Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms
Primary Purpose
B.E.D AND BULIMIA PATIENT, SMARTPHONE OWNER, BASIC ENGLISH SPEAKER
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
application
psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for B.E.D AND BULIMIA PATIENT focused on measuring APPLICATION, SMARTPHONE, BULIMIA, B.E.D, BINGE EATING DISORDER
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of binge eating disorder
- clinical diagnosis of bulimia
- smrtphone owner
- english speaker
Exclusion Criteria:
- clinical diagnosis of type 1 diabetes
- clinical diagnosis of other axis 1 psychological problems
- pregnancy
- clinical diagnosis of celiac disease
Sites / Locations
- Eating Disorder Dept.Sheba Medical Center Tel Hashomer
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
psychotherapy only
application
Arm Description
Outcomes
Primary Outcome Measures
EDI-2 REDUCED SCORE
Secondary Outcome Measures
EAT-26 REDUCED SCORES
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02130037
Brief Title
Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms
Official Title
The Effect Size of Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
no grants
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: research show that cognitive behavioral therapy (CBT) is effective inreducing bulimia nervosa (BN) and binge eating disorder's (BED) symptoms. Today, with the development of technology there are efforts being made for developinga treatment to these eating disorders threw the media, most of these attempts are based on the CBT method. The size of the effect that CBT given threw the internet has on BN and BED is still not entirely clear. Research presented today are mostly based on treatments that were given threw email or Skypeor an automatic self- help stage program. These researches show heterogenic results about the effect it had on eating disorders. In this research we aim to investigate the effect size that a CBT treatment threw a smartphone application that combines a clinician online reply and an automatic feedback in addition to astandard ones a week clinic treatment has on BN and BED symptoms frequency.
Methods: Our aim is to make a research using an application that treats that offers an automatic and human therapist and dietitian reply threw a similar application that is suited for them. A selected 40 BN or sub-threshold BN or BED patients, men and women ages 18-60 ,that will turn to the "Sheba eating disorder medical center" will include the research. Half of the participants will receive aCBT treatment threw a smartphone application along with astandardclinical treatment that includes ones a week session with a therapist and ones a week session with a dietitian and the other half will receive a standardclinic treatment alone. We will test the eating disorder symptoms using eating disorders questionnaires at the starting point, at the end of a six months treatment and six months after finishing the treatment.
Importance: This research will allow testing the need and benefit that a personal and direct patient- therapist connection has over a standardones a week meeting connection format. In addition, treating with a web application in the future might have a benefit of saving time spent on getting to the clinic, will allow to shorten the time of the session in the clinic and will save cost of the face to face treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B.E.D AND BULIMIA PATIENT, SMARTPHONE OWNER, BASIC ENGLISH SPEAKER
Keywords
APPLICATION, SMARTPHONE, BULIMIA, B.E.D, BINGE EATING DISORDER
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
psychotherapy only
Arm Type
Active Comparator
Arm Title
application
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
application
Other Intervention Name(s)
recovery record
Intervention Description
along standard psychotharpy we use a smartphone application that allows the patient to monitor her meals, behaviours, emotions and thoughts and to communicate them directly in real time to their therapists.
Intervention Type
Other
Intervention Name(s)
psychotherapy
Intervention Description
standard psychotherapy for eating disorders
Primary Outcome Measure Information:
Title
EDI-2 REDUCED SCORE
Time Frame
BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
Secondary Outcome Measure Information:
Title
EAT-26 REDUCED SCORES
Time Frame
BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of binge eating disorder
clinical diagnosis of bulimia
smrtphone owner
english speaker
Exclusion Criteria:
clinical diagnosis of type 1 diabetes
clinical diagnosis of other axis 1 psychological problems
pregnancy
clinical diagnosis of celiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EITAN GUR, MD
Organizational Affiliation
Director of the Eating Disorder Dept.Sheba Medical Center Tel Hashomer
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
NIR BEN YOHANA, MA
Organizational Affiliation
Eating Disorder Dept. Sheba Medical Center Tel Hashomer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
SHIR ZILBERSHTAIN, BA
Organizational Affiliation
Eating Disorder Dept.Sheba Medical Center Tel Hashomer
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
MICHAL WOHL-LOTAN, PHD
Organizational Affiliation
Eating Disorder Dept. Sheba Medical Center Tel Hashomer
Official's Role
Study Chair
Facility Information:
Facility Name
Eating Disorder Dept.Sheba Medical Center Tel Hashomer
City
Ramat Gan
State/Province
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
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Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms
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