Using Visual Feedback to Influence Rapid Response in the Treatment of Eating Disorders
Primary Purpose
Bulimia Nervosa, Binge Eating Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Visual feedback of symptom frequency
Sponsored by
About this trial
This is an interventional treatment trial for Bulimia Nervosa focused on measuring Rapid response, Eating Disorders, Cognitive Behavior Therapy, Bulimia Nervosa, Binge Eating Disorder, Purging Disorder
Eligibility 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
Sites / Locations
- St. Joseph's Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Visual feedback of symptom frequency
No visual feedback of symptom frequency
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02940613
First Posted
October 18, 2016
Last Updated
March 22, 2021
Sponsor
St. Joseph's Healthcare Hamilton
1. Study Identification
Unique Protocol Identification Number
NCT02940613
Brief Title
Using Visual Feedback to Influence Rapid Response in the Treatment of Eating Disorders
Official Title
Do Visuals of Symptom Change Increase Rates of Rapid Response in First Weeks of CBT for Eating Disorders?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Binge Eating Disorder
Keywords
Rapid response, Eating Disorders, Cognitive Behavior Therapy, Bulimia Nervosa, Binge Eating Disorder, Purging Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Visual feedback of symptom frequency
Arm Type
Experimental
Arm Description
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.
Arm Title
No visual feedback of symptom frequency
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Visual feedback of symptom frequency
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in eating disorder symptoms from baseline
Description
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).
Time Frame
Administered weekly up to week 25 (end of group treatment)
Secondary Outcome Measure Information:
Title
The behavioral section of the Eating Disorders Examination (EDE)
Description
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.
Time Frame
At week 6, 10, and up to 25 weeks (end of group treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele M Laliberte, Ph.D.
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
For reasons of confidentiality, only aggregated data will be made available.
Citations:
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Using Visual Feedback to Influence Rapid Response in the Treatment of Eating Disorders
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