Plain English Summary
Background and study aims
People with Eating Disorders (EDs) have socio-emotional difficulties. In particular, they show a bias towards negative information about the self and others attitudes. Previous studies from our unit found an attentional bias towards critical and angry faces, and lower implicit self-esteem and self-compassion in EDs than healthy subjects. A computerized training programme has been developed that aims to modify negative cognitive bias to social and self-relevant stimuli. The aim of this study is to test the acceptability and impact of this programme on clinical symptoms, interpersonal functioning (between self and others), and self-evaluation in patients with EDs.
Who can participate?
Patients with an eating disorder
What does the study involve?
Participants meet the researcher four times, on four different days, over the course of 7-10 days. During the first day (baseline; 60 min), participants complete a set of questionnaires. Then, participants are randomly allocated to one of four groups:
1. Attentional Bias intervention (experimental) group
2. Attentional Bias control group
3. Self-Esteem intervention (experimental) group
4. Self-Esteem control group.
The experimental groups receive computerized training (training session 1 - day 2; training session 2 - day 3; training session 3 - day 4) to develop a bias towards others (module 1) and self-related positive information (module 2). Participants in the control groups receive a different version of the training, where both positive and negative information are presented. At the end of the last training session (day 4), all participants complete follow-up measures of clinical symptoms, implicit and explicit self-esteem, interpersonal functioning, vigilance to social stimuli and interpretation of social situations (45 min). Participants in the control group are offered the intervention at this stage.
What are the possible benefits and risks of participating?
It is hoped that this intervention will be associated with a reduction of negative bias towards self- and others-related information and with improved self-esteem and social functioning in people with eating disorders. It is also hoped this intervention will be associated with a reduction of the eating disorders symptoms. The study will be testing participants with eating disorders who may be considered as at risk. They may experience mild distress or discomfort in completing some of the questionnaires because of the topics investigated (i.e., symptoms associated with the eating disorder). Also, participants may find it somewhat stressful to be involved in the study for a relatively long period of time (about 1 month). Throughout the study, precautions will be made to ensure that the participants are as protected as possible. If interested in taking part in the study, participants will be able to contact the researcher directly by email or telephone, to schedule an appointment with them. Otherwise, they could choose to let their consultant or primary nurse on the site know so that they contact the researcher by email or phone for the patient to schedule an appointment with them. During the face-to-face meeting with the researcher, the patient will be able to discuss the details of the project. Before agreeing to sign the consent form, the researcher will review the information sheet with the participant, offering them the opportunity to ask questions, and will remind the participant that they are free to withdraw at any time without having to specify a reason. During the screening phase, participants will be interviewed to understand whether they are eligible to take part. While completing the questionnaire materials, participants will be invited to take breaks as needed. Participants will also be invited to express the reasons for their distress so that they can be provided with additional guidance and support to address these issues. They will be reassured and reminded that they can withdraw from the study at any point. In case this reassurance is not sufficient to alleviate participant distress, they will then be asked to speak with Prof. Treasure, who has several years of experience working with people with Eating Disorders.
Where is the study run from?
The study sessions with volunteers from the local community will take place at King's College London. The study sessions with outpatients and inpatients will take place at South London and Maudsley NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
October 2013 to October 2015
Who is funding the study?
The Psychiatry Research Trust (UK)
Who is the main contact?
1. Dr Valentina Cardi
valentina.cardi@kcl.ac.uk
2. Miss Charlotte Rhind
charlotte.c.rhind@kcl.ac.uk
3. Prof. Janet Treasure
janet.treasure@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Janet Treasure
ORCID ID
Contact details
The Basement
103 Denmark Hill
London
SE5 8AF
United Kingdom
+44 (0)20 7848 5978
janet.treasure@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Cognitive bias modification training in eating disorders: a pilot study
Acronym
Study hypothesis
The computerised training developed will reduce the cognitive bias towards negative social and self-relevant stimuli.
Ethics approval
Camberwell and St Giles Research Ethics Committee (London), approved 22/11/2013, amendment approved 02/05/2014, REC ref: 13/LO/1492
Study design
Pilot feasibility multicentre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Eating Disorders
Intervention
Participants will be randomly allocated to one of four groups. Each of the four modules will entail four sessions (about 30 min/each).
1. Attentional Bias intervention (experimental) group
2. Attentional Bias control group
3. Self-Esteem intervention (experimental) group
4. Self-Esteem control group.
They will meet the researcher four times, on four different occasions (in 1 week/10 day-time). Together, the two modules comprise a full cognitive bias modification programme; they are divided into two modules to minimise the burden on patients and to keep the experimental sessions brief for the purpose of this pilot study.
During the first session (session 1; 40 min) participants will complete the baseline questionnaires and computerized tasks. During sessions 2 and 3 they will receive two training or placebo sessions (30 min in study 1; 15 min in study 2). During session 4 participants will receive the last session of training or placebo and will complete the follow-up questionnaires and computerized tasks (45 min). At the end of the study participants in the placebo group will be offered the intervention.
A follow-up will be conducted 30 days after the end of the project. Participants will receive some questionnaires and a brief structured phone interview to evaluate eating disorders and mood symptoms, interpersonal functioning, and self-esteem.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Acceptability and feasibility of the computerised training developed (qualitative feedback to be collected during the last study session)
2. Reduction of the negative bias towards social and self-related information (computerised tasks to be completed during the last study session)
Secondary outcome measures
An improvement of socio-emotional functioning and reduction of eating disorders symptoms (questionnaires to be completed during the last study session)
Overall trial start date
01/10/2013
Overall trial end date
01/10/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of eating disorders (anorexia nervosa, bulimia nervosa, subclinical anorexia nervosa or bulimia nervosa; binge eating disorder)
2. Fluency in English
3. No visual impairment
4. No cognitive impairment
5. No drugs or alcohol abuse
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. No English language fluency
2. Visual impairment
3. Drug or alcohol abuse
4. Cognitive impairment
Recruitment start date
01/10/2013
Recruitment end date
01/10/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Basement
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Room 1.8 Hodgkin Building
Guy's Campus
London
SE1 4UL
United Kingdom
+44 (0)20 7848 6960
keith.brennan@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Psychiatry Research Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary