Targeted prevention for women with subclinical anorexia nervosa - Student Bodies-AN (SB-AN)
| ISRCTN | ISRCTN70380261 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70380261 |
| Secondary identifying numbers | 2012_A01 |
- Submission date
- 03/04/2014
- Registration date
- 22/04/2014
- Last edited
- 08/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Anorexia nervosa (AN) is a condition with serious medical and psychological complications, high mortality and rather poor long-term outcome. Despite the seriousness of the disorder, there have not been a lot of studies. Early treatments before the onset of the full disorder are therefore urgently needed. Existing treatments do not specifically target women most at risk of AN (who have lower body weight and/or high restrained eating in addition to high weight and shape concerns). An initial study showed that recruitment of women at risk of AN is feasible, and that compliance with the treatment was good. The aim of this study is to assess how well a new approach, called Student Bodies AN (SB-AN), works.
Who can participate?
Women aged 18 and diagnosed with AN.
What does the study involve?
Participants will be randomly allocated to one of two groups: Student Bodies AN (SB-AN) group or waiting-list group. SB-AN is an internet-based cognitive-behavioural prevention program which consists of 10 weekly sessions and a booster session and which includes interactive components moderated by trained clinical psychologists. Further assessments will take place at the end of the study , then 6 and 12 months later. Participants in the waiting list group will be offered SB-AN after 12 months.
What are the possible benefits and risks of participating?
There are no risks for the participants. Participants whose eating disorder gets worse during the treatment will be referred to outpatient treatment clinics or will be helped to find a therapist. Future women at risk of AN may benefit from the development and evaluation of a treatment that works at low cost.
Where is the study run from?
Participants will be recruited through German universities (planned cities: Dresden, Halle, Leipzig, Berlin, Hamburg) and two higher-risk environments (eg advisory center for eating disorders ANAD e. V., Munich) via local media.
When is the study starting and how long is it expected to run for?
November 2012 to November 2015.
Who is funding the study?
Else Kröner-Fresenius-Stiftung (Germany)
Who is the main contact?
Prof. Dr. Corinna Jacobi
corinna.jacobi@tu-dresden.de
Contact information
Scientific
Technische Universität Dresden
Klinische Psychologie und Psychotherapie
Chemnitzer Straße 46
Dresden
01187
Germany
| Phone | +49 (0) 351 463 38576 |
|---|---|
| corinna.jacobi@tu-dresden.de |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Targeted prevention for women with subclinical anorexia nervosa - Student Bodies-AN (SB-AN): a randomized controlled trial |
| Study acronym | SB-AN |
| Study objectives | Women with subclinical anorexia nervosa participating in an indicated, internet-based prevention program (SB-AN) will show significantly fewer eating disorder symptoms compared to a wait-list control group at 12-month follow-up. At 12-month follow-up, initially underweight women (17.5 ≤ BMI ≤ 19) of the SB-AN intervention group will show a significantly higher BMI in comparison to a wait-list control group. On 23/06/2015 the target number of participants was changed from 143 to 168. |
| Ethics approval(s) | Dresden Technical University Ethics Committee, main approval: 26/09/2012, approvals for amendments: 25/04/2013, 10/09/2013, 21/02/2014, Ref: EK264082012 |
| Health condition(s) or problem(s) studied | Women with subclinical anorexia nervosa and/or at risk for the development of anorexia nervosa |
| Intervention | Eligible women (aged 18 and above) will be screened at universities in different cities in Germany (planned cities: Dresden, Halle, Leipzig, Berlin, Hamburg) and two higher-risk environments. Following informed consent, primary and secondary outcomes as well as inclusion and exclusion criteria will be assessed via interview and self-report questionnaires. Participants fulfilling the inclusion criteria will be randomized to one of the following two groups: 1. Student Bodies AN (SB-AN): the Internet-based cognitive-behavioral prevention programme (Student Bodies-AN) consists of 10 weekly sessions and a booster session and is moderated by trained clinical psychologists supervised by the study PI. Further assessments will take place at post-intervention, 6- and 12-month follow-up. 2. Waiting list condition: participants will be offered SB-AN after the 12-month follow-up. |
| Intervention type | Other |
| Primary outcome measure | 1. The rates (%) of participants with a decrease in the Eating Disorder Examination (EDE) total score below a score of 1.87 between pre-intervention and 12-month follow-up 2. The rates (%) of underweight participants with a BMI increase of at least 0.8 kg/m² between pre-intervention and 12-month follow-up |
| Secondary outcome measures | The following outcomes will be measured at baseline, after the last session of SB-AN (10 weeks), six months after the program was finished and 12 months after the program was finished: 1. Eating Disorder Examination subscales (EDE-Weight Concern, EDE-Shape Concern, EDE-Eating Concern, EDE-Restraint) 2. Number of binges (for binge eating subgroup) 3. Frequency of participants fulfilling criteria for EDNOS The following outcomes will be measured at baseline, after the fifth session of SB-AN, after the last session of SB-AN (10 weeks), six months after the program was finished, 12 months after the program was finished: 1. Weight Concern Scale (WCS) 2. Eating Disorder Inventory-2 (EDI-2), subscales: Drive for Thinness, Bulimia, Body Dissatisfaction 3. Beck Depression Inventory-II (BDI-II) 4. Brief Symptom Inventory (BSI) 5. Exercise Dependence Questionnaire (EDQ) 6. Frost Multidimensional Perfectionism Scale (FMPS) 7. Clinical Impairment Assessment (CIA) 8. Knowledge test |
| Overall study start date | 15/11/2012 |
| Completion date | 15/11/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | To be allocated to intervention and control conditions: N=168 |
| Total final enrolment | 168 |
| Key inclusion criteria | 1. Age ≥ 18 years 2. Informed consent 3. Female gender 4. High weight and shape concerns (WCS > 42) 5. 17.5 ≤ BMI ≤ 21 OR 21 < BMI ≤ 25 AND restrictive eating (EDE-Q Restraint ≥ 2.6; = more than 1 SD above the mean of healthy controls) |
| Key exclusion criteria | 1. Current full-syndrome (DSM-IV) anorexia nervosa, bulimia nervosa or binge eating disorder 2. Serious medical or mental problems that would prohibit participation in the trial, i.e. current substance abuse, acute or chronic organic or schizophrenic psychosis 3. Severe suicidal ideation or behavior 4. No Internet access |
| Date of first enrolment | 15/11/2012 |
| Date of final enrolment | 15/11/2015 |
Locations
Countries of recruitment
- Germany
Study participating centre
01187
Germany
Sponsor information
Charity
Postfach 1852
61288 Bad Homburg v.d.H
Bad Homburg v.d.H.
61288
Germany
| Phone | +49 (0)6172 8975 0 |
|---|---|
| kontakt@ekfs.de | |
| Website | http://www.ekfs.de/de/start.html |
"ROR" |
https://ror.org/03zcxha54 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Else Kroener-Fresenius-Stiftung, Else Kröner Fresenius-Stiftung, Else Kroner-Fresenius Foundation, EKFS
- Location
- Germany
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 02/06/2022 | 08/06/2022 | Yes | No |
Editorial Notes
08/06/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added.
