Clinical trial NCT00430560: Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia
Official title: Work Activity Augmented by Cognitive Rehabilitation: Continuation and Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: work therapy
cognitive rehabilitation
schizophrenia
schizoaffective disorder
treatment outcome
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Connecticut Healthcare System
First posted: 2007-02-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research investigates the benefits of productive activity and cognitive rehabilitation for patients with schizophrenia. Key questions are:

1. does cognitive rehabilitation plus work activity produce better outcomes than work activity alone?
2. Is cognitive rehabilitation more helpful for individuals with moderate or greater cognitive impairment than for individuals without such impairment?
3. Does cognitive rehabilitation reduce the dropout rate and increase participation in work activity for cognitively impaired subjects?
4. What features of cognitive rehabilitation are most important for clinical and rehabilitation outcomes?

Detailed description: This is a randomized, matching study in which subjects are stratified by degree of cognitive impairment, then randomly assigned to one of two conditions: Work Services Only vs. Work Services plus cognitive rehabilitation. Longitudinal analysis of work activity, work performance, symptoms, quality of life, cognitive function and service utilization are made.

Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

* change in psychiatric medications or housing within 30 days of study intake
* episode of drug abuse within 30 days of study intake
* GAF score 30 or less
* known neurological disease or developmental disability

Primary outcomes:
measure: Neuropsychological test performance
timeFrame: data collection completed
Secondary outcomes:
measure: Hours of productive activity
timeFrame: data collection completed
measure: Hours worked
timeFrame: data collection completed
measure: Quality of life
timeFrame: data collection completed
measure: Psychiatric symptoms
timeFrame: data collection completed
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Morris D Bell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wexler BE, Bell MD. Cognitive remediation and vocational rehabilitation for schizophrenia. Schizophr Bull. 2005 Oct;31(4):931-41. doi: 10.1093/schbul/sbi038. Epub 2005 Aug 3.
citation: Bell M, Bryson G, Wexler BE. Cognitive remediation of working memory deficits: durability of training effects in severely impaired and less severely impaired schizophrenia. Acta Psychiatr Scand. 2003 Aug;108(2):101-9. doi: 10.1034/j.1600-0447.2003.00090.x.
citation: Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.
citation: Fiszdon JM, Cardenas AS, Bryson GJ, Bell MD. Predictors of remediation success on a trained memory task. J Nerv Ment Dis. 2005 Sep;193(9):602-8. doi: 10.1097/01.nmd.0000177790.23311.ba.
citation: Fiszdon JM, Whelahan H, Bryson GJ, Wexler BE, Bell MD. Cognitive training of verbal memory using a dichotic listening paradigm: impact on symptoms and cognition. Acta Psychiatr Scand. 2005 Sep;112(3):187-93. doi: 10.1111/j.1600-0447.2005.00565.x.
citation: Bell MD, Fiszdon JM, Greig TC, Bryson GJ. Can older people with schizophrenia benefit from work rehabilitation? J Nerv Ment Dis. 2005 May;193(5):293-301. doi: 10.1097/01.nmd.0000161688.47164.71.
citation: Bell MD, Bryson GJ, Greig TC, Fiszdon JM, Wexler BE. Neurocognitive enhancement therapy with work therapy: Productivity outcomes at 6- and 12-month follow-ups. J Rehabil Res Dev. 2005 Nov-Dec;42(6):829-38. doi: 10.1682/jrrd.2005.03.0061.
citation: Fiszdon JM, Choi J, Bryson GJ, Bell MD. Impact of intellectual status on response to cognitive task training in patients with schizophrenia. Schizophr Res. 2006 Oct;87(1-3):261-9. doi: 10.1016/j.schres.2006.04.011. Epub 2006 Jun 5.
citation: Bell MD, Fiszdon J, Bryson G, Wexler BE. Effects of neurocognitive enhancement therapy in schizophrenia: normalisation of memory performance. Cogn Neuropsychiatry. 2004 Aug;9(3):199-211. doi: 10.1080/13546800344000084.