How Avatar Can Enhance Autobiographical Memory of Patients With Substance Use Disorder

January 30, 2025 updated by: Fabio Frisone, Le.L.A.T. Lega Lotta Aids E Tossicodipendenza
The goal of this study is to investigate whether the use of artificial intelligence platforms can promote the retrieval of specific positive autobiographical memories.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The decision to focus on the retrieval of positive autobiographical memories was made for ethical reasons and is not tied to any specific research hypothesis. Specifically, the study aims to assess whether artificial intelligence facilitates the sharing of personal experiences and reflection on autobiographical memories related to substance use disorders, taking into account the potential influence of individual characteristics such as recent mood state, and overall memory functioning.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Italy
      • Messina, Italy, 98124
        • Le.L.A.T. Lega Lotta Aids E Tossicodipendenza

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of substance use disorder
  • Admitted to the drug rehabilitation center for at least 3 months
  • Aged 18 years or older

Exclusion Criteria:

  • Previous neurological pathologies
  • Previous cognitive deficits

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Avatar / Face-to-face
SUD patients were investigated using the Autobiographical Memory Test in two conditions: face-to-face and avatar-based interactions. Patients had to recall 6 neutral cue words and 6 substance-related cue words for each condition.
Device: avatar-based interactions
SUD patients were investigated using the Autobiographical Memory Test in two conditions: face-to-face and avatar-based interactions. Patients had to recall 6 neutral cue words and 6 substance-related cue words for each condition.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Specific Autobiographical Memory Recall
Time Frame: During the intervention sessions for both conditions (avatar-based and face-to-face). This outcome directly reflects the study's objective by quantifying the change of AM recall through avatar-based interventions.
The primary outcome measure is the difference in the number of specific autobiographical memories recalled between the avatar-based interaction condition and the face-to-face condition, as assessed by the Autobiographical Memory Test (AMT). Specificity of recalled memories are scored using standardized criteria. This measure evaluates the effectiveness of avatar-based interventions in changing AM recall in patients with substance use disorder (SUD).
During the intervention sessions for both conditions (avatar-based and face-to-face). This outcome directly reflects the study's objective by quantifying the change of AM recall through avatar-based interventions.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Latency of Autobiographical Memory Recall
Time Frame: During the intervention sessions for both conditions (avatar-based and face-to-face).
The secondary outcome measure is the comparison of latency times (time taken to recall a memory) between the avatar-based interaction condition and the face-to-face condition, as recorded during the Autobiographical Memory Test (AMT). This measure evaluates whether the use of avatar-based interventions change the speed of autobiographical memory recall in patients with substance use disorder (SUD).
During the intervention sessions for both conditions (avatar-based and face-to-face).
Pleasantness of Autobiographical Memories Recalled
Time Frame: During the intervention sessions for both conditions (avatar-based and face-to-face).
The secondary outcome measure is the comparison of pleasantness ratings of autobiographical memories recalled between the avatar-based interaction condition and the face-to-face condition. Pleasantness is assessed during the Autobiographical Memory Test (AMT). This measure evaluates whether avatar-based interventions change the emotional valence of the memories retrieved by patients with substance use disorder (SUD).
During the intervention sessions for both conditions (avatar-based and face-to-face).
Change in Age Memory Recall
Time Frame: During the intervention sessions for both conditions (avatar-based and face-to-face).
The secondary outcome measure is the change in age memory recall, defined as the participants' ability to identify the age at which autobiographical memories occurred, comparing the avatar-based interaction condition to the face-to-face condition. Age memory is assessed during the Autobiographical Memory Test (AMT) for each recalled memory. This measure evaluates whether avatar-based interventions change temporal specificity in autobiographical memory recall among patients with substance use disorder (SUD).
During the intervention sessions for both conditions (avatar-based and face-to-face).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Le.L.A.T. Lega Lotta Aids E Tossicodipendenza

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Catholic University of the Sacred Heart

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fabio Frisone, PhD, Catholic University of the Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEM-AV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share the Individual Participant Data (IPD) starting from January 25, 2025. The data will be made available for research purposes to qualified researchers who submit a formal request and have an approved data-sharing agreement. Access will be contingent upon ensuring that proper data protection and confidentiality measures are followed, in compliance with ethical guidelines and applicable data protection laws. The data will not be shared for commercial purposes without further approval. The IPD will be made available for 5 years from the date of release.

IPD Sharing Time Frame

The data will become available starting from January 25, 2025. The data will remain available for 5 years from the date of release. Access to the data will be granted to qualified researchers upon request and following approval of a data-sharing agreement to ensure proper use and confidentiality.

IPD Sharing Access Criteria

Access to the data will be granted to qualified researchers who have a legitimate research purpose. Researchers must submit a formal request detailing the proposed study, its objectives, and the intended use of the data. Access will be contingent upon approval of a data-sharing agreement, which will outline the terms and conditions of use, including confidentiality and data security measures. The data will be provided only for research purposes and cannot be used for commercial purposes without further agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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