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

NCT03955549 | Completed Phase 3 DMC

• 1 other identifier: 16-09
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Mean Change in Psychopathology as measured by The Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

  The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) is a 30-item, seven-point (1-7) scale and it is the most widely used instrument for the assessment of schizophrenia symptoms in clinical trials. Ratings follow semi-structured interviews and clear standard operating procedures. Symptoms are rated according to their presence in the past 2 weeks. The PANSS was used many times before in trials of MCT \& insight in schizophrenia, which makes it more suitable allowing comparison of results.

  Pre-Intervention at Week 4, and Post-Intervention at Week 8

• Mean Change in Psychopathology as measured by The Psychotic Symptom Rating Scale (PSYRATS)

  The PSYRATS is a 17-item multidimensional measure of more qualitative aspects of hallucinations and delusions. Symptoms are rated over the past 2 weeks. Two subscales exist; for auditory hallucinations (11 items), and for delusions (6 items).

  Pre-Intervention at Week 4, and Post-Intervention at Week 8

• Mean Change in Insight Scores as measured by The Scale to Assess Unawareness of Mental Disorder (SUMD)

  The SUMD evaluates insight into various dimensions of the disease. The SUMD is a standardized scale that relies on a direct interview with the patient.

  Pre-Intervention at Week 4, and Post-Intervention at Week 8

• Mean Change in Insight Scores as measured by The Beck Cognitive Insight Scale (BCIS)

  The BCIS is a self-report consisting of 15 statements rated on a 4-point Likert scale. It is divided into 2 subscales; self-reflectiveness, and self-certainty. Self-reflectiveness consists of 9 items measuring objectivity, reflectiveness and openness to feedback. Self-certainty consists of 6 items measuring decision-making and resistance to feedback. Overall cognitive insight was defined by Beck and associates as the difference between self-reflectiveness and self- certainty and labeled composite index.

  Pre-Intervention at Week 4, and Post-Intervention at Week 8

• Mean Change in Metacognition Scores as measured by The Metacognition Assessment Scale - Adapted version (MAS-A)

  The MAS-A is scored on the basis of the transcript of the Indiana Psychiatric Illness Interview (IPII). Scoring is performed by a consensus group of at least three trained raters. The four domains of metacognition are reflected in the four ordinal complexity scales of the MAS-A: self-reflectivity, understanding the other's mind, decentration, and mastery. The raters assign one point for each function on each scale that they judge is accomplished in the transcript.

  Pre-Intervention at Week 4, and Post-Intervention at Week 8

Secondary Outcomes (8)

• Mean Change in Scores as measured by The Personal and social performance scale (PSP)

  Pre-Intervention at Week 4, and Post-Intervention at Week 8

• Mean Change in Neuropsychological Functioning Scores as measured by The Trail making test (TMT)

  Pre-Intervention at Week 4, and Post-Intervention at Week 8

• Mean Change in Neuropsychological Functioning Scores as measured by The Digit Symbol Substitution Test (DSST)

  Pre-Intervention at Week 4, and Post-Intervention at Week 8

• Mean Change in Neuropsychological Functioning Scores as measured by The story subtest of the Rivermead Behavioural Memory Task.

  Pre-Intervention at Week 4, and Post-Intervention at Week 8

• Mean Change in Neuropsychological Functioning Scores as measured by The Porteus Mazes task.

  Pre-Intervention at Week 4, and Post-Intervention at Week 8

Other Outcomes (1)

• Subjective Acceptance of the Interventions as measured by an Acceptance Questionnaire

  At Week 8

Study Arms (3)

Insight Enhancement Program (IEP)

EXPERIMENTAL

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.

Behavioral: Insight Enhancement Program (IEP); Drug: Treatment As Usual (TAU)

Metacognitive Training for Psychosis (MCT)

EXPERIMENTAL

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.

Behavioral: Metacognitive Training for Psychosis (MCT); Drug: Treatment As Usual (TAU)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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.

Drug: Treatment As Usual (TAU)

Interventions

Insight Enhancement Program (IEP) BEHAVIORAL

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.

Also known as: Insight Enhancement Therapy

Insight Enhancement Program (IEP)

Metacognitive Training for Psychosis (MCT) BEHAVIORAL

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).

Also known as: Metacognitive Training

Metacognitive Training for Psychosis (MCT)

Treatment As Usual (TAU) DRUG

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.

Also known as: Control Group

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Agiad Psychiatry Hospital: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Agiad Psychiatry Hospital

Ţalkhā, Dakahliya, 35716, Egypt

Location

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Therapeutics; Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ahmed A. Dobie, Msc.

  Agiad Psychiatry Hospital

  PRINCIPAL INVESTIGATOR

• Mai M. El-Bassosy, Msc.

  Agiad Psychiatry Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to treatment allocation, and specific measures will be undertaken to preserve blinding and prevent a Rosenthal effect (e.g., assessors will not be employees of the same hospital, and before each assessment participants will be explicitly instructed not to disclose their group assignment to the assessor). Randomization will be according to a randomization plan using stratified permuted block randomization with each block containing four participants. This method will be used to achieve balance among groups in terms of subjects' baseline characteristics. Stratified randomization is achieved by generating a separate block for each covariate such as age \& gender.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: May 1, 2019
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: 6 months after publishing
• Access Criteria: Other Researchers

Locations

EG (1)