Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa Via a Combined Real-Time Neurofeedback and Smartphone Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
Study Overview
Brief Summary
The purpose of this study is to examine the effects of noninvasive prefrontal cortex (PFC) neurofeedback during eating in women with bulimia nervosa (BN) using wearable brain imaging, functional near-infrared spectroscopy (fNIRS), together with a brain-based 4-week text-messaging intervention. The investigators will examine how these interventions may influence inhibitory control and eating disorder symptoms in women with bulimia nervosa.
Detailed Description
The purpose of this study is to examine the effects of PFC neurofeedback during eating in women with bulimia nervosa (BN) using fNIRS and a 4-week text messaging intervention. Specifically, the study aims 1) to use neurofeedback during eating to evaluate the causal role of PFC function in BN; and 2) to test individualized, neuro-based text messaging for treatment of BN. Data will be collected from women with BN who will be randomly assigned to one of two group conditions (real or sham-control neurofeedback during eating and text-messaging intervention). Participation includes a phone screening assessment, psychodiagnostic assessment, one in-person assessment, six in-person neurofeedback training sessions, 4 weeks of text-message intervention, behavioral tasks, online questionnaires, and online symptom assessments (before the neurofeedback visits and following the 4-week text message intervention), and a follow-up remote assessment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 to 55 years
- •Meet diagnostic criteria for bulimia nervosa (BN) or BN of low frequency and/or limited duration
- •Current body mass index greater than or equal to 18.5kg/m2 but under 40kg/m2
- •English-speaking
Exclusion Criteria
- •Ongoing medical treatment or planned/recent change in medical treatment, major medical condition, or psychiatric disorder that may interfere with study variables or participation
- •Current psychotherapy focused primarily on eating disorder symptoms
- •Pregnancy or planned pregnancy, or lactation during the study period
- •Allergy to ingredients in the shake
Investigators
Laura Berner
Associate Professor of Psychiatry
Icahn School of Medicine at Mount Sinai