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

NCT02130037 | Withdrawn

• 1 other identifier: SHEBA-14-1001-EG-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

APPLICATION; SMARTPHONE; BULIMIA; B.E.D; BINGE EATING DISORDER

Outcome Measures

Primary Outcomes (1)

• EDI-2 REDUCED SCORE

  BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION

Secondary Outcomes (1)

• EAT-26 REDUCED SCORES

  BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION

Study Arms (2)

psychotherapy only

ACTIVE COMPARATOR

Other: psychotherapy

application

EXPERIMENTAL

Behavioral: application; Other: psychotherapy

Interventions

application 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.

Also known as: recovery record

application

psychotherapy OTHER

standard psychotherapy for eating disorders

application; psychotherapy only

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinical diagnosis of binge eating disorder
• clinical diagnosis of bulimia
• smrtphone owner
• english speaker

You may not qualify if:

• clinical diagnosis of type 1 diabetes
• clinical diagnosis of other axis 1 psychological problems
• pregnancy
• clinical diagnosis of celiac disease

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Eating Disorder Dept.Sheba Medical Center Tel Hashomer

Ramat Gan, Tel Hashomer, 52621, Israel

Location

MeSH Terms

Conditions

Bulimia; Binge-Eating Disorder

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• EITAN GUR, MD

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

  PRINCIPAL INVESTIGATOR

• NIR BEN YOHANA, MA

  Eating Disorder Dept. Sheba Medical Center Tel Hashomer

  STUDY DIRECTOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 2, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

IL (1)