Bulimia NervosaNCT01832792
Guided Self-help for Binge Eating
A study testing Face-to-face self-help, E-mail self-help and Waiting List in people with Bulimia Nervosa and Eating Disorder Not Otherwise Specified, run by Oxford Health NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Guided self-help (GSH) is a recommended first-step treatment for bulimia nervosa, binge eating disorder, and atypical variants of these disorders. The current study proposes to investigate the effectiveness of providing GSH either face-to-face or via e-mail, also using a delayed treatment control condition. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Bulimia Nervosa, Eating Disorder Not Otherwise Specified, Binge Eating Disorder
- What is being tested?
- Face-to-face self-help, E-mail self-help and Waiting List
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Mar 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Registration with a General Practitioner covered by Oxford Health NHS Foundation Trust (typically: Oxfordshire, Buckinghamshire, parts of Wiltshire)
- Primary diagnosis of an eating disorder with recurrent binge eating (BN, EDNOS [BN-type] or BED)
- Age above 17.5 years (box below requires whole numbers)
Who cannot join
- A severe eating disorder (e.g., one complicated by medical issues that would not be best managed by a self-help intervention)
- BMI <18.5
- Rapid weight loss (regardless of BMI)
- current excessive drug use
- active and untreated psychosis (the latter two are usually exclusion criteria to the EDS)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Health NHS Foundation Trust
Oxford, Oxfordshire, OX3 7JX
About this study
Guided self-help (GSH) is a recommended first-step treatment for bulimia nervosa, binge eating disorder, and atypical variants of these disorders. The current study proposes to investigate the effectiveness of providing GSH either face-to-face or via e-mail, also using a delayed treatment control condition. Symptom outcomes will be assessed, and an estimate of cost-effectiveness made. Results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision.
Please note that we are only able to offer the intervention to individuals who are currently registered with a General Practitioner that is covered by Oxford Health NHS Foundation Trust - this is typically restricted to practices in Oxfordshire, Buckinghamshire, and parts of Wiltshire.
- Being tested
- Face-to-face self-help, E-mail self-help, Waiting List
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face self-helpOther
Participants in this arm will receive face-to-face self-help; that is, self-help with the support of a therapist, attending the clinic in person.
E-mail self-helpOther
Participants in this arm will receive e-mail self-help; that is, self-help with the support of a therapist, provided via e-mail.
Waiting ListOther
Waiting list condition - participants assigned to a waiting list (no intervention) condition
| Study group | Role | What they receive |
|---|---|---|
| Self-help | Experimental | In this condition, participants complete a self-help intervention with the support of a therapist. This lasts 12 weeks. Receives: Other: Face-to-face self-help; Other: E-mail self-help |
| Waiting List | Other | One third of participants will be allocated to a treatment waiting list, after which they will be randomised to one of the other two arms. Receives: Other: Waiting List |
What is being measured
The primary outcome is the main question the study is designed to answer.
EDE-Q
The EDE-Q is given as a measure of eating disorder symptoms in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient's first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up. Binge eating is the primary outcome measure, with other eating disorder symptoms as secondary measures. Change in these symptoms will be assessed over the course of treatment.
Measured: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
Secondary outcomes (5)
CORE-OM
The CORE-OM is given as a measure of psychological distress in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient's first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.
Measured: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
RSES
The RSES is given as a measure of self-esteem in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient's first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.
Measured: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
CIA
The CIA is given as a measure of psychological functioning (quality of life) in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient's first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.
Measured: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
HAq-II
The Helping Alliance Questionnaire is given as a measure of therapeutic alliance after Session 3 of treatment (after 3 weeks from start of treatment) and again at end-of-treatment.
Measured: End of Session 3 of treatment (3 weeks into treatment)
Healthcare Use
A measure of healthcare use was developed for the study and is given at Start-of-treatment, End-of-treatment, and 6-month follow-up. Start-of-treatment will proceed as soon as possible after assessment; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up.
Measured: Change in healthcare use between Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- 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
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Health NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Paul E Jenkins, DClinPsychol, Principal investigator, Oxford Health NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832792
- Sponsor's protocol ID
- OxGSH1
- Status last verified
- Mar 2017
- First submitted
- 9 Apr 2013
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jenkins PE, Luck A, Burrows A, Boughton N. Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial. Trials. 2014 May 22;15:181. doi: 10.1186/1745-6215-15-181.
PubMed 24886555
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Self-help for Binge Eating
- ClinicalTrials.gov ID
- NCT01832792
- Acronym / sponsor ID
- OxGSH1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Oxford Health NHS Foundation TrustOther government
- Study start
- Aug 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 Apr 2013 (estimated)
- 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.
Guided self-help (GSH) is a recommended first-step treatment for bulimia nervosa, binge eating disorder, and atypical variants of these disorders. The current study proposes to investigate the effectiveness of providing GSH either face-to-face or via e-mail, also using a delayed treatment control condition. Symptom outcomes will be assessed, and an estimate of cost-effectiveness made. Results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision.
Please note that we are only able to offer the intervention to individuals who are currently registered with a General Practitioner that is covered by Oxford Health NHS Foundation Trust - this is typically restricted to practices in Oxfordshire, Buckinghamshire, and parts of Wiltshire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help | Experimental | Other: Face-to-face self-help, Other: E-mail self-helpIn this condition, participants complete a self-help intervention with the support of a therapist. This lasts 12 weeks. |
| Waiting List | Other | Other: Waiting ListOne third of participants will be allocated to a treatment waiting list, after which they will be randomised to one of the other two arms. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Registration with a General Practitioner covered by Oxford Health NHS Foundation Trust (typically: Oxfordshire, Buckinghamshire, parts of Wiltshire)
- Primary diagnosis of an eating disorder with recurrent binge eating (BN, EDNOS [BN-type] or BED)
- Age above 17.5 years (box below requires whole numbers)
Key exclusion criteria (5 listed)
- A severe eating disorder (e.g., one complicated by medical issues that would not be best managed by a self-help intervention)
- BMI <18.5
- Rapid weight loss (regardless of BMI)
- current excessive drug use
- active and untreated psychosis (the latter two are usually exclusion criteria to the EDS)
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 |
|---|---|---|
| Face-to-face self-helpParticipants in this arm will receive face-to-face self-help; that is, self-help with the support of a therapist, attending the clinic in person. | Other | Self-help |
| E-mail self-helpParticipants in this arm will receive e-mail self-help; that is, self-help with the support of a therapist, provided via e-mail. | Other | Self-help |
| Waiting ListWaiting list condition - participants assigned to a waiting list (no intervention) condition | Other | Waiting List |
Primary outcome
EDE-Q
Time frame: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
The EDE-Q is given as a measure of eating disorder symptoms in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient's first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up. Binge eating is the primary outcome measure, with other eating disorder symptoms as secondary measures. Change in these symptoms will be assessed over the course of treatment.
5 secondary outcomes
CORE-OM
Time frame: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
RSES
Time frame: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
CIA
Time frame: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
HAq-II
Time frame: End of Session 3 of treatment (3 weeks into treatment)
Healthcare Use
Time frame: Change in healthcare use between Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up
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 4 Apr 2017.
- Derived from this study: PubMed 24886555Jenkins PE, Luck A, Burrows A, Boughton N. Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial. Trials. 2014 May 22;15:181. doi: 10.1186/1745-6215-15-181.
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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.
Paul E Jenkins, DClinPsychol principal investigator
Oxford Health NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face self-help, E-mail self-help and Waiting List in people with Bulimia Nervosa and Eating Disorder Not Otherwise Specified, run by Oxford Health NHS Foundation Trust 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 3 inclusion and 5 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 4 Apr 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?
EDE-Q (time frame: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01832792, which also lists 1 linked publication.
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 4 Apr 2017; AzTrials last refreshed its copy on 29 Oct 2026.