Bulimia Nervosa, Feeding and Eating Disorders, Mental Disorders
Conditions
Keywords
fNIRS, fNIRS neurofeedback, smartphone intervention, eating disorders, bulimia nervosa, bulimia
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.
Interventions
OTHERSmartPhone Intervention
Over the subsequent 4 weeks, at the specific times when each individual is most likely to engage in eating disorder symptoms, participants will receive personalized messages to use mental strategies from their real-time or their sham-control fNIRS neurofeedback.
Participants will be instructed to use sham-control fNIRS neurofeedback to non-invasively regulate neural activation associated with symptoms in individuals with bulimia nervosa. During the training, participants will view images on a computer screen, listen to sounds, and consume a shake.
Participants will be instructed to use real-time fNIRS neurofeedback to non-invasively regulate neural activation associated with symptoms in individuals with bulimia nervosa. During the training, participants will view images on a computer screen, listen to sounds, and consume a shake.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will be assigned to one of two conditions, either the experimental or sham-control arm.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Female * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity | Approximately 6 weeks | The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback. |
| Go/no-go task performance | Baseline through study completion, including 1-month follow-up (around 20 weeks) | Participants will complete a go/no-go task four times to measure inhibitory control. Participants' behavioral performance on the go/no-go task will be determined by the percentage of incorrect responses made as they are prompted to react to different pictorial stimuli. Participants' percentages of error can range from 0% to 100%. A higher percentage indicates lower behavioral performance on the task. |
| Loss-of-control eating and compensatory behavior frequencies | Baseline through study completion, including 1-month follow-up (around 20 weeks) | Frequency of loss-of-control eating and compensatory episodes in the past 28 days assessed via the EDE-Q. Participants will self-report on how often loss-of-control eating and compensatory episodes occur before and after each phase of intervention (neurofeedback training and 4-week text messaging intervention) and at follow-up. |
| Eating Loss of Control Severity Subscale Score | Baseline through study completion, including 1-month follow-up (around 20 weeks) | Participants will rate the severity of their feelings of loss of control over eating in the past 28 days before and after each phase of intervention (neurofeedback training and 4-week text messaging intervention) and at follow-up on a Likert-type scale from 0-10. Higher score indicates greater severity of loss of control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loss-of-control eating and compensatory behavior frequencies | Baseline through study completion, including 1-month follow-up (around 20 weeks) | Participants will report how often loss-of-control eating and compensatory episodes occur using electronic surveys throughout each phase of the intervention and at follow-up. |
| Severity of loss-of-control eating | Baseline through study completion, including 1-month follow-up (around 20 weeks) | Participants will rate the severity of their feelings of loss of control over eating throughout each phase of the intervention and at follow-up on a Likert-type scale from 1-5. Higher score indicates greater severity of loss of control. |
Countries
United States
Contacts
CONTACTSila Sozeri, B.A.
CONTACTLaura A. Berner, Ph.D.
PRINCIPAL_INVESTIGATORLaura A. Berner, Ph.D.
Icahn School of Medicine at Mount Sinai
Outcome results
None listed