Neuropsychological Rehabilitation on Cocaine/Crack Dependents

NCT01914835 | Unknown

• 1 other identifier: CNPq, Grant 402721/2010-1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

cocaine dependence; neuropsychological rehabilitation; executive functions

Outcome Measures

Primary Outcomes (1)

• 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.

  three weeks

Secondary Outcomes (1)

• Psychopathological rating scales

  three weeks

Other Outcomes (4)

• Functional Magnetic Resonance Imaging

  three weeks

• Brain-derived neurotrophic factor levels

  three weeks

• Treatment adherence and relapse - follow up

  one, three and six months after intervention is concluded

Study Arms (1)

Motivational Chess & Active Control

EXPERIMENTAL

Ten meetings of 90 minutes each.

Behavioral: Motivational Chess

Interventions

Motivational Chess BEHAVIORAL

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).

Also known as: Cognitive stimulation, Neuropsychological reahabilitation

Motivational Chess & Active Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

University of São Paulo, Institute of Psychiatry

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 24913200 RESULT

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Arthur G de Andrade, M.D., Ph.D

  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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priscila Dib Gonçalves

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: August 2, 2013
• Study Start: April 1, 2011
• Primary Completion: April 1, 2017
• Study Completion: October 1, 2017
• Last Updated: May 26, 2016

Record last verified: 2016-05

Locations

BR (1)