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 |
| Protocol serial number | N/A |
| Sponsor | Institute of Psychiatry, King's College London (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (ref: TW11 0XX) |
- 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
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
Scientific
Dept. Academic Psychiatry
5th Floor, Bermondsey Wing
Guy's Hospital
London
SE1 9RT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Longitudinal multicentre pragmatic randomised controlled intervention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Patient - time to relapse: |
| Key secondary outcome measure(s) |
1. Patients (all measured at baseline, discharge, 6 month and 12 month follow up): |
| Completion date | 20/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 334 |
| 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
- United Kingdom
- England
Study participating centre
SE1 9RT
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 | results | 20/08/2015 | Yes | No | |
| Results article | results | 01/08/2017 | Yes | No | |
| Protocol article | protocol | 01/01/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/09/2017: Publication reference added.
07/10/2016: Publication reference added.
29/01/2016: Plain English summary added.
