Smartphone Technology and CBT-GSH in Binge Eaters

NCT02399982 | Completed Phase 1

• 2 other identifiers: GCO 11-04545R41MH096435-02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

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; ecological momentary intervention

Outcome Measures

Primary Outcomes (1)

• Eating Disorder Examination version 16

  Frequency of objective binge episodes

  up to 9 months

Secondary Outcomes (1)

• Treatment Adherence

  3 months of treatment

Other Outcomes (1)

• Acceptability measure assessed by verbal qualitative data

  up to 9 months

Study Arms (2)

CBT-GSH

ACTIVE COMPARATOR

Traditional CBT-GSH with paper and pencil self-monitoring

Other: CBT-GSH

CBT-GSH + Noom Monitor

EXPERIMENTAL

CBT-GSH with smartphone application for self-monitoring

Other: CBT-GSH; Other: Noom Monitor

Interventions

CBT-GSH OTHER

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.

CBT-GSH; CBT-GSH + Noom Monitor

Noom Monitor OTHER

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.

CBT-GSH + Noom Monitor

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Noom Inc.: collaborator
• Kaiser Foundation Hospitals, Center for Health Research: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 28960384 DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia Nervosa; Bulimia; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Tom Hildebrandt, PsyD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 26, 2015
• Study Start: February 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 3, 2016

Record last verified: 2016-05

Locations

US (1)