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

Agiad Psychiatry Hospital

Status and phase: Completed; Phase 3

Conditions: Schizophrenia Spectrum and Other Psychotic Disorders

Treatments: Behavioral: Insight Enhancement Program (IEP); Drug: Treatment As Usual (TAU); Behavioral: Metacognitive Training for Psychosis (MCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03955549

16-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 3 patient groups

Insight Enhancement Program (IEP)

Experimental group

Description:

The insight enhancement program is a dynamo-cognitive therapeutic modality with the main target of improving insight in psychotic patients as a means of improving their overall outcome.

Treatment:

Drug: Treatment As Usual (TAU)

Behavioral: Insight Enhancement Program (IEP)

Metacognitive Training for Psychosis (MCT)

Experimental group

Description:

The metacognitive training program, developed by Moritz et al. (Moritz \& Woodward, 2007) targets cognitive biases putatively involved in the formation and maintenance of psychotic symptoms.

Treatment:

Behavioral: Metacognitive Training for Psychosis (MCT)

Drug: Treatment As Usual (TAU)

Treatment As Usual (TAU)

Active Comparator group

Description:

Treatment as usual will be used as a control condition to assure ethicality of our procedure. Medications: In order to standardize treatment, Risperidone (Risperdal ) will be used as the antipsychotic medication in all three groups with a dose up to 6-8 milligrams according to clinical severity. The same dose will be used for 1 month prior to starting interventions). In case of occurrence of mild extrapyramidal symptoms associated with high doses of risperidone, an anticholinergic drug (Benztropine) might be used.

Treatment:

Drug: Treatment As Usual (TAU)