Condition category
Mental and Behavioural Disorders
Date applied
05/02/2007
Date assigned
02/04/2007
Last edited
05/02/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
While most women with bulimia nervosa experience short-term benefits from treatment, relapse rates are high and especially the first months after achieving abstinence from binge eating and purging are critical. The aim of our study is to examine whether an internet-based aftercare program for women who have successfully completed specialized inpatient treatment can help reduce relapse risk. The program runs over 9 months and is guided by clinical psychologists specialized in eating disorder treatment.

Who can participate?
Women aged 18 and over who received inpatient treatment for bulimia nervosa in 13 cooperating psychosomatic hospitals in Germany are eligible to be enrolled in the study.

What does the study involve?
Study participants will be randomly assigned to one of two groups. The women in the intervention group will receive the internet-based aftercare program for 9 months after hospital discharge in addition to their usual treatment. The women in the control group will only receive their usual treatment. Both groups will be interviewed about their eating disorder symptoms via telephone 9 and 18 months after hospital discharge and we will then compare the two groups.

What are the possible benefits and risks of participating?
We hope that women who participate in the program will decrease their relapse risk. The women in the control group will have an opportunity to receive the treatment after the study is completed. During the study period, participants will be asked to monitor eating disorder symptoms. This may cause temporary discomfort in some individuals.

Where is the study run from?
The study is run by the Institute of Clinical Psychology and Psychotherapy at Technische Universität Dresden (Germany).

When is the study starting and how long is it expected to run for?
Recruitment started in August 2007 and was completed by January 2012.

Who is funding the study?
The study is funded by the German Federal Ministry of Education and Research.

Who is the main contact?
Prof. Dr Corinna Jacobi
Corinna.Jacobi@tu-dresden.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Corinna Jacobi

ORCID ID

Contact details

Technische Universität Dresden
Klinische Psychologie und Psychotherapie
Chemnitzer Strasse 46
01187
Dresden
01187
Germany
+49 (0)351 463 38576
cjacobi@psychologie.tu-dresden.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

011GV0603

Study information

Scientific title

Internet-based aftercare for eating disorders following inpatient treatment: randomized controlled trial for bulimia nervosa

Acronym

IN@

Study hypothesis

Current hypothesis as of 17/04/2014, according to the study protocol approved in July 2007:
Bulimic patients participating in an Internet-based aftercare program after inpatient treatment will have a significantly higher abstinence rate in comparison to a treatment-as-usual control group at post-treatment (after 9 months) and at 18-month follow-up.

Previous hypothesis:
Bulimic patients participating in an Internet-based relapse prevention program after inpatient treatment will have a significantly lower rate of of binges and purges in comparison to a treatment-as-usual control group at post-treatment (after 9 months) and at one-year follow-up.

The following changes to the trial record were made on 17/04/2014, according to the study protocol approved in July 2007:
1. The public title was changed from 'Internet-based relapse prevention for eating disorders following inpatient treatment: randomized controlled trial for bulimia nervosa' to 'Internet-based aftercare for eating disorders following inpatient treatment: randomized controlled trial for bulimia nervosa'
2. The study design was changed from 'Multi-center prospective randomised superiority trial with two parallel arms' to 'Prospective randomised superiority trial with two parallel arms'
3. The overall trial end date was changed from 31/12/2009 to 31/12/2013

Ethics approval

Ethikkommission, Technische Universität Dresden, Ref: EK247112006

Study design

Prospective randomised superiority trial with two parallel arms

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Bulimia nervosa (eating disorders)

Intervention

Current interventions as of 17/04/2014, according to the study protocol approved in July 2007:
1. Nine-month Internet-based aftercare program in addition to Treatment As Usual (TAU)
2. Treatment As Usual (TAU)

Previous interventions:
1. Nine-month Internet-based relapse prevention program
2. Treatment As Usual (TAU)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Current primary outcome measures as of 17/04/2014, according to the study protocol approved in July 2007:
The primary efficacy endpoint will be the percentage of patients abstinent from core bulimia nervosa behaviors at the end of the treatment (9 months). Abstinence is defined as the absence of binge eating and inappropriate compensatory behaviour (e.g., vomiting) for at least two months at post-intervention.

Previous primary outcome measures:
The primary efficacy endpoint will be the frequency of relapses at the end of the treatment (12 month). Relapses are defined as the presence of binging and/or inappropriate compensatory behaviour (i.e. including vomiting) at least twice per week for three months during the 12 month follow-up.

Secondary outcome measures

Current secondary outcome measures as of 17/04/2014, according to the study protocol approved in July 2007:
1. Abstinence from core bulimia nervosa behaviours at follow-up (18 months after randomization)
2. Eating disorder diagnoses (as measured by Structured Inventory for Anorexic and Bulimic Syndromes) at the end of treatment and follow-up
3. Changes in eating disorder related behaviours and attitudes (as measured by Eating Disorder Inventory and Eating Disorder Examination Questionnaire) between baseline and end-of-treatment/follow-up
4. Changes in general psychopathology (as measured by global severity index of the BSI) between baseline and end-of-treatment/follow-up
5. Changes in depressive symptoms (as measured by BDI) between baseline and end-of-treatment/follow-up
6. Changes in impulsiveness (as measured by Barrat Impulsiveness Scale) between baseline and end-of-treatment/follow-up
7. Changes in self-esteem (as measured by Rosenberg Self Esteem Scale) between baseline and end-of-treatment/follow-up

Previous secondary outcome measures:
1. Expert interviews for the assessment of primary and secondary outcomes (T0, T1, T3):
1.1. Structured Inventory for Anorexic and Bulimic Syndromes (SIAB-EX)
1.2. Psychiatric Status Rating (PSR)
1.3. Structured Clinical Interview for DSM-IV (SCID-I)
2. Self-rating instruments (T0, T1, T2a-e, T3):
2.1. Eating Disorder Inventory (EDI-2)
2.2. SIAB-S self-rating
2.3. Symptom-Checklist (SCL-56)
2.4. Barrett Impulsiveness Scale (BIS-11)

Overall trial start date

01/04/2007

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age at least 16 years
2. Informed consent by patient and - if necessary - by her legal guardian
3. Female
4. Diagnosis of bulimia nervosa (BN) according to DSM-IV-TR at the time of admission to inpatient treatment
5. Successful completion of inpatient treatment as defined by at least 50% reduction in binge eating and purging during the last two weeks prior to discharge from inpatient treatment

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

To be allocated to intervention and control conditions: 258

Participant exclusion criteria

1. Mental or physical condition that does not allow the patient's participation in the trial
2. Acute psychosis, chronic organic or schizophrenic psychosis
3. Severe suicidal ideation or behaviour
4. Premature discharge from inpatient treatment

Recruitment start date

01/08/2007

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Technische Universität Dresden
Dresden
01187
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research (Germany)

Sponsor details

Projektträger im DLR
Heinrich-Konen-Str. 1
53227
Bonn
53227
Germany
+49 (0)228 3821 269
martin.goller@dlr.de

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Federal Ministry of Education and Research (Germany)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

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

Publication citations

Additional files

Editorial Notes