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Smartphone Technology and CBT-GSH in Binge Eaters

Primary Purpose

Binge Eating Disorder, Bulimia Nervosa

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBT-GSH
Noom Monitor
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder focused on measuring 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

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CBT-GSH

CBT-GSH + Noom Monitor

Arm Description

Traditional CBT-GSH with paper and pencil self-monitoring

CBT-GSH with smartphone application for self-monitoring

Outcomes

Primary Outcome Measures

Eating Disorder Examination version 16
Frequency of objective binge episodes

Secondary Outcome Measures

Treatment Adherence
Self-monitoring data from paper and pencil records and smartphone app data

Full Information

First Posted
March 20, 2015
Last Updated
May 2, 2016
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Noom Inc., Kaiser Foundation Hospitals, Center for Health Research, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02399982
Brief Title
Smartphone Technology and CBT-GSH in Binge Eaters
Official Title
Innovative Use of the Noom Monitor Mobile Application for CBT-GSH in Binge Eaters
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Noom Inc., Kaiser Foundation Hospitals, Center for Health Research, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, ecological momentary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-GSH
Arm Type
Active Comparator
Arm Description
Traditional CBT-GSH with paper and pencil self-monitoring
Arm Title
CBT-GSH + Noom Monitor
Arm Type
Experimental
Arm Description
CBT-GSH with smartphone application for self-monitoring
Intervention Type
Other
Intervention Name(s)
CBT-GSH
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Noom Monitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Eating Disorder Examination version 16
Description
Frequency of objective binge episodes
Time Frame
up to 9 months
Secondary Outcome Measure Information:
Title
Treatment Adherence
Description
Self-monitoring data from paper and pencil records and smartphone app data
Time Frame
3 months of treatment
Other Pre-specified Outcome Measures:
Title
Acceptability measure assessed by verbal qualitative data
Time Frame
up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Hildebrandt, PsyD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28960384
Citation
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.
Results Reference
derived

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Smartphone Technology and CBT-GSH in Binge Eaters

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