SchizophreniaPhase 4NCT01036282
Cognitive Skills Training Using Computer for Patients With Severe Mental Illness
A Phase 4 study testing Computerized Cognitive Skill Training and CRT and Social Cognition in people with Schizophrenia and Schizoaffective Disorder, run by Nathan Kline Institute for Psychiatric Research at 1 site in United States.
Trial summary
The study is designed to evaluate the effectiveness of computerized cognitive skills training for improving memory and problem-solving skills in inpatients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Computerized Cognitive Skill Training and CRT and Social Cognition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Dec 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above;
- In- and out-patients;
- DSM-IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder with illness duration >5 years;
- Auditory and visual acuity adequate to complete cognitive tests;
- Stable dose of oral atypical antipsychotic for at least 4 weeks;
- Total PANSS score > 60;
Show all 9Show fewer
- Good physical health determined by physical examination from medical chart review;
- Capacity and willingness to give written informed consent.
- MMSE > 24
Who cannot join
- Inability to read or speak English;
- Documented disease of the central nervous system;
- History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation);
- Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematological conditions;
- HIV +;
- Patients diagnosed with substance dependence;
- Currently participating in another experimental study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Psychiatric Center
New York, New York, 10605
About this study
Official title: Computerized Cognitive Skills Training in Severe Mental Illness
The study is designed to evaluate the effectiveness of computerized cognitive skills training for improving memory and problem-solving skills in inpatients with schizophrenia.
Read the detailed description
Subjects are stable inpatients and outpatients with schizophrenia or schizoaffective disorder who are receiving atipsychotic medication at Manhattan Psychiatric Center.
Patients receive baseline assessments (MCCB-MATRICS; Personal and Social Performance Scale, FEDT/FEIT and PANSS) and then are assigned to Cognitive Remediation (CRT) using the COGPACK program, patients are then randomly assigned to a social cognition program (Mind Reader Interactive Guide to Emotions) for a period of 12 weeks. Following 12 weeks of treatment in either CRT + Mind Reader or CRT alone, assessments are repeated by raters.
Cognitive Remediation (CRT): CRT (COGPACK, Marker and Olbrich, 1998) consists of computerized practice tests for seven cognitive domains. There are 64 programs for testing and training, each with several variants for the domains of visuomotor skills, comprehension, reaction, vigilance, memory, language, and intellectual skills. Exercises in COGPACK can be edited and expanded. Patients attend 2 (45-minutes each) groups and 1 discussion group.
Social Cognition Training: Mind Reader (Baron-Cohen et al, 2004) is an interactive computerized program of emotions and mental states. It is based on a taxonomic system of 412 emotions and mental states, grouped into 24 emotion groups, and six developmental levels (from age 4 to adulthood). The emotions and mental states are organized systematically, according to the emotion groups and developmental levels. Patients assigned to Mind Reader attend 1 group per week.
Both the CRT and Mind Reader are administered in small groups of six to eight patients each.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Computerized Cognitive Skill Training, CRT and Social Cognition
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive Skill TrainingBehavioural
Also called Cognitive Remediation Therapy
Behavioral: Cognitive Remediation 45 mins 2 times per week sessions of cognitive remediation (COGPACK) over twelve weeks.
CRT and Social CognitionBehavioural
Also called Social Emotional Functioning
Mind Reading, The Interactive Guide to Emotions for one 45 minute session per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Remediation | Experimental | Two arms: 1. Computerized Cognitive Remediation treatment using COGPACK. and 2. PositScience. Each arm is further randomized to either MindReader or no Mindreader.(Social Cognition Training). Receives: Behavioral: Computerized Cognitive Skill Training |
| CRT + Social Cognition Training | Experimental | Two 45-minute sessions of Computerized Cognitive Remediation using COGPACK, one 45-minute discussion session, plus one 45 minute Mind Reader Interactive Guide to Emotions per week for 12 weeks. compared to two 45-minute sessions of PositScience, plus one 45-min Discussion session plus one minute of Mind Reader, Interactive Guide to Emotions Receives: Behavioral: CRT and Social Cognition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Comprehensive battery of neuro-cognitive tests
Measured: Week 0, and Week 12 (after completion of Cognitive Remediation)
Secondary outcomes (3)
Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT)
Test of facial emotion presentations on pictures to patients
Measured: Week 0, and Week 12 (after compeltion of Cognitive Remediation)
Personal and Social Performance Scale (PSP)
Social function scale with four sub domains of social functioning
Measured: Week 0, and Week 12 after completion of Cognitive Remediation
Positive and Negative Syndrome Scale (PANSS)
30 item Gold standard for measurement of psychiatric symptoms
Measured: Week 0, Week 6 (Midpoint) and Week 12 after completion of Cognitive Remediation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startFeb 2003
- Primary completionDec 2016
- Study completionDec 2016
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm, parallel group, randomized, blinded 12 -week intervention study of two forms of cognitive remediation in patients with chronic schizophrenia
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathan Kline Institute for Psychiatric Research
- Sponsor type
- University, hospital or other
- Collaborators
- Manhattan Psychiatric Center
- Responsible party
- Principal investigator, Jean-Pierre Lindenmayer, Nathan Kline Institute for Psychiatric Research
- Investigators
- Jean-Pierre Lindenmayer, M.D., Principal investigator, Nathan S. Kline Institute for Psychiatric Research and Manhattan Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036282
- Sponsor's protocol ID
- 03I/C14
- Status last verified
- Jul 2017
- First submitted
- 18 Dec 2009
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lindenmayer JP, McGurk SR, Mueser KT, Khan A, Wance D, Hoffman L, Wolfe R, Xie H. A randomized controlled trial of cognitive remediation among inpatients with persistent mental illness. Psychiatr Serv. 2008 Mar;59(3):241-7. doi: 10.1176/ps.2008.59.3.241.
PubMed 18308903Lindenmayer JP, Fregenti S, Kang G, Ozog V, Ljuri I, Khan A, Goldring A, McGurk SR. The relationship of cognitive improvement after cognitive remediation with social functioning in patients with schizophrenia and severe cognitive deficits. Schizophr Res. 2017 Jul;185:154-160. doi: 10.1016/j.schres.2017.01.007. Epub 2017 Jan 13.
PubMed 28094171
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Skills Training in Severe Mental Illness
- ClinicalTrials.gov ID
- NCT01036282
- Acronym / sponsor ID
- 03I/C14
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Nathan Kline Institute for Psychiatric ResearchUniversity, hospital or other
- Collaborators
- Manhattan Psychiatric Center
- Study start
- Feb 2003 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Dec 2009 (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 study is designed to evaluate the effectiveness of computerized cognitive skills training for improving memory and problem-solving skills in inpatients with schizophrenia.
Detailed description
Subjects are stable inpatients and outpatients with schizophrenia or schizoaffective disorder who are receiving atipsychotic medication at Manhattan Psychiatric Center.
Patients receive baseline assessments (MCCB-MATRICS; Personal and Social Performance Scale, FEDT/FEIT and PANSS) and then are assigned to Cognitive Remediation (CRT) using the COGPACK program, patients are then randomly assigned to a social cognition program (Mind Reader Interactive Guide to Emotions) for a period of 12 weeks. Following 12 weeks of treatment in either CRT + Mind Reader or CRT alone, assessments are repeated by raters.
Cognitive Remediation (CRT): CRT (COGPACK, Marker and Olbrich, 1998) consists of computerized practice tests for seven cognitive domains. There are 64 programs for testing and training, each with several variants for the domains of visuomotor skills, comprehension, reaction, vigilance, memory, language, and intellectual skills. Exercises in COGPACK can be edited and expanded. Patients attend 2 (45-minutes each) groups and 1 discussion group.
Social Cognition Training: Mind Reader (Baron-Cohen et al, 2004) is an interactive computerized program of emotions and mental states. It is based on a taxonomic system of 412 emotions and mental states, grouped into 24 emotion groups, and six developmental levels (from age 4 to adulthood). The emotions and mental states are organized systematically, according to the emotion groups and developmental levels. Patients assigned to Mind Reader attend 1 group per week.
Both the CRT and Mind Reader are administered in small groups of six to eight patients each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arm, parallel group, randomized, blinded 12 -week intervention study of two forms of cognitive remediation in patients with chronic schizophrenia
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Remediation | Experimental | Behavioral: Computerized Cognitive Skill TrainingTwo arms: 1. Computerized Cognitive Remediation treatment using COGPACK. and 2. PositScience. Each arm is further randomized to either MindReader or no Mindreader.(Social Cognition Training). |
| CRT + Social Cognition Training | Experimental | Behavioral: CRT and Social CognitionTwo 45-minute sessions of Computerized Cognitive Remediation using COGPACK, one 45-minute discussion session, plus one 45 minute Mind Reader Interactive Guide to Emotions per week for 12 weeks. compared to two 45-minute sessions of PositScience, plus one 45-min Discussion session plus one minute of Mind Reader, Interactive Guide to Emotions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 and above;
- In- and out-patients;
- DSM-IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder with illness duration >5 years;
- Auditory and visual acuity adequate to complete cognitive tests;
- Stable dose of oral atypical antipsychotic for at least 4 weeks;
Key exclusion criteria (7 listed)
- Inability to read or speak English;
- Documented disease of the central nervous system;
- History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation);
- Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematological conditions;
- HIV +;
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 |
|---|---|---|
| Computerized Cognitive Skill TrainingAlso: Cognitive Remediation TherapyBehavioral: Cognitive Remediation 45 mins 2 times per week sessions of cognitive remediation (COGPACK) over twelve weeks. | Behavioural | Computerized Cognitive Remediation |
| CRT and Social CognitionAlso: Social Emotional FunctioningMind Reading, The Interactive Guide to Emotions for one 45 minute session per week for 12 weeks. | Behavioural | CRT + Social Cognition Training |
Primary outcome
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS)
Time frame: Week 0, and Week 12 (after completion of Cognitive Remediation)
Comprehensive battery of neuro-cognitive tests
3 secondary outcomes
Facial Emotional Discrimination Task (FEDT) and Facial Emotional Identification Task (FEIT)
Time frame: Week 0, and Week 12 (after compeltion of Cognitive Remediation)
Personal and Social Performance Scale (PSP)
Time frame: Week 0, and Week 12 after completion of Cognitive Remediation
Positive and Negative Syndrome Scale (PANSS)
Time frame: Week 0, Week 6 (Midpoint) and Week 12 after completion of Cognitive Remediation
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 21 Jul 2017.
- Results publication: PubMed 18308903Lindenmayer JP, McGurk SR, Mueser KT, Khan A, Wance D, Hoffman L, Wolfe R, Xie H. A randomized controlled trial of cognitive remediation among inpatients with persistent mental illness. Psychiatr Serv. 2008 Mar;59(3):241-7. doi: 10.1176/ps.2008.59.3.241.
- Derived from this study: PubMed 28094171Lindenmayer JP, Fregenti S, Kang G, Ozog V, Ljuri I, Khan A, Goldring A, McGurk SR. The relationship of cognitive improvement after cognitive remediation with social functioning in patients with schizophrenia and severe cognitive deficits. Schizophr Res. 2017 Jul;185:154-160. doi: 10.1016/j.schres.2017.01.007. Epub 2017 Jan 13.
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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.
Jean-Pierre Lindenmayer, M.D. principal investigator
Nathan S. Kline Institute for Psychiatric Research and Manhattan Psychiatric Center
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 Computerized Cognitive Skill Training and CRT and Social Cognition in people with Schizophrenia and Schizoaffective Disorder, run by Nathan Kline Institute for Psychiatric Research at 1 site 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 9 inclusion and 7 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 21 Jul 2017. 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 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.
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?
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?
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) (time frame: Week 0, and Week 12 (after completion of Cognitive Remediation)). 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 NCT01036282, 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 21 Jul 2017.