Abstract
BACKGROUND: Cognitive behavioral therapy for psychosis (CBTp) is not sufficiently widespread in clinical practice, although evidence has been presented. OBJECTIVE: The purpose of this study was to explore whether one-on-one videoconference-based CBTp (vCBTp) is more effective than usual care (UC) alone for improving psychiatric symptoms in patients with schizophrenia attending outpatient clinics. METHODS: In this exploratory randomized controlled trial, patients with schizophrenia and schizoaffective disorders who were still taking medication in an outpatient clinic were randomly assigned to either the vCBTp plus UC group (n=12) or the UC group (n=12). The vCBTp program was conducted once a week, with each session lasting for 50 minutes, for a total of 7 sessions conducted in real-time and in a one-on-one format remotely using a loaned tablet computer (iPad). The primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score, which measures the difference in the mean change from baseline (week 0) to posttest (week 8). RESULTS: The study included 24 participants. There were no significant differences between the 2 groups at baseline. With regard to significant differences between the 2 groups in terms of the primary outcome, the mean change in the PANSS total score from baseline to week 8 in the vCBTp plus UC group was -9.5 (95% CI -12.09 to -6.91) and the mean change in the UC alone group was 6.9 (95% CI 1.54-12.30). The difference between the 2 groups was significant (P<.001). In addition, significant improvements were observed in the subscales of positive (P<.001) and negative (P=.004) symptoms and general psychopathology (P<.001). Significant differences were also observed in the secondary outcomes of the General Anxiety Disorder-7 (GAD-7; P=.04) and EQ-5D-5L (P=.005). There were no dropouts and no serious adverse events in this study. CONCLUSIONS: A total of 7 remote vCBTp sessions conducted in the vCBTp plus UC group could be safely administered to patients with schizophrenia. They were also observed to be effective for psychiatric symptoms, general anxiety, and quality of life. However, because of the observed worsening of scores in the UC group, caution is required in interpreting significant differences between the 2 groups. This approach is expected to improve accessibility to CBTp for outpatients with schizophrenia and social anxiety regarding transportation use and financial and physical burdens related to transportation, and to contribute to promoting CBTp acceptability by compensating for the shortage of implementers. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry UMIN000043396; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049544. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2022-069734.