Clinical trial NCT04424745: Neuromodulation with Attention Bias Modification Training for Binge Eating Disorder
Official title: A Feasibility Study of Transcranial Direct Current Stimulation with Attention Bias Modification Training for Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge-Eating Disorder
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Binge eating disorder (BED) is a common and disabling eating disorder (ED) which has significant effects on psychological wellbeing, physical health, and quality of life. Talking therapies, most notably cognitive behaviour therapy (CBT), are presently recommended for the treatment of BED. However, outcomes from treatment are inadequate. Therefore, there is a need for development of new treatments.

This study aims to investigate the feasibility of combining Attention Bias Modification Training (ABMT) and Transcranial Direct Current Stimulation (tDCS) to reduce binge-eating behaviour and craving for food in people with BED.

ABMT is a computerised training that seeks to alter responses towards food that people are not consciously aware of. During ABMT, participants are trained to 'look towards' low-calorie food and 'look away' from high-calorie food. TDCS is a safe, well tolerated, non-invasive form of brain stimulation which is suitable for supervised self-administration. It stimulates specific brain areas using a mild electrical current (2 mA) via small electrodes placed on the scalp. In this study, participants will be randomly allocated to receive either ABMT with real tDCS or ABMT with sham tDCS. ABMT and real/sham tDCS will be delivered simultaneously, i.e. participants will engage in ABM training whilst receiving tDCS. All participants will be remotely supervised by the study researcher for the duration of each treatment session.

Biological male and female adults (aged 18-60) of any gender will be eligible to take part if they have a DSM-V of BED and they are overweight or obese.

Taking part will involve completing 10 sessions of combined ABMT and real or sham tDCS over 2-3 weeks. Binge frequency, food craving and other outcomes will be measured at the start of the study, end of the study, and at the 6-week follow-up.


Eligibility criteria: Inclusion Criteria:

* Overweight or obese according to WHO criteria (BMI\>25 kg/m²)
* Meet criteria for full-syndrome DSM-5 Binge Eating Disorder (BED)
* Right-handed
* Must use and understand English as a language for everyday conversation
* Access to a laptop or desktop computer with webcam

Exclusion Criteria:

* Visual impairments that cannot be corrected with contact lenses or glasses
* Pregnancy
* History of neurological disease and/or seizure
* Having any metallic implants anywhere in the head or body
* History of head or eye injury
* Significant health problems in the previous six months
* Lifetime diagnosis of substance dependence, psychosis, bipolar disorder, borderline personality disorder
* Other primary psychiatric disorder requiring treatment in its own right
* Taking psychotropic medication other than a stable dosage of selective serotonin reuptake inhibitors (SSRI) for at least 14 days prior to study enrollment
* Adults consuming more than 14 units of alcohol per week who are unwilling to reduce their alcohol intake for the duration of the treatment.
* Current illicit drug use.
* Learning difficulties that would preclude safe tDCS self-administration and/or completion of questionnaire measures and neurocognitive tasks.

Primary outcomes:
measure: Achievement of a 'steady state' of recruitment
timeFrame: Start of Recruitment to 12 months
Secondary outcomes:
measure: Eating Disorder Symptoms
timeFrame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
measure: Craving for food
timeFrame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
measure: General psychopathology
timeFrame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
measure: Physical Health
timeFrame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
measure: Food related attention
timeFrame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
measure: Attention Bias for Food
timeFrame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
measure: Working Memory
timeFrame: Baseline to post treatment (on average 18 days after baseline assessment)
measure: Face Affective Go/No Go
timeFrame: Baseline to post treatment (on average 18 days after baseline assessment)
measure: Cognitive Flexibility
timeFrame: Baseline to post treatment (on average 18 days after baseline assessment)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Ulrike Schmidt, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: