Real-Time Mobile Cognitive Behavioral Intervention for Serious Mental Illness
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a mobile real-time cognitive
      behavioral intervention for serious mental illness (SMI) and to identify the facilitators,
      barriers, and costs of implementation. We would like to determine whether the addition of a
      mobile phone monitoring software program to a brief behavioral intervention for bipolar
      disorder or schizophrenia improves symptoms arising from the disorders. In this study we will
      be assessing the feasibility, acceptability and short term effect of the mobile phone
      enhanced intervention for bipolar disorder and schizophrenia.
    

Detailed description: 
      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.
    

Intervention name(s): CBT2go; Smartphone
Intervention type(s): Behavioral; Device
Intervention description(s): CBT administered using mobile intervention.; A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment