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Completed

NCT Number: NCT01279070

Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Parc Sanitari Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, 08930, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Repyflec cognitive remediation training

Behavioral

Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.

Other names: Cognitive remediation therapy, Cognitive rehabilitation, Cognitive training

Primary outcomes

  1. Executive Function

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

    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.

  2. Executive Function

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

    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.

Secondary outcomes

  1. Psychosocial Functioning

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

  2. Psychosocial Functioning

    Time frame: Change from baseline in social functioning 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.

  3. 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.

  4. Psychiatric Symptoms

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

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2011
First posted
Jan 19, 2011
Registry last updated
Aug 23, 2013

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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