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

Anorexia Nervosa Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107221
• Other study ID #: 2015MH19
• Status: Completed
• Phase: N/A
• First received: December 12, 2016
• Last updated: November 28, 2017
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Disease
• Feeding and Eating Disorders
• Other Specified Feeding or Eating Disorder

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	NHS Tayside Eating Disorders Service	Dundee	Tayside

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in eating psychopathology captured by the Eating Disorders Inventory 3	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
Other	Improvement in quality of life captured by an increase in scores on the SF-36 formal measure	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
Other	Change in stage of motivation for change captured by the MSCARED formal measure	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
Other	Reduction in symptoms of anxiety captured by the Beck Anxiety Inventory	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
Other	Reduction in symptoms of depression captured by the Beck Depression Inventory II	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
Primary	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	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

External Links

•   Website hosting all formal measures