NCT01942954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

7.2 years

First QC Date

August 30, 2013

Last Update Submit

May 9, 2023

Conditions

Alcohol-Induced Disorders, Nervous SystemAlcohol Dependence

Keywords

Alcohol DependenceCognitive TherapyExecutive FunctionMobile HealthRecovery of FunctionRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before cognitive rehabilitation - After cognitive rehabilitation (1month - after 10 sessions)

Study Arms (2)

Mobile health cognitive stimulation

EXPERIMENTAL

Experimental group

Other: Mobile health cognitive stimulation

Treatment-as-usual

NO INTERVENTION

This group consists of treatment-as-usual for alcohol abstinence according to the Minnesota Model.

Interventions

Mobile health cognitive stimulationOTHER
Mobile health cognitive stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ares do Pinhal. Associação de Recuperação de Toxicodependentes

Sintra, Lisbon District, 2725, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 24742381DERIVED

MeSH Terms

Conditions

Alcohol-Induced Disorders, Nervous SystemAlcoholism

Condition Hierarchy (Ancestors)

Neurotoxicity SyndromesNervous System DiseasesPoisoningChemically-Induced DisordersAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersMental Disorders

Study Officials

  • Pedro SP Gamito, PhD

    Universidade Lusófona de Humanidades e Tecnologias

    STUDY CHAIR

  • Jorge AG Oliveira, PhD

    Universidade Lusófona de Humanidades e Tecnologias

    PRINCIPAL INVESTIGATOR

  • Paulo JF Lopes, PhD

    Universidade Lusófona de Humanidades e Tecnologias

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD (Full Professor)

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 16, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2019

Study Completion

July 1, 2021

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

PT(1)