Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02130037
Other study ID # SHEBA-14-1001-EG-CTIL
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date August 2015

Study information

Verified date September 2021
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

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:
psychotherapy
standard psychotherapy for eating disorders

Locations

Country Name City State
Israel Eating Disorder Dept.Sheba Medical Center Tel Hashomer Ramat Gan Tel Hashomer

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary EDI-2 REDUCED SCORE BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
Secondary EAT-26 REDUCED SCORES BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION