Welcome
Support Centre
29 August 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A randomised pragmatic trial comparing the cost effectiveness of supplementing standard care with an intervention for carers (Carers Assessment, Skills and Information Sharing [CASIS]) of people with eating disorders
ISRCTN ISRCTN06149665
DOI 10.1186/ISRCTN06149665
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised pragmatic trial comparing the cost effectiveness of supplementing standard care with an intervention for carers (Carers Assessment, Skills and Information Sharing [CASIS]) of people with eating disorders
Scientific title
Acronym CASIS
Serial number at source N/A
Study hypothesis Eating Disorders are serious psychiatric illnesses. Life-time prevalence rates for anorexia nervosa are at minimum 1.6% in women and 0.3% in men. It is a life-threatening illness with the highest mortality rate of any functional psychiatric disorder. Educational, vocational and social functioning is commonly impaired in people who have an eating disorder. Quality of life is severely impaired in family members of someone affected as these people are often the main carers of their loved one with an eating disorder.

Eating disorders are also one of the most costly psychiatric conditions to treat, mainly due to the need for prolonged and/or repeated hospital admissions. Twenty seven percent of stays over 90 days in specialist inpatient units are due to eating disorders. Eating disorders are the most common diagnostic group in adolescent beds. Therefore, the cost of eating disorders to the individual, the family and society are high.

Hypothesis:
1. Patients whose carers receive the skills training intervention materials will have a lower relapse rate than those whose carers do not receive the materials after discharge from inpatient care
2. Depression and anxiety in carers who receive the materials will be lower than those who do not receive the materials over time
3. Providing carers with skills training intervention will decrease the cost of illness to the affected individual, carers and society in terms of reducing the number of inpatient days and a reduction in costs to the family (health care, out-of-pocket expenses and lost productivity) compared to those who do not receive the skills training intervention
Lay summary Lay summary under review 3
Ethics approval Core ethics approval received from the National Research Ethics Office at Royal Free Hospital on the 15th May 2008 (ref: 08/H0720/41).
Study design Longitudinal multicentre pragmatic randomised controlled intervention trial
Countries of recruitment United Kingdom
Disease/condition/study domain Anorexia nervosa
Participants - inclusion criteria 1. Patients:
1.1. Diagnosis of an eating disorder
1.2. 13 years or older, either sex
1.3. Current inpatient
1.4. Has a carer
2. Carer:
2.1. Cares for someone with an eating disorder
2.2. English speaking
Participants - exclusion criteria 1. Patients:
1.1. Not currently admitted to an inpatient unit
1.2. No diagnosis of Eating Disorder
1.3. 12 years old or younger
2. Carer:
2.1. Does not speak English
Anticipated start date 20/08/2008
Anticipated end date 20/02/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 334 families
Interventions Randomisation will be conducted independently from the trial team by the Clinical Trials Unit (CTU).

Intervention arm:
5 x skills training DVDs and 1 x skills training for carers of someone with an eating disorder developed by Professor Treasure and colleagues using a carers distress model and the techniques of motivational interviewing to teach communication strategies specifically for someone with an eating disorder. These materials will be accompanied by telephone coaching provided by "expert carers" or coaches trained in the model and in motivational interviewing techniques. Carers will receive 3 x half hour telephone coaching sessions.

Control arm:
Inpatient treatment as usual.

Treatment will occur for about 3 - 6 months, and follow-up will take place for one year.
Primary outcome measure(s) 1. Patient - time to relapse:
1.1. Body mass index (BMI) below 17.5 kg/m^2 for patients who were fully weight recovered at the time of discharge, measured at monthly intervals, or
1.2. A drop in 1 BMI point (approx 3 kg) for those who entered the study at a below normal weight and absolute weight, measured at monthly intervals
2. Carers - distress: Depression, Anxiety and Stress Scale (DASS), measured at patient discharge, 6 months, and 12 months follow up
3. Cost: Client Service Receipt Interview (carer and patient version), measured at baseline, discharge, 6 and 12 month follow up; except not at discharge for patient
Secondary outcome measure(s) 1. Patients (all measured at baseline, discharge, 6 month and 12 month follow up):
1.1. Eating pathology: Eating Disorder Questionnaire (EDE-Q)
1.2. Distress: DASS
1.3. Quality of Life: World Health Organisation Quality of Life Questionnaire (WHOQuol)
2. Carers (all measured at baseline, discharge, 6 month and 12 month follow up except ECI which will not be measured at discharge):
2.1. Care giving burden: Experience of Caregiving Inventory, Eating Disorder
2.2. Symptom Impact Scale
2.3. Expressed emotion: Family Questionnaire, Levels of Expressed Emotion (patient perspective)
2.4. Quality of Life: WHOQuol
Sources of funding National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (ref: TW11 0XX)
Trial website
Publications 1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22961838
Contact name Prof  Janet  Treasure
  Address Dept. Academic Psychiatry
5th Floor, Bermondsey Wing
Guy's Hospital
  City/town London
  Zip/Postcode SE1 9RT
  Country United Kingdom
Sponsor Institute of Psychiatry, King's College London (UK)
  Address Box P005
De Crespigny Park
Denmark Hill
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Sponsor website: http://iop.kcl.ac.uk/RandD
Date applied 19/08/2008
Last edited 20/06/2013
Date ISRCTN assigned 07/11/2008
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.