Neuromodulation with Attention Bias Modification Training for Binge Eating Disorder

NCT04424745 | Completed DMC

• 1 other identifier: TANDEM01
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder

Outcome Measures

Primary Outcomes (1)

• Achievement of a 'steady state' of recruitment

  Recruitment rate/month over months will be assessed to demonstrate that recruitment targets for the main trial can be met within an adequate time-frame. An average of 3 patients per month must be recruited (randomised) over a consecutive 12 month period (a minimum of 36 patients) in order to demonstrate a 'steady state' of recruitment.

  Start of Recruitment to 12 months

Secondary Outcomes (9)

• Eating Disorder Symptoms

  Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)

• Craving for food

  Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)

• General psychopathology

  Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)

• Physical Health

  Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)

• Food related attention

  Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)

Study Arms (2)

Attention Bias Modification Training with real tDCS

ACTIVE COMPARATOR

Other: Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS)

Attention Bias Modification Training with sham tDCS

PLACEBO COMPARATOR

Other: Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS)

Interventions

Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS) OTHER

Participants will receive 10 sessions of computerised attention bias modification training with either real or sham tDCS. Participants will self-administer tDCS at home, with research supervision, and complete attention bias modification training on a laptop or desktop computer while receiving stimulation. Sessions will be completed week daily for 2-3 weeks.

Attention Bias Modification Training with real tDCS; Attention Bias Modification Training with sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, London, SE58AF, United Kingdom

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Ulrike Schmidt, MD PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 11, 2020
• Study Start: February 25, 2021
• Primary Completion: January 31, 2022
• Study Completion: September 30, 2022
• Last Updated: January 22, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)