Indication for Modification of Patient Cognitive StatusPhase 4NCT01279070

Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia

A Phase 4 study testing Repyflec cognitive remediation training in people with Indication for Modification of Patient Cognitive Status, run by Fundació Sant Joan de Déu at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Indication for Modification of Patient Cognitive Status
What is being tested?: Repyflec cognitive remediation training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteSpain
Study dates: Sep 2006to Mar 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, 08930

Other trials in Spain

About this study

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

Conditions: Indication for Modification of Patient Cognitive Status
Being tested: Repyflec cognitive remediation training
Keywords: Schizophrenia, Cognitive remediation, Group training, Executive function, Social functioning
Medical subject headings: Schizophrenia, Social Adjustment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Repyflec cognitive remediation trainingBehavioural
Also called Cognitive remediation therapy, Cognitive rehabilitation, Cognitive training
Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.

Study groups in NCT01279070
Study group	Role	What they receive
REPYFLEC cognitive remediation training	Experimental	REPYFLEC cognitive remediation as a Problem solving and Cognitive flexibility group training. Receives: Behavioral: Repyflec cognitive remediation training
Leisure group	Active comparator	Leisure group is a stimulating activity focused on socialization through group dynamics, board games, "coffee and talk". Receives: Behavioral: Repyflec cognitive remediation training

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline in executive function at 16 weeks (post-treatment)
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.
Measured: Change from baseline in executive functioning at 40 weeks

Secondary outcomes (4)

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.
Measured: Change from baseline in social functioning scales at 16 weeks
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.
Measured: Change from baseline in social functioning scales at 40 weeks
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.
Measured: Change from baseline in psychiatric symptoms scales at 16 weeks
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.
Measured: Change from baseline in psychiatric symptoms scales at 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Mar 2011

First posted19 Jan 2011 (estimated)
Study startSep 2006
Primary completionJan 2009
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Indication for Modification of Patient Cognitive StatusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01279070
Sponsor's protocol ID: REPYFLEC Clinical Trial
Status last verified: May 2013
First submitted: 14 Jan 2011
Last updated: 23 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Repyflec Cognitive Remediation Group Training in Cognition, Functional Outcomes and Psychiatric Symptoms of Outpatients With Schizophrenia.
ClinicalTrials.gov ID: NCT01279070
Acronym / sponsor ID: REPYFLEC Clinical Trial
Conditions: Indication for Modification of Patient Cognitive Status
Keywords: Schizophrenia, Cognitive remediation, Group training, Executive function, Social functioning
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Fundació Sant Joan de DéuUniversity, hospital or other
Study start: Sep 2006
Primary completion: Jan 2009 (actual)
Study completion: Mar 2011 (actual)
First posted: 19 Jan 2011 (estimated)
Results: Posted 15 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
REPYFLEC cognitive remediation training	Experimental	Behavioral: Repyflec cognitive remediation trainingREPYFLEC cognitive remediation as a Problem solving and Cognitive flexibility group training.
Leisure group	Active comparator	Behavioral: Repyflec cognitive remediation trainingLeisure group is a stimulating activity focused on socialization through group dynamics, board games, "coffee and talk".

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Repyflec cognitive remediation trainingAlso: Cognitive remediation therapy, Cognitive rehabilitation, Cognitive trainingComparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.	Behavioural	Leisure group, REPYFLEC cognitive remediation training

Primary outcome

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.
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.

4 secondary outcomes

Psychosocial Functioning
Time frame: Change from baseline in social functioning scales at 16 weeks
Psychosocial Functioning
Time frame: Change from baseline in social functioning scales at 40 weeks
Psychiatric Symptoms
Time frame: Change from baseline in psychiatric symptoms scales at 16 weeks
Psychiatric Symptoms
Time frame: Change from baseline in psychiatric symptoms scales at 40 weeks

Results and safety

Results posted to the registry on 15 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group (Repyflec Cognitive Remediation)	34	29
Leisure Group (Control Group)	28	24

Primary outcome: Executive Function

Time frame: Change from baseline in executive function at 16 weeks (post-treatment). Mean (Standard Deviation). Unit: units on a scale

Measure	REPYFLEC Cognitive Remediation Group Training n = 29	Leisure & Socialization Group n = 24
BADS total standardized score (from 12 to 129)	99.5 (14.5)	95.7 (13.5)
BADS Key search subscale (from 0 to 4)	2.7 (1.2)	1.7 (1.3)

REPYFLEC Cognitive Remediation Group Training vs Leisure & Socialization Group: Effect size: 0.43 (95% CI 0.1 to 0.7), p <0.05, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Executive Function

Time frame: Change from baseline in executive functioning at 40 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	REPYFLEC Cognitive Group Trainining n = 28	Leisure & Socialization Group n = 19
BADS standardized total score (min.12-max.129)	101.8 (10.1)	94.5 (14.7)
BADS Key search subscale (from 0 to 4)	3 (1.1)	1.7 (1.4)

REPYFLEC Cognitive Group Trainining vs Leisure & Socialization Group: Effect Size: 0.42 (95% CI 0.1 to 0.7), p <0.05, Mixed Models Analysis

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: At baseline (week 0), post-treatment (week 16) and follow-up assessments (week 40). Two times per week during 16 weeks of intervention groups.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Leisure Group	0 of 24 (0%)	0 of 24 (0%)	Not reported
Repyflec Training	0 of 29 (0%)	0 of 29 (0%)	Not reported

Limitations and caveats (from the sponsor): It would be useful to widen the assessment of cognitive measures and negative symptoms. Metacognition has not been appropriately studied.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aida Farreny, PhD Psycho. principal investigator

Fundació Sant Joan de Déu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Repyflec cognitive remediation training in people with Indication for Modification of Patient Cognitive Status, run by Fundació Sant Joan de Déu at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Executive Function (time frame: Change from baseline in executive function at 16 weeks (post-treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01279070.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.