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	https://doi.org/10.1186/ISRCTN06149665
Secondary identifying numbers	N/A

Submission date: 19/08/2008
Registration date: 07/11/2008
Last edited: 12/09/2017

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

Background and study aims
Eating disorders are serious psychiatric illnesses characterised by an abnormal attitude towards food that causes someone to change their eating habits and behaviour. Quality of life is also severely impaired in the family members of those affected, as these people often act as their main carers. The aim of this study is to help the carers of people with eating disorders in order to reduce their distress. It uses a self-management intervention for carers supplemented by coaching from experienced carers who have been trained in caregiving skills.

Who can participate?
Eating disorder inpatients aged 13 or older and their carers

What does the study involve?
Carers are randomly allocated to receive either the guided self-help intervention (in addition to treatment as usual) or treatment as usual only. Treatment takes about 3 - 6 months, and follow-up continues for one year. The outcomes measured are health and quality of life for carers and the person they care for at the end of inpatient treatment and for the following two years.

What are the possible benefits and risks of participating?
The information from this study may help to provide better services and treatment for future patients with an eating disorder.

Where is the study run from?
15 specialised eating disorder centres in the UK

When is the study starting and how long is it expected to run for?
August 2008 to February 2012

Who is funding the study?
1. National Institute for Health Research (NIHR) (UK)
2. South London and Maudsley NHS Foundation Trust (UK)

Who is the main contact?
Prof. Janet Treasure

Contact information

Prof Janet Treasure
Scientific

Dept. Academic Psychiatry
5th Floor, Bermondsey Wing
Guy's Hospital
London
SE1 9RT
United Kingdom

Study information

Study design	Longitudinal multicentre pragmatic randomised controlled intervention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific 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
Study acronym	CASIS
Study objectives	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
Ethics approval(s)	National Research Ethics Office at Royal Free Hospital, 15/05/2008, ref: 08/H0720/41
Health condition(s) or problem(s) studied	Anorexia nervosa
Intervention	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.
Intervention type	Other
Primary outcome measure	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 measures	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
Overall study start date	20/08/2008
Completion date	20/02/2012

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	334 families
Key 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
Key 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
Date of first enrolment	20/08/2008
Date of final enrolment	20/02/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Guy's Hospital

London
SE1 9RT
United Kingdom

Sponsor information

Institute of Psychiatry, King's College London (UK)
University/education

Box P005
De Crespigny Park
Denmark Hill
London
SE5 8AF
England
United Kingdom

Website	http://iop.kcl.ac.uk/RandD
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (ref: TW11 0XX)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/01/2013	Yes	No
Results article	results	20/08/2015	Yes	No
Results article	results	01/08/2017	Yes	No

Editorial Notes

12/09/2017: Publication reference added.
07/10/2016: Publication reference added.
29/01/2016: Plain English summary added.