Loading clinical trials...

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

COMPLETEDPHASE3

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

NCT03955549•Agiad Psychiatry Hospital

View on ClinicalTrials.gov

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.

Detailed Description

Specific aims include: 1. Aim #1: Evaluate the efficacy of complementary "Insight Enhancement Program" (IEP), compared to TAU, in reducing psychopathology particularly positive symptoms and delusional ideation, and improving insight and metacognitive capacity as well as social functioning. 2. Aim #2: Evaluate the efficacy of complementary "Metacognitive Training for Psychosis" (MCT), compared to TAU, in reducing psychopathology particularly positive symptoms and delusional ideation, and improving insight and metacognitive capacity as well as social functioning. 3. Aim #3: Compare the efficacy of complementary "Insight Enhancement Program" (IEP), compared to "Metacognitive Training for Psychosis" (MCT), in reducing psychopathology and improving insight and metacognitive capacity as well as social functioning. 4. Aim #4: Examine the associations between insight, metacognition, and psychopathology.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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).

Locations (1)

Agiad Psychiatry Hospital

Ţalkhā, Dakahliya, Egypt

Key Dates

Start Date

May 1, 2019

Primary Completion Date

January 30, 2021

Completion Date

January 30, 2021

Last Updated

August 6, 2021

Enrollment

ACTUAL participants

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Insight Enhancement Program (IEP)

BEHAVIORAL

Metacognitive Training for Psychosis (MCT)

BEHAVIORAL

Treatment As Usual (TAU)

DRUG

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

View study

COMPLETEDNA

ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention

NCT04298450

First Episode PsychosisPsychosis+9 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention

Repetitive TMS & Cognitive Training in Adults With Schizophrenia

Plan D- Vitamin D Supplementation in Psychotic Disorders

Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder

Antipsychotic Induced Hyperprolactinemaia as Risk Factor for Periodontitis in Schizophrenic Patients