Anorexia NervosaNCT03107221
Eating Disorders: Online Self-help & Usual Treatment (TAU) vs TAU Only
A study testing "Smart Eating" internet-based self-help programme in people with Anorexia Nervosa and Bulimia Nervosa, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder
- What is being tested?
- "Smart Eating" internet-based self-help programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS Tayside Eating Disorders Service
Dundee, Tayside, DD3 6HH
About this study
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
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.
Read the 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.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding or Eating Disorder
- Being tested
- "Smart Eating" internet-based self-help programme
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Smart Eating" internet-based self-help programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Access to online self-help programme "Smart Eating" along with usual treatment from a specialist eating disorder service Receives: Behavioral: "Smart Eating" internet-based self-help programme |
| Control | No intervention | Usual treatment from a specialist eating disorder service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startAug 2016
- Primary completionSep 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside
- Responsible party
- Sponsor
- Investigators
- Eleanor Filgate, MSc, Principal investigator, NHS Tayside/University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107221
- Sponsor's protocol ID
- 2015MH19
- Status last verified
- Nov 2017
- First submitted
- 12 Dec 2016
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: A summary of study findings for participants are available on request
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03107221
- Acronym / sponsor ID
- 2015MH19
- Conditions
- Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Other Specified Feeding or Eating Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Tayside
- Study start
- Aug 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: "Smart Eating" internet-based self-help programmeAccess to online self-help programme "Smart Eating" along with usual treatment from a specialist eating disorder service |
| Control | No intervention | –Usual treatment from a specialist eating disorder service |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Smart Eating" internet-based self-help programmeAn 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. | Behavioural | Intervention |
Primary outcome
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)
1 secondary outcome
Acceptability of "Smart Eating" programme will be captured through qualitative information gathered by a feedback questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Individual participant dataSharing planned: Yes. A summary of study findings for participants are available on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor Filgate, MSc principal investigator
NHS Tayside/University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Smart Eating" internet-based self-help programme in people with Anorexia Nervosa and Bulimia Nervosa, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in eating disorder behaviours captured by the Eating Disorders Examination Questionnaire (EDE-Q) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.