Augmenting Hospitalization for Serious Mental Illness: Cognitive Bias Modification

Treatment in acute psychiatric hospital settings is brief, and many individuals continue to experience residual symptoms and impairment upon discharge. The months following discharge from hospitalization are particularly risky, as individuals transition from a highly structured and supportive environment to home, acute stressors, and uncertain aftercare. Currently, there are few interventions available to accelerate improvement during brief hospital stays, or to provide a bridge to outpatient care. Thus, there is an urgent need to develop augmentations to hospital care that both more efficiently reduce symptoms during the acute hospital stay and provide continuation of care during the transition to home. Such new interventions are critical to reduce the risk of relapse, re-hospitalization, and suicide in individuals with Serious Mental Illness (SMI).

The long-term goal of this study is to develop effective and scalable interventions that target key mechanisms in psychopathology and are easily implemented in real world settings. The overall objective of this study is to develop a low-intensity augmentation to psychiatric partial hospital care that can be continued during the transition to home. "I-Change", a personalized, smart-phone delivered cognitive bias modification (CBM) treatment, is expected to hasten improvement in pathological cognitive processes and clinical outcomes during hospitalization and following discharge compared to a control. This hypothesis is based on the principal investigator's (PI) 14 years of research developing and testing CBM treatments, including a pilot study of 65 patients attending a partial hospital program that showed excellent feasibility, acceptability, large effects on cognitive bias, and moderate effects on clinical outcomes compared to a placebo control.

I-Change will target the maladaptive interpretative style that maintains emotional disorders. The way in which individuals automatically resolve the countless ambiguous situations encountered each day has a large impact on their affect and behavior. Interpretation bias, the tendency to resolve such ambiguity negatively, is a crucial therapeutic target because it is associated with poor emotion regulation, rumination, symptom severity, suicidal ideation, and treatment response. Although existing treatments target interpretation bias, most notably Cognitive Behavioral Therapy (CBT), they require individuals to recognize their automatic interpretations and use complex techniques to reappraise them. Individuals experiencing symptoms sufficiently acute to require hospital care often experience difficulty applying these techniques. In contrast, the PI validated a computerized training task that utilizes quick, repeated practice and feedback to more efficiently reinforce a healthier interpretive style. Ten studies demonstrate that the task engages interpretation bias and leads to improved clinical outcomes in individuals with mood and anxiety disorders, including a psychiatric hospital sample. The CBM task is highly acceptable and uniquely suited to acute psychiatric settings due to its low complexity and engaging qualities.

Specific Aim 1: Develop a smart-phone delivered intervention to augment hospital care.

This study will harness smart-phone technology to enhance the acquisition of a healthier interpretive style by personalizing the situations presented, prompting participants to complete sessions to ensure adequate dosage, and incorporating features to enhance adherence. Delivery via smart phone increases accessibility of the intervention by overcoming barriers (e.g., transportation, computer access) within the hospital and at home and allows better assessment of outcomes in "real time" via ecological momentary assessment. An Advisory Board of patients, hospital providers, experts in CBM and mobile health technology, and other stakeholders (i.e., directors of acute psychiatric clinics) will inform the development of I-Change.

Specific Aim 2: Obtain pilot data to support a fully-powered randomized controlled trial (RCT), including measures of (a) target engagement (improvement in interpretation bias), (b) feasibility and acceptability of I-Change and procedures for hospital and home delivery, and (c) global improvement and functioning Participants will complete I-Change daily while admitted to the partial hospital and three times per week at home during the 1-month following discharge. Consistent with a precision medicine and RDoC approach, participants will be selected based on baseline level of interpretation bias (not diagnosis). The investigators will first conduct an open trial of I-Change (n = 16) to inform refinements. The investigators will conduct a pilot RCT (n = 64) to obtain data to inform the design of a future trial. Participants will be randomly assigned to I-Change or a Symptom Tracking control and assessed at admission, discharge, 1-month and 3-months following discharge. Obtained data will be compared to a priori benchmarks of feasibility, acceptability, target engagement, and clinical improvement.

The final products of this study will be the I-Change app, RCT protocol, and pilot data to support a future confirmatory effectiveness trial. Achievement of these aims will result in a simple, scalable augmentation to psychiatric partial hospital care that can improve outcomes following hospital care.