Condition category
Mental and Behavioural Disorders
Date applied
20/08/2010
Date assigned
20/09/2010
Last edited
23/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www2.salut-ed.org/step

Contact information

Type

Scientific

Primary contact

Prof Alain Golay

ORCID ID

Contact details

Geneva University Hospitals
Service of Therapeutic Education for Chronic Diseases
Gabrielle-Perret-Gentil 4
Geneva
1211 Geneva 14
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Guided self-help treatment on the Internet for binge eating disorder: A randomised controlled trial

Acronym

Study hypothesis

The Internet program group will report improvements of eating behaviour, psychological health and quality of life compared to a control group after 6 months of intervention.
These improvements will be sustained after a 6-month follow-up

Ethics approval

The ethical committee of the University Hospitals of Geneva, Department of Community Medicine, approved on 19/11/2007 (protocol no: 07-167, ref: Med 07-045)

Study design

Single centre interventional randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Binge eating disorder

Intervention

Participants used an Internet self-help treatment program for binge eating disorder and benefited of a weekly e-mail contact with a psychologist during the time of intervention.
First group received a 6-month Internet intervention and then a 6-month follow-up. Second group had a 6-month waiting period before receiving the 6-month Internet intervention.
Assessors were not blinded to controlled conditions but assessments were conducted with self-report questionnaires, limiting biaises.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Eating Disorder Inventory (EDI-2) Bulimia subscale (Garner, Olmsted, & Polivy, 1983). Self reporting questionnaire which was chosen because it was sensitive to participants’ progress in previous studies using the Internet program.
Assessments were carried out at baseline, after 6-month intervention/waiting-list, after 6-month follow-up/intervention (= 0-6-12 months)

Secondary outcome measures

Self-report questionnaires:
1. EDI-2 subscales (Garner, Olmsted, & Polivy, 1983)
2. Eating Disorder Examination-Questionnaire (EDE-Q) (Fairburn & Beglin, 1994)
2.1. total score
2.2. number of objective binge episodes
3. Proportion of patients abstinent from bingeing (=0 binge episodes in the last 28 days)
4. Three-Factor Eating Questionnaire (TFEQ) scales (Stunkard & Messick, 1985)
5. Beck Depression Inventory-II (BDI-II) score (Beck, Steer, & Brown, 1996)
6. Symptom Check-List (SCL-90R) global severity index (Derogatis, 1977)
7. Impact of Weight on Quality of Life (IWQOL-Lite) total score (Kolotkin, Crosby, Kosloski, & Williams, 2001)
8. Rosenberg self-esteem scale (RSES) score (Rosenberg, 1965)
9. BMI (body mass index, taken out of the EDE-Q)
Assessments were carried out at baseline, after 6-month intervention/waiting-list, after 6-month follow-up/intervention (= 0-6-12 months)

Overall trial start date

08/01/2008

Overall trial end date

18/02/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women, age ≥ 18 years
2. Binge eating disorders and related eating disorders
3. 20<BMI<50

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

74

Participant exclusion criteria

1. Drug or alcohol dependence
2. Suicide attempt during the last year
3. Unmanaged severe psychiatric disorder
4. Gastric bypass
5. Current cognitive and behavioural therapy

Recruitment start date

08/01/2008

Recruitment end date

18/02/2010

Locations

Countries of recruitment

Switzerland

Trial participating centre

Geneva University Hospitals
Geneva
1211 Geneva 14
Switzerland

Sponsor information

Organisation

University Hospitals of Geneva (Switzerland)

Sponsor details

c/o Prof Alain Golay
Service of Therapeutic Education for Chronic Diseases
Gabrielle-Perret-Gentil 4
Geneva
1211 Geneva 14
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Hans Wilsdorf Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Marie Curie Research Training Network (Europe) - Individually tailored stepped care for women with eating disorders (INTACT) (MRTN-CT-2006-035988)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21641580

Publication citations

  1. Results

    Carrard I, Crépin C, Rouget P, Lam T, Golay A, Van der Linden M, Randomised controlled trial of a guided self-help treatment on the Internet for binge eating disorder., Behav Res Ther, 2011, 49, 8, 482-491, doi: 10.1016/j.brat.2011.05.004.

Additional files

Editorial Notes