Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness

Bipolar disorder (BD) and Schizophrenia (SZ) are leading causes of disability and are the
costliest disorders to treat among serious mental illnesses. Ample evidence exists that
evidence-based psychotherapies such as cognitive behavioral therapy (CBT) produce clinically
significant improvements in symptoms of BD and SZ, and yet only 5% of patients in the
community can access these treatments. Access to CBT for serious mental illnesses is limited
by the restricted pool of trained providers, the resource intensity of these treatments, and
cessation of reimbursement for psychological services in many public mental health systems.
Our research in BD and SZ over the past five years indicates that mobile phones can provide
automated yet personalized cognitive behavioral intervention that is feasible, acceptable,
and associated with improvements in symptoms, medication adherence and socialization. Our
intervention, called CBT2go, integrates ecological momentary assessment with personalized
interventions delivered in the moment that symptoms and related experiences occur. We have
developed an innovative platform that functions on various screen types, operating system,
or data access technologies, and we have begun to incorporate innovative features into
CBT2go, including location-based data and personalized predictive modeling, that can
potentially lead to transformative mobile interventions. We propose a research study with
the overarching aims of evaluating the effectiveness of CBT2go, gathering necessary data to
refine its innovative features, and examining its costs, facilitators, and barriers to
implementation in a public mental health system. We propose a randomized controlled trial
with three arms: 1) CBT2go, 2) an ecological momentary assessment only condition to control
for self-monitoring and device contact, and 3) standard care. A total of 255 participants
with either BD or SZ will be recruited from a large public mental health system that has
minimal access to CBT. Participants will be assessed at baseline, 6 weeks (mid-treatment),
12 weeks (post-treatment) and 24 weeks (follow-up). The primary outcome of the study will be
clinician rated global psychopathology, and secondary outcomes will include medication
adherence, social functioning, and mental health service utilization. Recognizing that not
all participants will benefit, we propose to examine differential effectiveness in
sub-groups. We will also examine mechanisms of change to inform mobile intervention design,
focusing on the impact of CBT2go on cognitive insight and dysfunctional attitudes, which are
two mediators of change in traditionally delivered CBT. Drawing from experience in
implementation research, we will employ a mixed methods approach to assessing the
facilitators, barriers, and costs of adoption of CBT2go from perspectives of consumers,
technology experts, administrators and front-line clinicians. This study will lay the
groundwork for CBT2go to be adapted and implemented with high fidelity in healthcare
settings.

Inclusion Criteria:

1. Male or female age 18-55

2. MINI Diagnosis of either BD I, SZ, or schizoaffective disorder

3. Currently outpatient, participating in routine psychiatric care and prescribed
medications for prior past six months

4. No psychotropic medication changes in the past 3 months

5. Capable of providing signed informed consent

Exclusion Criteria:

1. Diagnosis of dementia, seizure disorder, mental retardation, or past head trauma with
loss of consciousness for greater than 20 minutes

2. Cannot complete the assessment battery

3. Visual acuity (Snellen chart), reading ability, and manual dexterity sufficient to
navigate a touch screen device

4. Symptoms are in "remission" (i.e, scores on all key BPRS items < 3)

5. Currently participating in any other psychosocial interventions