Condition category
Mental and Behavioural Disorders
Date applied
29/09/2011
Date assigned
29/09/2011
Last edited
30/07/2014
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 Elizabeth Goddard

ORCID ID

Contact details

King's College London
Institute of Psychiaty
Department Of Academic Psychiatry
5th Floor
Bermondsey Wing
Guys Hospital
London
SE1 9RT
United Kingdom
+44 (0)207 188 0190
elizabeth.goddard@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9417

Study information

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

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 obsessive–compulsive 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

First MREC, 21/03/2011, ref: 11/H0724/4

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

10/06/2011

Overall trial end date

10/12/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

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 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

United Kingdom

Trial participating centre

King's College London
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

South London and Maudsley NHS Trust (UK)

Sponsor details

Michael Rutter Centre for Children
Maudsley Hospital
De Crespigny Park
London
SE5 8AZ
United Kingdom
+44 (0)20 3228 6000

Sponsor type

Hospital/treatment centre

Website

http://www.slam.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) ref: PB-PG-0609-19025

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24888426

Publication citations

  1. Protocol

    Rhind C, Hibbs R, Goddard E, Schmidt U, Micali N, Gowers S, Beecham J, Macdonald P, Todd G, Tchanturia K, Treasure J, Experienced Carers Helping Others (ECHO): protocol for a pilot randomised controlled trial to examine a psycho-educational intervention for adolescents with anorexia nervosa and their carers., Eur Eat Disord Rev, 2014, 22, 4, 267-277, doi: 10.1002/erv.2298.

Additional files

Editorial Notes