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

  • Portugal
    • Lisboa
      • 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.
Behavioral: Mobile health cognitive stimulation

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.

Sponsor

Pedro Gamito

Collaborators

Universidade Lusófona de Humanidades e Tecnologias
Ares Do Pinhal-Associação De Recuperação De Toxicodependentes

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

Keywords

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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