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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding or Eating Disorder

Intervention / Treatment
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* Behavioral: Smart Eating internet-based self-help programme


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>Usual treatment from a specialist eating disorder service | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | Acceptability will be evaluated via a participant feedback questionnaire | 6 months |