Effectiveness of a Video-Conference Cognitive Behavioral Therapy for Patients with Schizophrenia: A Pilot Randomized Controlled Trial.

Background: Background: Cognitive behavioral therapy for psychosis (CBTp) is not widespread enough in clinical practice, although evidence has been presented.

Objective: Objective: The purpose of this study was to explore whether one-on-one CBTp using video-conference (vCBTp) was more effective than usual care (UC) treatment alone in improving psychiatric symptoms in patients with schizophrenia attending outpatient clinics.

Methods: 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 was conducted once a week, with each section lasting for 50 min, for a total of seven sessions in real-time and 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 at week 0 to post-test at week 8.

Results: Results: There were 24 participants in the study. There were no significant differences between the two groups at baseline. With regard to significant differences between the two groups on the primary outcome, the mean change in PANSS total score from baseline to week 8 in the vCBTp plus UC group was -9.5 (95% CI -12.09 to -6.91); the mean change in the UC alone group was 6.9 (95% CI 1.54 to 12.30). The difference between the two groups was significant at 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 (GAD-7, P=.042) and the EuroQol 5-dimensions 5-lines (EQ-5D-5L, P=.005). There were no dropouts and no serious adverse events in this study.

Conclusions: Conclusions: A total of seven 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 (QoL). However, because of the observed worsening of scores in the UC group, caution is required in interpreting significant differences between the two groups. This approach is expected to improve accessibility to CBTp for outpatients with schizophrenia and social anxiety about transportation use and financial and physical burdens related to transportation, and to contribute to promoting CBTp acceptability by compensating for the shortage of implementers.

Clinicaltrial: 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: RR2-DOI: 10.1136/bmjopen-2022-069734.