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Research Article: Randomised controlled trial on the effect of video-conference cognitive behavioural therapy for patients with schizophrenia: a study protocol

Date Published: 2023-09-11

Abstract:
Introduction Cognitive behavioural therapy for psychosis (CBTp) has demonstrated effectiveness in reducing positive symptoms, improving depression, enhancing coping skills and increasing awareness of illness. However, compared with cognitive behavioural therapy for depression and anxiety, the spread of CBTp in clinical practice is minimal. The present study designed a randomised controlled trial (RCT) research protocol to evaluate whether real-time remote video-conference CBTp (vCBTp) could facilitate access to psychosocial interventions and effectively improve symptoms compared with usual care (UC) for patients with schizophrenia. Methods and analysis This exploratory RCT will consist of two parallel groups (vCBTp+UC?and UC alone) of 12 participants (n=24) diagnosed with schizophrenia, schizoaffective disorder or paranoid disorder, who remain symptomatic following pharmacotherapy. Seven 50-min weekly vCBTp interventions will be administered to test efficacy. The primary outcome will be the positive and negative syndrome scale score at week 8. The secondary outcome will be the Beck Cognitive Insight Scale to assess insight, the Patient Health Questionnaire-9 to assess depression, the Generalised Anxiety Disorder-7 to assess anxiety, the 5-level EuroQol 5-dimensional questionnaire to assess quality of life and the Impact of Event Scale-Revised to assess subjective distress about a specific stressful life event. We will take all measurements at 0 weeks (baseline) and at 8?weeks (post-intervention), and apply intention-to-treat analysis. Ethics and dissemination We will conduct this study in the outpatient department of Cognitive Behavioral Therapy Center at Chiba University Hospital. Further, all participants will be informed of the study and will be asked to sign consent forms. We will report according to the Consolidated Standards of Reporting Trials. Trial registration number UMIN000043396.

Introduction:
Based on the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), schizophrenia is a mental disorder associated with functional disability, poor quality of life and early death. 1 Schizophrenia is a severe, lifelong mental disorder that affects approximately 1% of the world’s population. 2 The illness tends to develop between the ages of 16 and 30 years. 3 Individuals with schizophrenia use a substantial amount of healthcare services. This condition imposes a significant economic…

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