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Completed

NCT Number: NCT03955549

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

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.

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Key information

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Agiad Psychiatry Hospital

Ţalkhā, Dakahliya, 35716, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Insight Enhancement Therapy

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).

Other names: Metacognitive Training

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.

Other names: Control Group

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Agiad Psychiatry Hospital

Other

Collaborators

  • University of Pittsburgh

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 20, 2019
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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