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NCT Number: NCT03107221

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

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.

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Key information

Conditions

Anorexia Nervosa Binge Eating Disorder Binge-Eating Disorder Bulimia Nervosa Feeding and Eating Disorders Mental Disorders Other Specified Feeding or Eating Disorder Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Tayside Eating Disorders Service

Dundee, Tayside, DD3 6HH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"Smart Eating" internet-based self-help programme

Behavioral

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 outcomes

  1. 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)

Secondary outcomes

  1. 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

Other outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • NHS Tayside

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2017
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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