Online treatment of bulimia nervosa

ISRCTN	ISRCTN06477195
DOI	https://doi.org/10.1186/ISRCTN06477195
Secondary identifying numbers	N/A

Submission date: 30/03/2010
Registration date: 14/04/2010
Last edited: 09/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Mr Bart Schrieken
Scientific

Postbus 3884
Amsterdam
1001AR
Netherlands

Phone	+31 (0)20 798 8300
Email	schrieken@interapy.nl

Study information

Study design	Single centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Can be found at http://www.vn.nl/extra/pdf/Fact%20bulimia.pdf (Dutch only)
Scientific title	Online cognitive behavioural treatment of bulimia nervosa: a randomised controlled trial with a one-year follow-up
Study hypothesis	In comparison to bibliotherapy and a waitlist, online (therapist-assisted) cognitive behaviour therapy is more effective in reducing bulimic symptoms.
Ethics approval(s)	Study Review Board of the Department of Clinical Psychology of the University of Amsterdam approved in March 2006
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
Primary outcome measure	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 study start date	01/07/2006
Overall study end date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	105
Total final enrolment	105
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 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

Study participating centre

Postbus 3884

Amsterdam
1001AR
Netherlands

Sponsor information

Interapy PLC (Netherlands)
Industry

Postbus 3884
Amsterdam
1001AR
Netherlands

Phone	+31 (0)20 798 8300
Email	research@interapy.nl
Website	http://www.interapy.nl

Funders

Funder type

Research organisation

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		01/03/2009		Yes	No
Results article		01/02/2012	09/04/2021	Yes	No

Editorial Notes

09/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.