Binge Eating DisorderPhase 1NCT02399982
Smartphone Technology and CBT-GSH in Binge Eaters
A Phase 1 study testing CBT-GSH and Noom Monitor in people with Binge Eating Disorder and Bulimia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study aims to utilize emerging mobile application technology, as a tool for increasing the potency, accessibility, and efficacy of a guided self-help version of cognitive-behavioral therapy (CBT-GSH) for binge eating. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Binge Eating Disorder, Bulimia Nervosa
- What is being tested?
- CBT-GSH and Noom Monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 2016
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- meet criteria for DSM-V BN or BED or must have objective binge episodes with sub-threshold BN or BED criteria
- an upper limit BMI of 40
- between the ages of 18 and 55
- are medically stable for outpatient treatment as determined by their primary care physician
- free of psychiatric medications for at least 2-weeks prior to study, or on a stable dose of medication for 4 weeks prior to the study
Who cannot join
- prior lap band or other bariatric procedure completed
- meeting current of drug or alcohol dependence or bipolar disorder
- active psychotic symptoms by SCID-I screen questions
- current suicidal ideation
- prior Cognitive behavioral therapy for eating disorders
- concurrent psychological treatment of any type
- Previously read Chris Fairburn's Overcoming Binge Eating
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Innovative Use of the Noom Monitor Mobile Application for CBT-GSH in Binge Eaters
This study aims to utilize emerging mobile application technology, as a tool for increasing the potency, accessibility, and efficacy of a guided self-help version of cognitive-behavioral therapy (CBT-GSH) for binge eating. The feasibility and efficacy of the adapted smartphone application created by Noom Inc., Noom Monitor, will be examined through a randomized control trial comparing CBT-GSH + APP with CBT-GSH conducted at the Mount Sinai School of Medicine's Eating and Weight Disorders Program. The investigators hypothesize that CBT-GSH with the addition of the Noom Monitor, will be significantly more acceptable, have greater uptake of self-monitoring, greater adherence to treatment, and greater reduction in objective binge episodes (OBEs) than standard CBT-GSH.
Read the detailed description
Bulimia nervosa (BN) and Binge Eating Disorder (BED) are both characterized by the primary symptoms of binge eating and by significant levels of impairment and psychiatric co-morbidity, affecting approximately 3-5% of the US population. Guided self-help cognitive behavioral (CBT-GSH) therapy has been shown to be an efficacious treatment to reduce binge eating, performing comparatively to full-scale psychotherapy interventions and is a cost-effective empirically supported treatment that has been demonstrated to reduce total health care costs when delivered by trained professionals in primary care settings. Despite the evidence that CBT-GSH offers an effective and financially advantageous treatment for BN and BED, there is evidence of limited uptake for CBT-GSH among both clients and therapists as evidenced by high dropout rates and perceived impediments to therapeutic change. The primary intervention in the CBT-GSH is self-monitoring, which is uniquely effective at reducing binge eating episodes and is packaged with other behavioral strategies including regular eating, using alternatives to binges or purging, problem solving, eliminating rigid dietary practices, and regular weighing. Self-monitoring in CBT-GSH is both time-intensive and cumbersome in its traditional paper format and behavioral strategies require a high degree of engagement outside of session. These burdens lead to reduced therapeutic adherence, which is essential to the efficacy of CBT-GSH. Initial evidence with text messaging interventions suggest increased treatment and self-monitoring adherence for BN. A yet unexplored advantage of mobile application technology is the ability to synthesize real-time data to provide feedback on patient progress. Providing therapists with direct feedback about patient progress has a well-documented effect on treatment outcome and adherence. Thus, mobile application technology offers an innovative opportunity to increase client and therapist uptake of CBT-GSH by (1) reducing the burden of self-monitoring and de-stigmatizing the act of real-time meal recording, (2) offering between-session application of CBT-GSH principles , (3) facilitating feedback to therapists about patient progress. This study proposes to develop a commercial product, the "Noom Monitor," to capitalize on emerging mobile application technology thus enhancing the acceptability and efficacy of CBT-GSH. This will be accomplished by adapting Noom Inc.'s current commercial mobile product, Noom, into a therapy transfer application for individuals with BN. The acceptability, treatment adherence, and preliminary efficacy of the adapted application will be examined through a randomized control trial comparing CBT-GSH + Noom Monitor with traditional CBT-GSH conducted at the Mount Sinai School of Medicine's Eating and Weight Disorders Program. The innovative utilization of technology to assist in mental health interventions has widespread implications outside of this proposal, which will be used to strategize the further development and commercialization of this product.
- Conditions
- Binge Eating Disorder, Bulimia Nervosa
- Being tested
- CBT-GSH, Noom Monitor
- Keywords
- Smartphone Application, mobile mental health, Binge Eating, Cognitive behavioral therapy, Eating Disorder treatment, Cognitive behavioral therapy guided self-help, self-monitoring, eating disorders, ecological momentary intervention
- Medical subject headings
- Binge-Eating Disorder, Bulimia Nervosa, Bulimia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-GSHOther
The treatment will be based on Overcoming Binge Eating. The treatment is divided into a user-friendly section on binge eating and a six-step self-help program. The first session will last 60 min, with each subsequent section lasting 20-25 minutes in length. Sessions are weekly over 3 months. Working with the therapist, participants will use the self-help guide to develop regular and moderate eating using selfmonitoring, problem solving, and other CBT techniques.
Noom MonitorOther
This treatment will be exactly the same as CBT-GSH with the exception that all self-monitoring will be conducted through Noom Monitor and individuals will receive a specialized set of instructions on how to use the monitor. Therapists will also be asked to check feedback report on clients before each session. Therapists will receive weekly letter grades regarding each patient based on weekly level of OBEs/Purging, treatment adherence, and weekly weighing.
| Study group | Role | What they receive |
|---|---|---|
| CBT-GSH | Active comparator | Traditional CBT-GSH with paper and pencil self-monitoring Receives: Other: CBT-GSH |
| CBT-GSH + Noom Monitor | Experimental | CBT-GSH with smartphone application for self-monitoring Receives: Other: CBT-GSH; Other: Noom Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination version 16
Frequency of objective binge episodes
Measured: up to 9 months
Secondary outcomes (1)
Treatment Adherence
Self-monitoring data from paper and pencil records and smartphone app data
Measured: 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startFeb 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Noom Inc., Kaiser Foundation Hospitals, Center for Health Research, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Tom Hildebrandt, PsyD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399982
- Sponsor's protocol ID
- GCO 11-0454
- Other IDs
- 5R41MH096435-02
- Status last verified
- May 2016
- First submitted
- 20 Mar 2015
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hildebrandt T, Michaelides A, Mackinnon D, Greif R, DeBar L, Sysko R. Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. Int J Eat Disord. 2017 Nov;50(11):1313-1322. doi: 10.1002/eat.22781. Epub 2017 Sep 27.
PubMed 28960384
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Use of the Noom Monitor Mobile Application for CBT-GSH in Binge Eaters
- ClinicalTrials.gov ID
- NCT02399982
- Acronym / sponsor ID
- GCO 11-0454
- Conditions
- Binge Eating Disorder, Bulimia Nervosa
- Keywords
- Smartphone Application, mobile mental health, Binge Eating, Cognitive behavioral therapy, Eating Disorder treatment, Cognitive behavioral therapy guided self-help, self-monitoring, eating disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Noom Inc., Kaiser Foundation Hospitals, Center for Health Research, National Institute of Mental Health (NIMH)
- Study start
- Feb 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Mar 2015 (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.
This study aims to utilize emerging mobile application technology, as a tool for increasing the potency, accessibility, and efficacy of a guided self-help version of cognitive-behavioral therapy (CBT-GSH) for binge eating. The feasibility and efficacy of the adapted smartphone application created by Noom Inc., Noom Monitor, will be examined through a randomized control trial comparing CBT-GSH + APP with CBT-GSH conducted at the Mount Sinai School of Medicine's Eating and Weight Disorders Program. The investigators hypothesize that CBT-GSH with the addition of the Noom Monitor, will be significantly more acceptable, have greater uptake of self-monitoring, greater adherence to treatment, and greater reduction in objective binge episodes (OBEs) than standard CBT-GSH.
Detailed description
Bulimia nervosa (BN) and Binge Eating Disorder (BED) are both characterized by the primary symptoms of binge eating and by significant levels of impairment and psychiatric co-morbidity, affecting approximately 3-5% of the US population. Guided self-help cognitive behavioral (CBT-GSH) therapy has been shown to be an efficacious treatment to reduce binge eating, performing comparatively to full-scale psychotherapy interventions and is a cost-effective empirically supported treatment that has been demonstrated to reduce total health care costs when delivered by trained professionals in primary care settings. Despite the evidence that CBT-GSH offers an effective and financially advantageous treatment for BN and BED, there is evidence of limited uptake for CBT-GSH among both clients and therapists as evidenced by high dropout rates and perceived impediments to therapeutic change. The primary intervention in the CBT-GSH is self-monitoring, which is uniquely effective at reducing binge eating episodes and is packaged with other behavioral strategies including regular eating, using alternatives to binges or purging, problem solving, eliminating rigid dietary practices, and regular weighing. Self-monitoring in CBT-GSH is both time-intensive and cumbersome in its traditional paper format and behavioral strategies require a high degree of engagement outside of session. These burdens lead to reduced therapeutic adherence, which is essential to the efficacy of CBT-GSH. Initial evidence with text messaging interventions suggest increased treatment and self-monitoring adherence for BN. A yet unexplored advantage of mobile application technology is the ability to synthesize real-time data to provide feedback on patient progress. Providing therapists with direct feedback about patient progress has a well-documented effect on treatment outcome and adherence. Thus, mobile application technology offers an innovative opportunity to increase client and therapist uptake of CBT-GSH by (1) reducing the burden of self-monitoring and de-stigmatizing the act of real-time meal recording, (2) offering between-session application of CBT-GSH principles , (3) facilitating feedback to therapists about patient progress. This study proposes to develop a commercial product, the "Noom Monitor," to capitalize on emerging mobile application technology thus enhancing the acceptability and efficacy of CBT-GSH. This will be accomplished by adapting Noom Inc.'s current commercial mobile product, Noom, into a therapy transfer application for individuals with BN. The acceptability, treatment adherence, and preliminary efficacy of the adapted application will be examined through a randomized control trial comparing CBT-GSH + Noom Monitor with traditional CBT-GSH conducted at the Mount Sinai School of Medicine's Eating and Weight Disorders Program. The innovative utilization of technology to assist in mental health interventions has widespread implications outside of this proposal, which will be used to strategize the further development and commercialization of this product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-GSH | Active comparator | Other: CBT-GSHTraditional CBT-GSH with paper and pencil self-monitoring |
| CBT-GSH + Noom Monitor | Experimental | Other: CBT-GSH, Other: Noom MonitorCBT-GSH with smartphone application for self-monitoring |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- meet criteria for DSM-V BN or BED or must have objective binge episodes with sub-threshold BN or BED criteria
- an upper limit BMI of 40
- between the ages of 18 and 55
- are medically stable for outpatient treatment as determined by their primary care physician
- free of psychiatric medications for at least 2-weeks prior to study, or on a stable dose of medication for 4 weeks prior to the study
Key exclusion criteria (7 listed)
- prior lap band or other bariatric procedure completed
- meeting current of drug or alcohol dependence or bipolar disorder
- active psychotic symptoms by SCID-I screen questions
- current suicidal ideation
- prior Cognitive behavioral therapy for eating disorders
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 |
|---|---|---|
| CBT-GSHThe treatment will be based on Overcoming Binge Eating. The treatment is divided into a user-friendly section on binge eating and a six-step self-help program. The first session will last 60 min, with each subsequent section lasting 20-25 minutes in length. Sessions are weekly over 3 months. Working with the therapist, participants will use the self-help guide to develop regular and moderate eating using selfmonitoring, problem solving, and other CBT techniques. | Other | CBT-GSH, CBT-GSH + Noom Monitor |
| Noom MonitorThis treatment will be exactly the same as CBT-GSH with the exception that all self-monitoring will be conducted through Noom Monitor and individuals will receive a specialized set of instructions on how to use the monitor. Therapists will also be asked to check feedback report on clients before each session. Therapists will receive weekly letter grades regarding each patient based on weekly level of OBEs/Purging, treatment adherence, and weekly weighing. | Other | CBT-GSH + Noom Monitor |
Primary outcome
Eating Disorder Examination version 16
Time frame: up to 9 months
Frequency of objective binge episodes
1 secondary outcome
Treatment Adherence
Time frame: 3 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Derived from this study: PubMed 28960384Hildebrandt T, Michaelides A, Mackinnon D, Greif R, DeBar L, Sysko R. Randomized controlled trial comparing smartphone assisted versus traditional guided self-help for adults with binge eating. Int J Eat Disord. 2017 Nov;50(11):1313-1322. doi: 10.1002/eat.22781. Epub 2017 Sep 27.
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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.
Tom Hildebrandt, PsyD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBT-GSH and Noom Monitor in people with Binge Eating Disorder and Bulimia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 3 May 2016. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Eating Disorder Examination version 16 (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399982, which also lists 1 linked publication.
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 3 May 2016.