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

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ClinicalTrials.gov Identifier: NCT03107221
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : November 30, 2017
Sponsor:
Collaborator:
NHS Tayside
Information provided by (Responsible Party):
University of Edinburgh

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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Bulimia Nervosa Binge Eating Disorder Other Specified Feeding or Eating Disorder Behavioral: "Smart Eating" internet-based self-help programme Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
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 Start Date : August 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Intervention
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
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.

No Intervention: Control
Usual treatment from a specialist eating disorder service



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107221


Locations
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United Kingdom
NHS Tayside Eating Disorders Service
Dundee, Tayside, United Kingdom, DD3 6HH
Sponsors and Collaborators
University of Edinburgh
NHS Tayside
Investigators
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Principal Investigator: Eleanor Filgate, MSc NHS Tayside/University of Edinburgh

Additional Information:
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03107221     History of Changes
Other Study ID Numbers: 2015MH19
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A summary of study findings for participants are available on request
Additional relevant MeSH terms:
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Disease
Anorexia
Bulimia
Feeding and Eating Disorders
Anorexia Nervosa
Binge-Eating Disorder
Bulimia Nervosa
Mental Disorders
Hyperphagia
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms