Condition category
Mental and Behavioural Disorders
Date applied
05/04/2006
Date assigned
29/01/2007
Last edited
30/11/2016
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

Dr Ivan Eisler

ORCID ID

Contact details

Department of Family Therapy - PO73
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)207 848 0199
i.eisler@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1206/1287

Study information

Scientific title

A MultiCentre randomised Trial of the outcome, acceptability and cost-effectiveness of family therapy and multi-family day treatment compared with inpatient care and outpatient family therapy for Adolescent Anorexia Nervosa

Acronym

MCTAAN

Study hypothesis

The following main research hypotheses will be tested:
1. In severely ill patients Multi-Family Day Treatment (MFDT) will be equally effective as inpatient treatment in returning patients to a normal nutritional state by the three month assessment.
2. The overall cost-effectiveness of MFDT will be significantly higher than inpatient treatment and will compare favourably with outpatient family therapy.
3. In less severely ill patients MFDT will lead to a more rapid nutritional recovery than outpatient family therapy.
4. MFDT will lead to the highest levels of client and family satisfaction of the three treatments.

A subsidiary hypothesis is that MFDT will lead to the greatest reduction of distress and difficulties experienced by other family members.

Independent research assessors will evaluate the outcome, costs and client acceptability before the start of treatment, at three months, 12 months (end of treatment) and 18 months (six month follow-up).

Ethics approval

1. Institute of Psychiatry Ethics Approval, 10/10/2002, ref: 234/02
2. London MREC approval, 25/08/2004, ref: 04/MREC/022

Study design

Multi-centre randomised treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Anorexia Nervosa (in adolescents)

Intervention

Group one:
Inpatient treatment is based around a carefully structured nursing regimen, the main aims of which are:
1. To form a therapeutic alliance
2. To achieve weight restoration
Other members of the multidisciplinary team provide additional therapeutic input depending on the needs of individual patients. Patients allocated to inpatient treatment will be admitted to a specialist Eating Disorder Unit for approximately 12 weeks. The actual length of inpatient stay will be determined by the time needed for each individual patient to reach a healthy weight. The study design, however, will limit the length of time from reaching a healthy weight to discharge from hospital to two weeks. Following discharge from hospital they will receive regular follow-up treatment for six months for themselves and their families. We are currently developing a modification of the outpatient family therapy treatment manual so that it can be used for patients entering family therapy at a point when their weight is normal. To ensure continuity of treatment the therapist responsible for the follow-up treatment will engage the patient and her family during the last two weeks of the inpatient stay. The overall length of treatment (i.e. inpatient plus follow-up) will be 12 months.

Group two:
Outpatient family therapy for adolescent anorexia nervosa has been the focus of our previous treatment trials and a treatment manual has been developed to guide the therapists' interventions. Patients are seen for a number of sessions over a period of 12 months. These are mainly conjoint family meetings although some individual sessions are included where appropriate (particularly with older adolescents at later stages of the treatment). Therapy begins with an emphasis on the parents taking control of re-nutrition, with a gradual move towards conversations exploring more general implications of adolescence for children and parents as soon as the nutrition level is safe. The aim is to help the family to disentangle individual psychological issues (e.g. self esteem, individuation, psychosocial functioning) and family relationship issues from the eating disorder behaviour and the interactional patterns that have developed around it.

Group three:
MFDT is a new treatment programme that has been developed over the past three years at the Maudsley Hospital and at the Eating Disorder Service in Dresden. The treatment provides a more intensive form of family intervention than the usual outpatient family therapy but is conceptually very similar. In common with our outpatient family therapy, MFDT aims to help families rediscover their own resources by emphasising ways in which parents can take control of re-nutrition. At the same time the families are encouraged to use the group setting to explore how the eating disorder and the interactional patterns in the family have become entangled, making it difficult for the family to follow the normal developmental course of the family life-cycle. The sharing of experiences and the dynamics of the multiple family group are important components of the treatment. The treatment starts with an intensive one week multiple family day programme for up to six families and is followed by a further four to five one day meetings at four to eight week intervals. Individual family meetings are scheduled in the intervals between group meetings as needed, with the overall length of treatment for each family being 12 months. A wide range of intervention techniques is used (including group, family, psycho-educational and creative techniques) with multiple family, parent or adolescent groups as well as individual family meetings. There is also practical input around managing mealtimes and food.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Symptomatic change:
1.1. Body Mass Index (kg/m^2)
1.2. SEverity of Eating Disorder (SEED) symptomatology
1.3. Eating Disorder Examination (EDE)
1.4. Children's Eating Disorder Examination (C-EDE)
2. Health economic costs:
2.1. Client service receipt inventory

Secondary outcome measures

1. Client/family satisfaction questionnaire
2. Experience of caregiving

Overall trial start date

01/07/2003

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients referred to five eating disorder services (South London and Maudsley NHS Trust, St Georges and South West London NHS Trust , Blackwater Valley Primary Health Care Trust, Central & Northwest London Trust, The Child and Adolescent Eating Disorder Service of the Royal Free Hampstead Trust), who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for anorexia nervosa or eating disorders not otherwise specified and who are aged between 13 and 20 years.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Patients in care
2. Patients with learning disabilities, psychosis or alcohol/substance dependence
3. Patients with medical condition that may lead to significant weight loss (e.g. Crohn's disease)

Recruitment start date

01/07/2003

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

The Health Foundation (UK)

Sponsor details

90 Long Acre
London
WC2E 9RA
United Kingdom

Sponsor type

Research organisation

Website

http://www.health.org.uk

Funders

Funder type

Charity

Funder name

The Health Foundation (UK) (ref. 1206/1287)

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

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27881106

Publication citations

Additional files

Editorial Notes

30/11/2016: Publication reference added.