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

NCT ID: NCT03107221

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Intervention

Access to online self-help programme "Smart Eating" along with usual treatment from a specialist eating disorder service

Group Type EXPERIMENTAL

"Smart Eating" internet-based self-help programme

Intervention Type 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.

Control

Usual treatment from a specialist eating disorder service

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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"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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Tayside

OTHER_GOV

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eleanor Filgate, MSc

Role: PRINCIPAL_INVESTIGATOR

NHS Tayside/University of Edinburgh

Locations

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NHS Tayside Eating Disorders Service

Dundee, Tayside, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2015MH19

Identifier Type: -

Identifier Source: org_study_id