Smartphone Technology and CBT-GSH in Binge Eaters
Condition: Binge Eating Disorder; Bulimia Nervosa
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): CBT-GSH; Noom Monitor
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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