Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms

September 20, 2021 updated by: Dr. Eitan Gur MD, Sheba Medical Center

The Effect Size of Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms

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.

Study Overview

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tel Hashomer
      • Ramat Gan, Tel Hashomer, Israel, 52621
        • Eating Disorder Dept.Sheba Medical Center Tel Hashomer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: psychotherapy only
standard psychotherapy for eating disorders
Experimental: application
standard psychotherapy for eating disorders
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.
Other Names:
  • recovery record

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EDI-2 REDUCED SCORE
Time Frame: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION

Secondary Outcome Measures

Outcome Measure
Time Frame
EAT-26 REDUCED SCORES
Time Frame: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: EITAN GUR, MD, Director of the Eating Disorder Dept.Sheba Medical Center Tel Hashomer
  • Study Director: NIR BEN YOHANA, MA, Eating Disorder Dept. Sheba Medical Center Tel Hashomer
  • Study Chair: SHIR ZILBERSHTAIN, BA, Eating Disorder Dept.Sheba Medical Center Tel Hashomer
  • Study Chair: MICHAL WOHL-LOTAN, PHD, Eating Disorder Dept. Sheba Medical Center Tel Hashomer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Actual)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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