Optimizing a Smartphone Application for Individuals With Eating Disorders

Eating Disorders (ED) are common and serious psychological disorders. Anorexia Nervosa (AN)
has a prevalence estimated at between 0.48% and 0.70% among young females. Bulimia Nervosa
(BN) is a serious mental health problem, with a prevalence of between 1-2% of young women
while clinically significant bulimic behaviors occur in an additional 2-3%. There are
significant barriers to access of evidence-based treatments and current models of individual
psychotherapy will likely never meet the enormous need for psychological services for ED.
Unfortunately, even with treatment, rates of recovery are modest with the best performing
treatments achieving remission in only about 50% of cases while relapse rates are high,
especially if the ED becomes chronic. It is widely acknowledged that a major shift in
intervention practice is needed and that smartphone apps will almost certainly play a role
due to their reach and breadth of functionality.

As the first commercially available smartphone app for EDs, Recovery Record (RR) has
established wide reach and user acceptability. The app provides users with meal and ED
symptom self-monitoring and coping skill strategies in an evidence-based CBT format.
Preliminary pilot data suggest that for a proportion of RR users, using RR is associated
with clinically significant symptom reduction. However, a limitation of the current app is
that it is a "one-size-fits-all" product that does not account for the heterogeneity of ED
symptoms. Genetic, personality and neurocognitive data support distinct clusters of ED
presentations that also differ according to response to treatment, course and outcome. Pilot
data confirm that clinical response to RR is not homogenous across groups and that extent of
cognitive distortions is the most potent factor to predict outcome. There is considerable
opportunity to increase RR's effectiveness across a range of ED symptoms and behaviors by
creating adaptive and tailored content focused on remediation of cognitive distortions.

During Phase 1 of this study screening algorithm will be validated against an unseen,
prospective test dataset of approximately 2,000 users. All candidate predictor variables
will be entered into a Signal Detection Analysis to confirm the sensitivity and specificity
of the screen. Informed by the resultant algorithms, adaptive content will be developed that
targets ED-specific cognitive distortions. To evaluate acceptability, adapted content will
be piloted with approximately 200 individuals for a period of one month. Participant
feedback and utilization data will inform content acceptability and feasibility. By the end
of the first phase tailored content that is acceptable to individuals with specific symptom
presentations will be developed.

Phase 2 will focus on an evaluation of whether an adaptive app offering tailored content
addressing eating related cognitive distortions in a stepped way can outperform the current
standard app. The adaptive content will be integrated into a new, dynamic version of the app
(RR-A) that will then be evaluated against the current app (RR-S). Approximately 10,000
registered users of RR will be randomized to receive either RR augmented with targeted
content (RR-A), or RR in its current standard format (RR-S) over a two-month period. Outcome
data will be measured at baseline, one month, end of treatment, and at six-month follow-up.
At the end of the study period it is predicted that the resultant evidence-based product
will have demonstrated ability to bring about clinically significant reduction in symptoms
in more users than the current app, and thus will have potential to make a substantial
public health impact.

Inclusion Criteria:

- Meets criteria for clinically significant symptoms of eating disorder using
self-report measures

- Has an Android or iPhone and is willing to use phone for the study

- Is able to speak and read English

- Lives within the United States of America

- Is at least 16 years of age

Exclusion Criteria:

- Has visual, hearing, voice, or motor impairment that would prevent completion of
study and treatment procedures

- Has any psychiatric condition for which participation in a clinical trial of
psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders,
bipolar disorders, severe post traumatic stress disorder, etc.).

- Exhibits severe suicidality, including ideation, plan, and intent.

- Currently receiving weekly psychotherapy or planning to receive weekly psychotherapy
for eating disorder during the 12 weeks of the study.