NCT01598220

Brief Summary

The purpose of this study is to determine whether computer-assisted cognitive remediation therapy is effective in the treatment of cognitive deficits in schizophrenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2002

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
Last Updated

May 18, 2012

Status Verified

May 1, 2012

Enrollment Period

3.3 years

First QC Date

April 3, 2012

Last Update Submit

May 17, 2012

Conditions

Schizophrenia

Keywords

schizophreniacognitive remediation therapycognitionquality of life

Outcome Measures

Primary Outcomes (1)

  • Change in neurocognitive outcomes

    Attention:Continuous Performance TestII(CPT II)d'índex, Psychomotor Speed:Symbol Digit Modalities Test (SDMT; Smith, 1973,2002). Phonemic fluency FAS test (Benton \& Hamsher 1976, 1989).Working Memory: Subtest Letter-Number Sequencing (WAIS-III):Verbal Learning:California Verbal Learning Test (CVLT, Delis et al 2000)short- term and long-term free recall.Executive function: Wisconsing Card Sorting Test(WCST; R.Heaton computer version CV3) categories and perseverations, Stroop test ( Stroop Color and Word Test; Stroop,1935; Golden,1994) , Matrix Reasoning (Adult Intelligence Scale-III ;WAIS-III).

    Change from Baseline in neurocognitive measures up to the end of intervention at 6 months

Secondary Outcomes (1)

  • Change in functional outcomes

    Change from Baseline in functional measures up to the end of intervention at 6 months

Study Arms (2)

Computer-assisted cognitive remediation therapy

EXPERIMENTAL
Behavioral: Computer-assisted cognitive remediation therapy

attentional task

PLACEBO COMPARATOR
Other: attentional task

Interventions

Computer-assisted cognitive remediation therapyBEHAVIORAL

Comparison of two groups: The experimental group performs 48 sessions of computer exercices designed to remedy cognitive domains(attention, speed of processing, working memory,reasoning and problem solving) frequently affected in schizophrenia. The intervention has a period 6 months , two sessions a week. All exercises provided a visual or verbal feedback to immediately terminate the execution.In addition to, the therapist after the sessions interactively explain the results and the strategies employed by the patient.

Also known as: cognitive remediation therapy
Computer-assisted cognitive remediation therapy
attentional taskOTHER

The Control group performs 48 sessions of watching videos and answer questions about these videos, in a period of 6 months , two sessions a week.

attentional task

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DSM-IV (APA, 1994)criteria for schizophrenia disorder
  • Estimated IQ of 85 or superior by Vocabulary subtest, Wechsler Adult Intelligence Scale-III (WAIS-III)

You may not qualify if:

  • Non presence of cognitive impairment confirmed by neurocognitive assessment
  • Traumatic brain injury or history of neurologic illness.
  • Electroconvulsive therapy in the last year.
  • Psychiatric comorbidity.
  • Plan to change medication during the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Related Publications (2)

  • Wykes T, Reeder C, Landau S, Everitt B, Knapp M, Patel A, Romeo R. Cognitive remediation therapy in schizophrenia: randomised controlled trial. Br J Psychiatry. 2007 May;190:421-7. doi: 10.1192/bjp.bp.106.026575.

    PMID: 17470957BACKGROUND

  • Grynszpan O, Perbal S, Pelissolo A, Fossati P, Jouvent R, Dubal S, Perez-Diaz F. Efficacy and specificity of computer-assisted cognitive remediation in schizophrenia: a meta-analytical study. Psychol Med. 2011 Jan;41(1):163-73. doi: 10.1017/S0033291710000607. Epub 2010 Apr 12.

    PMID: 20380784BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Gemma Garrido Garcia

    Consorci Sanitari de Terrassa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Efficacy study of a computer cognitive remediation program in patients with schizophrenia

Study Record Dates

First Submitted

April 3, 2012

First Posted

May 15, 2012

Study Start

September 1, 2002

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

May 18, 2012

Record last verified: 2012-05

Locations

ES(1)