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

NCT03107221 | Completed DMC

• 1 other identifier: 2015MH19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Bulimia Nervosa; Binge Eating Disorder; Other Specified Feeding or Eating Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability of "Smart Eating" programme will be captured through qualitative information gathered by a feedback questionnaire

  6 months

Other Outcomes (5)

• Improvement in eating psychopathology captured by the Eating Disorders Inventory 3

  6 months

• Improvement in quality of life captured by an increase in scores on the SF-36 formal measure

  6 months

• Change in stage of motivation for change captured by the MSCARED formal measure

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual treatment from a specialist eating disorder service

Interventions

"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.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Tayside: collaborator

Study Sites (1)

NHS Tayside Eating Disorders Service

Dundee, Tayside, DD3 6HH, United Kingdom

Location

MeSH Terms

Conditions

Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eleanor Filgate, MSc

  NHS Tayside/University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: April 11, 2017
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 30, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)