Cognitive Rehabilitation in Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00248794
First received: November 2, 2005
Last updated: October 2, 2009
Last verified: October 2009
  Purpose

The study will investigate the viability of two cognitive rehabilitation strategies to improve functional outcomes for people with schizophrenia. Many people with schizophrenia experience impairments in cognitive function which limit their abilities. These impairments have been shown to precede the onset of illness and represent a vulnerability factor which is exacerbated by emerging psychotic symptoms. These impairments affect a range of functional domains including symptom severity, work function, symptom management, treatment, and overall quality of life. Recognizing the link between cognitive impairment and function, a few clinicals and researchers have attempted to remediate cognitive impairments by providing cognitive retraining programs similar to those used in traumatic brain injured patients or adaptive skills training. Cognitive retraining involves repetitive exercises to increase elemental cognitive functions including memory, attention, psychomotor speed, planning, and cognitive flexibility. Adaptive skill training involves didactic group exercises in social skills, activities of daily living, and symptom management. Each approach has demonstrated some rehabilitation benefits. This study will investigate the effectiveness of a combination of these two approaches on outcomes in schizophrenia.


Condition Intervention
Cognitive Impairment
Schizophrenia
Behavioral: Cognitive rehabilitation (CRT and ICBR)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Cognitive Rehabilitation on Function in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • neuropsychological test performance [ Time Frame: 16 weeks and 30 week follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2004
Study Completion Date: October 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cognitive Remediaton therapy
Behavioral: Cognitive rehabilitation (CRT and ICBR)
Methods to improve cognitive abilities
Experimental: 2
Individualized Computer Based Cognitive Remediation
Behavioral: Cognitive rehabilitation (CRT and ICBR)
Methods to improve cognitive abilities
No Intervention: 3
Life skills group + up to five individual contacts with research staff without active cognitive training

Detailed Description:

Objective: Many people with schizophrenia experience impairments in cognitive function which limit their abilities. These impairments affect a range of functional domains including symptom severity, work function, symptom management, treatment, and overall quality of life. Recognizing the link between cognitive impairment and function, a few clinicians and researchers have attempted to remediate cognitive impairments by providing cognitive retraining programs similar to those used in traumatic brain injured patients or adaptive skills training. Cognitive retraining involves repetitive exercises to increase elemental cognitive functions including memory, attention, psychomotor speed, planning, and cognitive flexibility. Adaptive skill training involves didactic group exercises in social skills, activities of daily living, and symptom management. This study investigates the effectiveness of a combination of these two approaches on outcomes in schizophrenia. This will be a three group randomized clinical trial investigating the effects of cognitive rehabilitation on outcomes ranging from proximal (training tasks performance and neuropsychological test performance), to more distal outcomes (treatment group performance and quality of life ratings). We believe that the cognitive augmentation will have significant impact on training task and neuro-psychological test performance and attenuated, but significant effect on performance in the treatment groups. Finally, we hypothesize that the combination of adaptive training and cognitive rehabilitation will have measurable impact on the most distal outcomes such as daily living skills and quality of life. Method: One hundred (100) individuals will be invited to participate in a 30-week program. After informed consent is obtained and diagnosis established, participants will receive an extensive assessment of neuropsychological, psychological and psychosocial functioning. Participants will be randomly assigned to one of three conditions using a stratified procedure based on cognitive test performance (this will ensure that there are similar numbers of severely and less severely impaired participants in each condition). The three conditions will be: (1) a usual care control group which is the Life Skills Development Group (LSDG), (2) Individualized computer based cognitive rehabilitation (ICBCR) augmenting the LSDG; and (3) Cognitive Remediation Therapy (CRT) with LSDG. Participants will be compared on: (1) LSDG performance, (2) neuropsychological test performance and (3) psychosocial functioning. Attendance in groups and remediation sessions will be compensated at a rate of $5 per session. The key questions t be answered are which Cognitive Rehabilitation strategy is more effective at improving cognitive function? Does Cognitive Rehabilitation produce better performance in the Life Skills Development Group (LSDG)? Does Life Skills Development Group augmented by Cognitive Rehabilitation produce better psychosocial outcomes than the standard care control group?

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of schizophrenia or schizoaffective disorder. Between the ages of 18-65. Stable medication regime (no changes in last 30 days)Minimum of 30 days since last hospitalization. No hx of TBI

Exclusion Criteria:

  • Current Substance abuse, no comorbid neurological disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248794

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Investigators
Principal Investigator: Gary Bryson VA Connecticut Health Care System (West Haven)
  More Information

No publications provided

Responsible Party: Bryson, Gary - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00248794     History of Changes
Other Study ID Numbers: O3251R
Study First Received: November 2, 2005
Last Updated: October 2, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Cognitive Impairment
Rehabilitation

Additional relevant MeSH terms:
Schizophrenia
Cognition Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

ClinicalTrials.gov processed this record on April 16, 2014