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Completed

NCT Number: NCT00063336

Treatment Response to Rehabilitation in Patients With Schizophrenia

This study will examine the ways in which schizophrenia-related symptoms affect response to a rehabilitation program for people with schizophrenia.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schizophrenia Rehabilitation Program, Institutes of Living

Hartford, Connecticut, 06106, United States

About this study

Patients with schizophrenia often suffer neurocognitive impairment and psychosocial and vocational difficulties. This study will help identify those patients most likely to benefit from existing behavioral treatments and provide clues for how to modify treatments for those who do not benefit.

Two studies will be conducted. The first will investigate the relationship of symptoms and neurocognitive variables at study entry to psychosocial and vocational status 2 years later. The second study will investigate the relationship of symptoms and neurocognitive variables at study entry to treatment response in patients assigned to either a cognitive remediation track or a computer skills track as part of their rehabilitation treatment.

Both the cognitive remediation and computer skills training programs will last 4 to 6 months. Participants will be assessed pre- and post-treatment. Neuropsychological, psychosocial and vocational status will be measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DSM-IV criteria for schizophrenia or schizoaffective disorder
  • In need of intensive outpatient care
  • Treatment with atypical antipsychotic medication for a minimum of 6 months prior to study entry

Exclusion criteria

  • Auditory or visual impairment
  • Mental retardation (IQ less than 70)
  • Traumatic brain injury with loss of consciousness
  • Presence or history of any neurological illness that may affect brain physiology
  • Lack of proficiency in English
  • Concurrent substance abuse and/or dependence

Treatment and study plan

Cognitive Remediation

Behavioral

A computerized cognitive rehabilitation treatment with day-program activities

Computer-skills training

Behavioral

A computerized cognitive rehabilitation treatment with day-program activities

Primary outcomes

  1. Neuropsychological test battery, including measures of visual, verbal memory, and problem-solving abilities

    Time frame: Measured pre- and post-treatment

  2. Schizophrenia symptoms

    Time frame: Measured pre- and post-treament

  3. UCSD Performance-Based Skills Assessment

    Time frame: Measured pre- and post-treatment

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treatment Response to Rehabilitation in Schizophrenia

Important dates

Study start
2001
Primary completion
2005
Study completion
2005
First posted
Jun 27, 2003
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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