Clinical trial NCT02130037: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: B.E.D AND BULIMIA PATIENT
SMARTPHONE OWNER
BASIC ENGLISH SPEAKER
Keywords: APPLICATION
SMARTPHONE
BULIMIA
B.E.D
BINGE EATING DISORDER
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-05-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: EDI-2 REDUCED SCORE
timeFrame: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
Secondary outcomes:
measure: EAT-26 REDUCED SCORES
timeFrame: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Eating Disorder Dept.Sheba Medical Center Tel Hashomer
state: Tel Hashomer
Study officials:
affiliation: Director of the Eating Disorder Dept.Sheba Medical Center Tel Hashomer
name: EITAN GUR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eating Disorder Dept. Sheba Medical Center Tel Hashomer
name: NIR BEN YOHANA, MA
role: STUDY_DIRECTOR
affiliation: Eating Disorder Dept.Sheba Medical Center Tel Hashomer
name: SHIR ZILBERSHTAIN, BA
role: STUDY_CHAIR
affiliation: Eating Disorder Dept. Sheba Medical Center Tel Hashomer
name: MICHAL WOHL-LOTAN, PHD
role: STUDY_CHAIR
References: