Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Scale of therapeutic compliance |
This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance). |
Baseline |
|
| Primary |
Scale of therapeutic compliance |
This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance). |
3 months |
|
| Primary |
Scale of therapeutic compliance |
This scale in French version (Fond et al. 2017), is one of the most widely used tools to assess compliance in individuals with schizophrenia. This is a self-administered questionnaire with 10 yes/no items offering a total score from 0 (low compliance) to 10 (high compliance). |
6 months |
|
| Secondary |
Therapeutic alliance |
It is a self-administered questionnaire with 11 items that measures the alliance perceived by a patient towards his or her doctor. The scale is a 4-point ordinal scale ("Yes, it is true" to "No, it is totally false"). It has been validated in French (Misdrahi et al., 2009) and is a valid tool for measuring therapeutic alliance in schizophrenia. It concerns the patient's feelings about the therapeutic alliance. The 4 Ordinal Point Alliance Scale consists of eleven clearly stated items and easy to understand. |
Baseline |
|
| Secondary |
Therapeutic alliance |
It is a self-administered questionnaire with 11 items that measures the alliance perceived by a patient towards his or her doctor. The scale is a 4-point ordinal scale ("Yes, it is true" to "No, it is totally false"). It has been validated in French (Misdrahi et al., 2009) and is a valid tool for measuring therapeutic alliance in schizophrenia. It concerns the patient's feelings about the therapeutic alliance. The 4 Ordinal Point Alliance Scale consists of eleven clearly stated items and easy to understand. |
3 months |
|
| Secondary |
Therapeutic alliance |
It is a self-administered questionnaire with 11 items that measures the alliance perceived by a patient towards his or her doctor. The scale is a 4-point ordinal scale ("Yes, it is true" to "No, it is totally false"). It has been validated in French (Misdrahi et al., 2009) and is a valid tool for measuring therapeutic alliance in schizophrenia. It concerns the patient's feelings about the therapeutic alliance. The 4 Ordinal Point Alliance Scale consists of eleven clearly stated items and easy to understand. |
6 months |
|
| Secondary |
Positive and Negative Symptom Scale |
The PANSS (Kay et al., 1987) is a 30-item scale for measuring symptomatology specific to psychotic disorders, including schizophrenia. It has been validated in French (Lançon et al., 2000). It is a 7-point Likert scale that ranges from 1 (absent) to 7 (extremely present), giving a positive symptomatology score that ranges from 7 to 49, negative symptomatology (7 to 49), general psychopathology (16 to 112) and a total score (30 to 210). |
Baseline |
|
| Secondary |
Positive and Negative Symptom Scale |
The PANSS (Kay et al., 1987) is a 30-item scale for measuring symptomatology specific to psychotic disorders, including schizophrenia. It has been validated in French (Lançon et al., 2000). It is a 7-point Likert scale that ranges from 1 (absent) to 7 (extremely present), giving a positive symptomatology score that ranges from 7 to 49, negative symptomatology (7 to 49), general psychopathology (16 to 112) and a total score (30 to 210). |
3 months |
|
| Secondary |
Positive and Negative Symptom Scale |
The PANSS (Kay et al., 1987) is a 30-item scale for measuring symptomatology specific to psychotic disorders, including schizophrenia. It has been validated in French (Lançon et al., 2000). It is a 7-point Likert scale that ranges from 1 (absent) to 7 (extremely present), giving a positive symptomatology score that ranges from 7 to 49, negative symptomatology (7 to 49), general psychopathology (16 to 112) and a total score (30 to 210). |
6 months |
|
| Secondary |
Clinical Assessment Interview for Negative Symptoms |
CAINS is a recently developed tool to evaluate the 2 dimensions of negative symptomatology highlighted in the literature, i.e. the motivation dimension and the decreased emotional expressivity dimension. It has been translated into French by our team (Raffard et al., currently under validation). It includes 13 items (9 for the motivation dimension and 4 for the expressivity dimension) evaluated during a semi-structured interview. |
Baseline |
|
| Secondary |
Clinical Assessment Interview for Negative Symptoms |
CAINS is a recently developed tool to evaluate the 2 dimensions of negative symptomatology highlighted in the literature, i.e. the motivation dimension and the decreased emotional expressivity dimension. It has been translated into French by our team (Raffard et al., currently under validation). It includes 13 items (9 for the motivation dimension and 4 for the expressivity dimension) evaluated during a semi-structured interview. |
3 months |
|
| Secondary |
Clinical Assessment Interview for Negative Symptoms |
CAINS is a recently developed tool to evaluate the 2 dimensions of negative symptomatology highlighted in the literature, i.e. the motivation dimension and the decreased emotional expressivity dimension. It has been translated into French by our team (Raffard et al., currently under validation). It includes 13 items (9 for the motivation dimension and 4 for the expressivity dimension) evaluated during a semi-structured interview. |
6 months |
|
| Secondary |
Functioning Remission of General Schizophrenia |
The FROGS scale will be used to assess patient functioning. This questionnaire was developed, in French, according to the method of a consensus of experts, following a search in the main databases. This questionnaire has a good internal consistency (a=0.909) and good external validity (GFE score, r=0.56). The factor analysis identified 3 areas: "social functioning", "daily life", "treatment". The stability of the questionnaire was validated with a new evaluation at 1.5 years of patients and shows a good correlation of FROGS scores with other functioning evaluation scales. This questionnaire therefore has solid psychometric qualities. A total score is computed based on the sum of its 19 items ranging each from 1 (do not do) to 5 (do perfectly). The lower the score, the lower the functioning. |
Baseline |
|
| Secondary |
Functioning Remission of General Schizophrenia |
The FROGS scale will be used to assess patient functioning. This questionnaire was developed, in French, according to the method of a consensus of experts, following a search in the main databases. This questionnaire has a good internal consistency (a=0.909) and good external validity (GFE score, r=0.56). The factor analysis identified 3 areas: "social functioning", "daily life", "treatment". The stability of the questionnaire was validated with a new evaluation at 1.5 years of patients and shows a good correlation of FROGS scores with other functioning evaluation scales. This questionnaire therefore has solid psychometric qualities. A total score is computed based on the sum of its 19 items ranging each from 1 (do not do) to 5 (do perfectly). The lower the score, the lower the functioning. |
3 months |
|
| Secondary |
Functioning Remission of General Schizophrenia |
The FROGS scale will be used to assess patient functioning. This questionnaire was developed, in French, according to the method of a consensus of experts, following a search in the main databases. This questionnaire has a good internal consistency (a=0.909) and good external validity (GFE score, r=0.56). The factor analysis identified 3 areas: "social functioning", "daily life", "treatment". The stability of the questionnaire was validated with a new evaluation at 1.5 years of patients and shows a good correlation of FROGS scores with other functioning evaluation scales. This questionnaire therefore has solid psychometric qualities. A total score is computed based on the sum of its 19 items ranging each from 1 (do not do) to 5 (do perfectly). The lower the score, the lower the functioning. |
6 months |
|
| Secondary |
French National Adult Reading Test |
The Premorbid IQ will be assessed by the French National Adult Reading Test (fNART) (McKinnon & Mulligan, 2005). Based on the ability to pronounce 40 words with irregular spelling (1 point per correct answer), this test provides an estimate of the subject's premorbid IQ. |
Baseline |
|
| Secondary |
French National Adult Reading Test |
The Premorbid IQ will be assessed by the French National Adult Reading Test (fNART) (McKinnon & Mulligan, 2005). Based on the ability to pronounce 40 words with irregular spelling (1 point per correct answer), this test provides an estimate of the subject's premorbid IQ. |
3 months |
|
| Secondary |
French National Adult Reading Test |
The Premorbid IQ will be assessed by the French National Adult Reading Test (fNART) (McKinnon & Mulligan, 2005). Based on the ability to pronounce 40 words with irregular spelling (1 point per correct answer), this test provides an estimate of the subject's premorbid IQ. |
6 months |
|
| Secondary |
California Verbal Learning Test |
The experimenter reads a list of 16 words. The patient must then return as many words as possible (immediate free recall), repeated 5 times. The experimenter reads a new list of 16 words, this new list serves as an interference. The patient is asked to return as many words as possible from the second list (immediate free recall). Then the patient is instructed to try to return as many words as possible from first list (free short term recall), then comes an indication phase. 20 minutes break without verbal tests. The patient is instructed again to return as many words as possible from first list (free long-term recall) and arrives to complete a new phase of indication (long-term indexed recall). This test highlights long-term memory recovery processes as well as long-term memory consolidation processes. The standard score is the Total Recall Responses (160). |
Baseline |
|
| Secondary |
California Verbal Learning Test |
The experimenter reads a list of 16 words. The patient must then return as many words as possible (immediate free recall), repeated 5 times. The experimenter reads a new list of 16 words, this new list serves as an interference. The patient is asked to return as many words as possible from the second list (immediate free recall). Then the patient is instructed to try to return as many words as possible from first list (free short term recall), then comes an indication phase. 20 minutes break without verbal tests. The patient is instructed again to return as many words as possible from first list (free long-term recall) and arrives to complete a new phase of indication (long-term indexed recall). This test highlights long-term memory recovery processes as well as long-term memory consolidation processes. The standard score is the Total Recall Responses (160). |
3 months |
|
| Secondary |
California Verbal Learning Test |
The experimenter reads a list of 16 words. The patient must then return as many words as possible (immediate free recall), repeated 5 times. The experimenter reads a new list of 16 words, this new list serves as an interference. The patient is asked to return as many words as possible from the second list (immediate free recall). Then the patient is instructed to try to return as many words as possible from first list (free short term recall), then comes an indication phase. 20 minutes break without verbal tests. The patient is instructed again to return as many words as possible from first list (free long-term recall) and arrives to complete a new phase of indication (long-term indexed recall). This test highlights long-term memory recovery processes as well as long-term memory consolidation processes. The standard score is the Total Recall Responses (160). |
6 months |
|
| Secondary |
Trail Making Test |
This test is used to evaluate executive functions and more particularly mental flexibility. It is a timed test, with five conditions: visual exploration (condition 1), number order (condition 2), letter order (condition 3), number-letter flexibility (condition 4) and motor speed (condition 5). The main dependent variable to note is the difference in time between condition 4 - condition 1. |
Baseline |
|
| Secondary |
Trail Making Test |
This test is used to evaluate executive functions and more particularly mental flexibility. It is a timed test, with five conditions: visual exploration (condition 1), number order (condition 2), letter order (condition 3), number-letter flexibility (condition 4) and motor speed (condition 5). The main dependent variable to note is the difference in time between condition 4 - condition 1. |
3 months |
|
| Secondary |
Trail Making Test |
This test is used to evaluate executive functions and more particularly mental flexibility. It is a timed test, with five conditions: visual exploration (condition 1), number order (condition 2), letter order (condition 3), number-letter flexibility (condition 4) and motor speed (condition 5). The main dependent variable to note is the difference in time between condition 4 - condition 1. |
6 months |
|
| Secondary |
Energy Motion Analysis |
Motion Energy Analysis is a valid, robust and objective measure of the degree of Motor Synchrony between two people.It is captured using two cameras oriented respectively towards the patient and the clinician. This video analysis consists in extracting the amount of movement present between two successive images (Number of pixels that differs between two successive video frames) and thus automatically extracting the activity of the patient and that of the clinician during an interview. The comparison between these two time series by cross-correlation gives a single measure r representing the quantity of Motor Synchrony present in the exchange between the patient and the clinician. Therefore MS ranges from 0 (no synchrony) to 1 (perfect synchrony).The higher the value, the higher the synchronisation. |
Baseline |
|
| Secondary |
Energy Motion Analysis |
Motion Energy Analysis is a valid, robust and objective measure of the degree of Motor Synchrony between two people.It is captured using two cameras oriented respectively towards the patient and the clinician. This video analysis consists in extracting the amount of movement present between two successive images (Number of pixels that differs between two successive video frames) and thus automatically extracting the activity of the patient and that of the clinician during an interview. The comparison between these two time series by cross-correlation gives a single measure r representing the quantity of Motor Synchrony present in the exchange between the patient and the clinician. Therefore MS ranges from 0 (no synchrony) to 1 (perfect synchrony).The higher the value, the higher the synchronisation. |
3 months |
|
| Secondary |
Energy Motion Analysis |
Motion Energy Analysis is a valid, robust and objective measure of the degree of Motor Synchrony between two people.It is captured using two cameras oriented respectively towards the patient and the clinician. This video analysis consists in extracting the amount of movement present between two successive images (Number of pixels that differs between two successive video frames) and thus automatically extracting the activity of the patient and that of the clinician during an interview. The comparison between these two time series by cross-correlation gives a single measure r representing the quantity of Motor Synchrony present in the exchange between the patient and the clinician. Therefore MS ranges from 0 (no synchrony) to 1 (perfect synchrony).The higher the value, the higher the synchronisation. |
6 months |
|
