Potential Inventory ([CAP]), © 1980, 1986, Joel S. Milner, PhD.)
timeFrame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
measure: Parenting Stress Index
timeFrame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
measure: Parenting Sense of Competence scale
timeFrame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
measure: The Crying Patterns Questionnaire
timeFrame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
measure: The Baby Pediatric Symptom Checklist of the Survey of Well-Being for Young Children
timeFrame: The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
measure: Neuro-QoL Item Bank v1.0 - Emotional and Behavioral Dyscontrol - Short Form
timeFrame: Weekly, throughout the course of the 3-month intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References: