Condition category
Mental and Behavioural Disorders
Date applied
30/03/2010
Date assigned
14/04/2010
Last edited
14/04/2010
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://www.interapy.nl/behandelingen/eetproblemen/index.html

Contact information

Type

Scientific

Primary contact

Mr Bart Schrieken

ORCID ID

Contact details

Postbus 3884
Amsterdam
1001AR
Netherlands
+31 (0)20 798 8300
schrieken@interapy.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Online cognitive behavioural treatment of bulimia nervosa: a randomised controlled trial with a one-year follow-up

Acronym

Study hypothesis

In comparison to bibliotherapy and a waitlist, online (therapist-assisted) cognitive behaviour therapy is more effective in reducing bulimic symptoms.

Ethics approval

Study Review Board of the Department of Clinical Psychology of the University of Amsterdam approved in March 2006

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Can be found at http://www.vn.nl/extra/pdf/Fact%20bulimia.pdf (Dutch only)

Condition

Bulimia nervosa

Intervention

The online treatment is a twenty-week program based on existing - evidence-based - treatment manuals, and incorporates cognitive behaviour therapy interventions such as psycho-education, self-monitoring, diet management, exposure, response prevention, cognitive restructuring, interventions promoting self-esteem and relapse prevention. These treatments were therapist-guided (therapist time: 7 to 14 hours).

Participants in the bibliotherapy group received a hard-copy of "Overcoming bulimia and binge eating", a Dutch self-help book for BN by Johan Vanderlinden, which is based on the same cognitive-behavioral principles as applied in the online treatment. Apart from an initial introductory e-mail with instructions how to use this book, no support was provided to participants in this group.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Global severity of eating disorder symptoms and binging and purging frequency as measured by the Eating Disorder Examination Questionnaire (EDE-Q). Primary and secondary measures were administered at pretest, immediately after treatment (post-test), six weeks after treatment, and one year after treatment.

Secondary outcome measures

Cognitive-attitudinal distortion in body experience, as measured by the Body Attitude Test (BAT). Primary and secondary measures were administered at pretest, immediately after treatment (post-test), six weeks after treatment, and one year after treatment.

Overall trial start date

01/07/2006

Overall trial end date

01/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Recurrent binging
2. Extreme weight-control behaviour (either in the form of purging as well as physical exercise)
3. Extreme concern with body shape and weight
4. Downloaded, signed, and returned an Informed Consent form
5. Aged greater than or equal to 16 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

105

Participant exclusion criteria

1. Aged less than 16 years
2. Body mass index (BMI) less than 18 kg/m^2
3. Heightened risk of dissociation or psychosis
4. Suicidal ideation indicative of plans or a history of recent suicide attempts within the past 3 years
5. Drug and alcohol abuse
6. Use of neuroleptic medication or unstable dosages of other psychiatric medication
7. Concurrent psychotherapy, or indications that another psychological disorder was prevalent

Excluded respondents were referred to their GPs or to mental health centres in their vicinity.

Recruitment start date

01/07/2006

Recruitment end date

01/07/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Postbus 3884
Amsterdam
1001AR
Netherlands

Sponsor information

Organisation

Interapy PLC (Netherlands)

Sponsor details

Postbus 3884
Amsterdam
1001AR
Netherlands
+31 (0)20 798 8300
research@interapy.nl

Sponsor type

Industry

Website

http://www.interapy.nl

Funders

Funder type

Research organisation

Funder name

The Dutch Innovation Fund of Collaborative Health Insurances (Innovatiefonds Zorgverzekeraars) (Netherlands) - awarded a grant to initiate the project

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Interapy PLC (Netherlands) - provided consultancy, technical assistance, web-application development and application hosting support

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

2009 Protocol:
Renteria-Agirre, A., Lange, A. (2009). Boulimie online overwinnen: beschrijving van een behandelprotocol via internet [Overcoming Bulimia Online: description of a treatment manual for online treatment] . Directieve Therapie, 29(1), 26-47.

Publication citations

Additional files

Editorial Notes