Clinical trial NCT03955549: Insight Enhancement Program vs. Metacognitive Training for Psychosis in Patients With Schizophrenia: A Three-Armed Comparative Randomized Controlled Trial
Official title: Insight Enhancement Program vs. Metacognitive Training for Psychosis in Patients With Schizophrenia: A Three-Armed Comparative Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
Keywords: Insight Enhancement Program
Insight Enhancement Therapy
Metacognitive Training for Psychosis
Psychotherapeutic Interventions for Schizophrenia
Research on Schizophrenia in Egypt
Lead sponsor: Agiad Psychiatry Hospital
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2019-05-20
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a three-armed parallel group, assessor-blind, randomized controlled trial comparing "Insight Enhancement Program" (IEP) and "Metacognitive Training for Psychosis" (MCT) with "Treatment As Usual" (TAU). Once the participant gives his/her consent, he/she will be randomized either to (IEP+TAU), or (MCT+TAU), or (TAU). Both interventions consist of eight session administered over 4 weeks. The total study duration will be 2 months as participants must be on a fixed dose of the antipsychotic medication for 4 weeks prior to starting the interventions. Participants will be assessed twice during the study period; the first assessment will be after 4 weeks of receiving the antipsychotic medication prior to starting the interventions, and the final assessment will be at the end of the study after finishing the interventions. A total of 120 participants will be recruited in the study and randomized across the three groups in a 1:1:1 proportion.
Primary purpose: TREATMENT

Brief 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 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).

Primary outcomes:
measure: Mean Change in Psychopathology as measured by The Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Mean Change in Psychopathology as measured by The Psychotic Symptom Rating Scale (PSYRATS)
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Mean Change in Insight Scores as measured by The Scale to Assess Unawareness of Mental Disorder (SUMD)
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Mean Change in Insight Scores as measured by The Beck Cognitive Insight Scale (BCIS)
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Mean Change in Metacognition Scores as measured by The Metacognition Assessment Scale - Adapted version (MAS-A)
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
Secondary outcomes:
measure: Mean Change in Scores as measured by The Personal and social performance scale (PSP)
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Mean Change in Neuropsychological Functioning Scores as measured by The Trail making test (TMT)
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Mean Change in Neuropsychological Functioning Scores as measured by The Digit Symbol Substitution Test (DSST)
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Mean Change in Neuropsychological Functioning Scores as measured by The story subtest of the Rivermead Behavioural Memory Task.
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Mean Change in Neuropsychological Functioning Scores as measured by The Porteus Mazes task.
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Mean Change in IQ as measured by The Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Mean Change in Self-Esteem Scores as measured by The Rosenberg Self-esteem Scale (RSES) - Arabic Version -
timeFrame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
measure: Adverse Events will be measured by The Systematic Monitoring of Adverse Events Related to Treatments Checklist (SMARTS)
timeFrame: At Baseline, Week 2, Week 4, Week 6, Week 8
Other outcomes:
measure: Subjective Acceptance of the Interventions as measured by an Acceptance Questionnaire
timeFrame: At Week 8
Locations:
city: Talkha
country: Egypt
facility: Agiad Psychiatry Hospital
state: Dakahliya
Study officials:
affiliation: Agiad Psychiatry Hospital
name: Ahmed A. Dobie, Msc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Agiad Psychiatry Hospital
name: Mai M. El-Bassosy, Msc.
role: PRINCIPAL_INVESTIGATOR
References: