NCT03781921

Brief Summary

This project aims to explore emotional processing and regulation in individuals with Bulimia Nervosa (BN) with a view to better understand its underlying causes. Previous research suggests that binge eating and purging behaviours may be linked to difficulties with emotions and impulses. However, most of the research has been conducted using self-report methods, despite the fact that these individuals have difficulties identifying and describing their emotions (known as alexithymia), making the use of self-report questionable. This project is the first to use electroencephalography (EEG) as an objective method to disentangle emotional processing and regulation in these individuals. A combination of three tasks and questionnaires will be used to measure various aspects of an emotional response and its link to impulsive behaviours in individuals with BN (N=35) and healthy controls (N=35). This study has the potential to inform future treatment for these individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3.8 years

First QC Date

December 10, 2018

Last Update Submit

February 27, 2024

Conditions

Keywords

eating disorderElectroencephalographyemotion regulationemotion processingnegative urgency

Outcome Measures

Primary Outcomes (4)

  • LPP

    Late Positive Potential differences in amplitude between the different groups and different conditions

    Only once on the day of the electroencephalography task

  • N1

    Differences in amplitude between the different groups and different conditions

    Only once on the day of the electroencephalography task

  • P50

    Differences in amplitude between the different groups and different conditions

    Only once on the day of the electroencephalography task

  • False alarm rate

    Differences in rate between the different groups and different conditions

    Only once on the day of the task

Study Arms (2)

BN

Females with a current diagnosis of Bulimia Nervosa between 18 and 50 years old

Other: No intervention

Controls

Females with no current or past diagnosis of any eating disorder; between 18 and 50 years old

Other: No intervention

Interventions

There is no intervention. Each group will conduct the same tasks and questionnaires and we will compare performances between groups.

BNControls

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly individuals being genetically females (As opposed to simply identifying as one) will be taking part in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be identified as they come to be diagnosed at Kimmeridge Court in Bournemouth, the local NHS clinic for people with eating disorders. Leaflets will be left in the waiting room area and their clinician will also give individual leaflets to individuals those patients meeting our inclusion criteria.

You may qualify if:

  • Females
  • Fluent in English
  • With a diagnosis of bulimia nervosa for the BN group and without a diagnosis of any eating disorder for the control group

You may not qualify if:

  • Males
  • Under 18 or over 50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bournemouth University

Bournemouth, BH12 5BB, United Kingdom

Location

Dorset Healthcare University NHS Foundation Trust

Bournemouth, United Kingdom

Location

MeSH Terms

Conditions

Bulimia NervosaFeeding and Eating DisordersEmotional Regulation

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSelf-ControlSocial BehaviorBehavior

Study Officials

  • Laura Renshaw-Vuillier, PhD

    Bournemouth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2018

First Posted

December 20, 2018

Study Start

October 30, 2019

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Other researchers in the team will have access to the participant anonymised data for further analysis. This will be shared through a secure server. The anonymised data will also be saved on Bournemouth secured data repository for other researchers outside the research team to have access to it (requirement for publications etc)

Time Frame
The participant's anonymous data will be saved for 10 years on Bournemouth secured online data repository
Access Criteria
Anyone with the link will be able to acess the data. The link will be distributed during the publication process.

Locations