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

ISRCTN	ISRCTN08870215
DOI	https://doi.org/10.1186/ISRCTN08870215
Protocol serial number	011GV0603
Sponsor	Federal Ministry of Education and Research (Germany)
Funder	Federal Ministry of Education and Research (Germany)

Submission date: 05/02/2007
Registration date: 02/04/2007
Last edited: 25/09/2017

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 of protocol

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

What does the study involve?
Participants are randomly allocated to one of two groups. The women in the intervention group receive the internet-based aftercare program for 9 months after hospital discharge in addition to their usual treatment. The women in the control group only receive their usual treatment. Both groups are 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?
It is hoped that women who participate in the program will decrease their relapse risk. The women in the control group have an opportunity to receive the treatment after the study is completed. During the study period, participants are 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?
April 2007 to December 2013

Who is funding the study?
Federal Ministry of Education and Research (Germany)

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

Contact information

Prof Corinna Jacobi
Scientific

Technische Universität Dresden
Klinische Psychologie und Psychotherapie
Chemnitzer Strasse 46
01187
Dresden
01187
Germany

Phone	+49 (0)351 463 38576
Email	cjacobi@psychologie.tu-dresden.de

Study information

Primary study design	Interventional
Study design	Prospective randomised superiority trial with two parallel arms
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Internet-based aftercare for eating disorders following inpatient treatment: randomized controlled trial for bulimia nervosa
Study acronym	IN@
Study objectives	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.
Ethics approval(s)	Ethikkommission, Technische Universität Dresden, ref: EK247112006
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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)
Completion date	31/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	258
Key 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
Key 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
Date of first enrolment	01/08/2007
Date of final enrolment	01/01/2012

Locations

Countries of recruitment

Germany

Study participating centre

Technische Universität Dresden

Dresden
01187
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/09/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/09/2017: Publication reference added.

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.