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

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ClinicalTrials.gov Identifier: NCT03955549
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Ahmed Ahmed Dobie, Agiad Psychiatry Hospital

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Spectrum and Other Psychotic Disorders Behavioral: Insight Enhancement Program (IEP) Behavioral: Metacognitive Training for Psychosis (MCT) Drug: Treatment As Usual (TAU) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Insight Enhancement Program vs. Metacognitive Training for Psychosis in Patients With Schizophrenia: A Three-Armed Comparative Randomized Controlled Trial
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: Insight Enhancement Program (IEP)

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 Name: Insight Enhancement Therapy

Drug: Treatment As Usual (TAU)

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 Name: Control Group

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.
Behavioral: Metacognitive Training for Psychosis (MCT)
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 Name: Metacognitive Training

Drug: Treatment As Usual (TAU)

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 Name: Control Group

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.

Drug: Treatment As Usual (TAU)

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 Name: Control Group




Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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).

  3. 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 ]
    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.

  4. 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 ]
    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.

  5. 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 ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    This test will be administered to determine immediate and delayed recall.

  5. 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 ]
    The Porteus Mazes task was used to assess reasoning and problem solving.

  6. 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 ]
    • 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).

  7. 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 ]
    • 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

  8. 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 ]
    The SMARTS checklist aims to strike a balance between brevity and capturing the most common and important antipsychotic side effects.


Other Outcome Measures:
  1. Subjective Acceptance of the Interventions as measured by an Acceptance Questionnaire [ Time Frame: At Week 8 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955549


Contacts
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Contact: Ahmed A. Dobie, Msc. +201000611588 ahmaddobea@hotmail.com

Locations
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Egypt
Agiad Psychiatry Hospital Recruiting
Talkha, Dakahliya, Egypt, 35716
Contact: Ahmed A. Dobie, Msc.    +201000611588    ahmaddobea@hotmail.com   
Sponsors and Collaborators
Agiad Psychiatry Hospital
University of Pittsburgh
Investigators
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Principal Investigator: Ahmed A. Dobie, Msc. Agiad Psychiatry Hospital
Principal Investigator: Mai M. El-Bassosy, Msc. Agiad Psychiatry Hospital

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Responsible Party: Ahmed Ahmed Dobie, Specialist of Psychiatry, Agiad Psychiatry Hospital
ClinicalTrials.gov Identifier: NCT03955549     History of Changes
Other Study ID Numbers: 16-09
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A plan is still being put together
Supporting Materials: Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 6 months after publishing
Access Criteria: Other Researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ahmed Ahmed Dobie, Agiad Psychiatry Hospital:
Insight Enhancement Program
Insight Enhancement Therapy
Metacognitive Training for Psychosis
Psychotherapeutic Interventions for Schizophrenia
Research on Schizophrenia in Egypt
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents