Refractory SchizophreniaOTSchizoNCT01879956
Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Schizophrenia
A study testing Craft Activities and OGI Method in people with Refractory Schizophrenia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Primary Objective: Efficacy of Occupational Therapy (OT) based Occupational Goal Intervention (OGI) in improving executive functions in patients with refractory schizophrenia as measured by the BADS. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Refractory Schizophrenia
- What is being tested?
- Craft Activities and OGI Method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2012to Sep 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pacients with diagnosis of schizophrenia for DMS IV-R.
- Pacients that signed the consent in writing and receive explanations about the nature of the study.
- Patients who carefully counted another responsible person to provide reliable support to the patient and ensure adherence to the same study treatment.
- Patients with minimum education: five years (elementary school).
- Patients who present rates below those expected for their age group in at least 3 of the executive functions assessed on neuropsychological tests, and evaluation of executive functions.
- Patients with stable clozapine and which have not been recently admitted (3 months).
Who cannot join
- Comorbid diagnosis of substance dependence or other psychiatric Axis I;
- History of head trauma and / or other neurological problems;
- Medical problems that compromise somehow the central nervous system;
- History of mental retardation;
- Patients treated with medication other than clozapine;
- Patients who are suffering other psychosocial treatments.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Psiquiatria do HCFMUSP
São Paulo, São Paulo, 05403000
Adriana Vizzotto, BSc, +55 11 26618043, adrivizzotto@usp.br
Helio Elkis, MD PhD, helkis@usp.br
About this study
Official title: Randomized Controlled Trial for the Evaluation of the Efficacy of Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Refractory Schizophrenia
Primary Objective:
Efficacy of Occupational Therapy (OT) based Occupational Goal Intervention (OGI) in improving executive functions in patients with refractory schizophrenia as measured by the BADS.
Secondary Objectives: improvement of functional aspects,basic and instrumental activities of daily living,negative symptoms and cognitive functions improvement
Hypothesis: OT is more effective than control group to improve executive functions in patients with refractory schizophrenia.
Read the detailed description
A single-center, randomized, single blind, controlled study, lasting one year, including the follow-up.
The study is conducted in two groups:the experimental group is based on the OGI method (N=30 patients) and the control group receives craft activities (N = 30 patients).
Psychiatric, neuropsychological and functional aspects are assessed at the beginning, after 30 sessions and 6 months after the intervention. The scale PANSS (Positive and Negative Syndrome Scale) is used for monitoring psychopathological symptoms during the study.
Scales BADS, DAFS-R, ILSS-BR respectively assess executive functions, functionality and basic and instrumental activities of daily living. The neuropsychological evaluation includes a battery to measure attention, executive functions, memory and estimated intellectual efficiency.
Statistical analysis to be used: ANOVA (Analysis of Variance)for repeated measures; data are also calculated to messure clinical efficacy, effect size and needed number to treat.
- Conditions
- Refractory Schizophrenia
- Being tested
- Craft Activities, OGI Method
- Keywords
- Executive Functions, Schizophrenia, Occupational Therapy
- Medical subject headings
- Schizophrenia, Treatment-Resistant, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craft ActivitiesOther
There is no intervention method used to perform the task.
OGI MethodBehavioural
metacognitive approach to assess executive functions.
| Study group | Role | What they receive |
|---|---|---|
| OGI Method | Active comparator | - experimental group: use the OGI method to improve the executive functioning of patients with refractory schizophrenia. Receives: Behavioral: OGI Method |
| craft activities | Placebo comparator | - control group: use of craft activities, attend the same-number of sessions, but without the intervention of therapists. Receives: Other: Craft Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
BADS (Behavioral Assessment of Functional Status)
It is a battery which measures neuropsychological executive functions.
Measured: up to 6 months follow-up.
Secondary outcomes (3)
DAFS-BR ( Direct Assessment of Functional Status), ILSS-BR (Habilities of Daily Living-Brazilian validated version).
DAFS-BR - Evaluates functional aspects of daily living such as dealing with money, shopping, social comunication ILSS-BR- similar to DAFS.
Measured: at baseline, after 30 sessions of treatment and follow-up 6 months.
Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.
Neuropsychological Battery (Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test,Rey Complex Figure, Fluência Verbal, Tapping Visual and Memória Logica)which measure cognitive functions.
Measured: at baseline, after 30 sessions of treatment and 6 months follo-up.
Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.
Neuropsychological Battery (Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test,Rey Complex Figure, Verbal Fluency, Tapping Visual and Memória Logica)which measure cognitive functions.
Measured: at baseline, after 30 sessions of treatment and 6 months follo-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startFeb 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Helio Elkis, University of Sao Paulo
- Investigators
- Helio Elkis, MD PhD, Principal investigator, Departamento de Psiquiatria da FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879956
- Sponsor's protocol ID
- OT Schizophrenia_1
- Acronym
- OTSchizo
- Status last verified
- Jun 2013
- First submitted
- 29 May 2013
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for the Evaluation of the Efficacy of Occupational Therapy in the Rehabilitation of Executive Functions in Patients With Refractory Schizophrenia
- ClinicalTrials.gov ID
- NCT01879956
- Acronym / sponsor ID
- OTSchizo / OT Schizophrenia_1
- Conditions
- Refractory Schizophrenia
- Keywords
- Executive Functions, Schizophrenia, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 18 Jun 2013 (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.
Primary Objective:
Efficacy of Occupational Therapy (OT) based Occupational Goal Intervention (OGI) in improving executive functions in patients with refractory schizophrenia as measured by the BADS.
Secondary Objectives: improvement of functional aspects,basic and instrumental activities of daily living,negative symptoms and cognitive functions improvement
Hypothesis: OT is more effective than control group to improve executive functions in patients with refractory schizophrenia.
Detailed description
A single-center, randomized, single blind, controlled study, lasting one year, including the follow-up.
The study is conducted in two groups:the experimental group is based on the OGI method (N=30 patients) and the control group receives craft activities (N = 30 patients).
Psychiatric, neuropsychological and functional aspects are assessed at the beginning, after 30 sessions and 6 months after the intervention. The scale PANSS (Positive and Negative Syndrome Scale) is used for monitoring psychopathological symptoms during the study.
Scales BADS, DAFS-R, ILSS-BR respectively assess executive functions, functionality and basic and instrumental activities of daily living. The neuropsychological evaluation includes a battery to measure attention, executive functions, memory and estimated intellectual efficiency.
Statistical analysis to be used: ANOVA (Analysis of Variance)for repeated measures; data are also calculated to messure clinical efficacy, effect size and needed number to treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OGI Method | Active comparator | Behavioral: OGI Method- experimental group: use the OGI method to improve the executive functioning of patients with refractory schizophrenia. |
| craft activities | Placebo comparator | Other: Craft Activities- control group: use of craft activities, attend the same-number of sessions, but without the intervention of therapists. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pacients with diagnosis of schizophrenia for DMS IV-R.
- Pacients that signed the consent in writing and receive explanations about the nature of the study.
- Patients who carefully counted another responsible person to provide reliable support to the patient and ensure adherence to the same study treatment.
- Patients with minimum education: five years (elementary school).
- Patients with stable clozapine and which have not been recently admitted (3 months).
Key exclusion criteria (6 listed)
- Comorbid diagnosis of substance dependence or other psychiatric Axis I;
- History of head trauma and / or other neurological problems;
- Medical problems that compromise somehow the central nervous system;
- History of mental retardation;
- Patients treated with medication other than clozapine;
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 |
|---|---|---|
| Craft ActivitiesThere is no intervention method used to perform the task. | Other | craft activities |
| OGI Methodmetacognitive approach to assess executive functions. | Behavioural | OGI Method |
Primary outcome
BADS (Behavioral Assessment of Functional Status)
Time frame: up to 6 months follow-up.
It is a battery which measures neuropsychological executive functions.
3 secondary outcomes
DAFS-BR ( Direct Assessment of Functional Status), ILSS-BR (Habilities of Daily Living-Brazilian validated version).
Time frame: at baseline, after 30 sessions of treatment and follow-up 6 months.
Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.
Time frame: at baseline, after 30 sessions of treatment and 6 months follo-up.
Trail Making A/B, Digit Span, Wisconsin Card Sorting Test, Stroop Color Test, Rey Complex Figure, Verbal Fluency,Tapping Visual and Logical Memory.
Time frame: at baseline, after 30 sessions of treatment and 6 months follo-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
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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.
Helio Elkis, MD PhD principal investigator
Departamento de Psiquiatria da FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Craft Activities and OGI Method in people with Refractory Schizophrenia, run by University of Sao Paulo at 1 site in Brazil.
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 6 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: status not confirmed, as of the sponsor's last update on 18 Jun 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helio Elkis, MD PhD (+55 11 26617581, helkis@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BADS (Behavioral Assessment of Functional Status) (time frame: up to 6 months follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2013.