Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia

Indication for Modification of Patient Cognitive Status Clinical Trial

Official title:

Efficacy of Repyflec Cognitive Remediation Group Training in Cognition, Functional Outcomes and Psychiatric Symptoms of Outpatients With Schizophrenia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279070
• Other study ID #: REPYFLEC Clinical Trial
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2011
• Last updated: August 14, 2013
• Start date: September 2006
• Est. completion date: March 2011

Study information

• Verified date: May 2013
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Departament de Salut de la Generalitat de Catalunya
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to develop an integrative intervention for schizophrenia taking into account previous efficacious therapies. Thus, our aim was to evaluate the efficacy of our cognitive remediation group training: Problem Solving and Cognitive Flexibility training (REPYFLEC), focused to improve neurocognition and functioning in schizophrenia patients. We hypothesized that training executive function and metacognition would allow us to achieve improvements in neurocognition, functioning and psychiatric symptoms of patients with schizophrenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2011
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia or schizoaffective disorder

• More than 2 years illness duration

• Literate

• Mini Mental Status Examination score over 24

• Global Assessment of Functioning scores between 40 and 70

Exclusion Criteria:

• Current acute illness exacerbation

• Mental Retardation

• Neurological disorder which impairs cognition

• Currently participating in social skills training or cognitive remediation

• Change of antipsychotic medication one month before the trial or during the 40 study weeks

• Diagnosis of alcohol or drug dependence within 6 months of trial commencement.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Indication for Modification of Patient Cognitive Status
• Schizophrenia

Intervention

Behavioral:
• Repyflec cognitive remediation training
Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.

Locations

Country	Name	City	State
Spain	Parc Sanitari Sant Joan de Déu	Sant Boi de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive Function	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.	Change from baseline in executive function at 16 weeks (post-treatment)	No
Primary	Executive Function	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.	Change from baseline in executive functioning at 40 weeks	No
Secondary	Psychosocial Functioning	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.	Change from baseline in social functioning scales at 16 weeks	No
Secondary	Psychosocial Functioning	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.	Change from baseline in social functioning scales at 40 weeks	No
Secondary	Psychiatric Symptoms	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.	Change from baseline in psychiatric symptoms scales at 16 weeks	No
Secondary	Psychiatric Symptoms	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.	Change from baseline in psychiatric symptoms scales at 40 weeks	No