SchizophreniaTARANCT01773239
Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia
A study testing TARA computer-based exercises in people with Schizophrenia, run by Posit Science Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to test a new computerized training program as well as to find out whether the computer training might help people who have schizophrenia. The investigators will study the effects of the computer training on how people with schizophrenia think about social interaction and on their social… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- TARA computer-based exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Jul 2013
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The investigators will study outpatient volunteer subjects who have schizophrenia, schizophreniform disorder or schizoaffective disorder and have experienced their first psychotic episode within the past 5 years, who are clinically stable, and who are between the ages of 18 and 35 years. Approximately 35-40% of the subjects recruited will be female, approximately 50-60% of potential subjects will be Euro-American, 10-20% will be Asian-American, 15-20% Latino, 15-20% African-American. The subject sample will reflect the racial and ethnic diversity of Northern California and the prevalence of schizophrenia across gender in this age period.
- The investigators will study volunteer subjects at high risk for psychosis who are clinically stable, and who are between the ages of 12-35. Approximately 35-40% of the subjects recruited will be female, approximately 50-60% of potential subjects will be Euro-American, 10-20% will be Asian-American, 15-20% Latino, 15-20% African-American. Our subject sample will reflect the racial and ethnic diversity of the San Francisco Bay Area.
- The study will have volunteer healthy controls matched by age and gender to our subjects at high risk for psychosis.
- The study subjects will not have their medications changed by the study researchers. If a subject's personal doctor changes a medication, the change will simply be documented by the study researchers.
- Investigators will recruit subjects with a clinical diagnosis of schizophrenia, schizophreniform or schizoaffective disorder with first psychotic episode within the last 5 years, good general physical health; age between 12 and 35 years; Is fluent and proficient in the English language; no neurological disorder. In addition, all subjects must have achieved clinical stability, defined as outpatient status for at least 3 months prior to study participation, plus stable doses of psychiatric medications for at least one month prior to study participation using the following operationalized definition: stable low to moderate dose of antipsychotic medication (<1000 mg. chlorpromazine equivalents) for at least 4 weeks prior to study, plus stable doses of all other psychotropic medications (anticholinergics, benzodiazepines) for at least 4 weeks prior to entry. However, subjects are not required to be on medications during participation. Minors must have parental/legal guardian consent to participate. Although investigators request that a family member also participate in the clinical assessments, this is not required for a participant to be eligible.
- This study will also recruit subjects who meet criteria for a Prodromal Syndrome as defined on the SIPS:
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- Attenuated Positive Prodromal Syndrome: Ideas of reference, odd beliefs or magical thinking, paranoid ideation, odd thinking and speech, odd behavior and appearance that are at a prodromal level of intensity that is rated at the level of 3-5 on the Scale of Prodromal Symptoms (SOPS). Symptoms must occur at an average frequency of at least once per week in the past month.
- Brief Intermittent Psychotic Syndrome: Positive symptoms rated at psychotic intensity as a score of 6 on the SOPS that are not disorganizing or dangerous, do not last more than 1 hour per day at an average frequency of four days per week over one month, and have begun in the past three months, currently present at least several minutes a day at a frequency of at least once per month.
- Genetic Risk and Deterioration Syndrome: Schizotypal personality disorder OR first degree relative with a DSM-IV psychotic disorder, PLUS significant decrease in functioning defined as 30% or greater drop in GAF score during the last month compared to 12 months ago.
- High Risk Syndromes: Individuals who experience subthreshold psychotic symptoms without restrictions on frequency of onset, functional impairment, or family history of psychosis.
- Investigators will recruit age and gender matched healthy comparison subjects who do not meet criteria for any Axis I diagnosis on the SCID. They cannot meet prodromal criteria on the Prodromal Questionnaire administered during the screening.
- All subjects must be in good general physical health; Fluent and proficient in the English language.
- Minors must have parental/legal guardian consent to participate. Although investigators request that a family member also participate in the clinical assessments, this is not required for a proband to be eligible.
- Individuals with a diagnosis of schizophrenia do not need to be within the 5 years of onset, as that might have passed while in the first part of the study. Also, they must be at least 18 years of age due to the developmental considerations for the social cognition software of someone who is under the age of 18. The 16 healthy controls also run in this part of the study will be age and gender matched to the individuals with a diagnosis of schizophrenia.
Who cannot join
- Recent Onset Schizophrenia Subjects: Investigators will exclude subjects with a history of psychoactive substance abuse in past 6 months determined by DSM-IV criteria from the SCID interview.
- Prodromal Subjects: Psychotic disorder previously diagnosed as schizophrenia or schizoaffective disorder or psychotic syndrome as defined by the SIPS: Fully psychotic symptoms have occurred at least one hour per day at a minimum average frequency of 4 days per week over one month OR the psychotic symptom is seriously disorganizing or dangerous.
- Healthy Control Subjects: Criteria is met for any Axis I diagnosis on the SCID. Healthy controls cannot have any first or second degree relative with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder. Any previous psychiatric hospitalizations will exclude a healthy control from the study.
- Any subject presenting a significant danger to self or others who requires inpatient treatment will be referred for that treatment and evaluated for study eligibility only after acute care treatment is no longer necessary.
- Subjects will also be excluded if they have a neurological disorder, or mental retardation (IQ < 70 previously documented, or by intellectual testing, if necessary), or autism.
- Physical disability that prohibits testing (deafness or blindness).
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- Subjects will be excluded if they currently meet DSM-IV criteria for alcohol/substance dependence or has met criteria within the last 6 months OR prodromal symptoms are present only during use and withdrawal from alcohol/substances OR subject is unable to attend assessments sober.
- Any contraindications to receiving an MRI scan, including having metal implants or metal fragments in their body.
- Any history of head injury with loss of consciousness greater than 30 minutes.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
Langley Porter Psychiatric Institute, UCSF
San Francisco, California, 94143
About this study
Official title: Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia -Targeted Affective Remediation Approach (TARA)
The purpose of this study is to test a new computerized training program as well as to find out whether the computer training might help people who have schizophrenia. The investigators will study the effects of the computer training on how people with schizophrenia think about social interaction and on their social skills. At completion of training, TARA subjects will show improvement on measures of social cognition compared to their baseline performance.
Read the detailed description
This study employs two computerized programs: TARA (the treatment program), and a set of ordinary computer games (the active control program). Participants will be asked to use their assigned program (treatment or active control) for one hour per session, for four-five sessions per week, over 8-10 weeks (40 total sessions). Several elements of flexibility are allowed in the schedule to accommodate the challenges that people with ASD can face.
- Conditions
- Schizophrenia
- Being tested
- TARA computer-based exercises
- Keywords
- social cognition, cognitive deficits, prodromal schizophrenia, recent-onset schizophrenia, remediation, computer training, cognitive training exercises
- Medical subject headings
- Schizophrenia, Cognition Disorders, Schizotypal Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TARA computer-based exercisesBehavioural
Also called Targeted Affective Remediation Approach, TARA
| Study group | Role | What they receive |
|---|---|---|
| TARA computer-based exercises | Experimental | TARA is a computerized social cognitive (SC) remediation program consisting of a set of specific SC exercises. The program creates a game-like experience where the participant is encouraged to earn points and in-game rewards to further advance in each 'game'. Participants perform tens to hundred of trials over the course of their session, with each trial providing auditory and visual feedback and rewards to indicate if the trial was performed correctly or incorrectly. After each trial, the difficulty of the next trial is updated to ensure that within each session, the participant gets ~85% of trials correct. Summary screens including game metrics (points, levels) and exercise metrics (usage, progress) are shown to the participant at the end of each session.
Participants in the TARA computer-based exercises arm will complete baseline- assessments, 24 hours of TARA computer based-exercises, and repeat post-assessments. Receives: Behavioral: TARA computer-based exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Source Memory Test
Measured: Baseline
Temporal Experience of Pleasure Scale
Measured: Baseline
Quality of Life Scale
Measured: Baseline
Social Functioning Scale
Measured: Baseline
Global Social and Role Functioning Scale
Measured: Baseline
Theories of Intelligence
Measured: Baseline
Faux Pas test
Measured: Baseline
Behavioral Inhibition/Behavioral Activation Scale
Measured: Baseline
Wechsler Test of Adult Reading
Measured: Assessed up to four weeks after training
Penn Facial Memory Test
Measured: Assessed up to four weeks after training
Measure of Insight into Cognition
Measured: Assessed up to four weeks after training
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Measured: Assessed up to four weeks after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Sophia Vinogradiv, MD, Principal investigator, San Francisco Veterans Affairs Medical CenterMor Nahum, Ph.D., Principal investigator, Posit Science CorporationRachel Loewy, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773239
- Sponsor's protocol ID
- 1R43MH091793-01A1
- Acronym
- TARA
- Status last verified
- Sep 2016
- First submitted
- 17 Jan 2013
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia -Targeted Affective Remediation Approach (TARA)
- ClinicalTrials.gov ID
- NCT01773239
- Acronym / sponsor ID
- TARA / 1R43MH091793-01A1
- Conditions
- Schizophrenia
- Keywords
- social cognition, cognitive deficits, prodromal schizophrenia, recent-onset schizophrenia, remediation, computer training, cognitive training exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Jan 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.
The purpose of this study is to test a new computerized training program as well as to find out whether the computer training might help people who have schizophrenia. The investigators will study the effects of the computer training on how people with schizophrenia think about social interaction and on their social skills. At completion of training, TARA subjects will show improvement on measures of social cognition compared to their baseline performance.
Detailed description
This study employs two computerized programs: TARA (the treatment program), and a set of ordinary computer games (the active control program). Participants will be asked to use their assigned program (treatment or active control) for one hour per session, for four-five sessions per week, over 8-10 weeks (40 total sessions). Several elements of flexibility are allowed in the schedule to accommodate the challenges that people with ASD can face.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TARA computer-based exercises | Experimental | Behavioral: TARA computer-based exercisesTARA is a computerized social cognitive (SC) remediation program consisting of a set of specific SC exercises. The program creates a game-like experience where the participant is encouraged to earn points and in-game rewards to further advance in each 'game'. Participants perform tens to hundred of trials over the course of their session, with each trial providing auditory and visual feedback and rewards to indicate if the trial was performed correctly or incorrectly. After each trial, the difficulty of the next trial is updated to ensure that within each session, the participant gets ~85% of trials correct. Summary screens including game metrics (points, levels) and exercise metrics (usage, progress) are shown to the participant at the end of each session. Participants in the TARA computer-based exercises arm will complete baseline- assessments, 24 hours of TARA computer based-exercises, and repeat post-assessments. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- The investigators will study outpatient volunteer subjects who have schizophrenia, schizophreniform disorder or schizoaffective disorder and have experienced their first psychotic episode within the past 5 years, who are clinically stable, and who are between the ages of 18 and 35 years. Approximately 35-40% of the subjects recruited will be female, approximately 50-60% of potential subjects will be Euro-American, 10-20% will be Asian-American, 15-20% Latino, 15-20% African-American. The subject sample will reflect the racial and ethnic diversity of Northern California and the prevalence of schizophrenia across gender in this age period.
- The investigators will study volunteer subjects at high risk for psychosis who are clinically stable, and who are between the ages of 12-35. Approximately 35-40% of the subjects recruited will be female, approximately 50-60% of potential subjects will be Euro-American, 10-20% will be Asian-American, 15-20% Latino, 15-20% African-American. Our subject sample will reflect the racial and ethnic diversity of the San Francisco Bay Area.
- The study will have volunteer healthy controls matched by age and gender to our subjects at high risk for psychosis.
- The study subjects will not have their medications changed by the study researchers. If a subject's personal doctor changes a medication, the change will simply be documented by the study researchers.
- Investigators will recruit subjects with a clinical diagnosis of schizophrenia, schizophreniform or schizoaffective disorder with first psychotic episode within the last 5 years, good general physical health; age between 12 and 35 years; Is fluent and proficient in the English language; no neurological disorder. In addition, all subjects must have achieved clinical stability, defined as outpatient status for at least 3 months prior to study participation, plus stable doses of psychiatric medications for at least one month prior to study participation using the following operationalized definition: stable low to moderate dose of antipsychotic medication (<1000 mg. chlorpromazine equivalents) for at least 4 weeks prior to study, plus stable doses of all other psychotropic medications (anticholinergics, benzodiazepines) for at least 4 weeks prior to entry. However, subjects are not required to be on medications during participation. Minors must have parental/legal guardian consent to participate. Although investigators request that a family member also participate in the clinical assessments, this is not required for a participant to be eligible.
Key exclusion criteria (9 listed)
- Recent Onset Schizophrenia Subjects: Investigators will exclude subjects with a history of psychoactive substance abuse in past 6 months determined by DSM-IV criteria from the SCID interview.
- Prodromal Subjects: Psychotic disorder previously diagnosed as schizophrenia or schizoaffective disorder or psychotic syndrome as defined by the SIPS: Fully psychotic symptoms have occurred at least one hour per day at a minimum average frequency of 4 days per week over one month OR the psychotic symptom is seriously disorganizing or dangerous.
- Healthy Control Subjects: Criteria is met for any Axis I diagnosis on the SCID. Healthy controls cannot have any first or second degree relative with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder. Any previous psychiatric hospitalizations will exclude a healthy control from the study.
- Any subject presenting a significant danger to self or others who requires inpatient treatment will be referred for that treatment and evaluated for study eligibility only after acute care treatment is no longer necessary.
- Subjects will also be excluded if they have a neurological disorder, or mental retardation (IQ < 70 previously documented, or by intellectual testing, if necessary), or autism.
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 |
|---|---|---|
| TARA computer-based exercisesAlso: Targeted Affective Remediation Approach, TARA | Behavioural | TARA computer-based exercises |
Primary outcome
Source Memory Test
Time frame: Baseline
Temporal Experience of Pleasure Scale
Time frame: Baseline
Quality of Life Scale
Time frame: Baseline
Social Functioning Scale
Time frame: Baseline
Global Social and Role Functioning Scale
Time frame: Baseline
Theories of Intelligence
Time frame: Baseline
Faux Pas test
Time frame: Baseline
Behavioral Inhibition/Behavioral Activation Scale
Time frame: Baseline
Wechsler Test of Adult Reading
Time frame: Assessed up to four weeks after training
Penn Facial Memory Test
Time frame: Assessed up to four weeks after training
Measure of Insight into Cognition
Time frame: Assessed up to four weeks after training
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Time frame: Assessed up to four weeks after training
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 30 Sep 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.
Sophia Vinogradiv, MD principal investigator
San Francisco Veterans Affairs Medical Center
Mor Nahum, Ph.D. principal investigator
Posit Science Corporation
Rachel Loewy principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TARA computer-based exercises in people with Schizophrenia, run by Posit Science Corporation at 2 sites in United States.
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 14 inclusion and 9 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 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Source Memory Test (time frame: Baseline). The study lists 12 primary outcomes in all. 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 30 Sep 2016.