Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01914835
Status:
UNKNOWN
Last Update Posted:
2016-05-26
First Post:
2013-04-22
Brief Title:
Neuropsychological Rehabilitation on CocaineCrack Dependents
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
The Impact of Neuropsychological Rehabilitation on CocaineCrack Dependents a Placebo-controlled Study Using Cognitive Tests and Functional Magnetic Resonance Imaging
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CocaineCrack Dependence has been associated with neuropsychological impairments mainly in executive functions and decision-making which are predominantly managed by the prefrontal cortex PFC in the brain However none study in Neuropsychological Rehabilitation NR has been done in order to remediate the executive functioning in this population The aim of this research is to investigate the impact of neuropsychological intervention based on the stimulation of cognitive functions such as attention planning organization logical reasoning executive functioning and decision making For this research it will be proposed interventions through motivational strategies and board games especially chess because it has been associated with PFC functioning since it is a game which requires complex cognitive abilities such as inhibitory control mental flexibility sustained attention future planning and decision-making There will be two groups of patients with cocainecrack dependence n 56 one with NR group A n 28 and another without NR group B n 28 Group B will be submitted to the placebo intervention Both groups will be submitted to an extensive battery of neuropsychological tests and psychopathological rating scales before and after interventions A sub-group will also be submitted to functional magnetic resonance imaging and biomarkers measures BDNF and cortisol The hypothesis is that group A will present a pronounced improvement not only on the neuropsychological test but also on the PFC functioning in neuropsychological functions compared to group B
Detailed Description:
Cognitive Stimulation - The Motivational Chess MC was designed to stimulate executive cognitive functioning The idea of combining Motivational Interviewing 25 with chess game was to stimulate discrepancy motivation and support self-efficacy Volunteers will be submitted to 10 sessions of 90 minutes over three weeks total 15 hours 10 hours of chess practice and 5 hours of motivational interviewing At the beginning of each session the participants will be divided into pairs and received a sheet containing the game rules that sheet worked as a kind of working memory aid During the game practice there will be a therapist coordinator observing helping and motivating the participants for goal-directed behaviors The therapist interventions will be focused on patients behavior analyzing if they know the game rules are able to follow the rules have visual perception of the pieces and use strategies considering short or long-term consequences Another relevant role of the therapist will be empathic with the patients and to help them deal with their own resistance to change or to adapt to new situations
The last 30 minutes of MC will be divided into three stages 1 a short presentation on the cognitive deficits due to CD Giving Information 2 participants will report their impressions about their performance in chess linking it to real life situations such as drug-related events difficulty monitoring and directing behavior controlling craving and relapse Developing Discrepancy 3 discussions encouraging healthy decision making focusing on future and favorable real-life long-term behaviors as opposed to immediate and high risk behaviors Supporting Self-Efficacy
Control Group - The Active Control AC group will occur exactly on the same conditions of the MC group It consists of one hour of recreational activities to stimulate more basic cognitive functions such as simple attention for example to follow a simple sequence of actions motor coordination and visual functions Ten activities were structured using cardboard paper crayons among others In the last 30 minutes there will be a presentation also based on Motivational Interviewing but limited to providing information about basic cognitive functions Giving Information and promoting motivation to engagement to the activities
Procedures To enroll in this study the participants must have a positive urine test for cocaine and will answer to semi-structured clinical interviews SCID and ASI-6 on the first week When the urine test becomes negative mean in days 948 306 the pre assessment will be applied Neuropsychological and Psychopathological Assessment Functional Magnetic Resonance Imaging Brain-derived neurotrophic factor levels and Cortisol levels Then the participants will participate in 10 sessions of MC or AC for approximately 3 weeks At the end if the urine test remains negative the post assessment will be applied about one month of abstinence of cocaine use The urine toxicology test will be used to have an objective measure of recent use and abstinence
The last 30 minutes of MC will be divided into three stages 1 a short presentation on the cognitive deficits due to CD Giving Information 2 participants will report their impressions about their performance in chess linking it to real life situations such as drug-related events difficulty monitoring and directing behavior controlling craving and relapse Developing Discrepancy 3 discussions encouraging healthy decision making focusing on future and favorable real-life long-term behaviors as opposed to immediate and high risk behaviors Supporting Self-Efficacy
Control Group - The Active Control AC group will occur exactly on the same conditions of the MC group It consists of one hour of recreational activities to stimulate more basic cognitive functions such as simple attention for example to follow a simple sequence of actions motor coordination and visual functions Ten activities were structured using cardboard paper crayons among others In the last 30 minutes there will be a presentation also based on Motivational Interviewing but limited to providing information about basic cognitive functions Giving Information and promoting motivation to engagement to the activities
Procedures To enroll in this study the participants must have a positive urine test for cocaine and will answer to semi-structured clinical interviews SCID and ASI-6 on the first week When the urine test becomes negative mean in days 948 306 the pre assessment will be applied Neuropsychological and Psychopathological Assessment Functional Magnetic Resonance Imaging Brain-derived neurotrophic factor levels and Cortisol levels Then the participants will participate in 10 sessions of MC or AC for approximately 3 weeks At the end if the urine test remains negative the post assessment will be applied about one month of abstinence of cocaine use The urine toxicology test will be used to have an objective measure of recent use and abstinence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None