Investigating the thinking styles and emotion processing in people with anorexia nervosa before and after a social cognitive intervention; in people with anorexia nervosa receiving treatment as usual; in people with bulimia nervosa and healthy controls.

ISRCTN	ISRCTN92765046
DOI	https://doi.org/10.1186/ISRCTN92765046
Protocol serial number	6108
Sponsor	King's College London (KCL) (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research

Submission date: 19/05/2010
Registration date: 19/05/2010
Last edited: 10/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Helen Davies
Scientific

Institute Of Psychiatry
16 De Crespigny Park
London
SE5 8AF
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre non-randomised interventional treatment trial
Secondary study design	Non randomised controlled trial
Scientific title	Investigating the thinking styles and emotion processing in people with anorexia nervosa before and after a social cognitive intervention; in people with anorexia nervosa receiving treatment as usual; in people with bulimia nervosa and healthy controls.
Study acronym	Thinking Styles and Emotion Processing in People with Eating Disorders
Study objectives	We wish to explore in five different groups of individuals with eating disorders and without eating disorders, central coherence style (whether the individual processes information in a global manner - looking at the bigger picture, or in a local manner - focusing on small details), set shifting ability (whether the individual has a rigid or flexible thinking style - how easy it is for them to change from doing something one way to doing it another way) and emotional processing (how easy the individual finds it to identify, regulate, interpret and express emotion in themselves as well as identifying and interpreting emotions in others). The first group are anorexia nervosa inpatients at Bethlem Royal Hospital, London, who will be receiving standard inpatient treatment plus a social cognition and an emotional coaching intervention. The second group are anorexia nervosa patients based at Cheadle Royal Hospital, Cheshire, who will receive standard inpatient treatment only. The third cohort will be outpatients and volunteer participants with eating disorders. The fourth group will be people recovered from an eating disorder. The final and fifth group will be healthy controls.
Ethics approval(s)	MREC approved (ref: 08/H0606)
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Eating disorders; Disease: Eating disorders
Intervention	Participants in the eating disorder group at the Bethlem Royal Hospital referred by health professionals engaged in their care to the social cognition and emotional coaching will then embark on 10 sessions of this intervention. Social cognition andemotional coaching comprises of 10 one hour sessions in which the therapist (nurses trained to grade 8 standard, supervised by Dr Kate Tchanturia, Consultant Clinical Psychologist) and the patient cover a range of exercises which involve understanding. Study entry: registration only
Intervention type	Other
Primary outcome measure(s)	1. Body Mass Index (BMI) 2. Eating Disorder Questionnaire (EDE-Q)
Key secondary outcome measure(s)	1. Depression, Anxiety and Stress Scale (DASS) 2. Difficulties in Emotion Regulation Scale (DERS) 3. Emotion expressivity scale 4. National Adult Reading Test (NART) 5. Obsessive Compulsive Inventory (OCI-R) 6. Participants will take part in a series of paper based and computerised assessments 7. Social Anhedonia scale
Completion date	31/07/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	60
Total final enrolment	81
Key inclusion criteria	Anorexia nervosa group: 1. Participants must be clinically diagnosed as having anorexia nervosa as defined by DSM-IV 2. Patients with symptoms of anxiety and depression will still be included Recovered from eating disorder group: 3. Normal weight (body mass index [BMI] 18.5 - 24.9 kg/m^2) 4. Regular menstruation 5. Absence of eating disorder behaviours such as binging, purging and restricting All groups: 6. Aged 18 years or over, either sex
Key exclusion criteria	All groups: 1. Under the age of 18 years 2. Severe suicidal ideation 3. History of brain trauma, learning disabilities 4. Unable to provide informed consent for themselves 5. English is not the first language
Date of first enrolment	01/07/2008
Date of final enrolment	31/07/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute Of Psychiatry

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	qualitative results	01/09/2011	10/08/2020	Yes	No
Results article	results	01/05/2012	10/08/2020	Yes	No

Editorial Notes

10/08/2020: The following changes were made to the trial record:
1. Publication references added.
2. The total final enrolment was added.
21/07/2016: No publications found, verifying study status with principal investigator