Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aida Farreny, Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier:
NCT01279070
First received: January 14, 2011
Last updated: August 14, 2013
Last verified: May 2013
Results First Received: November 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Indication for Modification of Patient Cognitive Status
Intervention: Behavioral: Repyflec cognitive remediation training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started on January 2007 and finished on May 2010. We have worked in different outpatient Rehabilitation Centers and we incorporated experimental and control group as a part of their rehabilitation planning. We have worked in 6 different centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Experimental Group (Repyflec Cognitive Remediation)

Cognitive remediation (CR) group training (Repyflec)

REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations,examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF).

Leisure Group (Control Group)

Leisure group

Parallel to the experimental group, a leisure control group was established which participated in 32 stimulating and socializing activities (e.g., card games, board games, "coffee & talk", etc.) over 4 months twice a week and lasting 1 h.


Participant Flow:   Overall Study
    Experimental Group (Repyflec Cognitive Remediation)     Leisure Group (Control Group)  
STARTED     34 [1]   28 [2]
COMPLETED     29 [3]   24 [4]
NOT COMPLETED     5     4  
Withdrawal by Subject                 2                 3  
Acute exacerbation                 3                 1  
[1] 34 outpatients were randomly assigned to 32 sessions of REPYFLEC.
[2] 28 outpatients were randomly assigned to 32 sessions of leisure group.
[3] 5 outpatients left the treatment up to 2 months after starting REPYFLEC.
[4] 4 outpatients left the leisure group up to 2 months after starting Leisure group.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Leisure Group Leisure group has got same number of sessions and timing than experimental group
Repyflec Training Cognitive remediation treatment
Total Total of all reporting groups

Baseline Measures
    Leisure Group     Repyflec Training     Total  
Number of Participants  
[units: participants]
  28     34     62  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     28     34     62  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.9  ± 6.7     39.6  ± 8.2     40.6  ± 7.6  
Gender  
[units: participants]
     
Female     9     11     20  
Male     19     23     42  
Region of Enrollment  
[units: participants]
     
Spain     28     34     62  



  Outcome Measures
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1.  Primary:   Executive Function   [ Time Frame: Change from baseline in executive function at 16 weeks (post-treatment) ]

2.  Primary:   Executive Function   [ Time Frame: Change from baseline in executive functioning at 40 weeks ]

3.  Secondary:   Psychosocial Functioning   [ Time Frame: Change from baseline in social functioning scales at 16 weeks ]

4.  Secondary:   Psychosocial Functioning   [ Time Frame: Change from baseline in social functioning scales at 40 weeks ]

5.  Secondary:   Psychiatric Symptoms   [ Time Frame: Change from baseline in psychiatric symptoms scales at 16 weeks ]

6.  Secondary:   Psychiatric Symptoms   [ Time Frame: Change from baseline in psychiatric symptoms scales at 40 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
It would be useful to widen the assessment of cognitive measures and negative symptoms. Metacognition has not been appropriately studied.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Aida Farreny
Organization: Parc Sanitari Sant Joan de Déu
phone: +34 936406350 ext 2373
e-mail: afarreny@pssjd.org


No publications provided


Responsible Party: Aida Farreny, Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT01279070     History of Changes
Other Study ID Numbers: REPYFLEC Clinical Trial
Study First Received: January 14, 2011
Results First Received: November 16, 2011
Last Updated: August 14, 2013
Health Authority: Spain: Departament de Salut de la Generalitat de Catalunya