Eating Disorders: Online Self-help & Usual Treatment (TAU) vs TAU Only
Primary Purpose
Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
"Smart Eating" internet-based self-help programme
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
Eligibility Criteria
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.
Sites / Locations
- NHS Tayside Eating Disorders Service
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Access to online self-help programme "Smart Eating" along with usual treatment from a specialist eating disorder service
Usual treatment from a specialist eating disorder service
Outcomes
Primary Outcome Measures
Improvement in eating disorder behaviours captured by the Eating Disorders Examination Questionnaire (EDE-Q)
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)
Secondary Outcome Measures
Acceptability of "Smart Eating" programme will be captured through qualitative information gathered by a feedback questionnaire
Acceptability will be evaluated via a participant feedback questionnaire
Full Information
NCT ID
NCT03107221
First Posted
December 12, 2016
Last Updated
November 28, 2017
Sponsor
University of Edinburgh
Collaborators
NHS Tayside
1. Study Identification
Unique Protocol Identification Number
NCT03107221
Brief Title
Eating Disorders: Online Self-help & Usual Treatment (TAU) vs TAU Only
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Tayside
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding or Eating Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Access to online self-help programme "Smart Eating" along with usual treatment from a specialist eating disorder service
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual treatment from a specialist eating disorder service
Intervention Type
Behavioral
Intervention Name(s)
"Smart Eating" internet-based self-help programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in eating disorder behaviours captured by the Eating Disorders Examination Questionnaire (EDE-Q)
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Acceptability of "Smart Eating" programme will be captured through qualitative information gathered by a feedback questionnaire
Description
Acceptability will be evaluated via a participant feedback questionnaire
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Improvement in eating psychopathology captured by the Eating Disorders Inventory 3
Description
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).
Time Frame
6 months
Title
Improvement in quality of life captured by an increase in scores on the SF-36 formal measure
Description
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.
Time Frame
6 months
Title
Change in stage of motivation for change captured by the MSCARED formal measure
Description
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.
Time Frame
6 months
Title
Reduction in symptoms of anxiety captured by the Beck Anxiety Inventory
Description
Improvement will be captured by a reduction in physiological and cognitive symptoms of anxiety by the 21-item formal measure the Beck Anxiety Inventory
Time Frame
6 months
Title
Reduction in symptoms of depression captured by the Beck Depression Inventory II
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleanor Filgate, MSc
Organizational Affiliation
NHS Tayside/University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Tayside Eating Disorders Service
City
Dundee
State/Province
Tayside
ZIP/Postal Code
DD3 6HH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
A summary of study findings for participants are available on request
Links:
URL
http://www.smart-eating.com
Description
Website hosting all formal measures
Learn more about this trial
Eating Disorders: Online Self-help & Usual Treatment (TAU) vs TAU Only
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