A multicentre pilot study testing Expert Carers Helping Others: a self-help skills training intervention for carers of someone with anorexia nervosa
| ISRCTN | ISRCTN83003225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83003225 |
| Secondary identifying numbers | 9417 |
- Submission date
- 29/09/2011
- Registration date
- 29/09/2011
- Last edited
- 05/10/2018
- 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
Not provided at time of registration
Contact information
Ms Elizabeth Goddard
Scientific
Scientific
King's College London
Institute of Psychiaty
Department Of Academic Psychiatry
5th Floor, Bermondsey Wing
Guys Hospital
London
SE1 9RT
United Kingdom
| Phone | +44 (0)207 188 0190 |
|---|---|
| elizabeth.goddard@kcl.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Does a proven intervention to improve functioning of carers also benefit the anorexia nervosa sufferer for whom they care? A pilot study of our Expert Carer Helping Others (ECHO) intervention |
| Study acronym | ECHO |
| Study hypothesis | We aim to find out if ECHO results in more rapid and stable reduction in AN symptoms of patients aged 13-21 compared to treatment as usual (TAU) alone by providing carers with information and effective skills. In a third arm we will find if the addition of coaching (ECHOc) from 'expert carers' i.e. individuals with their own experience of living with an ED, makes a difference. Secondary research questions are: 1. What are the relative costs between arms? 2. What are the effects on carers wellbeing between arms? 3. Do reductions in maintaining variables mediate outcome for patients? 4. Do obsessivecompulsive disorder (OCD) traits in individual and parents (autistic, OCD) have a moderate effect on ECHO on carer and patient outcome? 5. Does parental attitudes and behaviour to food and weight/shape moderate carer and patient outcome? 6. Can ECHOc be delivered to a high level of competence? 7. Are there therapist effects? |
| Ethics approval(s) | First MREC, 21/03/2011, ref: 11/H0724/4 |
| Condition | Anorexia Nervosa and Eating Disorder Not Otherwise Specified (Anorexic subtype) |
| Intervention | Expert Carers Helping Others: a self-help, skills training intervention for carers of someone with an eating disorder. Intervention materials (book, DVDs, accompanying manual) are posted to carers. Those who are in the guided self-help arm receive 10 telephone coaching sessions delivered by a trained 'Expert Coach'. This coach has previous experience of eating disorders, either having recovered themselves or having cared for someone affected. Only carers receive the intervention and it can be shared between carers (e.g. mother and father). The intervention is additional to what the family would be offered as part of their clinical treatment. Treatment as usual refers to the standard treatment offered as part of the clinical package and should not change as a result of the project. |
| Intervention type | Other |
| Primary outcome measure | Summary score of core eating disorder symptoms of patients collected using the Short Evaluation of Eating Disorders Symptom (SEED) |
| Secondary outcome measures | 1. Carers' wellbeing (General Health Questionnaire) and distress (Depression, Anxiety and Stress Scale) (baseline, 6 months, 12 months follow-up) 2. Expressed emotion (Family Questionnaire - carer response; Brief Dyadic Scale of Expressed Emotion - patient response; baseline, 6 months) 3. Accommodating and enabling behaviours (Accommodating and Enabling for Eating Disorders; carer response baseline, 6 months) 4. Caregiving self efficacy (carer and patient response; baseline and 6 months) 5. Patient diagnostic category (Development and Well-Being Assessment; baseline, 12 months) 6. Patient distress (Depression, Anxiety and Stress Scale; baseline, 6 months, 12 months) 7. Health economic assessment for carers and patient (Client Service Receipt Inventory; baseline, 6 months, 12 months) |
| Overall study start date | 10/06/2011 |
| Overall study end date | 10/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 21 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 350; UK Sample Size: 350; Description: 175 patients will be recruited (accounting for drop out) and at least one carer |
| Participant inclusion criteria | 1. Person with anorexia nervosa (AN) or eating disorder not otherwise specified - anorexia nervosa (EDNOS-AN) type referred to outpatient clinic for their eating disorder 2. Patient aged 13-21 years old 3. Carers living with someone diagnosed with AN or EDNOS-AN currently and for the next year at minimum outside of term time 4. Person with AN and carers (at least one) consent 5. New referral to outpatient eating disorder service |
| Participant exclusion criteria | 1. Either patient or carer has insufficient knowledge of English 2. AN comorbid with severe psychiatric or physical comorbidity e.g. learning disability, psychotic illness (including bipolar disorder), alcohol/drug abuse, metabolic or gastrointestinal problems (diabetes mellitus, celiac disease) (not including mood disorder, OCD, BDD, ASD) 3. Family in a concurrent treatment trial |
| Recruitment start date | 10/06/2011 |
| Recruitment end date | 10/12/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College London
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
South London and Maudsley NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Michael Rutter Centre for Children
Maudsley Hospital
De Crespigny Park
London
SE5 8AZ
England
United Kingdom
| Phone | +44 (0)20 3228 6000 |
|---|---|
| a@b.com | |
| Website | http://www.slam.nhs.uk/ |
"ROR" |
https://ror.org/015803449 |
Funders
Funder type
Government
NIHR (UK) ref: PB-PG-0609-19025
No information available
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 | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/07/2014 | Yes | No | |
| Results article | results | 20/12/2014 | Yes | No | |
| Results article | results | 01/07/2016 | Yes | No | |
| Results article | results | 01/11/2017 | Yes | No |
Editorial Notes
05/10/2018: Publication references added.
