Condition category
Mental and Behavioural Disorders
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
21/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Helen Davies

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6108

Study information

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.

Acronym

Thinking Styles and Emotion Processing in People with Eating Disorders

Study hypothesis

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

MREC approved (ref: 08/H0606)

Study design

Multicentre non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Body Mass Index (BMI)
2. Eating Disorder Questionnaire (EDE-Q)

Secondary outcome measures

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

Overall trial start date

01/07/2008

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Planned sample size: 60; UK sample size: 60

Participant 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

Recruitment start date

01/07/2008

Recruitment end date

31/07/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute Of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (KCL) (UK)

Sponsor details

Strand
London
WC2R 2LS
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research

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

Publication citations

Additional files

Editorial Notes

21/07/2016: No publications found, verifying study status with principal investigator