Eating Disorders: Online Self-help & Usual Treatment (TAU) vs TAU Only

November 28, 2017 updated by: University of Edinburgh

The Effectiveness and Acceptability of the Internet-based "Smart Eating" Self-help Programme Alongside Treatment as Usual for the Management of Eating Disorders: A Pilot Study

A pilot study exploring whether individuals receiving usual treatment (CBT) from the specialist NHS Tayside Eating Disorders Service and accessing the online self-help "Smart Eating" programme have improved treatment outcomes compared to those receiving usual treatment only. The study will also explore acceptability of the "Smart Eating" self-help programme via a feedback questionnaire.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This controlled-comparison pilot study will explore whether individuals receiving usual treatment (CBT) from the specialist NHS Tayside Eating Disorders Service and accessing the online self-help "Smart Eating" programme have improved treatment outcomes compared to those receiving usual treatment only. All participants would be involved in the trial for 6 months, capturing their motivation for change, eating disorder psychopathology and quality of life at four time-points (pre-treatment, mid-treatment, end of treatment, 3-month follow-up). Some participants may continue to receive usual treatment after study end, which will be detailed in the study analysis. Following trial completion, all participants will be able to access the "Smart Eating" programme. The study will also explore acceptability of the "Smart Eating" self-help programme via a feedback questionnaire to inform programme adaptations and a possible pragmatic randomised controlled trial planned for the future. Currently, no other UK study is piloting the use of the "Smart Eating" programme as an adjunct to specialist NHS eating disorder treatment.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tayside
      • Dundee, Tayside, United Kingdom, DD3 6HH
        • NHS Tayside Eating Disorders Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged 16-65 years
  • meet diagnostic criteria for an eating disorder
  • commencing treatment under the NHS Tayside Eating Disorders Service
  • fluent in English
  • provide written consent
  • literate to the extent of understanding self-report questionnaires & following verbal instructions
  • access to a computer

Exclusion Criteria:

  • deemed too emotionally or physically frail to participate by clinical staff;
  • currently presenting with active suicidal intent;
  • unable to read English or follow verbal English instructions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Access to online self-help programme "Smart Eating" along with usual treatment from a specialist eating disorder service
Behavioral: "Smart Eating" internet-based self-help programme
An internet-based self-help programme using cognitive behavioural therapy principles to treat individuals receiving input from a specialist eating disorders service. The programme takes 3 months to complete.
NO_INTERVENTION: Control
Usual treatment from a specialist eating disorder service

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in eating disorder behaviours captured by the Eating Disorders Examination Questionnaire (EDE-Q)
Time Frame: 6 months
Improvement will be captured by a reduction in the frequency of behaviours indicative of an eating disorder over a 28-day period across the 41-item Eating Disorders Examination Questionnaire (EDE-Q)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of "Smart Eating" programme will be captured through qualitative information gathered by a feedback questionnaire
Time Frame: 6 months
Acceptability will be evaluated via a participant feedback questionnaire
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in eating psychopathology captured by the Eating Disorders Inventory 3
Time Frame: 6 months
Improvement will be captured by a reduction in symptoms indicative of an eating disorder as captured by the 91-item Eating Disorders Inventory (3 scales specific to eating disorders, 9 non-specific, general psychological scales).
6 months
Improvement in quality of life captured by an increase in scores on the SF-36 formal measure
Time Frame: 6 months
Improvement in quality of life will be captured by an increase in scores on the 36-Item Short Form Health Survey (SF-36) formal measures, whereby high scores indicate good quality of life.
6 months
Change in stage of motivation for change captured by the MSCARED formal measure
Time Frame: 6 months
Motivation for change is identified by the formal measure: Motivational Stage of Change for Adolescents Recovering from an Eating Disorder (MSCARED). The measure captures participants' current stage of change, and whether they play an active participation in recovery as identified by whether in the active, maintenance or recovery stage.
6 months
Reduction in symptoms of anxiety captured by the Beck Anxiety Inventory
Time Frame: 6 months
Improvement will be captured by a reduction in physiological and cognitive symptoms of anxiety by the 21-item formal measure the Beck Anxiety Inventory
6 months
Reduction in symptoms of depression captured by the Beck Depression Inventory II
Time Frame: 6 months
Improvement will be captured by a reduction in physiological and cognitive symptoms of depression by the 21-item formal measure the Beck Depression Inventory II.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Tayside

Investigators

  • Principal Investigator: Eleanor Filgate, MSc, NHS Tayside/University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

April 4, 2017

First Posted (ACTUAL)

April 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 28, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015MH19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A summary of study findings for participants are available on request

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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