NCT02940613

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

October 18, 2016

Last Update Submit

September 30, 2025

Conditions

Keywords

Rapid responseEating DisordersCognitive Behavior TherapyBulimia NervosaBinge Eating DisorderPurging Disorder

Outcome Measures

Primary Outcomes (1)

  • 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).

    Administered weekly up to week 25 (end of group treatment)

Secondary Outcomes (1)

  • The behavioral section of the Eating Disorders Examination (EDE)

    At week 6, 10, and up to 25 weeks (end of group treatment)

Study Arms (2)

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.

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.

Interventions

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.

Visual feedback of symptom frequency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI (Body Mass Index) over 19
  • Diagnosis of Bulimia Nervosa, Binge Eating Disorder, or Other Specified Feeding and Eating Disorder (OSFED) Purging Disorder.

You may not qualify if:

  • BMI below 19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (20)

  • Agras 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.

    PMID: 10910795BACKGROUND
  • Bulik 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.

    PMID: 10422602BACKGROUND
  • Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.

    PMID: 7866415BACKGROUND
  • 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.

    PMID: 15569910BACKGROUND
  • Grilo 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.

    PMID: 17659254BACKGROUND
  • Grilo 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.

    PMID: 16822116BACKGROUND
  • Grilo 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.

    PMID: 21923964BACKGROUND
  • Grilo 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.

    PMID: 25622201BACKGROUND
  • MacDonald 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.

    PMID: 25800137BACKGROUND
  • Masheb 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.

    PMID: 17663617BACKGROUND
  • McFarlane 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.

    PMID: 23580395BACKGROUND
  • McFarlane 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.

    PMID: 18473336BACKGROUND
  • Olmsted 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.

    PMID: 8704727BACKGROUND
  • Olmsted 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.

    PMID: 25545720BACKGROUND
  • Raykos 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.

    PMID: 23913536BACKGROUND
  • Thompson-Brenner H, Shingleton RM, Sauer-Zavala S, Richards LK, Pratt EM. Multiple measures of rapid response as predictors of remission in cognitive behavior therapy for bulimia nervosa. Behav Res Ther. 2015 Jan;64:9-14. doi: 10.1016/j.brat.2014.11.004. Epub 2014 Nov 13.

    PMID: 25462877BACKGROUND
  • Vall E, Wade TD. Predictors of treatment outcome in individuals with eating disorders: A systematic review and meta-analysis. Int J Eat Disord. 2016 Apr;49(4):432-3. doi: 10.1002/eat.22518. No abstract available.

    PMID: 27084797BACKGROUND
  • Vaz AR, Conceicao E, Machado PP. Early response as a predictor of success in guided self-help treatment for bulimic disorders. Eur Eat Disord Rev. 2014 Jan;22(1):59-65. doi: 10.1002/erv.2262. Epub 2013 Oct 4.

    PMID: 24123526BACKGROUND
  • Wilson GT, Fairburn CC, Agras WS, Walsh BT, Kraemer H. Cognitive-behavioral therapy for bulimia nervosa: time course and mechanisms of change. J Consult Clin Psychol. 2002 Apr;70(2):267-74.

    PMID: 11952185BACKGROUND
  • Zunker C, Peterson CB, Cao L, Mitchell JE, Wonderlich SA, Crow S, Crosby RD. A receiver operator characteristics analysis of treatment outcome in binge eating disorder to identify patterns of rapid response. Behav Res Ther. 2010 Dec;48(12):1227-31. doi: 10.1016/j.brat.2010.08.007. Epub 2010 Sep 6.

    PMID: 20869041BACKGROUND

MeSH Terms

Conditions

Bulimia NervosaBinge-Eating DisorderFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michele M Laliberte, Ph.D.

    St. Joseph's Healthcare Hamilton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Director and Psychologist, Eating Disorders Clinic

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 21, 2016

Study Start

December 1, 2016

Primary Completion

March 20, 2020

Study Completion

March 20, 2020

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

For reasons of confidentiality, only aggregated data will be made available.

Locations