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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Eitan Gur MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02130037
First received: May 1, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

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.


Condition Intervention
B.E.D AND BULIMIA PATIENT
SMARTPHONE OWNER
BASIC ENGLISH SPEAKER
Behavioral: application
Other: psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect Size of Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • EDI-2 REDUCED SCORE [ Time Frame: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EAT-26 REDUCED SCORES [ Time Frame: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: psychotherapy only Other: psychotherapy
standard psychotherapy for eating disorders
Experimental: application Behavioral: application
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 Name: recovery record
Other: psychotherapy
standard psychotherapy for eating disorders

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130037

Contacts
Contact: eitan gur, MD +972-3-5305105 eitan.gur@sheba.health.gov.il
Contact: nir ben - yohana, MA +972-3-5305105 nir.ben.yohana@gmail.com

Locations
Israel
Eating Disorder Dept.Sheba Medical Center Tel Hashomer Recruiting
Ramat Gan, Tel Hashomer, Israel, 52621
Contact: EITAN GUR, MD    +972-3-5305105    eitan.gur@sheba.health.gov.il   
Principal Investigator: eitan gur, md         
Sponsors and Collaborators
Sheba Medical Center
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
  More Information

No publications provided

Responsible Party: Dr. Eitan Gur MD, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02130037     History of Changes
Other Study ID Numbers: SHEBA-14-1001-EG-CTIL
Study First Received: May 1, 2014
Last Updated: May 1, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
APPLICATION
SMARTPHONE
BULIMIA
B.E.D
BINGE EATING DISORDER

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014