Digital Therapeutic Engagement May Improve Schizophrenia Symptoms

Researchers reported the findings of a post-hoc analysis conducted to determine the impact of engagement with a digital medicine system on symptom severity in patients with schizophrenia or bipolar I disorder.

The following article is a part of conference coverage from Psych Congress 2021 , held October 29th through November 1, 2021, in San Antonio, Texas. The team at Psychiatry Advisor will be reporting on the latest news and research conducted by leading experts in psychiatry. Check back for more from the Psych Congress 2021.


Patients with schizophrenia or bipolar I disorder who engaged more often with the digital medicine component of aripiprazole treatment were found to experience greater symptom improvement than patients who engaged less with the app or not at all. The study authors presented the results of their research at Psych Congress 2021, held both virtually and in person in San Antonio, Texas, from October 29 to November 1, 2021.

The digital medicine system (DMS) included aripiprazole tablets, an ingestible sensor, wearable sensor patches, and a smartphone application. The system provides objective medication ingestion information and other data to patients and healthcare providers.

The researchers conducted a post-hoc analysis to determine the impact of engagement with the DMS on symptom severity and performance of the system. Data were collected during a phase 3b clinical trial ( Identifier: NCT03892889) conducted to assess hospitalization rates of patients receiving treatment with an oral standard-of-care antipsychotic agent for 6 months followed by use of the DMS for 3 months. At the 3-month visit, the investigators decided whether patients would continue with the DMS or switch to standard of care.

The study enrolled 277 patients. The researchers assessed baseline and end-of-study symptoms using the Clinical Global Impression Scale (Severity of Illness and Improvement of Illness scales), Personal and Social Performance Scale, and Positive and Negative Syndrome Scale.

The post-hoc analysis grouped patients by study completion status and an algorithm based on how patients used the DMS: fraction of expected time on DMS, patch wear rate, patch-normalized ingestion rate, and application log-in rate. Based on the results of the analysis, the researchers grouped patients into high-engagement, moderate-engagement, or dropout groups. A total of 164 patients dropped out before the 3-month completion date (50 discontinued by the sponsor); 63 were considered moderate engagement and 50 were considered high engagement. Out of all patients, 88.1% were taking aripiprazole before the study.

The researchers found the patch-normalized ingestion rate to be high among all groups. Patients in all 3 groups reported improved symptoms. Highly engaged patients reported improved symptoms for all clinical scores and subscores. Patients with moderate engagement reported improvements for all assessments except PANSS subscales.

The researchers concluded that the improvements were related to more consistent medication intake as well as higher engagement with the DMS. Therefore, a digital health component to treatment for schizophrenia or bipolar I disorder may improve symptoms beyond the use of oral pharmacotherapy alone.

Disclosure: This study was supported and funded by Otsuka Pharmaceuticals, which also employed 5 of the study authors.  Please refer to the original document for a full list of disclosures.


Visit Psychiatry Advisor’s meetings section for complete coverage of Psych Congress 2021.



Cochran JM, Fang H, Le Gallo C, Peters-Strickland T, Lindenmayer J-P, Reuteman-Fowler JC. Correlation between patient engagement with a digital medicine system and clinical symptom improvement. Poster presented at: Psych Congress 2021, October 29-November 1, 2021; San Antonio, Texas. Poster 46.