Back to resultsHealth Mobile Cognitive Stimulation in Alcohol Use Disorder
Primary Purpose
Alcohol-Induced Disorders, Nervous System, Alcohol Dependence
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Mobile health cognitive stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol-Induced Disorders, Nervous System focused on measuring Alcohol Dependence, Cognitive Therapy, Executive Function, Mobile Health, Recovery of Function, Rehabilitation
Eligibility Criteria
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.
Sites / Locations
- Ares do Pinhal. Associação de Recuperação de Toxicodependentes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mobile health cognitive stimulation
Treatment-as-usual
Arm Description
Experimental group
This group consists of treatment-as-usual for alcohol abstinence according to the Minnesota Model.
Outcomes
Primary Outcome Measures
Change in the results of Frontal Assessment Battery - FAB
The participants were assessed in Frontal Lobe Cognitive Functioning (Retention, Attention and Calculation, Language and Visual-spatial abilities)at the beginning of the rehabilitation and after 10 rehabilitation sessions, which had the approximate duration of one month.
Secondary Outcome Measures
Full Information
NCT ID
NCT01942954
First Posted
August 30, 2013
Last Updated
May 9, 2023
Sponsor
Pedro Gamito
Collaborators
Universidade Lusófona de Humanidades e Tecnologias
1. Study Identification
Unique Protocol Identification Number
NCT01942954
Brief Title
Health Mobile Cognitive Stimulation in Alcohol Use Disorder
Official Title
Executive Functioning in Patients With Alcohol Use Disorder Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
July 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pedro Gamito
Collaborators
Universidade Lusófona de Humanidades e Tecnologias
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Induced Disorders, Nervous System, Alcohol Dependence
Keywords
Alcohol Dependence, Cognitive Therapy, Executive Function, Mobile Health, Recovery of Function, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile health cognitive stimulation
Arm Type
Experimental
Arm Description
Experimental group
Arm Title
Treatment-as-usual
Arm Type
No Intervention
Arm Description
This group consists of treatment-as-usual for alcohol abstinence according to the Minnesota Model.
Intervention Type
Other
Intervention Name(s)
Mobile health cognitive stimulation
Primary Outcome Measure Information:
Title
Change in the results of Frontal Assessment Battery - FAB
Description
The participants were assessed in Frontal Lobe Cognitive Functioning (Retention, Attention and Calculation, Language and Visual-spatial abilities)at the beginning of the rehabilitation and after 10 rehabilitation sessions, which had the approximate duration of one month.
Time Frame
Before cognitive rehabilitation - After cognitive rehabilitation (1month - after 10 sessions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro SP Gamito, PhD
Organizational Affiliation
Universidade Lusófona de Humanidades e Tecnologias
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jorge AG Oliveira, PhD
Organizational Affiliation
Universidade Lusófona de Humanidades e Tecnologias
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo JF Lopes, PhD
Organizational Affiliation
Universidade Lusófona de Humanidades e Tecnologias
Official's Role
Study Director
Facility Information:
Facility Name
Ares do Pinhal. Associação de Recuperação de Toxicodependentes
City
Sintra
State/Province
Lisboa
ZIP/Postal Code
2725
Country
Portugal
12. IPD Sharing Statement
Citations:
PubMed Identifier
24742381
Citation
Gamito P, Oliveira J, Lopes P, Brito R, Morais D, Silva D, Silva A, Rebelo S, Bastos M, Deus A. Executive functioning in alcoholics following an mHealth cognitive stimulation program: randomized controlled trial. J Med Internet Res. 2014 Apr 17;16(4):e102. doi: 10.2196/jmir.2923.
Results Reference
derived
Learn more about this trial
Health Mobile Cognitive Stimulation in Alcohol Use Disorder
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