Neuropsychological Rehabilitation on Cocaine/Crack Dependents
Primary Purpose
Cocaine Dependence
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Motivational Chess
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine dependence, neuropsychological rehabilitation, executive functions
Eligibility Criteria
Inclusion Criteria:
- Meet the DSM-IV-TR (APA, 2003) criteria for substance dependence through SCID
- Age from18 to 45 years
- Estimated intelligence average or above (≥ 80 IQ)
- Minimum Education: complete basic education (up to fourth grade).
Exclusion Criteria:
- Diagnostic of comorbidity with Axis I psychiatric disorders such as Schizophrenia, Dementia, Major Depression (Severe) and Bipolar Affective Disorder (BD)
- History of head trauma with loss of consciousness for a period longer than one hour and / or other neurological problems;
- Medical conditions that compromise in any way the central nervous system;
- Subjects who are not in 3 to 7 days of abstinence.
Sites / Locations
- University of São Paulo, Institute of Psychiatry
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Motivational Chess & Active Control
Arm Description
Ten meetings of 90 minutes each.
Outcomes
Primary Outcome Measures
Neuropsychological tests
Trail Making Test, Stroop Color Test, Wisconsin Card Sorting Test, Behavioral Assessment of the Dysexecutive Syndrome, Digit Span Test, Iowa Gambling Test, Spatial Addition (Wechsler Memory Scale), Frontal Assessment Battery, Rey Complex Figure.
Secondary Outcome Measures
Psychopathological rating scales
Beck Depression Inventory, State-Trait Anxiety Inventory for Adults, Social Adjustment Scale, Barratt Impulsiveness Scale (BIS 11), World Health Organization Quality of Life Bref (WHOQOF).
Full Information
NCT ID
NCT01914835
First Posted
April 22, 2013
Last Updated
May 24, 2016
Sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT01914835
Brief Title
Neuropsychological Rehabilitation on Cocaine/Crack Dependents
Official Title
The Impact of Neuropsychological Rehabilitation on Cocaine/Crack Dependents: a Placebo-controlled Study Using Cognitive Tests and Functional Magnetic Resonance Imaging.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cocaine/Crack 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 cocaine/crack 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 patient's 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: 9.48 ± 3.06), 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
cocaine dependence, neuropsychological rehabilitation, executive functions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Motivational Chess & Active Control
Arm Type
Experimental
Arm Description
Ten meetings of 90 minutes each.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Chess
Other Intervention Name(s)
Cognitive stimulation, Neuropsychological reahabilitation
Intervention Description
The Motivational Chess (MC) combines Motivational Interviewing with chess game. Volunteers are submitted to 10 sessions of 90 minutes, over three weeks (total 15 hours: 10 hours of chess practice and 5 hours of motivational interviewing).
The Active Control (AC) group consists of ten structured activities using cardboard, paper, crayons, among others. Volunteers are submitted to 10 sessions of 90 minutes, over three weeks (total 15 hours: 10 hours of recreational activities and 5 hours of information about basic cognitive functions).
Primary Outcome Measure Information:
Title
Neuropsychological tests
Description
Trail Making Test, Stroop Color Test, Wisconsin Card Sorting Test, Behavioral Assessment of the Dysexecutive Syndrome, Digit Span Test, Iowa Gambling Test, Spatial Addition (Wechsler Memory Scale), Frontal Assessment Battery, Rey Complex Figure.
Time Frame
three weeks
Secondary Outcome Measure Information:
Title
Psychopathological rating scales
Description
Beck Depression Inventory, State-Trait Anxiety Inventory for Adults, Social Adjustment Scale, Barratt Impulsiveness Scale (BIS 11), World Health Organization Quality of Life Bref (WHOQOF).
Time Frame
three weeks
Other Pre-specified Outcome Measures:
Title
Functional Magnetic Resonance Imaging
Time Frame
three weeks
Title
Brain-derived neurotrophic factor levels
Time Frame
three weeks
Title
Treatment adherence and relapse - follow up
Time Frame
one, three and six months after intervention is concluded
Title
Salivary cortisol levels
Time Frame
three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the DSM-IV-TR (APA, 2003) criteria for substance dependence through SCID
Age from18 to 45 years
Estimated intelligence average or above (≥ 80 IQ)
Minimum Education: complete basic education (up to fourth grade).
Exclusion Criteria:
Diagnostic of comorbidity with Axis I psychiatric disorders such as Schizophrenia, Dementia, Major Depression (Severe) and Bipolar Affective Disorder (BD)
History of head trauma with loss of consciousness for a period longer than one hour and / or other neurological problems;
Medical conditions that compromise in any way the central nervous system;
Subjects who are not in 3 to 7 days of abstinence.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur G de Andrade, M.D., Ph.D
Organizational Affiliation
Program of the Interdisciplinary Group of Studies on Alcohol and Drugs (GREA), School of Medicine, Institute and Department of Psychiatry, University of Sao Paulo - USP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo, Institute of Psychiatry
City
São Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
24913200
Citation
Goncalves PD, Ometto M, Bechara A, Malbergier A, Amaral R, Nicastri S, Martins PA, Beraldo L, dos Santos B, Fuentes D, Andrade AG, Busatto GF, Cunha PJ. Motivational interviewing combined with chess accelerates improvement in executive functions in cocaine dependent patients: a one-month prospective study. Drug Alcohol Depend. 2014 Aug 1;141:79-84. doi: 10.1016/j.drugalcdep.2014.05.006. Epub 2014 May 24.
Results Reference
result
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Neuropsychological Rehabilitation on Cocaine/Crack Dependents
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