Smartphone Technology and CBT-GSH in Binge Eaters

May 2, 2016 updated by: Icahn School of Medicine at Mount Sinai

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT-GSH
Traditional CBT-GSH with paper and pencil self-monitoring
Other: CBT-GSH
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.
Experimental: CBT-GSH + Noom Monitor
CBT-GSH with smartphone application for self-monitoring
Other: CBT-GSH
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.
Other: Noom Monitor
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Disorder Examination version 16
Time Frame: up to 9 months
Frequency of objective binge episodes
up to 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Adherence
Time Frame: 3 months of treatment
Self-monitoring data from paper and pencil records and smartphone app data
3 months of treatment

Other Outcome Measures

Outcome Measure
Time Frame
Acceptability measure assessed by verbal qualitative data
Time Frame: up to 9 months
up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Collaborators

National Institute of Mental Health (NIMH)
Noom Inc.
Kaiser Foundation Hospitals, Center for Health Research

Investigators

  • Principal Investigator: Tom Hildebrandt, PsyD, ICAHN School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 11-0454
  • 5R41MH096435-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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