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Using Visual Feedback to Influence Rapid Response in the Treatment of Eating Disorders

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ClinicalTrials.gov Identifier: NCT02940613
Recruitment Status : Recruiting
First Posted : October 21, 2016
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Michele Laliberte, St. Joseph's Healthcare Hamilton

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.

Condition or disease Intervention/treatment Phase
Bulimia Nervosa Binge Eating Disorder Behavioral: Visual feedback of symptom frequency Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Do Visuals of Symptom Change Increase Rates of Rapid Response in First Weeks of CBT for Eating Disorders?
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Visual feedback of symptom frequency
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
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.

No Intervention: No visual feedback of symptom frequency
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. The behavioral section of the Eating Disorders Examination (EDE) [ Time Frame: At week 6, 10, and up to 25 weeks (end of group treatment) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI below 19

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940613


Contacts
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Contact: Michele M Laliberte, Ph.D. 905-522-1155 ext 34093 mlaliber@stjoes.ca
Contact: Danielle MacDonald, M.A. 416-458-5840 danielle.macdonald@psych.ryerson.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Michele M. Laliberte, Ph.D.    905-522-1155 ext 34093    mlaliber@stjoes.ca   
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Investigators
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Principal Investigator: Michele M Laliberte, Ph.D. St. Joseph's Healthcare Hamilton

Publications of Results:

Other Publications:
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Responsible Party: Michele Laliberte, Clinical Director and Psychologist, Eating Disorders Clinic, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02940613     History of Changes
Other Study ID Numbers: STJOES2016PAC
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: For reasons of confidentiality, only aggregated data will be made available.
Keywords provided by Michele Laliberte, St. Joseph's Healthcare Hamilton:
Rapid response
Eating Disorders
Cognitive Behavior Therapy
Bulimia Nervosa
Binge Eating Disorder
Purging Disorder
Additional relevant MeSH terms:
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Disease
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia Nervosa
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms