B.E.D AND BULIMIA PATIENTNCT02130037
Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms
A study testing application and psychotherapy in people with B.E.D AND BULIMIA PATIENT and SMARTPHONE OWNER, run by Sheba Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- B.E.D AND BULIMIA PATIENT, SMARTPHONE OWNER, BASIC ENGLISH SPEAKER
- What is being tested?
- application and psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- May 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of binge eating disorder
- clinical diagnosis of bulimia
- smrtphone owner
- english speaker
Who cannot join
- clinical diagnosis of type 1 diabetes
- clinical diagnosis of other axis 1 psychological problems
- pregnancy
- clinical diagnosis of celiac disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Eating Disorder Dept.Sheba Medical Center Tel Hashomer
Ramat Gan, Tel Hashomer, 52621
About this study
Official title: The Effect Size of Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms
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.
- Being tested
- application, psychotherapy
- Keywords
- APPLICATION, SMARTPHONE, BULIMIA, B.E.D, BINGE EATING DISORDER
- Medical subject headings
- Bulimia, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
applicationBehavioural
Also called recovery record
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.
psychotherapyOther
standard psychotherapy for eating disorders
| Study group | Role | What they receive |
|---|---|---|
| psychotherapy only | Active comparator | Not described Receives: Other: psychotherapy |
| application | Experimental | Not described Receives: Behavioral: application; Other: psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
EDI-2 REDUCED SCORE
Measured: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
Secondary outcomes (1)
EAT-26 REDUCED SCORES
Measured: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: no grants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B.E.D AND BULIMIA PATIENTStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Eitan Gur MD, Sheba Medical Center
- Investigators
- EITAN GUR, MD, Principal investigator, Director of the Eating Disorder Dept.Sheba Medical Center Tel HashomerNIR BEN YOHANA, MA, Study director, Eating Disorder Dept. Sheba Medical Center Tel HashomerSHIR ZILBERSHTAIN, BA, Study chair, Eating Disorder Dept.Sheba Medical Center Tel HashomerMICHAL WOHL-LOTAN, PHD, Study chair, Eating Disorder Dept. Sheba Medical Center Tel Hashomer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130037
- Sponsor's protocol ID
- SHEBA-14-1001-EG-CTIL
- Status last verified
- Sep 2021
- First submitted
- 1 May 2014
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Size of Cognitive Behavioral Therapy Via a Smartphone Application on Bulimia Nervosa and Binge Eating Disorder Symptoms
- ClinicalTrials.gov ID
- NCT02130037
- Acronym / sponsor ID
- SHEBA-14-1001-EG-CTIL
- Keywords
- APPLICATION, SMARTPHONE, BULIMIA, B.E.D, BINGE EATING DISORDER
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no grants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychotherapy only | Active comparator | Other: psychotherapy |
| application | Experimental | Behavioral: application, Other: psychotherapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- clinical diagnosis of binge eating disorder
- clinical diagnosis of bulimia
- smrtphone owner
- english speaker
Key exclusion criteria (4 listed)
- clinical diagnosis of type 1 diabetes
- clinical diagnosis of other axis 1 psychological problems
- pregnancy
- clinical diagnosis of celiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| applicationAlso: recovery recordalong 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. | Behavioural | application |
| psychotherapystandard psychotherapy for eating disorders | Other | application, psychotherapy only |
Primary outcome
EDI-2 REDUCED SCORE
Time frame: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
1 secondary outcome
EAT-26 REDUCED SCORES
Time frame: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EITAN GUR, MD principal investigator
Director of the Eating Disorder Dept.Sheba Medical Center Tel Hashomer
NIR BEN YOHANA, MA study director
Eating Disorder Dept. Sheba Medical Center Tel Hashomer
SHIR ZILBERSHTAIN, BA study chair
Eating Disorder Dept.Sheba Medical Center Tel Hashomer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application and psychotherapy in people with B.E.D AND BULIMIA PATIENT and SMARTPHONE OWNER, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDI-2 REDUCED SCORE (time frame: BEFORE INTERVANTION, AFTER INTERVANTION, 6 MONTHES AFTER INTERVANTION). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.