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

Wayne State University

Status: Active, not recruiting

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

Treatments: Device: Neuroptimal (Zengar, Inc.) Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT06054412

IRB-23-02-5477

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Neurofeedback Training

Other group

Description:

Mothers in the Neurofeedback Training group will complete pre and post-training self-report surveys assessing trauma symptoms, mental health, parenting attitudes and behaviors, and infant crying patterns and socioemotional development. Mothers in this group will all be receiving in-person psychotherapy outside of the study, and they will all demonstrate clinically significant symptoms aligned with post-traumatic stress disorder and/or it's dissociative subtype.

Treatment:

Device: Neuroptimal (Zengar, Inc.) Neurofeedback