Cognitive Rehabilitation in Schizophrenia

NCT00248794 | Completed Results

• 2 other identifiers: O3251-R00471
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Schizophrenia

Keywords

Cognitive Impairment; Rehabilitation

Outcome Measures

Primary Outcomes (5)

• Wisconsin Card Sort Percent Perseverative Errors (Standard Score)

  This is a measure of cognitive flexibility and the ability to shift set in the face of a changing reinforcement. The measure reflects "density" of perseverative errors in relation to the overall test performance. It is computed by calculating the ration of perseverative errors to trials administered and multiplied by 100. Then the percentage score is translate using the available Standard Score Tables provided in the manual and converted to a standard score with a mean of 100, a maximum of 145 and a minimum of 55, with higher Standard Scores indicating better performance.

  16 weeks after intake

• Bell Lysaker Emotion Recognition Test

  21 Item audio-visual task that measures the ability to recognize affective states in others. Affective states presented include: Happiness, Sadness, Surprise, Disgust, Fear, Anger and No Emotion. The instrument is scored for total correct responses with scores ranging from 0 to 21 with higher scores indicate better overall performance.

  16 weeks from intake

• Continuous Performance Task X/A Version

  CPT relative X/A Percentage. This is a task-oriented computerized assessment of attention-related problems. This variable measures the relative sustained attention, and vigilance over the time of the task. Raw performance is standardize using available age and education norms yielding a Standardized Score with a mean of 100. Maximum Standard score is 145 and the minimum is 55 with higher scores reflect better performance.

  16 weeks after intake assessment

• Hopkins Verbal Learning Test- Total Recall Variable

  This is measure of verbal learning and memory for immediate recall. Respondents are read a list of 12 items and asked to repeat once the last item is given. The list if given 3 times. Each time all items are recorded giving a total score ranging from 0 to 36. The score is converted to T-scores (mean of 50 and sd of 10) using the norms in the manual. The data reported are that in T-Scores with higher scores indicating better functioning.

  16 weeks post intake assessment

• Independent Living Skills Survey

  Independent Living Skills Survey is a 103 items that assess 12 areas of skills; personal hygiene (6 items), appearance and care of clothing (12 items), care of personal possessions and living space (9 items), food preparation (9 items), care of one's own health and safety (10 items), money management (10 items), transportation (7 items), leisure and recreational activities (13 items), job seeking (6 items), job maintenance (3 items), eating behaviors (9 items), and social interactions (9 items). The items describe relatively specific skills such as "washes hair twice a week," and informants indicate how frequently an individual has performed each skill within the past month. The responses are yes (1 point) no (0 points). Scores reports are the average #of yes items/number of total items. Higher scores indicating better functioning.

  16 weeks after intake

Study Arms (3)

CRT + Skills Training

EXPERIMENTAL

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.

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

ICBCR and Skills Training

EXPERIMENTAL

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).

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

Skills Group Control

EXPERIMENTAL

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.

Behavioral: Skills Group (SDG)

Interventions

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

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

CRT + Skills Training

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

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

ICBCR and Skills Training

Skills Group (SDG) 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.

Also known as: Standard care

Skills Group Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current Substance abuse, no comorbid neurological disease

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Schizophrenia

Interventions

secoisolariciresinol; Standard of Care

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Gary Bryson
• Organization: VA Connecticut Healthcare System

gary.bryson@va.gov

860-594-6348

Study Officials

• Gary Bryson

  VA Connecticut Health Care System (West Haven)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 4, 2005
• Study Start: June 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: October 1, 2009
• Last Updated: May 25, 2016
• Results First Posted: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)