Cognitive ImpairmentNCT00248794
Cognitive Rehabilitation in Schizophrenia
A study testing Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG), Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG) and Skills Group (SDG) in people with Cognitive Impairment and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cognitive Impairment, Schizophrenia
- What is being tested?
- Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG), Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG) and Skills Group (SDG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Oct 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current Substance abuse, no comorbid neurological disease
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
About this study
Official title: The Effects of Cognitive Rehabilitation on Function in Schizophrenia
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.
Read the 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
- Being tested
- Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG), Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG), Skills Group (SDG)
- Keywords
- Cognitive Impairment, Rehabilitation
- Medical subject headings
- Cognitive Dysfunction, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG)Behavioural
CRT is a one on one cognitive skills training and Skill training is a group intervention to develop concrete skills of daily living.
Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG)Behavioural
ICBCR is a computerized cognitive skills training program and Skill training is a group intervention to develop concrete skills of daily living.
Skills Group (SDG)Behavioural
Also called Standard care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Behavioral: Skills Group (SDG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks after intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startJun 2004
- Primary completionDec 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gary Bryson, Principal investigator, VA Connecticut Health Care System (West Haven)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248794
- Sponsor's protocol ID
- O3251-R
- Other IDs
- 00471
- Status last verified
- Apr 2016
- First submitted
- 2 Nov 2005
- Last updated
- 25 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data to be written up in peer review journal and possibly presented at regional and national conferences, but there is no plan to de-identify and share
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cognitive Rehabilitation on Function in Schizophrenia
- ClinicalTrials.gov ID
- NCT00248794
- Acronym / sponsor ID
- O3251-R
- Conditions
- Cognitive Impairment, Schizophrenia
- Keywords
- Cognitive Impairment, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jun 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Nov 2005 (estimated)
- Results
- Posted 14 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRT + Skills Training | Experimental | Behavioral: Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG)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. |
| ICBCR and Skills Training | Experimental | Behavioral: Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG)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). |
| Skills Group Control | Experimental | Behavioral: Skills Group (SDG)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Current Substance abuse, no comorbid neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CRT + Skills Training |
| 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. | Behavioural | ICBCR and Skills Training |
| Skills Group (SDG)Also: Standard careSkill 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. | Behavioural | Skills Group Control |
Primary outcome
Wisconsin Card Sort Percent Perseverative Errors (Standard Score)
Time frame: 16 weeks after intake
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.
Bell Lysaker Emotion Recognition Test
Time frame: 16 weeks from intake
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.
Continuous Performance Task X/A Version
Time frame: 16 weeks after intake assessment
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.
Hopkins Verbal Learning Test- Total Recall Variable
Time frame: 16 weeks post intake assessment
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.
Independent Living Skills Survey
Time frame: 16 weeks after intake
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data to be written up in peer review journal and possibly presented at regional and national conferences, but there is no plan to de-identify and share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Bryson principal investigator
VA Connecticut Health Care System (West Haven)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Rehabilitation Therapy (CRT) + Skill Training (SDG), Individual Computer Based Cognitive Rehabilitation (ICBCR) and Skills Training (SDG) and Skills Group (SDG) in people with Cognitive Impairment and Schizophrenia, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wisconsin Card Sort Percent Perseverative Errors (Standard Score) (time frame: 16 weeks after intake). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.