Insight Enhancement Program vs. Metacognitive Training for Psychosis in Patients With Schizophrenia: A Three-Armed Comparative Randomized Controlled Trial
Condition: Schizophrenia Spectrum and Other Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Insight Enhancement Program (IEP); Metacognitive Training for Psychosis (MCT); Treatment As Usual (TAU)
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): IEP is comprised of 8 sessions, administered twice weekly, across a one month period. The session duration is 60-90 minutes. IEP will be administered in a group format with 8-12 patients in each group.
During sessions, different topics representing 8 different stages of illness are discussed according to a chronological schedule. These stages are presented on an Illness March Graph (IMG) and include: Stage I: Personality formation, Stage II: Pre onset confusion, Stage III: Prodroma, Stage IV: The illness, Stage V: Resistance, Stage VI: Remission, Stage VII: Maintenance, Stage VIII: Relapse. Patients actively participate through the exchange of their own experiences and interpretations, which are then reinterpreted by the therapist and by the patients themselves.; The training consists of eight modules that are administered within the framework of a group intervention program that involves eight 1-hour group sessions with 4 to 10 patients in each group. MCT is manualized and currently available in thirty languages and can been downloaded via the following web address: http://www.uke.de/mct. Among the problematic thinking styles recognized as potential contributors to the development of delusions are attributional distortions (module 1), a jumping to conclusions bias (module 2 and 7), a bias against disconfirmatory evidence (module 3), deficits in theory of mind (module 4 and 6), over-confidence in memory errors (module 5) and depressive cognitive patterns (module 8).; Treatment As Usual (TAU) consists of psychiatric management by a clinical team including at least one psychiatrist and one psychologist. Treatment involves antipsychotic medication, regular office-based contacts with the clinical team for treatment monitoring, recreational group activities, and unstructured psycho-educational groups. Participants in the interventional groups also will receive TAU.
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.
Other intervention name(s): Insight Enhancement Therapy; Metacognitive Training; Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insight Enhancement Program; Insight Enhancement Therapy; Metacognitive Training for Psychosis; Psychotherapeutic Interventions for Schizophrenia; Research on Schizophrenia in Egypt