Understanding and Targeting Self-Regulatory Control in Bulimia Nervosa
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Real fNIRS Neurofeedback
Other interventionParticipants 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.
Sham-Control fNIRS Neurofeedback
Other interventionParticipants 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.
SmartPhone Intervention
Other interventionOver 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Real fNIRS Neurofeedback and SmartPhone Intervention ArmExperimental treatment 2 interventions
Group B: Sham-Control fNIRS Neurofeedback and SmartPhone Intervention ArmSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Functional near-infrared spectroscopy (fNIRS)-measured neural activation and connectivity
The investigators will evaluate changes in PFC neural activation and connectivity as a function of neurofeedback.
Time frame
Approximately 6 weeks2
Go/no-go task performance
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.
Time frame
Baseline through study completion, including 1-month follow-up (around 20 weeks)3
Loss-of-control eating and compensatory behavior frequencies
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.
Time frame
Baseline through study completion, including 1-month follow-up (around 20 weeks)4
Eating Loss of Control Severity Subscale Score
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.
Time frame
Baseline through study completion, including 1-month follow-up (around 20 weeks)Secondary outcomes
1
Loss-of-control eating and compensatory behavior frequencies
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.
Time frame
Baseline through study completion, including 1-month follow-up (around 20 weeks)2
Severity of loss-of-control eating
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.
Time frame
Baseline through study completion, including 1-month follow-up (around 20 weeks)Other outcomes
1
Intensity of urges to eat and binge eat
Participants will rate the intensity of their urges to engage in eating and binge eating using daily electronic surveys before the start of the neurofeedback intervention and after the end of the smartphone intervention on a Likert-type scale from 1-5. Higher scores indicate greater intensity.
Time frame
4 weeks2
Intensity of food cravings
Participants will rate the intensity of their food cravings using daily electronic surveys before the start of the neurofeedback intervention and after the end of the smartphone intervention on a Likert-type scale from 1-5. Higher scores indicate greater intensity.
Time frame
4 weeks3
Sense of control over behavior in general
Participants will rate their sense of control over their behavior in general using daily electronic surveys before the start of the neurofeedback intervention and after the end of the smartphone intervention on a Likert-type scale from 1-5. Lower scores indicate greater control.
Time frame
4 weeks4
Sense of control over eating
Participants will rate their sense of control over their eating using daily electronic surveys before the start of the neurofeedback intervention and after the end of the smartphone intervention on a Likert-type scale from 1-5. Lower scores indicate greater control.
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov
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