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Schizophrenia Spectrum and Other Psychotic DisordersPhase 3NCT03955549

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

A Phase 3 study testing Insight Enhancement Program (IEP), Metacognitive Training for Psychosis (MCT) and Treatment As Usual (TAU) in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Agiad Psychiatry Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Insight Enhancement Program (IEP), Metacognitive Training for Psychosis (MCT) and Treatment As Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteEgypt
Study dates
1 May 2019to 30 Jan 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Egypt1 site

  • Agiad Psychiatry Hospital

    Ţalkhā, Dakahliya, 35716

Other trials in Egypt

About this study

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.

Read the 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.
Being tested
Insight Enhancement Program (IEP), Metacognitive Training for Psychosis (MCT), Treatment As Usual (TAU)
Keywords
Insight Enhancement Program, Insight Enhancement Therapy, Metacognitive Training for Psychosis, Psychotherapeutic Interventions for Schizophrenia, Research on Schizophrenia in Egypt
Medical subject headings
Schizophrenia Spectrum and Other Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insight Enhancement Program (IEP)Behavioural

    Also called Insight Enhancement Therapy

    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.

  • Metacognitive Training for Psychosis (MCT)Behavioural

    Also called Metacognitive Training

    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)Drug

    Also called Control Group

    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.

Study groups in NCT03955549
Study groupRoleWhat they receive
Insight Enhancement Program (IEP)ExperimentalThe 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.
Receives: Behavioral: Insight Enhancement Program (IEP); Drug: Treatment As Usual (TAU)
Metacognitive Training for Psychosis (MCT)ExperimentalThe metacognitive training program, developed by Moritz et al. (Moritz \& Woodward, 2007) targets cognitive biases putatively involved in the formation and maintenance of psychotic symptoms.
Receives: Behavioral: Metacognitive Training for Psychosis (MCT); Drug: Treatment As Usual (TAU)
Treatment As Usual (TAU)Active comparatorTreatment 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.
Receives: Drug: Treatment As Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Secondary outcomes (8)

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

    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.

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

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

    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.

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

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

    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.

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

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

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

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

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

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

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

  6. Mean Change in IQ as measured by The Wechsler Adult Intelligence Scale (WAIS-III)

    • 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).

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

  7. Mean Change in Self-Esteem Scores as measured by The Rosenberg Self-esteem Scale (RSES) - Arabic Version -

    • 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

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

  8. Adverse Events will be measured by The Systematic Monitoring of Adverse Events Related to Treatments Checklist (SMARTS)

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

    Measured: At Baseline, Week 2, Week 4, Week 6, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2019
  2. Study start1 May 2019
  3. Primary completion30 Jan 2021
  4. Study completion30 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955549
Sponsor's protocol ID
16-09
Status last verified
Aug 2021
First submitted
16 May 2019
Last updated
6 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A plan is still being put together

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insight Enhancement Program (IEP), Metacognitive Training for Psychosis (MCT) and Treatment As Usual (TAU) in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Agiad Psychiatry Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03955549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.

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