- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03955549
Insight Enhancement Program vs. Metacognitive Training for Psychosis in Patients With Schizophrenia: A Three-Armed Comparative Randomized Controlled Trial
Study Overview
Status
Detailed Description
Specific aims include:
- 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.
- 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.
- 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.
- Aim #4: Examine the associations between insight, metacognition, and psychopathology.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Dakahliya
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Talkha, Dakahliya, Egypt, 35716
- Agiad Psychiatry Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Insight Enhancement Program (IEP)
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.
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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.
Other Names:
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 Names:
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Experimental: Metacognitive Training for Psychosis (MCT)
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.
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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 Names:
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).
Other Names:
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Active Comparator: Treatment As Usual (TAU)
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 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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Psychopathology as measured by The Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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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.
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Mean Change in Psychopathology as measured by The Psychotic Symptom Rating Scale (PSYRATS)
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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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).
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Mean Change in Insight Scores as measured by The Scale to Assess Unawareness of Mental Disorder (SUMD)
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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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.
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Mean Change in Insight Scores as measured by The Beck Cognitive Insight Scale (BCIS)
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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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.
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Mean Change in Metacognition Scores as measured by The Metacognition Assessment Scale - Adapted version (MAS-A)
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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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.
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Scores as measured by The Personal and social performance scale (PSP)
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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The PSP was used to assess subjects' social functioning.
Patients' functioning is assessed in four core areas: Socially useful activities; personal and social relationships; self-care; and disturbing and aggressive behaviours.
A global item is rated by the interviewer, ranging from 1 to 100 at 10-point intervals with lower scores indicating poorer functioning.
The PSP shows good psychometric properties.
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Mean Change in Neuropsychological Functioning Scores as measured by The Trail making test (TMT)
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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The Trail Making Test (TMT) Part A and B will be used to assess sustained attention, visual-spatial search, and psychomotor speed.
The A-form requires the subject to combine numbers as fast as possible in ascending order.
In the B-part, the subject has to combine numbers and letters as quickly as possible in both alternating and ascending fashion.
The rating is based on the number of seconds needed to complete the test.
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Mean Change in Neuropsychological Functioning Scores as measured by The Digit Symbol Substitution Test (DSST)
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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The Digit Symbol Substitution Test (DSST) is part of the Wechsler Adult Intelligence Scale (Wechsler, 2008), and is used to assess visuo-motor processing speed.
The total score on this test is based on the amount of correctly completed symbols within 120 seconds.
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Mean Change in Neuropsychological Functioning Scores as measured by The story subtest of the Rivermead Behavioural Memory Task.
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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This test will be administered to determine immediate and delayed recall.
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Mean Change in Neuropsychological Functioning Scores as measured by The Porteus Mazes task.
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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The Porteus Mazes task was used to assess reasoning and problem solving.
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Mean Change in IQ as measured by The Wechsler Adult Intelligence Scale (WAIS-III)
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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• The Wechsler Adult Intelligence Scale (WAIS) III, (Wechsler, 1997).
Current IQ was measured using a short form of the Wechsler Adult Intelligence Scale (WAIS) III composed of 4 subtests: information, arithmetic, block design, and digit symbol and developed for use in schizophrenia (Blyler et al., 2000).
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Mean Change in Self-Esteem Scores as measured by The Rosenberg Self-esteem Scale (RSES) - Arabic Version -
Time Frame: Pre-Intervention at Week 4, and Post-Intervention at Week 8
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• The 10-item Rosenberg scale is considered the gold-standard for the assessment of self-esteem, and its good validity and reliability have been confirmed for the Arabic version
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Pre-Intervention at Week 4, and Post-Intervention at Week 8
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Adverse Events will be measured by The Systematic Monitoring of Adverse Events Related to Treatments Checklist (SMARTS)
Time Frame: At Baseline, Week 2, Week 4, Week 6, Week 8
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The SMARTS checklist aims to strike a balance between brevity and capturing the most common and important antipsychotic side effects.
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At Baseline, Week 2, Week 4, Week 6, Week 8
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Acceptance of the Interventions as measured by an Acceptance Questionnaire
Time Frame: At Week 8
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To assess acceptance, feasibility and subjective efficacy of the interventions, participants will be asked to anonymously appraise the training at post-treatment.
The questionnaire is modeled after versions administered in previous trials (Moritz and Woodward, 2007; Moritz et al., 2011), and is comprised of ten questions posed on a five-point Likert scale (1=fully agree to 5=fully disagree).
Acceptance and feasibility will also be assessed with the frequency of unattended sessions.
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At Week 8
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ahmed A. Dobie, Msc., Agiad Psychiatry Hospital
- Principal Investigator: Mai M. El-Bassosy, Msc., Agiad Psychiatry Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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