Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia

Behavioral Assessment of the Dysexecutive Syndrome (BADS). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgment, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min. 12-max. 129). A higher score indicates better performance.

Time frame: Change from baseline in executive function at 16 weeks (post-treatment)

Population: The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.

Behavioral Assessment of the Dysexecutive Syndrome (BADS) (Wilson et al., 1996). This scale evaluates cognitive flexibility, inhibition of impulsive responses, planning and organization, working memory and time-estimation capacity. All subscales (Rule shift cards, Action Program, Key search, Temporal judgement, Zoo map and Six elements) were administered. We used subscales raw scores which run from 0 to 4. The subscales' raw score is summarized and converted to standardized total score which run (min. 12-max. 129). A higher score indicates better performance.

Time frame: Change from baseline in executive functioning at 40 weeks

Population: The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.

The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30-max. 210) with a score of 30 representing an absence of psychiatric symptoms.

Time frame: Change from baseline in psychiatric symptoms scales at 16 weeks

The Spanish validation of the Positive and Negative Syndrome Scale (PANSS) was used for measuring positive, negative and general symptomatology. Total raw scoring obtained through the sum of the raw scores for each subscale was considered (min. 30-max. 210) with a score of 30 representing an absence of psychiatric symptoms.

Time frame: Change from baseline in psychiatric symptoms scales at 40 weeks

The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39-max. 156) with a higher score indicating a better result. The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0-max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation.

Time frame: Change from baseline in social functioning scales at 16 weeks

Population: The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.

The Spanish validation of the Life Skills Profile (LSP)was used. This scale measures functionality in daily life activities such as self-care, social behavior and autonomy. Raw scoring was used for the various subscales which are summarized for the total (min. 39-max. 156) with a higher score indicating a better result. The 5 subscales are: Self-care, Non-turbulence, Social contact, Communication and Responsibility. We used the Spanish validation of the Social Functioning Scale (SFS)for measuring social behavior and relationships, autonomy, employment-occupation and leisure. Raw scoring was used for each subscale and for total score (min. 0-max. 223) with a higher score indicating a better result. All 7 subscales were administered: social engagement/ withdrawal, interpersonal behavior, independence-competence, independence-performance, pro-social activities, recreation and employment/ occupation.

Time frame: Change from baseline in social functioning scales at 40 weeks

Population: The sample size required was calculated according to the main study objective which consisted of achieving an improvement in social functioning according to the Living Skills Profile (LSP) scale. It was estimated that a sample of 27 patients per group would have a power of 80% at a significance level of 5% to detect these differences.