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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Edinburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NHS Tayside

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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