Binge-Eating DisorderTANDEMNCT04424745
Neuromodulation with Attention Bias Modification Training for Binge Eating Disorder
A study testing Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS) in people with Binge-Eating Disorder, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Feb 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Transcranial Direct Current Stimulation with Attention Bias Modification Training for Binge Eating Disorder
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.
Read more
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
- Being tested
- Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS)
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Attention Bias Modification Training with real tDCS | Active comparator | Not described Receives: Other: Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS) |
| Attention Bias Modification Training with sham tDCS | Placebo comparator | Not described Receives: Other: Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start of Recruitment to 12 months
Secondary outcomes (9)
Eating Disorder Symptoms
The Eating Disorder Examination Questionnaire (EDE-Q) will be used to assess eating disorders symptoms. The EDE-Q is a 36-item self-report quesitonnaire, and a higher global score indicates more severe eating disorder symptoms.
Measured: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
Craving for food
The Food Craving Questionnaire (FCQ) will be used to assess trait-level craving for food. Total scores can range between 15 and 90, with higher scores indicating more frequent and intense food cravings.
Measured: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
General psychopathology
The Depression, Anxiety and Stress- Scale (DASS-21) is a 21-item self-report questionnaire which aims to evaluate mood, anxiety and stress levels over the previous week. Sum scores for the total DASS range between 0 and 120, with higher scores indicating more severe psychopathology. Sub-scales assess depression, anxiety and stress symptoms specifically, and scores range from 0 to 42, with higher scores indicating more severe symptoms.
Measured: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
Physical Health
Weight and height will be combined to report body mass index in kg/m^2
Measured: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
Food related attention
The Food Attention Network Task (Food-ANT) will be used to assess three components of attention (i.e. orienting, alerting and executive function) using food (low- and high-calorie) versus non-food pictures (neutral items). Change in reaction time will be used to assess change in orienting, alerting and executive function.
Measured: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
Attention Bias for Food
The Visual Probe Task (VP) will be used to assess visuo-spatial attention biases for food cues. Change in dwell time measured by eye tracking and reaction time will be used to assess change in attention bias for food cues.
Measured: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
Working Memory
Participants are presented with a continuous stream of stimuli (either faces or words), and for every stimulus, the participant must indicate (yes/no) whether or not the current stimulus is the same as the one presented three trials back. This is known as the N-Back and is a measure of working memory. Higher numbers of correct responses indicates superior working memory function.
Measured: Baseline to post treatment (on average 18 days after baseline assessment)
Face Affective Go/No Go
Neuropsychological task measuring information processing biases for positive and negative facial expressions. The participant is told a target emotion and asked to press a button only when the target emotion is present. The task consists of six blocks, each of which presents a series of faces showing either the target emotion or a differently valenced distractor. Reaction times are calculated for correct responses for each condition. Affective bias scores are calculated by subtracting the sad target/happy distractor condition reaction time from the happy target/sad distractor condition reaction time.
Measured: Baseline to post treatment (on average 18 days after baseline assessment)
Cognitive Flexibility
In Wisconsin Card Sorting Test (WCST) participants are asked to sort 64 cards to match either color (red, blue, yellow, or green), form (crosses, circles, triangles, or stars), or number of figures (one, two, three, four). During the task, the sorting rule changes discreetly from color to form or number of figures without the participants being informed. The participants have to shift sets accordingly and sort cards following the new sorting rule. Set shifting difficulties are indicated by preservative errors; thus, higher scores on this test represent poorer cognitive flexibility.
Measured: Baseline to post treatment (on average 18 days after baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start25 Feb 2021
- Primary completion31 Jan 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrike Schmidt, MD PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424745
- Sponsor's protocol ID
- TANDEM01
- Acronym
- TANDEM
- Status last verified
- Jun 2024
- First submitted
- 26 May 2020
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Transcranial Direct Current Stimulation with Attention Bias Modification Training for Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT04424745
- Acronym / sponsor ID
- TANDEM / TANDEM01
- Conditions
- Binge-Eating Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS)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. | Other | Attention Bias Modification Training with real tDCS, Attention Bias Modification Training with sham tDCS |
Primary outcome
Achievement of a 'steady state' of recruitment
Time frame: Start of Recruitment to 12 months
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.
9 secondary outcomes
Eating Disorder Symptoms
Time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
Craving for food
Time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
General psychopathology
Time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
Physical Health
Time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
Food related attention
Time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
Attention Bias for Food
Time frame: Baseline to 6 week follow up (on average, 8 weeks after baseline assessment)
Working Memory
Time frame: Baseline to post treatment (on average 18 days after baseline assessment)
Face Affective Go/No Go
Time frame: Baseline to post treatment (on average 18 days after baseline assessment)
Cognitive Flexibility
Time frame: Baseline to post treatment (on average 18 days after baseline assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrike Schmidt, MD PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS) in people with Binge-Eating Disorder, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of a 'steady state' of recruitment (time frame: Start of Recruitment to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.