- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02308878
Mobile Health Cognitive Stimulation in Heroin Users (Re@dict)
May 9, 2023 updated by: Pedro Gamito
Executive Functioning in Heroin Users Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial
Heroin use has been related to brain dysfunction particularly in the prefrontal cortex.
These effects are evident in neuropsychological impairments in attention, memory and executive functioning of heroin users.
To assess these deficits and the application of a novel approach of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried out a neuropsychological intervention program with mobile health technology.
Patients diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in a three-day/week basis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lisboa
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Sintra, Lisboa, Portugal, 2725
- Ares Do Pinhal-Associação De Recuperação De Toxicodependentes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 will be included in the study.
Exclusion Criteria:
- Patients with alcohol dependence or with history of previous neurological disorders will be excluded from the study. Patients will be also screened for minimal computer literacy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Treatment-as-usual
This group consists of treatment-as-usual for opioid dependence syndrome.
|
|
Experimental: Mobile health cognitive stimulation
Cognitive stimulation using mobile technology with m-Health applications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the results of Frontal Assessment Battery - FAB
Time Frame: 1 month
|
The participants were assessed in frontal lobe functions at the beginning of the rehabilitation and after 10 rehabilitation sessions, which had the approximate duration of one month.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
December 2, 2014
First Submitted That Met QC Criteria
December 3, 2014
First Posted (Estimate)
December 4, 2014
Study Record Updates
Last Update Posted (Estimate)
May 11, 2023
Last Update Submitted That Met QC Criteria
May 9, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLB_SUD01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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