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

NCT ID: NCT02130037

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-08-31

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.

Conditions

B.E.D AND BULIMIA PATIENT; SMARTPHONE OWNER; BASIC ENGLISH SPEAKER

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

psychotherapy only

Group Type: ACTIVE_COMPARATOR

psychotherapy

Intervention Type: OTHER

standard psychotherapy for eating disorders

application

Group Type: EXPERIMENTAL

application

Intervention Type: BEHAVIORAL

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.

psychotherapy

Intervention Type: OTHER

standard psychotherapy for eating disorders

Interventions

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.

Intervention Type: BEHAVIORAL

psychotherapy

standard psychotherapy for eating disorders

Intervention Type: OTHER

Other Intervention Names

recovery record

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Eitan Gur MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EITAN GUR, MD

Role: PRINCIPAL_INVESTIGATOR

Director of the Eating Disorder Dept.Sheba Medical Center Tel Hashomer

NIR BEN YOHANA, MA

Role: STUDY_DIRECTOR

Eating Disorder Dept. Sheba Medical Center Tel Hashomer

SHIR ZILBERSHTAIN, BA

Role: STUDY_CHAIR

Eating Disorder Dept.Sheba Medical Center Tel Hashomer

MICHAL WOHL-LOTAN, PHD

Role: STUDY_CHAIR

Eating Disorder Dept. Sheba Medical Center Tel Hashomer

Locations

Eating Disorder Dept.Sheba Medical Center Tel Hashomer

Ramat Gan, Tel Hashomer, Israel

Countries

Israel

Other Identifiers

SHEBA-14-1001-EG-CTIL

Identifier Type: -

Identifier Source: org_study_id