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SchizophreniaPhase 4NCT00930150

Feasibility of Providing Cognitive Remediation to People With Schizophrenia in a Clinical Network

A Phase 4 study testing Targeted cognitive training, Bridging groups and Health and wellness groups in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 9 sites in United States.

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

This study will test whether a cognitive remediation program to treat people with schizophrenia can be successfully implemented in a network of research clinics. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Schizophrenia
What is being tested?
Targeted cognitive training, Bridging groups and Health and wellness groups
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
9 sitesUnited States
Study dates
Jul 2009to Feb 2010
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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Demonstrates adequate decisional capacity to make a choice about participating in the research study
  • Diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
  • Positive and Negative Syndrome Scale (PANSS) hallucinatory behavior, unusual thought content, and conceptual disorganization ratings of no greater than moderately severe (i.e., item scores must be less than or equal to 5)
  • Meets all of the following cognitive performance and English language criteria:
  • Learned English before age 12
  • Able to complete the baseline Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) validly, based on the judgment of the investigator
Show all 9Show fewer
  • Raw score of 37 or greater on the Wide Range Achievement Test, reading subtest, 3rd edition (WRAT-3), used to establish minimum sixth grade reading level and estimated premorbid IQ
  • Able to state specific goals relevant to the intervention that participant would like to achieve
  • Able to participate in the computerized intervention, based on the judgment of the investigator

Who cannot join

  • Psychiatric hospitalization within 8 weeks of random assignment
  • Adjustment to antipsychotic treatment within 4 weeks of random assignment
  • Currently taking an anticholinergic medication
  • DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months
  • History of mental retardation, pervasive developmental disorder, or other neurological disorder (such as a traumatic brain injury, epilepsy, or Parkinson 's disease)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Emory University

    Atlanta, Georgia, 30329

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • The University of North Carolina

    Chapel Hill, North Carolina, 27599-7160

  • University of Iowa Hospital

    Iowa City, Iowa, 52242

  • University of Minnesota School of Medicine

    Minneapolis, Minnesota, 55454

  • Yale University/Connecticut Mental Health Center

    New Haven, Connecticut, 06519

  • Philadelphia VA Medical Center-116A

    Philadelphia, Pennsylvania, 19104

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • University of Massachusetts

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Cognitive Remediation in the Schizophrenia Trials Network

This study will test whether a cognitive remediation program to treat people with schizophrenia can be successfully implemented in a network of research clinics.

Read the detailed description

Neurocognitive impairments, or problems with thinking and brain function, are a core component of schizophrenia. Such impairments, which can range from moderate to severe, are strongly associated with decreased benefit from psychiatric rehabilitation and problems with treatment adherence, socialization, employment, quality of life, and relapse. Researchers believe that the failure of medication to improve cognition may occur because medication treatment lacks cognitive stimulation. Cognitive remediation programs are a way to provide that stimulation, and they have shown moderate efficacy in improving cognition in people with schizophrenia. Implementing these cognitive remediation programs as part of schizophrenia treatment has occurred only at individual sites with highly trained research personnel. This study will test whether cognitive remediation programs for schizophrenia can be feasibly implemented at a network of sites that do not specialize in cognitive remediation research. This pilot study will gather preliminary efficacy data, but a larger study is required to draw definitive conclusions about treatment effects.

Participation in this study will last approximately 8 weeks. Participants will be randomly assigned to the Posit Science intervention group or the control group. Those in the Posit Science group will receive targeted cognitive training (TCT)-40 hours of adaptive computer exercises-and participate in a weekly bridging group that helps participants apply cognitive skills to everyday contexts. Length of the TCT may vary, depending on the availability of participants to complete the exercises. Those in the control group will play commercially available video games for the same number of hours and participate in a weekly health and wellness group. All participants will undergo assessments at baseline, mid-treatment, and post-treatment. Assessments will include self-report questionnaires and clinical interviews.

Conditions
Schizophrenia
Being tested
Targeted cognitive training, Computer control, Bridging groups, Health and wellness groups
Keywords
Schizoaffective Disorder
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.

  • Targeted cognitive trainingBehavioural

    Adaptive computer exercises that systematically increase in task difficulty as each participant's performance ability improves

  • Computer controlBehavioural

    Commercially available computer games selected based on quality, ability to hold interest, and lack of disturbing content

  • Bridging groupsBehavioural

    Weekly group meetings that help participants apply their cognitive skills to everyday functioning, promote group identity, and promote socialization

  • Health and wellness groupsBehavioural

    Weekly group meetings that teach participants health and wellness skills

Study groups in NCT00930150
Study groupRoleWhat they receive
Posit Science InterventionExperimentalParticipants will receive targeted cognitive training and participate in a bridging group.
Receives: Behavioral: Targeted cognitive training; Behavioral: Bridging groups
ControlActive comparatorParticipants will play commercially available computer games and participate in weekly groups to discuss health and wellness.
Receives: Behavioral: Computer control; Behavioral: Health and wellness groups

What is being measured

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

  1. Feasibility of a multisite trial using cognitive remediation

    Measured: Measured at post-treatment

Secondary outcomes (1)

  1. Effect of cognitive remediation on functional outcomes, including change from baseline on UCSD Performance Based Skills Assessment (UPSA) total score, Specific Levels of Functioning (SLOF) total score, and Cognitive Assessment Interview (CAI) total score

    Measured: Measured at post-treatment

Timeline

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

  1. First posted30 Jun 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00930150
Sponsor's protocol ID
N01 MH090001-07
Other IDs
N01-MH090001-07, PCC: DSIR AT, N01MH090001
Status last verified
Nov 2010
First submitted
26 Jun 2009
Last updated
19 Apr 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.

    PubMed 33539561

  • Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.

    PubMed 28433500

  • Keefe RS, Vinogradov S, Medalia A, Buckley PF, Caroff SN, D'Souza DC, Harvey PD, Graham KA, Hamer RM, Marder SM, Miller DD, Olson SJ, Patel JK, Velligan D, Walker TM, Haim AJ, Stroup TS. Feasibility and pilot efficacy results from the multisite Cognitive Remediation in the Schizophrenia Trials Network (CRSTN) randomized controlled trial. J Clin Psychiatry. 2012 Jul;73(7):1016-22. doi: 10.4088/JCP.11m07100. Epub 2012 May 15.

    PubMed 22687548

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Targeted cognitive training, Bridging groups and Health and wellness groups in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 9 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 9 inclusion and 5 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 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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.

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?

Feasibility of a multisite trial using cognitive remediation (time frame: Measured at post-treatment). 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 NCT00930150, which also lists 3 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 19 Apr 2011.

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