JMIR Publications

ABSTRACT

Background:

Treatment-resistant schizophrenia (TRS) is a severe form of schizophrenia associated with low adherence to treatment and poor outcomes. Mobile health (mHealth) interventions may be effective in preventing relapses, increasing treatment adherence, and managing some of the symptoms of schizophrenia. Mobile therapeutic attention for treatment-resistant schizophrenia (m-RESIST) is an innovative mobile health (mHealth) solution based on novel technology offering high modular and flexible functioning developed specifically for TRS. To our best knowledge no studies have addressed the efficacy of mHealth applications on the symptoms and functional capacity, and on the quality of life in subjects having TRS.

Objective:

To evaluate the effects of m-RESIST on the clinical and functional outcomes, and on the perceived quality of life among participants having TRS.

Methods:

A feasibility study without a control group was performed to test the m-RESIST solution in TRS patients. Participants were recruited from Spain, Israel and Hungary. Study population (N=31) followed the 3 months of intervention. The m-RESIST was configured by an app, a wearable and a web-based platform. The severity of symptoms was evaluated by using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression Schizophrenia (CGI-SCH). Functionality was assessed by the Global Assessment of Functioning (GAF) and perceived quality of life was evaluated by the Analogue Visual Scale of EuroQol 5 dimensions 5 levels questionnaire (EQ-VAS).

Results:

Significant reductions were found in symptoms from pretrial to post trial on the PANSS total; mean difference -7.2 (P=.001), on the PANSS positive; -1.36 (P =.036) and PANSS negative; -2.1 (P <.001), and also on the PANSS general symptoms; -3.8 (P =.015). In almost one-fifth of the participants (6/31), the overall score for PANSS decreased by more than 20% which may be considered a clinically significant change. On CGI-SCH the sum of total severity of illness decreased significantly (P=.027). A decrease in the sum of positive and negative symptoms of the CGI-SCH-score was also found (P=.037 and P=.03, respectively). The sum of depressive or cognitive symptoms did not change. The functionality of participants increased significantly on the GAF (P =<.001). The perceived quality of life on EQ-VAS improved also (mean difference 6.7, P=.035).

Conclusions:

To our best knowledge, this was the first study collecting data on the symptoms, functional capacity, and quality of life in TRS by using the mHealth platform (m-RESIST solution). Our novel findings showed that implementing m-RESIS-solution decreased the symptoms and severity of illness, and improved the functionality and perceived quality of life among those having TRS. The change of symptoms on the PANSS total may be clinically significant. Modern technologies like mHealth interventions seem to be useful in treating symptoms and functionality even in TRS which is a major clinical challenge having usually poor outcomes. These results should be corroborated by performing a controlled trial. Clinical Trial: ClinicalTrials.gov NCT03064776; https://clinicaltrials.gov/ct2/show/record/NCT03064776 International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2017-021346