Alcohol-Induced Disorders, Nervous SystemNCT01942954
Health Mobile Cognitive Stimulation in Alcohol Use Disorder
A study testing Mobile health cognitive stimulation in people with Alcohol-Induced Disorders, Nervous System and Alcohol Dependence, run by Pedro Gamito at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol-Induced Disorders, Nervous System, Alcohol Dependence
- What is being tested?
- Mobile health cognitive stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2012to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Ares do Pinhal. Associação de Recuperação de Toxicodependentes
Sintra, Lisbon District, 2725
About this study
Official title: Executive Functioning in Patients With Alcohol Use Disorder Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial
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.
- Being tested
- Mobile health cognitive stimulation
- Keywords
- Alcohol Dependence, Cognitive Therapy, Executive Function, Mobile Health, Recovery of Function, Rehabilitation
- Medical subject headings
- Alcohol-Induced Disorders, Nervous System, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health cognitive stimulationOther
| Study group | Role | What they receive |
|---|---|---|
| Mobile health cognitive stimulation | Experimental | Experimental group Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before cognitive rehabilitation - After cognitive rehabilitation (1month - after 10 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2019
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol-Induced Disorders, Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedro Gamito
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Lusófona de Humanidades e Tecnologias
- Responsible party
- Sponsor-investigator, Pedro Gamito, Universidade Lusófona de Humanidades e Tecnologias
- Investigators
- Pedro SP Gamito, PhD, Study chair, Universidade Lusófona de Humanidades e TecnologiasJorge AG Oliveira, PhD, Principal investigator, Universidade Lusófona de Humanidades e TecnologiasPaulo JF Lopes, PhD, Study director, Universidade Lusófona de Humanidades e Tecnologias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942954
- Sponsor's protocol ID
- SLB_AUD01
- Status last verified
- May 2023
- First submitted
- 30 Aug 2013
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24742381
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive Functioning in Patients With Alcohol Use Disorder Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01942954
- Acronym / sponsor ID
- SLB_AUD01
- Keywords
- Alcohol Dependence, Cognitive Therapy, Executive Function, Mobile Health, Recovery of Function, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Pedro GamitoUniversity, hospital or other
- Collaborators
- Universidade Lusófona de Humanidades e Tecnologias
- Study start
- Oct 2012
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile health cognitive stimulation | Experimental | Other: Mobile health cognitive stimulationExperimental group |
| Treatment-as-usual | No intervention | –This group consists of treatment-as-usual for alcohol abstinence according to the Minnesota Model. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health cognitive stimulation | Other | Mobile health cognitive stimulation |
Primary outcome
Change in the results of Frontal Assessment Battery - FAB
Time frame: Before cognitive rehabilitation - After cognitive rehabilitation (1month - after 10 sessions)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 24742381Gamito 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.
Related trials for Alcohol-Induced Disorders, Nervous System
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Not yet recruiting
Effects of Olfactory Stimuli in Virtual Reality Cue Exposure on Craving and Attentional Bias in Alcohol Use Disorder
Alcohol Use Disorder
RecruitingPhase 2
Suvorexant for Treatment of AUD and PTSD
Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro SP Gamito, PhD study chair
Universidade Lusófona de Humanidades e Tecnologias
Jorge AG Oliveira, PhD principal investigator
Universidade Lusófona de Humanidades e Tecnologias
Paulo JF Lopes, PhD study director
Universidade Lusófona de Humanidades e Tecnologias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health cognitive stimulation in people with Alcohol-Induced Disorders, Nervous System and Alcohol Dependence, run by Pedro Gamito at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the results of Frontal Assessment Battery - FAB (time frame: Before cognitive rehabilitation - After cognitive rehabilitation (1month - after 10 sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01942954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.