Back to resultsMobile Health Cognitive Stimulation in Heroin Users (Re@dict)
Primary Purpose
Substance Use Disorder
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 Substance Use Disorder focused on measuring Opioid Abuse Disorder, Cognitive Therapy, Executive Function, Mobile Health, 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 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.
Sites / Locations
- Ares Do Pinhal-Associação De Recuperação De Toxicodependentes
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment-as-usual
Mobile health cognitive stimulation
Arm Description
This group consists of treatment-as-usual for opioid dependence syndrome.
Cognitive stimulation using mobile technology with m-Health applications.
Outcomes
Primary Outcome Measures
Change in the results of Frontal Assessment Battery - FAB
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02308878
First Posted
December 2, 2014
Last Updated
May 9, 2023
Sponsor
Pedro Gamito
Collaborators
Universidade Lusófona de Humanidades e Tecnologias, Ares Do Pinhal-Associação De Recuperação De Toxicodependentes
1. Study Identification
Unique Protocol Identification Number
NCT02308878
Brief Title
Mobile Health Cognitive Stimulation in Heroin Users
Acronym
Re@dict
Official Title
Executive Functioning in Heroin Users 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 2013 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pedro Gamito
Collaborators
Universidade Lusófona de Humanidades e Tecnologias, Ares Do Pinhal-Associação De Recuperação De Toxicodependentes
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder
Keywords
Opioid Abuse Disorder, Cognitive Therapy, Executive Function, Mobile Health, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment-as-usual
Arm Type
No Intervention
Arm Description
This group consists of treatment-as-usual for opioid dependence syndrome.
Arm Title
Mobile health cognitive stimulation
Arm Type
Experimental
Arm Description
Cognitive stimulation using mobile technology with m-Health applications.
Intervention Type
Behavioral
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 functions at the beginning of the rehabilitation and after 10 rehabilitation sessions, which had the approximate duration of one month.
Time Frame
1 month
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 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.
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
Plan to Share IPD
Undecided
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Mobile Health Cognitive Stimulation in Heroin Users
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