Cognitive Rehabilitation in Schizophrenia

NCT ID: NCT00248794

Last Updated: 2016-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2009-10-31

Brief Summary

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.

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?

Conditions

Cognitive Impairment; Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CRT + Skills Training

The intervention is call Cognitive Remediation Therapy (CRT) with a skill development group. Participants receive 15 weeks of cognitive training (with intake, 15 and 30 week assessment). This intervention is reliant upon didactic exchanges between trainer and participant, minimizing error, and behavioral modeling with the goal of developing better meta-cognitive skills. Procedures include paper and pencil activities (memory, planning and cognitive flexibility training) which are organized by difficulty. Sessions are organized to have a discussion between the trainer and the participant about the task and strategies, trainer modeling with articulation of strategy a participant attempts the task, talking aloud the steps, and finally the participant practices the task covertly. The trainer has the role of "error catcher and model." All subjects randomized to this condition also are receiving the weekly skills group (SDG)offered to participants in all experimental conditions.

Group Type: EXPERIMENTAL

Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG)

Intervention Type: BEHAVIORAL

CRT is a one on one cognitive skills training and Skill training is a group intervention to develop concrete skills of daily living.

ICBCR and Skills Training

This intervention is Individualized Computer Based Cognitive Remediation (ICBCR) and skills development group (SDG). Participants receive 15 weeks of computerized training (with intake, 15 and 30 week assessments). This intervention relies upon intense, frequent, repetition of tasks being made incrementally more challenging. Computer tasks are organized so that the initial trials are easily completed and more challenging levels are then attempted. Parameters such as duration of task, task speed, and intra-task variables all be are manipulated. A trainer will be present at each session to help set up the computer tasks and answer questions. Besides the first two sessions that will be orientation sessions, the trainer has little involvement during the training sessions. The role of the trainer is to help organize, support, and provide feedback to each participant. All subjects randomized to this condition also are receiving the weekly skills group (SDG).

Group Type: EXPERIMENTAL

Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG)

Intervention Type: BEHAVIORAL

ICBCR is a computerized cognitive skills training program and Skill training is a group intervention to develop concrete skills of daily living.

Skills Group Control

The control intervention is call the skills development group (SDG) and is augmented with up to five individual contacts with research staff. The Skills Group (SDG) control is standard care group which will receive 15 weeks of the skills development group (SDG) similar to that offered as a clinical service at the VA Medical Center. During the 15 weeks participants will attend 1.5 hours of skills group per week. The 15 sessions will include skills training related to: a) cooking and food preparation, b) negotiating the local transportation system, c) shopping, and d) planning leisure activities. The training activities are a blend of didactic learning, modeling and finally in vivo practice. Participants in this group will also be offered up to five weekly contacts with staff to balance out factors related to meeting with staff in the other conditions.

Group Type: EXPERIMENTAL

Skills Group (SDG)

Intervention Type: BEHAVIORAL

Skill training is a group intervention to develop concrete skills of daily living. This is augmented with the opportunity to receive up to 5 hours of individual staff contact.

Interventions

Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG)

CRT is a one on one cognitive skills training and Skill training is a group intervention to develop concrete skills of daily living.

Intervention Type: BEHAVIORAL

Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG)

ICBCR is a computerized cognitive skills training program and Skill training is a group intervention to develop concrete skills of daily living.

Intervention Type: BEHAVIORAL

Skills Group (SDG)

Skill training is a group intervention to develop concrete skills of daily living. This is augmented with the opportunity to receive up to 5 hours of individual staff contact.

Intervention Type: BEHAVIORAL

Other Intervention Names

Standard care

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Bryson

Role: PRINCIPAL_INVESTIGATOR

VA Connecticut Health Care System (West Haven)

Locations

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

00471

Identifier Type: OTHER

Identifier Source: secondary_id

O3251-R

Identifier Type: -

Identifier Source: org_study_id