A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity

NCT05865912 | Completed

• 1 other identifier: 3159550
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the feasibility of combining an app-based Mindfulness training (MT) with at-home administered transcranial direct current stimulation (tDCS) in adults with overweight or obesity and assess whether MT with tDCS may improve weight-related behaviours in this population. Specifically, the study will assess whether MT+ active tDCS, as opposed to MT+ sham tDCS or waiting list control, reduces high calorie food craving and consumption. Findings will inform the development of a future large-scale randomised controlled trial. The trial will be conducted in the UK.

Conditions

Adults With Overweight and Obesity

Keywords

Mindfulness, Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (4)

• The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention adherence

  By assessing the tDCS session completed and the number of the MT sessions completed will be tracked through the app across the full 8 weeks

  post treatment assessment (assessed at week 3 post start of treatment)

• The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention recruitment rate

  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.

  post treatment assessment (assessed at week 3 post start of treatment)

• The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention retention rates

  determine retention rates from randomization through intervention completion

  post treatment assessment (assessed at week 3 post start of treatment) and at follow up (assessed at week 8 post start of treatment)

• Participant views about treatment acceptability

  Treatment Acceptability Questionnaire: asking participants to indicate if MT with self-administered tDCS is an acceptable approach to treatment and whether they would recommend MT + tDCS to a friend if they were struggling with their weight.

  post treatment assessment (assessed at week 3 post start of treatment)

Secondary Outcomes (15)

• Change in high calorie food intake in the lab

  Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)

• Change in food cravings

  Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)

• Change in weight loss using the bioelectrical impedance machine

  Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)

• Change in emotion regulation using Emotion Regulation Questionnaire

  Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)

• Change in mood using the The Depression, Anxiety and Stress-Scale

  Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)

Study Arms (3)

[Mindfulness training + real tDCS]

EXPERIMENTAL

Combination Product: Mindfulness training + real tDCS

[Mindfulness training + sham tDCS]

PLACEBO COMPARATOR

Combination Product: Mindfulness training + sham tDCS

[Waiting list control group].

NO INTERVENTION

Interventions

Mindfulness training + real tDCS COMBINATION_PRODUCT

The MT is an established app-based programme delivered by Headspace®. During MT, participants complete guided meditation sessions which focus on mindful eating and on coping with cravings. Each MT session lasts 15 min. Participants in the MT+ real tDCS and MT+ sham tDCS groups will be given instructions to practice daily mindfulness for 3 weeks. During 10 of these sessions, MT and real/sham tDCS will be delivered concurrently. TDCS: During tDCS, a constant weak direct current is applied via electrodes (anode and cathode) placed on the scalp. In this study, the anode will be placed over the right dorsolateral prefrontal cortex (dlPFC) and the cathode will be placed over the left dlPFC. In the real tDCS condition, stimulation will be delivered at a constant current of 2 mA with a 10 second fade in/fade out for 20 minutes. In sham tDCS, the stimulator will deliver 60 seconds of active stimulation at the start ("ramping up") and end ("ramping down") of the 20 minute period.

[Mindfulness training + real tDCS]

Mindfulness training + sham tDCS COMBINATION_PRODUCT

Mindfulness training + sham tDCS

[Mindfulness training + sham tDCS]

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 to 60 w
• Overweight or obese (BMI ≥25 kg/ m2) according to World Health Organisation (WHO) criteria.
• Use and understand English as a language for everyday conversation.
• Have access to a laptop or desktop computer with webcam and to able to attend baseline, post intervention and follow up assessments in the Institute of Psychiatry, Psychology and Neuroscience (KCL).

You may not qualify if:

• Insufficient written and spoken English
• All known contraindications to tDCS (Brunoni et al., 2012)
• Pregnancy; history of neurological disease and/or seizure
• Having any metallic implants in the head or body
• History of head or eye injury
• Significant health problems in the previous six months
• A lifetime diagnosis of substance dependence, psychosis, bipolar disorder, borderline personality disorder; any other primary psychiatric disorder requiring treatment in its own right
• Taking psychotropic medication
• Taking medication for weight loss Regular, current or past, mindfulness meditation or yoga practice (defined as \> 20 minutes, twice or more per week during the past 2 months)
• 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 (e.g.; working memory and inhibitory control)
• Current atypical anorexia nervosa or purging once a week or more.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

CREW

London, Uk, SE5 8AF, United Kingdom

Location

Related Publications (1)

• Ageeli M, Flynn M, Lopes M, Ince B, Alves D, Westwood SJ, Campbell IC, Schmidt U. A feasibility study of the effects of concurrent transcranial direct current stimulation (tDCS) on mindfulness training in adults living with overweight or obesity: the MINDED trial protocol. Pilot Feasibility Stud. 2026 Jan 6. doi: 10.1186/s40814-025-01748-9. Online ahead of print.

  PMID: 41495839 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 19, 2023
• Study Start: October 17, 2023
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: July 28, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)