Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Subjective Acceptance of the Interventions as measured by an Acceptance Questionnaire |
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. |
At Week 8 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
|
| Primary |
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 |
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. |
Pre-Intervention at Week 4, and Post-Intervention at Week 8 |
|
| Secondary |
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. |
Pre-Intervention at Week 4, and Post-Intervention at Week 8 |
|
| Secondary |
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. |
Pre-Intervention at Week 4, and Post-Intervention at Week 8 |
|
| Secondary |
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. |
Pre-Intervention at Week 4, and Post-Intervention at Week 8 |
|
| Secondary |
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. |
Pre-Intervention at Week 4, and Post-Intervention at Week 8 |
|
| Secondary |
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). |
Pre-Intervention at Week 4, and Post-Intervention at Week 8 |
|
| Secondary |
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 |
Pre-Intervention at Week 4, and Post-Intervention at Week 8 |
|
| Secondary |
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. |
At Baseline, Week 2, Week 4, Week 6, Week 8 |
|
