Clinical trial NCT03107221: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Bulimia Nervosa
Binge Eating Disorder
Other Specified Feeding or Eating Disorder
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Tayside
First posted: 2017-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Improvement in eating disorder behaviours captured by the Eating Disorders Examination Questionnaire (EDE-Q)
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability of "Smart Eating" programme will be captured through qualitative information gathered by a feedback questionnaire
timeFrame: 6 months
Other outcomes:
measure: Improvement in eating psychopathology captured by the Eating Disorders Inventory 3
timeFrame: 6 months
measure: Improvement in quality of life captured by an increase in scores on the SF-36 formal measure
timeFrame: 6 months
measure: Change in stage of motivation for change captured by the MSCARED formal measure
timeFrame: 6 months
measure: Reduction in symptoms of anxiety captured by the Beck Anxiety Inventory
timeFrame: 6 months
measure: Reduction in symptoms of depression captured by the Beck Depression Inventory II
timeFrame: 6 months
Locations:
city: Dundee
country: United Kingdom
facility: NHS Tayside Eating Disorders Service
state: Tayside
Study officials:
affiliation: NHS Tayside/University of Edinburgh
name: Eleanor Filgate, MSc
role: PRINCIPAL_INVESTIGATOR
References: