Bulimia NervosaNCT02940613
Using Visual Feedback to Influence Rapid Response in the Treatment of Eating Disorders
A study testing Visual feedback of symptom frequency in people with Bulimia Nervosa and Binge Eating Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
This study has two aims: 1) to test the validity of an eating disorder symptom checklist against an established clinical interview; and 2) to examine whether providing eating disorder patients with visual graphs of their symptom frequency in the early sessions of active treatment will lead to higher numbers of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bulimia Nervosa, Binge Eating Disorder
- What is being tested?
- Visual feedback of symptom frequency
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2016to 20 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI (Body Mass Index) over 19
- Diagnosis of Bulimia Nervosa, Binge Eating Disorder, or Other Specified Feeding and Eating Disorder (OSFED) Purging Disorder.
Who cannot join
- BMI below 19
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Visuals of Symptom Change Increase Rates of Rapid Response in First Weeks of CBT for Eating Disorders?
This study has two aims: 1) to test the validity of an eating disorder symptom checklist against an established clinical interview; and 2) to examine whether providing eating disorder patients with visual graphs of their symptom frequency in the early sessions of active treatment will lead to higher numbers of patients achieving a "rapid response" (65% reduction in symptoms in the first 4 weeks of treatment). Groups where patients receive visual graphs of symptom frequency will be compared with groups where patients do not receive visual graphs of symptom frequency on rates of rapid response to cognitive behavior treatment for eating disorders.
Read the detailed description
There is a growing body of research indicating that the best predictor of treatment outcome for eating disorders is a "rapid response" - or a 65% drop in symptoms such as binge eating or purging - in the first four weeks of Cognitive Behavior Treatment (CBT). Research is only now beginning to look at whether it is possible to increase the number of rapid responders by directly encouraging this behavior in patients. This study has two aims: 1) to validate information obtained about symptoms in a Weekly Symptom Checklist (WSC) against information obtained in clinical interview; and 2) to examine whether, in a context where rapid response is being discussed and actively encouraged, the rates of rapid response can be improved by providing patients with visual of symptom change in the first weeks of treatment. Investigators hypothesize that there will be significant correspondence between the WSC and clinical interview. Investigators also hypothesize that being given a visual of symptom change in the first weeks of treatment will result in higher rates of rapid response in patients being encouraged to achieve these objectives; and that rapid response will be related to higher rates of symptom remission at the end of treatment. Participants will be 40 patients diagnosed with Bulimia Nervosa, Binge Eating Disorder or Purging Disorder. These patients will be spread across 6 treatment groups. Three groups will be randomly selected (balanced across clinicians) to either receive or not receive visual feedback on change in frequency of symptoms based on their responses to the Weekly Symptom Checklist (WSC).
- Conditions
- Bulimia Nervosa, Binge Eating Disorder
- Being tested
- Visual feedback of symptom frequency
- Keywords
- Rapid response, Eating Disorders, Cognitive Behavior Therapy, Bulimia Nervosa, Binge Eating Disorder, Purging Disorder
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual feedback of symptom frequencyBehavioural
Participants receive visual feedback of their symptom frequency over the first 4 weeks of active treatment, based on information they provide on a symptom checklist.
| Study group | Role | What they receive |
|---|---|---|
| Visual feedback of symptom frequency | Experimental | Participants in this arm receive visual feedback of their symptom frequency over the first 4 weeks of active treatment, based on information they provide on a symptom checklist. Receives: Behavioral: Visual feedback of symptom frequency |
| No visual feedback of symptom frequency | No intervention | Participants in this arm complete the symptom checklist as is typically done during treatment, but receive no visual feedback of their self-reported symptom frequency over the first 4 weeks of active treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eating disorder symptoms from baseline
Symptoms will be measured using a Weekly Symptom Checklist which asks participants to indicate frequency of the previous week's eating disorder symptoms (regular eating, objective and subjective binge eating, various methods of purging).
Measured: Administered weekly up to week 25 (end of group treatment)
Secondary outcomes (1)
The behavioral section of the Eating Disorders Examination (EDE)
The behavioural section of the Eating Disorders Examination (EDE) will be modified to focus on the 28-day period directly prior to the assessment, rather than the prior 3 months as is typical. The behavioural section of the EDE assesses frequency of regular eating (i.e., meals and snacks) and frequency of eating disorder behaviours such as objective binge eating episodes, subjective binge eating episodes, frequency of self-induced vomiting, laxative use, diuretic use, and frequency and duration of exercise for compensatory or weight control purposes.
Measured: At week 6, 10, and up to 25 weeks (end of group treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: Due to COVID-19 pandemic, patients stopped attending treatment in person. Patients have not returned to in-person treatment, and there is no plan for this to occur. The study could not be conducted virtually in secure manner.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Laliberte, St. Joseph's Healthcare Hamilton
- Investigators
- Michele M Laliberte, Ph.D., Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940613
- Sponsor's protocol ID
- STJOES2016PAC
- Status last verified
- Sep 2025
- First submitted
- 18 Oct 2016
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: For reasons of confidentiality, only aggregated data will be made available.
Publications
Fairburn CG, Agras WS, Walsh BT, Wilson GT, Stice E. Prediction of outcome in bulimia nervosa by early change in treatment. Am J Psychiatry. 2004 Dec;161(12):2322-4. doi: 10.1176/appi.ajp.161.12.2322.
PubMed 15569910Agras WS, Crow SJ, Halmi KA, Mitchell JE, Wilson GT, Kraemer HC. Outcome predictors for the cognitive behavior treatment of bulimia nervosa: data from a multisite study. Am J Psychiatry. 2000 Aug;157(8):1302-8. doi: 10.1176/appi.ajp.157.8.1302.
PubMed 10910795Bulik CM, Sullivan PF, Carter FA, McIntosh VV, Joyce PR. Predictors of rapid and sustained response to cognitive-behavioral therapy for bulimia nervosa. Int J Eat Disord. 1999 Sep;26(2):137-44. doi: 10.1002/(sici)1098-108x(199909)26:23.0.co;2-n.
PubMed 10422602Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
PubMed 7866415Grilo CM, Masheb RM. Rapid response predicts binge eating and weight loss in binge eating disorder: findings from a controlled trial of orlistat with guided self-help cognitive behavioral therapy. Behav Res Ther. 2007 Nov;45(11):2537-50. doi: 10.1016/j.brat.2007.05.010. Epub 2007 Jun 7.
PubMed 17659254Grilo CM, Masheb RM, Wilson GT. Rapid response to treatment for binge eating disorder. J Consult Clin Psychol. 2006 Jun;74(3):602-13. doi: 10.1037/0022-006X.74.3.602.
PubMed 16822116Grilo CM, White MA, Wilson GT, Gueorguieva R, Masheb RM. Rapid response predicts 12-month post-treatment outcomes in binge-eating disorder: theoretical and clinical implications. Psychol Med. 2012 Apr;42(4):807-17. doi: 10.1017/S0033291711001875. Epub 2011 Sep 16.
PubMed 21923964Grilo CM, White MA, Masheb RM, Gueorguieva R. Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. J Consult Clin Psychol. 2015 Apr;83(2):387-94. doi: 10.1037/a0038635. Epub 2015 Jan 26.
PubMed 25622201MacDonald DE, Trottier K, McFarlane T, Olmsted MP. Empirically defining rapid response to intensive treatment to maximize prognostic utility for bulimia nervosa and purging disorder. Behav Res Ther. 2015 May;68:48-53. doi: 10.1016/j.brat.2015.03.007. Epub 2015 Mar 17.
PubMed 25800137Masheb RM, Grilo CM. Rapid response predicts treatment outcomes in binge eating disorder: implications for stepped care. J Consult Clin Psychol. 2007 Aug;75(4):639-44. doi: 10.1037/0022-006X.75.4.639.
PubMed 17663617McFarlane TL, MacDonald DE, Royal S, Olmsted MP. Rapid and slow responders to eating disorder treatment: a comparison on clinically relevant variables. Int J Eat Disord. 2013 Sep;46(6):563-6. doi: 10.1002/eat.22136. Epub 2013 Apr 12.
PubMed 23580395McFarlane T, Olmsted MP, Trottier K. Timing and prediction of relapse in a transdiagnostic eating disorder sample. Int J Eat Disord. 2008 Nov;41(7):587-93. doi: 10.1002/eat.20550.
PubMed 18473336Olmsted MP, Kaplan AS, Rockert W, Jacobsen M. Rapid responders to intensive treatment of bulimia nervosa. Int J Eat Disord. 1996 Apr;19(3):279-85. doi: 10.1002/(SICI)1098-108X(199604)19:33.0.CO;2-J.
PubMed 8704727Olmsted MP, MacDonald DE, McFarlane T, Trottier K, Colton P. Predictors of rapid relapse in bulimia nervosa. Int J Eat Disord. 2015 Apr;48(3):337-40. doi: 10.1002/eat.22380. Epub 2014 Dec 26.
PubMed 25545720Raykos BC, Watson HJ, Fursland A, Byrne SM, Nathan P. Prognostic value of rapid response to enhanced cognitive behavioral therapy in a routine clinic sample of eating disorder outpatients. Int J Eat Disord. 2013 Dec;46(8):764-70. doi: 10.1002/eat.22169. Epub 2013 Aug 5.
PubMed 23913536
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Visuals of Symptom Change Increase Rates of Rapid Response in First Weeks of CBT for Eating Disorders?
- ClinicalTrials.gov ID
- NCT02940613
- Acronym / sponsor ID
- STJOES2016PAC
- Conditions
- Bulimia Nervosa, Binge Eating Disorder
- Keywords
- Rapid response, Eating Disorders, Cognitive Behavior Therapy, Bulimia Nervosa, Binge Eating Disorder, Purging Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 pandemic, patients stopped attending treatment in person. Patients have not returned to in-person treatment, and there is no plan for this to occur. The study could not be conducted virtually in secure manner.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 21 Oct 2016 (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.
This study has two aims: 1) to test the validity of an eating disorder symptom checklist against an established clinical interview; and 2) to examine whether providing eating disorder patients with visual graphs of their symptom frequency in the early sessions of active treatment will lead to higher numbers of patients achieving a "rapid response" (65% reduction in symptoms in the first 4 weeks of treatment). Groups where patients receive visual graphs of symptom frequency will be compared with groups where patients do not receive visual graphs of symptom frequency on rates of rapid response to cognitive behavior treatment for eating disorders.
Detailed description
There is a growing body of research indicating that the best predictor of treatment outcome for eating disorders is a "rapid response" - or a 65% drop in symptoms such as binge eating or purging - in the first four weeks of Cognitive Behavior Treatment (CBT). Research is only now beginning to look at whether it is possible to increase the number of rapid responders by directly encouraging this behavior in patients. This study has two aims: 1) to validate information obtained about symptoms in a Weekly Symptom Checklist (WSC) against information obtained in clinical interview; and 2) to examine whether, in a context where rapid response is being discussed and actively encouraged, the rates of rapid response can be improved by providing patients with visual of symptom change in the first weeks of treatment. Investigators hypothesize that there will be significant correspondence between the WSC and clinical interview. Investigators also hypothesize that being given a visual of symptom change in the first weeks of treatment will result in higher rates of rapid response in patients being encouraged to achieve these objectives; and that rapid response will be related to higher rates of symptom remission at the end of treatment. Participants will be 40 patients diagnosed with Bulimia Nervosa, Binge Eating Disorder or Purging Disorder. These patients will be spread across 6 treatment groups. Three groups will be randomly selected (balanced across clinicians) to either receive or not receive visual feedback on change in frequency of symptoms based on their responses to the Weekly Symptom Checklist (WSC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual feedback of symptom frequency | Experimental | Behavioral: Visual feedback of symptom frequencyParticipants in this arm receive visual feedback of their symptom frequency over the first 4 weeks of active treatment, based on information they provide on a symptom checklist. |
| No visual feedback of symptom frequency | No intervention | –Participants in this arm complete the symptom checklist as is typically done during treatment, but receive no visual feedback of their self-reported symptom frequency over the first 4 weeks of active treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI (Body Mass Index) over 19
- Diagnosis of Bulimia Nervosa, Binge Eating Disorder, or Other Specified Feeding and Eating Disorder (OSFED) Purging Disorder.
Key exclusion criteria (1 listed)
- BMI below 19
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 |
|---|---|---|
| Visual feedback of symptom frequencyParticipants receive visual feedback of their symptom frequency over the first 4 weeks of active treatment, based on information they provide on a symptom checklist. | Behavioural | Visual feedback of symptom frequency |
Primary outcome
Change in eating disorder symptoms from baseline
Time frame: Administered weekly up to week 25 (end of group treatment)
Symptoms will be measured using a Weekly Symptom Checklist which asks participants to indicate frequency of the previous week's eating disorder symptoms (regular eating, objective and subjective binge eating, various methods of purging).
1 secondary outcome
The behavioral section of the Eating Disorders Examination (EDE)
Time frame: At week 6, 10, and up to 25 weeks (end of group treatment)
Results and safety
The study was stopped early (reason given: Due to COVID-19 pandemic, patients stopped attending treatment in person. Patients have not returned to in-person treatment, and there is no plan for this to occur. The study could not be conducted virtually in secure manner.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Background: PubMed 15569910Fairburn CG, Agras WS, Walsh BT, Wilson GT, Stice E. Prediction of outcome in bulimia nervosa by early change in treatment. Am J Psychiatry. 2004 Dec;161(12):2322-4. doi: 10.1176/appi.ajp.161.12.2322.
- Results publication: PubMed 10910795Agras WS, Crow SJ, Halmi KA, Mitchell JE, Wilson GT, Kraemer HC. Outcome predictors for the cognitive behavior treatment of bulimia nervosa: data from a multisite study. Am J Psychiatry. 2000 Aug;157(8):1302-8. doi: 10.1176/appi.ajp.157.8.1302.
- Results publication: PubMed 10422602Bulik CM, Sullivan PF, Carter FA, McIntosh VV, Joyce PR. Predictors of rapid and sustained response to cognitive-behavioral therapy for bulimia nervosa. Int J Eat Disord. 1999 Sep;26(2):137-44. doi: 10.1002/(sici)1098-108x(199909)26:23.0.co;2-n.
- Results publication: PubMed 7866415Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.
- Results publication: PubMed 17659254Grilo CM, Masheb RM. Rapid response predicts binge eating and weight loss in binge eating disorder: findings from a controlled trial of orlistat with guided self-help cognitive behavioral therapy. Behav Res Ther. 2007 Nov;45(11):2537-50. doi: 10.1016/j.brat.2007.05.010. Epub 2007 Jun 7.
- Results publication: PubMed 16822116Grilo CM, Masheb RM, Wilson GT. Rapid response to treatment for binge eating disorder. J Consult Clin Psychol. 2006 Jun;74(3):602-13. doi: 10.1037/0022-006X.74.3.602.
- Results publication: PubMed 21923964Grilo CM, White MA, Wilson GT, Gueorguieva R, Masheb RM. Rapid response predicts 12-month post-treatment outcomes in binge-eating disorder: theoretical and clinical implications. Psychol Med. 2012 Apr;42(4):807-17. doi: 10.1017/S0033291711001875. Epub 2011 Sep 16.
- Results publication: PubMed 25622201Grilo CM, White MA, Masheb RM, Gueorguieva R. Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. J Consult Clin Psychol. 2015 Apr;83(2):387-94. doi: 10.1037/a0038635. Epub 2015 Jan 26.
- Results publication: PubMed 25800137MacDonald DE, Trottier K, McFarlane T, Olmsted MP. Empirically defining rapid response to intensive treatment to maximize prognostic utility for bulimia nervosa and purging disorder. Behav Res Ther. 2015 May;68:48-53. doi: 10.1016/j.brat.2015.03.007. Epub 2015 Mar 17.
- Results publication: PubMed 17663617Masheb RM, Grilo CM. Rapid response predicts treatment outcomes in binge eating disorder: implications for stepped care. J Consult Clin Psychol. 2007 Aug;75(4):639-44. doi: 10.1037/0022-006X.75.4.639.
- Results publication: PubMed 23580395McFarlane TL, MacDonald DE, Royal S, Olmsted MP. Rapid and slow responders to eating disorder treatment: a comparison on clinically relevant variables. Int J Eat Disord. 2013 Sep;46(6):563-6. doi: 10.1002/eat.22136. Epub 2013 Apr 12.
- Results publication: PubMed 18473336McFarlane T, Olmsted MP, Trottier K. Timing and prediction of relapse in a transdiagnostic eating disorder sample. Int J Eat Disord. 2008 Nov;41(7):587-93. doi: 10.1002/eat.20550.
- Individual participant dataSharing planned: No. For reasons of confidentiality, only aggregated data will be made available.
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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.
Michele M Laliberte, Ph.D. principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual feedback of symptom frequency in people with Bulimia Nervosa and Binge Eating Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 2 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: stopped early, as of the sponsor's last update on 6 Oct 2025. 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 Canada. 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. 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 was stopped early (reason given: Due to COVID-19 pandemic, patients stopped attending treatment in person. Patients have not returned to in-person treatment, and there is no plan for this to occur. The study could not be conducted virtually in secure manner.). Results are not available in the source record.
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 eating disorder symptoms from baseline (time frame: Administered weekly up to week 25 (end of group treatment)). 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 NCT02940613, which also lists 20 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 6 Oct 2025.