SchizophreniaCSrehacopSZNCT02796417
The Efficacy of REHACOP Program in Schizophrenia
A study testing REHACOP and Occupational activities in people with Schizophrenia, run by University of Deusto at 1 site in Spain.
Trial summary
This study examined the efficacy of an integrative cognitive remediation program (REHACOP) to improve cognition, social cognition, clinical symptoms and functional outcome in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- REHACOP and Occupational activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnostic criteria for Schizophrenia according to American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Who cannot join
- evidence of alcohol or drug abuse in the last 30 days
- previous history of significant lack of consciousness
- mental retardation
- relevant neurological or medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of REHACOP Cognitive Training Program in Schizophrenia
This study examined the efficacy of an integrative cognitive remediation program (REHACOP) to improve cognition, social cognition, clinical symptoms and functional outcome in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- REHACOP, Occupational activities
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REHACOPBehavioural
REHACOP group consists of 90-minute-long sessions 3 days per week. Specifically, REHACOP group remediation consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory; Language unit (3 weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit (2 weeks) training cognitive planning, proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas
Occupational activitiesBehavioural
Occupational group activities conducted included drawing, gardening, reading the daily news and constructing using different materials (such as paper or wood).
| Study group | Role | What they receive |
|---|---|---|
| Rehacop group | Experimental | Cognitive rehabilitation Receives: Behavioral: REHACOP |
| Control group | Active comparator | Occupational activities Receives: Behavioral: Occupational activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional competence after receiving cognitive remediation
functional competence was measured with San Diego UCSD Performance-Based Skills Assessment- UPSA
Measured: 4 months
Change in global functioning after receiving cognitive remediation
global functioning measured with Global Assessment of Functioning (GAF)
Measured: 4 months
change in verbal memory after receiving cognitive remediation
Verbal memory performance was assessed with the Hopkins Verbal Learning Test-HVLT (Brandt and Benedict 2001)
Measured: 4 months
change in processing speed after receiving cognitive remediation
Processing speed was assessed with Digit Symbol subtest from Wechsler Adult Intelligence Scale-III (Wechsler 1997)
Measured: 4 months
Secondary outcomes (4)
change in emotion perception after receiving cognitive remediation
emotion perception was assessed with Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Measured: 4 months
change in clinical symptoms after receiving cognitive remediation
Clinical symptoms was measured with Positive and Negative Syndrome Scale (PANSS)
Measured: 4 months
change in social perception after receiving cognitive remediation
Social perception was assessed with the Social Featuring Recognition Test (SFRT)
Measured: 4 months
change in theory of mind after receiving cognitive remediation
Theory of mind was assessed with Happe Strange Stories Test
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalia Ojeda, PhD, Principal investigator, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796417
- Sponsor's protocol ID
- NSMC-003-UD
- Acronym
- CSrehacopSZ
- Status last verified
- Jun 2016
- First submitted
- 13 May 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pena J, Ibarretxe-Bilbao N, Sanchez P, Uriarte JJ, Elizagarate E, Gutierrez M, Ojeda N. Mechanisms of functional improvement through cognitive rehabilitation in schizophrenia. J Psychiatr Res. 2018 Jun;101:21-27. doi: 10.1016/j.jpsychires.2018.03.002. Epub 2018 Mar 6.
PubMed 29525739Pena J, Ibarretxe-Bilbao N, Sanchez P, Iriarte MB, Elizagarate E, Garay MA, Gutierrez M, Iribarren A, Ojeda N. Combining social cognitive treatment, cognitive remediation, and functional skills training in schizophrenia: a randomized controlled trial. NPJ Schizophr. 2016 Nov 9;2:16037. doi: 10.1038/npjschz.2016.37. eCollection 2016.
PubMed 27868083
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of REHACOP Cognitive Training Program in Schizophrenia
- ClinicalTrials.gov ID
- NCT02796417
- Acronym / sponsor ID
- CSrehacopSZ / NSMC-003-UD
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examined the efficacy of an integrative cognitive remediation program (REHACOP) to improve cognition, social cognition, clinical symptoms and functional outcome in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehacop group | Experimental | Behavioral: REHACOPCognitive rehabilitation |
| Control group | Active comparator | Behavioral: Occupational activitiesOccupational activities |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnostic criteria for Schizophrenia according to American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Key exclusion criteria (4 listed)
- evidence of alcohol or drug abuse in the last 30 days
- previous history of significant lack of consciousness
- mental retardation
- relevant neurological or medical condition
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 |
|---|---|---|
| REHACOPREHACOP group consists of 90-minute-long sessions 3 days per week. Specifically, REHACOP group remediation consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory; Language unit (3 weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit (2 weeks) training cognitive planning, proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas | Behavioural | Rehacop group |
| Occupational activitiesOccupational group activities conducted included drawing, gardening, reading the daily news and constructing using different materials (such as paper or wood). | Behavioural | Control group |
Primary outcome
Change in functional competence after receiving cognitive remediation
Time frame: 4 months
functional competence was measured with San Diego UCSD Performance-Based Skills Assessment- UPSA
Change in global functioning after receiving cognitive remediation
Time frame: 4 months
global functioning measured with Global Assessment of Functioning (GAF)
change in verbal memory after receiving cognitive remediation
Time frame: 4 months
Verbal memory performance was assessed with the Hopkins Verbal Learning Test-HVLT (Brandt and Benedict 2001)
change in processing speed after receiving cognitive remediation
Time frame: 4 months
Processing speed was assessed with Digit Symbol subtest from Wechsler Adult Intelligence Scale-III (Wechsler 1997)
4 secondary outcomes
change in emotion perception after receiving cognitive remediation
Time frame: 4 months
change in clinical symptoms after receiving cognitive remediation
Time frame: 4 months
change in social perception after receiving cognitive remediation
Time frame: 4 months
change in theory of mind after receiving cognitive remediation
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Derived from this study: PubMed 29525739Pena J, Ibarretxe-Bilbao N, Sanchez P, Uriarte JJ, Elizagarate E, Gutierrez M, Ojeda N. Mechanisms of functional improvement through cognitive rehabilitation in schizophrenia. J Psychiatr Res. 2018 Jun;101:21-27. doi: 10.1016/j.jpsychires.2018.03.002. Epub 2018 Mar 6.
- Derived from this study: PubMed 27868083Pena J, Ibarretxe-Bilbao N, Sanchez P, Iriarte MB, Elizagarate E, Garay MA, Gutierrez M, Iribarren A, Ojeda N. Combining social cognitive treatment, cognitive remediation, and functional skills training in schizophrenia: a randomized controlled trial. NPJ Schizophr. 2016 Nov 9;2:16037. doi: 10.1038/npjschz.2016.37. eCollection 2016.
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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.
Natalia Ojeda, PhD principal investigator
University of Deusto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REHACOP and Occupational activities in people with Schizophrenia, run by University of Deusto 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 1 inclusion and 4 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 10 Jun 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in functional competence after receiving cognitive remediation (time frame: 4 months). The study lists 4 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 NCT02796417, which also lists 2 linked publications.
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 10 Jun 2016.