Eating DisorderssBodyProjectNCT02567890
Swedish Body Project for Prevention of Eating Disorders
A study testing Internet-based DBI and Expressive writing in people with Eating Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Women in general and young girls in particular are constantly exposed to unhealthy body and appearance ideals through media that contribute to body dissatisfaction and unhealthy behaviors such as rigid dieting, which in interaction with genes and other factors increase the risk of developing eating disorders such as… Read more about this study
- Who is it for?
- Ages 15 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Internet-based DBI and Expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 443 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2015to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Must have self-reported body dissatisfaction that is an established risk factor for the development of eating disorders.
Who cannot join
- Those who meet the diagnostic criteria for any eating disorder diagnosis, body dysmorphic disorder, or other serious conditions (e.g., bipolar disorders, schizophrenia) that require psychiatric care will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interactive Internet-based Program for Prevention of Eating Disorders on a Broad Basis
Women in general and young girls in particular are constantly exposed to unhealthy body and appearance ideals through media that contribute to body dissatisfaction and unhealthy behaviors such as rigid dieting, which in interaction with genes and other factors increase the risk of developing eating disorders such as anorexia nervosa and bulimia nervosa. The investigators aim is to investigate the extent to which an interactive prevention program, delivered through Internet, called the Swedish Body Project (sBody Project) can decrease the emergence of eating disorders among young females. The sBody Project is based on a "Dissonance-Based Intervention: (DBI)" that has shown very promising results. The adaptations and changes in the format of delivery accomplished in this study might help to disseminate the program on a broad basis, and consequently affect the health of young females on a much larger scale the ever before.
Read the detailed description
OVERALL AIM AND RESEARCH QUESTIONS The overall aim of this project is to adapt the DBI to be implementable on a large scale by means of interactive groups working online, and new methods for easily and effectively training program facilitators), with recruitment using the model of social media (e.g., through various websites, collaborative projects, and blogs that are popular among the youth), and to evaluate the effect of the adapted version of the DBI. The program will remain interactive, and its effect can most probably be maintained over time to a higher degree than when implemented in its original format, as booster sessions can easily be included with no major problems in terms of logistics, meetings, allocation of participants, etc. The new format will also provide a framework for recruitment which reduces the risk of stigmatization.
Research questions
- How effective is the Internet-based DBI, immediately after the intervention and 6, 12, 18, and 24 months later, to reduce the onset of eating disorders?
- What channels in the Internet / social media leads to the best recruitment of the target group?
- Can further use and implementation of Internet-based DBI be maintained through a collaborative project (e.g., Wikipreventia) where the principles and methods of implementation (from the training of facilitators to recruitment, implementation and evaluation) are described, facilitated, and the experiences are accumulated?
- Is the adapted DBI cost-effective?
- Secondary questions concern the new format's potential for engaging the participants in booster sessions, degree of stigma in recruitment, mediators and moderators of outcome, and subgroup analyses.
STUDY DESIGN, MATERIAL AND METHODS Study Design The DBI will be adapted to be widely implemented and delivered via Internet and through a mobile "app", while maintaining its interactivity and underlying principles and theories. An initial evaluation of this model, although in a simpler format than what is proposed here, has shown promising results.
In a randomized trial, a total of at least 400 girls aged 15-18 with self-reported high levels of body dissatisfaction that is an established risk factor for the development of eating disorders will be randomized into three groups:
- Internet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring,
- Expressive Writing (placebo/attention control), and
- A wait-list control condition.
Those in the wait-list condition will randomized into one of the active interventions as soon as they have done a 6-month follow-up assessment. Direct and long-term effects of the interventions (6, 12, 18, and 24 months post-intervention) will be investigated by systematic measurements.
Study population and sample size Following the ethical guidelines from the Swedish Research Council, informed consent will be obtained, and an initial assessment (telephone interview) will be conducted. Those who meet the diagnostic criteria for any eating disorder, body dysmorphic disorder, or other serious conditions that require psychiatric care will be excluded. A booster session will be available every six months.
With an effect size of d=.32 between the DBI and the active control condition regarding the main outcome variable (eating disorder pathology), with three conditions in total, and at least 3 measurements (pre, post and 6-months follow-up) the investigators need at least 260 participants with p < .05, an expected drop-out of 15%, and reliability of measures set between .75 and .95 to attain a power of at least .95. Given the recruitment channels, the investigators expect a much larger number than 260 to participate in the study, and to ensure adequate power for analyses using random effects and to take further drop-out over time into consideration the investigators aim for at least 400 participants.
Procedure Participants will be recruited through notes in different social media and the website of the project that will be linked to different fora which are known to engage adolescent girls. After obtaining informed consent, participants will be asked to download the "app" used for the study. Participants will then be asked to respond to the set of questionnaires (pre-intervention assessment) using a secure plattform, and they will be interviewed. They will then be asked to await feedback, and if included allocation to a group. Participants with significantly high scores on measures of depressive symptomatology or potential diagnosis of dysmorphophobia, eating disorders will be advised to seek professional help, and receive guidance on how to do it. The rest of the participants will be randomized to the study arms. They will then receive further information about their participations and use of the app.
The first session will be initiated by the facilitators who introduce basic issues about body image and the thin ideal.
The day before, and an hour before each meeting, the participants would receive a reminder.
The sessions will be each one hour long. The facilitators will guide the participants through the content of each session following a written manual. Participants who miss a session will be asked to listen to the recorded session ahead of the next session, and briefly discuss it with a facilitator.
Those randomized to Expressive Writing condition will be asked to reflect upon issues related to body image and self-concept according to a manual.
Participants will be asked to respond to the post-intervention assessment battery after the end of the fourth session. They will also be invited to participate in the booster sessions provided after the end of the intervention, and to respond to the follow-up assessments.
- Conditions
- Eating Disorders
- Being tested
- Internet-based DBI, Expressive writing
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based DBIBehavioural
Also called sBody Project
Participants will go through a four week interactive program that will improve body acceptance. Includes some homework assignments and monitoring.
Expressive writingBehavioural
Participants will be asked to reflect upon issues related to body image.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based DBI | Experimental | Internet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring Receives: Behavioral: Internet-based DBI |
| Expressive writing | Placebo comparator | Expressive Writing (placebo/attention control) where participants write texts. This is the active control condition. Receives: Behavioral: Expressive writing |
| Waiting list | No intervention | A wait-list control condition.Those in the wait-list condition will not receive any treatment until they have done the 6-month follow-up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the occurrence of Eating disorder diagnosis
Diagnostic interview to establish the diagnoses of eating disorders
Measured: 6 12, 18 and 24 months after the completed intervention that lasts 4 weeks
Secondary outcomes (8)
Composite EDE score
Standardised and summed scores of the EDE diagnostic items
Measured: Pre-assessment, and 6, 12, and 24 months post intervention
Self-reported ED symptoms based on the Eating Disorder Diagnostic Scale
Global symptom severity
Measured: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Positive and Negative Affect
Measured by the Positive and Negative Affect Schedule (PNAS),
Measured: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Restraint
Restraint subscale of the Eating Disorders Examination Questionnaire
Measured: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Functional impairment due to eating disorder problems
Measured by the Clinical Impairment Assessment
Measured: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Satisfaction and dissatisfaction with body parts
Measured by the Body Parts Dissatisfaction Scale
Measured: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Internalization of the thin beauty ideal
Measured by Ideal Body Stereotype Scale-revised
Measured: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Body shape dissatisfaction
Measured by the Body Shape Questionnaire
Measured: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startSep 2015
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Oregon Research Institute
- Responsible party
- Principal investigator, Ata Ghaderi, Karolinska Institutet
- Investigators
- Ata Ghaderi, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567890
- Sponsor's protocol ID
- P14-0838:1
- Acronym
- sBodyProject
- Status last verified
- Aug 2019
- First submitted
- 30 Sep 2015
- Last updated
- 5 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Stice E, Shaw H. Eating disorder prevention programs: a meta-analytic review. Psychol Bull. 2004 Mar;130(2):206-27. doi: 10.1037/0033-2909.130.2.206.
PubMed 14979770Stice E, Rohde P, Durant S, Shaw H. A preliminary trial of a prototype Internet dissonance-based eating disorder prevention program for young women with body image concerns. J Consult Clin Psychol. 2012 Oct;80(5):907-16. doi: 10.1037/a0028016. Epub 2012 Apr 16.
PubMed 22506791Stice E, Schupak-Neuberg E, Shaw HE, Stein RI. Relation of media exposure to eating disorder symptomatology: an examination of mediating mechanisms. J Abnorm Psychol. 1994 Nov;103(4):836-40. doi: 10.1037//0021-843x.103.4.836.
PubMed 7822589Stice E, Shaw H, Becker CB, Rohde P. Dissonance-based Interventions for the prevention of eating disorders: using persuasion principles to promote health. Prev Sci. 2008 Jun;9(2):114-28. doi: 10.1007/s11121-008-0093-x. Epub 2008 May 28.
PubMed 18506621Stice E, Shaw H, Marti CN. A meta-analytic review of eating disorder prevention programs: encouraging findings. Annu Rev Clin Psychol. 2007;3:207-31. doi: 10.1146/annurev.clinpsy.3.022806.091447.
PubMed 17716054Stice E, Trost A, Chase A. Healthy weight control and dissonance-based eating disorder prevention programs: results from a controlled trial. Int J Eat Disord. 2003 Jan;33(1):10-21. doi: 10.1002/eat.10109.
PubMed 12474195White JH. Women and eating disorders, Part I: Significance and sociocultural risk factors. Health Care Women Int. 1992 Oct-Dec;13(4):351-62. doi: 10.1080/07399339209516013.
PubMed 1478897Welch E, Miller JL, Ghaderi A, Vaillancourt T. Does perfectionism mediate or moderate the relation between body dissatisfaction and disordered eating attitudes and behaviors? Eat Behav. 2009 Aug;10(3):168-75. doi: 10.1016/j.eatbeh.2009.05.002. Epub 2009 May 21.
PubMed 19665100Welch E, Lagerstrom M, Ghaderi A. Body shape questionnaire: psychometric properties of the short version (BSQ-8C) and norms from the general Swedish population. Body Image. 2012 Sep;9(4):547-50. doi: 10.1016/j.bodyim.2012.04.009. Epub 2012 Jun 19.
PubMed 22721875Welch E, Birgegard A, Parling T, Ghaderi A. Eating disorder examination questionnaire and clinical impairment assessment questionnaire: general population and clinical norms for young adult women in Sweden. Behav Res Ther. 2011 Feb;49(2):85-91. doi: 10.1016/j.brat.2010.10.010. Epub 2010 Nov 2.
PubMed 21185552Treasure J, Macare C, Mentxaka IO, Harrison A. The use of a vodcast to support eating and reduce anxiety in people with eating disorder: A case series. Eur Eat Disord Rev. 2010 Nov-Dec;18(6):515-21. doi: 10.1002/erv.1034.
PubMed 20669153Ghaderi A, Stice E, Andersson G, Eno Persson J, Allzen E. A randomized controlled trial of the effectiveness of virtually delivered Body Project (vBP) groups to prevent eating disorders. J Consult Clin Psychol. 2020 Jul;88(7):643-656. doi: 10.1037/ccp0000506.
PubMed 32551736
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interactive Internet-based Program for Prevention of Eating Disorders on a Broad Basis
- ClinicalTrials.gov ID
- NCT02567890
- Acronym / sponsor ID
- sBodyProject / P14-0838:1
- Conditions
- Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Linkoeping University, Oregon Research Institute
- Study start
- Sep 2015
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women in general and young girls in particular are constantly exposed to unhealthy body and appearance ideals through media that contribute to body dissatisfaction and unhealthy behaviors such as rigid dieting, which in interaction with genes and other factors increase the risk of developing eating disorders such as anorexia nervosa and bulimia nervosa. The investigators aim is to investigate the extent to which an interactive prevention program, delivered through Internet, called the Swedish Body Project (sBody Project) can decrease the emergence of eating disorders among young females. The sBody Project is based on a "Dissonance-Based Intervention: (DBI)" that has shown very promising results. The adaptations and changes in the format of delivery accomplished in this study might help to disseminate the program on a broad basis, and consequently affect the health of young females on a much larger scale the ever before.
Detailed description
OVERALL AIM AND RESEARCH QUESTIONS The overall aim of this project is to adapt the DBI to be implementable on a large scale by means of interactive groups working online, and new methods for easily and effectively training program facilitators), with recruitment using the model of social media (e.g., through various websites, collaborative projects, and blogs that are popular among the youth), and to evaluate the effect of the adapted version of the DBI. The program will remain interactive, and its effect can most probably be maintained over time to a higher degree than when implemented in its original format, as booster sessions can easily be included with no major problems in terms of logistics, meetings, allocation of participants, etc. The new format will also provide a framework for recruitment which reduces the risk of stigmatization.
Research questions
- How effective is the Internet-based DBI, immediately after the intervention and 6, 12, 18, and 24 months later, to reduce the onset of eating disorders?
- What channels in the Internet / social media leads to the best recruitment of the target group?
- Can further use and implementation of Internet-based DBI be maintained through a collaborative project (e.g., Wikipreventia) where the principles and methods of implementation (from the training of facilitators to recruitment, implementation and evaluation) are described, facilitated, and the experiences are accumulated?
- Is the adapted DBI cost-effective?
- Secondary questions concern the new format's potential for engaging the participants in booster sessions, degree of stigma in recruitment, mediators and moderators of outcome, and subgroup analyses.
STUDY DESIGN, MATERIAL AND METHODS Study Design The DBI will be adapted to be widely implemented and delivered via Internet and through a mobile "app", while maintaining its interactivity and underlying principles and theories. An initial evaluation of this model, although in a simpler format than what is proposed here, has shown promising results.
In a randomized trial, a total of at least 400 girls aged 15-18 with self-reported high levels of body dissatisfaction that is an established risk factor for the development of eating disorders will be randomized into three groups:
- Internet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring,
- Expressive Writing (placebo/attention control), and
- A wait-list control condition.
Those in the wait-list condition will randomized into one of the active interventions as soon as they have done a 6-month follow-up assessment. Direct and long-term effects of the interventions (6, 12, 18, and 24 months post-intervention) will be investigated by systematic measurements.
Study population and sample size Following the ethical guidelines from the Swedish Research Council, informed consent will be obtained, and an initial assessment (telephone interview) will be conducted. Those who meet the diagnostic criteria for any eating disorder, body dysmorphic disorder, or other serious conditions that require psychiatric care will be excluded. A booster session will be available every six months.
With an effect size of d=.32 between the DBI and the active control condition regarding the main outcome variable (eating disorder pathology), with three conditions in total, and at least 3 measurements (pre, post and 6-months follow-up) the investigators need at least 260 participants with p < .05, an expected drop-out of 15%, and reliability of measures set between .75 and .95 to attain a power of at least .95. Given the recruitment channels, the investigators expect a much larger number than 260 to participate in the study, and to ensure adequate power for analyses using random effects and to take further drop-out over time into consideration the investigators aim for at least 400 participants.
Procedure Participants will be recruited through notes in different social media and the website of the project that will be linked to different fora which are known to engage adolescent girls. After obtaining informed consent, participants will be asked to download the "app" used for the study. Participants will then be asked to respond to the set of questionnaires (pre-intervention assessment) using a secure plattform, and they will be interviewed. They will then be asked to await feedback, and if included allocation to a group. Participants with significantly high scores on measures of depressive symptomatology or potential diagnosis of dysmorphophobia, eating disorders will be advised to seek professional help, and receive guidance on how to do it. The rest of the participants will be randomized to the study arms. They will then receive further information about their participations and use of the app.
The first session will be initiated by the facilitators who introduce basic issues about body image and the thin ideal.
The day before, and an hour before each meeting, the participants would receive a reminder.
The sessions will be each one hour long. The facilitators will guide the participants through the content of each session following a written manual. Participants who miss a session will be asked to listen to the recorded session ahead of the next session, and briefly discuss it with a facilitator.
Those randomized to Expressive Writing condition will be asked to reflect upon issues related to body image and self-concept according to a manual.
Participants will be asked to respond to the post-intervention assessment battery after the end of the fourth session. They will also be invited to participate in the booster sessions provided after the end of the intervention, and to respond to the follow-up assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet-based DBI | Experimental | Behavioral: Internet-based DBIInternet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring |
| Expressive writing | Placebo comparator | Behavioral: Expressive writingExpressive Writing (placebo/attention control) where participants write texts. This is the active control condition. |
| Waiting list | No intervention | –A wait-list control condition.Those in the wait-list condition will not receive any treatment until they have done the 6-month follow-up assessment. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Must have self-reported body dissatisfaction that is an established risk factor for the development of eating disorders.
Key exclusion criteria (1 listed)
- Those who meet the diagnostic criteria for any eating disorder diagnosis, body dysmorphic disorder, or other serious conditions (e.g., bipolar disorders, schizophrenia) that require psychiatric care will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based DBIAlso: sBody ProjectParticipants will go through a four week interactive program that will improve body acceptance. Includes some homework assignments and monitoring. | Behavioural | Internet-based DBI |
| Expressive writingParticipants will be asked to reflect upon issues related to body image. | Behavioural | Expressive writing |
Primary outcome
Change in the occurrence of Eating disorder diagnosis
Time frame: 6 12, 18 and 24 months after the completed intervention that lasts 4 weeks
Diagnostic interview to establish the diagnoses of eating disorders
8 secondary outcomes
Composite EDE score
Time frame: Pre-assessment, and 6, 12, and 24 months post intervention
Self-reported ED symptoms based on the Eating Disorder Diagnostic Scale
Time frame: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Positive and Negative Affect
Time frame: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Restraint
Time frame: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Functional impairment due to eating disorder problems
Time frame: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Satisfaction and dissatisfaction with body parts
Time frame: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Internalization of the thin beauty ideal
Time frame: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Body shape dissatisfaction
Time frame: Pre-assessment, and 6, 12, 18, and 24 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Background: PubMed 14979770Stice E, Shaw H. Eating disorder prevention programs: a meta-analytic review. Psychol Bull. 2004 Mar;130(2):206-27. doi: 10.1037/0033-2909.130.2.206.
- Background: PubMed 22506791Stice E, Rohde P, Durant S, Shaw H. A preliminary trial of a prototype Internet dissonance-based eating disorder prevention program for young women with body image concerns. J Consult Clin Psychol. 2012 Oct;80(5):907-16. doi: 10.1037/a0028016. Epub 2012 Apr 16.
- Background: PubMed 7822589Stice E, Schupak-Neuberg E, Shaw HE, Stein RI. Relation of media exposure to eating disorder symptomatology: an examination of mediating mechanisms. J Abnorm Psychol. 1994 Nov;103(4):836-40. doi: 10.1037//0021-843x.103.4.836.
- Background: PubMed 18506621Stice E, Shaw H, Becker CB, Rohde P. Dissonance-based Interventions for the prevention of eating disorders: using persuasion principles to promote health. Prev Sci. 2008 Jun;9(2):114-28. doi: 10.1007/s11121-008-0093-x. Epub 2008 May 28.
- Background: PubMed 17716054Stice E, Shaw H, Marti CN. A meta-analytic review of eating disorder prevention programs: encouraging findings. Annu Rev Clin Psychol. 2007;3:207-31. doi: 10.1146/annurev.clinpsy.3.022806.091447.
- Background: PubMed 12474195Stice E, Trost A, Chase A. Healthy weight control and dissonance-based eating disorder prevention programs: results from a controlled trial. Int J Eat Disord. 2003 Jan;33(1):10-21. doi: 10.1002/eat.10109.
- Background: PubMed 1478897White JH. Women and eating disorders, Part I: Significance and sociocultural risk factors. Health Care Women Int. 1992 Oct-Dec;13(4):351-62. doi: 10.1080/07399339209516013.
- Background: PubMed 19665100Welch E, Miller JL, Ghaderi A, Vaillancourt T. Does perfectionism mediate or moderate the relation between body dissatisfaction and disordered eating attitudes and behaviors? Eat Behav. 2009 Aug;10(3):168-75. doi: 10.1016/j.eatbeh.2009.05.002. Epub 2009 May 21.
- Background: PubMed 22721875Welch E, Lagerstrom M, Ghaderi A. Body shape questionnaire: psychometric properties of the short version (BSQ-8C) and norms from the general Swedish population. Body Image. 2012 Sep;9(4):547-50. doi: 10.1016/j.bodyim.2012.04.009. Epub 2012 Jun 19.
- Background: PubMed 21185552Welch E, Birgegard A, Parling T, Ghaderi A. Eating disorder examination questionnaire and clinical impairment assessment questionnaire: general population and clinical norms for young adult women in Sweden. Behav Res Ther. 2011 Feb;49(2):85-91. doi: 10.1016/j.brat.2010.10.010. Epub 2010 Nov 2.
- Background: PubMed 20669153Treasure J, Macare C, Mentxaka IO, Harrison A. The use of a vodcast to support eating and reduce anxiety in people with eating disorder: A case series. Eur Eat Disord Rev. 2010 Nov-Dec;18(6):515-21. doi: 10.1002/erv.1034.
- Derived from this study: PubMed 32551736Ghaderi A, Stice E, Andersson G, Eno Persson J, Allzen E. A randomized controlled trial of the effectiveness of virtually delivered Body Project (vBP) groups to prevent eating disorders. J Consult Clin Psychol. 2020 Jul;88(7):643-656. doi: 10.1037/ccp0000506.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ata Ghaderi, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based DBI and Expressive writing in people with Eating Disorders, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the occurrence of Eating disorder diagnosis (time frame: 6 12, 18 and 24 months after the completed intervention that lasts 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02567890, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.