NCT03946540

Brief Summary

The research proposed here seeks to delineate the outcomes of people who have received treatment for an eating disorder at a specialist eating disorder service in childhood or adolescence (hereafter 'former patients'). This will inform our understanding of the maintenance of treatment effects beyond initial trial follow-ups, and together with data collected during treatment will allow for identification of factors predicting chronicity which will inform further treatment development.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 14, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

April 10, 2019

Last Update Submit

January 4, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Receipt of further treatment for an eating disorder in the first four years after discharge from treatment

    Self report of whether subsequent treatment for an eating disorder has been received since discharge. Self report of treatment received in the period between discharge and research follow up - including number and duration of outpatient treatment, hospital admission and day patient treatment. The four year outcome is the primary outcome as it allows for the most complete dataset for follow up.

    From discharge from service to L-FED research assessment. Discharges between 2009 and 2014 (4-10) year follow up. Proportion of sample needing treatment in the first four years post discharge will be reported

  • Eating Disorder Examination Questionnaire (EDEQ). Fairburn & Beglin, 1994

    Self reported eating disorder symptoms. This is a 28 item self report questionnaire which is scored using a 7 - point (0-6) rating scale. Four subscales are derived through adding together relevant items and diving by the number of items to give a score range for each subscale of 0-6. A total score is derived by adding together the subscales and diving by the number of subscales (ie 4) also giving a score range of 0-6. Higher scores indicate greater impairment.

    28 days prior to L-FED research assessment

  • Work and social adjustment scale (WSAS) Mundt, J. C., I. M. Marks, et al. (2002).

    Self reported impact of symptoms on functioning. This is a self report measure of the impact of illness on work and social functioning. It is a five item questionnaire with each item scored 0-8 giving a total score range of 0-40 where high scores indicate greater impairment.

    At time of L-FED research assessment. Discharges between 2009 and 2014 (4-10) year follow up. Variation in time since discharge will be stratified in analysis.

Secondary Outcomes (2)

  • Receipt of treatment for an eating disorder >4 years after discharge from treatment

    From four years post discharge from service to L-FED research assessment. Proportion

  • Psychosocial wellbeing

    At time of L-FED assessment.Discharges between 2009 and 2014 (4-10) year follow up. Variation in time since discharge will be stratified in analysis.

Other Outcomes (3)

  • Receipt of treatment for any other mental health difficulties in four years post discharge, and at >4 years post discharge.

    1: Up to four years post discharge. 2: as applicable up to 10 years post discharge as described able for receipt of treatment for an eating disorder

  • Self harm since discharge

    Four time points assesed: while in treatment, since discharge, in the past three months on in the past month. Variation in time since discharge will be stratified in analysis.

  • Current eating disorder symptoms

    At time of L-FED assessment. Discharges between 2009 and 2014 (4-10) year follow up. Variation in time since discharge will be stratified in analysis.

Study Arms (1)

L-FED sample

All young people treated in Maudsley Child and Adolescent Eating Disorder Service between 1/8/2009 and 31/1/2014.

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

People who were assessed and offered treatment at the National and Specialist CAMHS Eating Disorder Service, South London and Maudsley NHS Foundation Trust between 1/8/2009 and 31/1/2014

You may qualify if:

  • People who were assessed and offered treatment at the National and Specialist CAMHS Eating Disorder Service, South London and Maudsley NHS Foundation Trust between 1/8/2009 and 31/1/2014.

You may not qualify if:

  • young people who were referred for treatment but did not attend assessment
  • young people who were referred for treatment but did not meet criteria for an eating disorder
  • young people who were referred for treatment but did not accept treatment (or attended for fewer than 3 sessions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maudsley Centre for Child and Adolescent Eating Disorders

London, SE5 8AZ, United Kingdom

Location

MeSH Terms

Conditions

Feeding and Eating Disorders of ChildhoodAnorexia NervosaBulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Catherine s Stewart, }hD DClinPsy

    South London and Maudsley NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Clinical Psychologist

Study Record Dates

First Submitted

April 10, 2019

First Posted

May 10, 2019

Study Start

July 14, 2019

Primary Completion

July 27, 2020

Study Completion

February 28, 2021

Last Updated

January 5, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations