Insight Enhancement Program vs. Metacognitive Training for Psychosis in Patients With Schizophrenia: A Three-Armed Comparative Randomized Controlled Trial

• Status: Completed
• Trial end date: 2021-01-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to explore new safe effective psychotherapeutic interventions for schizophrenia through assessing the efficacy and acceptability of complementary "Insight Enhancement Program" (IEP) and "Metacognitive Training for Psychosis" (MCT), in relation to each other, and in relation to "Treatment As Usual" (TAU). It is hypothesized that at the end of therapy, compared to "Treatment As Usual", patients undergoing whether (IEP) or (MCT) will display a significant reduction in psychopathology particularly positive symptoms and delusional ideation, and a significant improvement in Insight and metacognitive capacity. Additionally, it is hypothesized that the acceptance of (IEP) and (MCT) will be higher than acceptance of (TAU). This study also aims to examine whether metacognition is associated with insight even after controlling for the effects of psychiatric symptomatology.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agiad Psychiatry Hospital
• Collaborator: University of Pittsburgh
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• A diagnosis of a Schizophrenia Spectrum Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5).

• A present or prior episode of delusional symptoms, as assessed via clinical interview.

• Within the first five years since the onset of psychosis.

• Age between 18 and 65 years.

• Egyptian Nationality.

• Fluent command of the Arabic language.

• Capacity to understand the study description and provide informed consent.

In order to examine the efficacy of IEP and MCT in cases with minor symptom load, no minimum symptom threshold was defined for inclusion.

Exclusion Criteria:

• Comorbid Substance Dependence Disorder.

• Comorbid medical conditions, whose pathology or treatment could alter the presentation or treatment of schizophrenia.

• Intellectual disability (IQ of less than 70).

• Known sensitivity to Risperidone.

• Pregnant or Breast feeding women.

• Scores of 5 or higher on the PANSS hostility item and of 6 or higher on PANSS suspiciousness item (As group settings can be disrupted by behavioral disturbances, patients with very severe forms of delusions, formal thought disorder and hostility should refrain from participating in MCT or IEP until some remission has taken place).