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Completed

NCT Number: NCT01832792

Guided Self-help for Binge Eating

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.

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Key information

Conditions

Bulimia Nervosa Binge Eating Disorder Binge-Eating Disorder Eating Disorder Not Otherwise Specified Feeding and Eating Disorders Mental Disorders

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxford Health NHS Foundation Trust

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)

Treatment and study plan

Face-to-face self-help

Other

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-help

Other

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 List

Other

Waiting list condition - participants assigned to a waiting list (no intervention) condition

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. HAq-II

    Time frame: End of Session 3 of treatment (3 weeks into treatment)

    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.

  5. 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

    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.

Other outcomes

  1. Therapist Time

    Time frame: After every contact with the patient (approx. weekly), including weekly sessions during treatment (12 weeks)

    Therapists are asked to indicate (to the nearest 5 minutes) how much time they spend doing clinical / administrative tasks for each patient (patient name not included). Although there are no formal guidelines for how therapists report their time, it should accurately record all contact with patients, and thus is suggested to be completed approximately weekly.

Sponsors and collaborators

Lead sponsor

Oxford Health NHS Foundation Trust

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 16, 2013
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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