Overview

This trial is active, not recruiting.

Conditions alcohol-induced disorders, nervous system, alcohol dependence
Treatment mobile health cognitive stimulation
Sponsor Pedro Gamito
Collaborator Universidade Lusófona de Humanidades e Tecnologias
Start date October 2012
End date March 2013
Trial size 54 participants
Trial identifier NCT01942954, labpsicom-001

Summary

The consequences of alcohol dependence are severe and may range from physical diseases to neuropsychological deficits in several cognitive domains. Alcohol abuse has also been related to brain dysfunction specifically in the prefrontal cortex. To assess these deficits and the application of a novel approach of cognitive stimulation to alcoholics, we have carried out a neuropsychological intervention program with mobile health technology. Patients diagnosed with alcohol dependence syndrome were submitted to cognitive stimulation during four weeks in a three-day/week basis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Experimental group
mobile health cognitive stimulation
(No Intervention)
This group consists of treatment-as-usual for alcohol abstinence according to the Minnesota Model.

Primary Outcomes

Measure
Change in the results of Frontal Assessment Battery - FAB
time frame: Before cognitive rehabilitation - After cognitive rehabilitation (1month - after 10 sessions)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: Only patients that scored higher than the cutoff values for their age on the Mini Mental Examination Test and with no clinical scores on the Symptoms Checklist Revised were included in the study. Exclusion Criteria: Patients with dependency from substances other than alcohol or with history of previous neurological disorders were excluded from the study. Patients were also screened for minimal computer literacy; no patients were excluded due to lack of this criterion.

Additional Information

Official title Executive Functioning in Alcoholics Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial
Principal investigator Jorge AG Oliveira, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Universidade Lusófona de Humanidades e Tecnologias.