- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06806943
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
42
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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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.
Collaborators
Investigators
- 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
- Nandrino JL, Gandolphe MC, El Haj M. Autobiographical memory compromise in individuals with alcohol use disorders: Towards implications for psychotherapy research. Drug Alcohol Depend. 2017 Oct 1;179:61-70. doi: 10.1016/j.drugalcdep.2017.06.027. Epub 2017 Jul 21.
- Nandrino JL, Gandolphe MC. Characterization of Self-Defining Memories in Individuals with Severe Alcohol Use Disorders After Mid-Term Abstinence: The Impact of the Emotional Valence of Memories. Alcohol Clin Exp Res. 2017 Aug;41(8):1484-1491. doi: 10.1111/acer.13424. Epub 2017 Jun 14.
- De Groote C, Cottencin O, Tison P, Triquet C, Nandrino JL. Autobiographical memories cued by self-statements in patients with alcohol use disorder: linking self-conceptions to past events. Memory. 2023 May;31(5):732-746. doi: 10.1080/09658211.2023.2191899. Epub 2023 Mar 22.
- Nandrino JL, El Haj M, Torre J, Naye D, Douchet H, Danel T, Cottencin O. Autobiographical Memory Deficits in Alcohol-Dependent Patients with Short- and Long-Term Abstinence. Alcohol Clin Exp Res. 2016 Apr;40(4):865-73. doi: 10.1111/acer.13001. Epub 2016 Mar 17.
- Fernandez-Alvarez J, Colombo D, Suso-Ribera C, Chirico A, Serino S, Di Lernia D, Palacios AG, Riva G, Botella C. Using virtual reality to target positive autobiographical memory in individuals with moderate-to-moderately severe depressive symptoms: A single case experimental design. Internet Interv. 2021 May 27;25:100407. doi: 10.1016/j.invent.2021.100407. eCollection 2021 Sep.
- Lenormand D, Mentec I, Gaston-Bellegarde A, Orriols E, Piolino P. Decoding episodic autobiographical memory in naturalistic virtual reality. Sci Rep. 2024 Oct 27;14(1):25639. doi: 10.1038/s41598-024-76944-3.
- Frisone F, Brizzi G, Riva G. VR-MEM: Harnessing Virtual Reality for Autobiographical Memory Enhancement in High School Settings. Cyberpsychol Behav Soc Netw. 2024 Jan;27(1):91-93. doi: 10.1089/cyber.2023.29300.ceu. Epub 2023 Nov 16. No abstract available.
- Frisone F, Calabro G, Rossi C, Riva G. MEM-AV: A VR-Based Approach to Improve Autobiographical Memory Retrieval in Addiction. Cyberpsychol Behav Soc Netw. 2024 May;27(5):353-355. doi: 10.1089/cyber.2024.42624. Epub 2024 May 8. No abstract available.
- Pitel AL, Eustache F, Beaunieux H. Component processes of memory in alcoholism: pattern of compromise and neural substrates. Handb Clin Neurol. 2014;125:211-25. doi: 10.1016/B978-0-444-62619-6.00013-6.
- Conway MA, Pleydell-Pearce CW. The construction of autobiographical memories in the self-memory system. Psychol Rev. 2000 Apr;107(2):261-88. doi: 10.1037/0033-295x.107.2.261.
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)
July 1, 2024
Primary Completion (Actual)
December 15, 2024
Study Completion (Actual)
December 15, 2024
Study Registration Dates
First Submitted
January 27, 2025
First Submitted That Met QC Criteria
January 30, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 30, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Substance Use Disorder (SUD)
-
Hacettepe UniversityRecruitingSubstance Use Disorder (SUD)Turkey (Türkiye)
-
Mclean HospitalNational Institute on Drug Abuse (NIDA)Recruiting
-
Pakistan Institute of Living and LearningCapaital University of Sceince of TechnologyRecruitingSubstance Use Disorder (SUD)Pakistan
-
UpTru Inc.Not yet recruiting
-
West Virginia School of Osteopathic MedicineWest Virginia First Foundation, Inc.Not yet recruitingSubstance Use Disorder (SUD)United States
-
St. Joseph's Healthcare HamiltonCorrectional Service of CanadaRecruitingSubstance Use Disorder (SUD)Canada
-
Friends Research Institute, Inc.Completed
-
Massachusetts General HospitalViiV Healthcare; Fenway Community HealthRecruitingHIV | Substance Use Disorder (SUD) | Injection Drug UseUnited States
-
VA Office of Research and DevelopmentUniversity of California, Los AngelesNot yet recruitingHomelessness | Substance Use Disorder (SUD)United States
-
Icahn School of Medicine at Mount SinaiNational Institute on Drug Abuse (NIDA); Soterix MedicalRecruitingCocaine Use Disorder | Cocaine Dependence | Substance Use Disorder (SUD)United States
Clinical Trials on avatar-based interactions
-
Boston UniversityCompletedAlzheimer Disease | Mild Cognitive Impairment | Memory DisordersUnited States
-
University of Southern CaliforniaUniformed Services University of the Health Sciences; Blue Star Families; Wilcox...CompletedQuality of Life | Communication | Social Skills | Mental Health Disorder | Social Isolation | Military FamilyUnited States
-
Yale UniversityAmerican Heart AssociationSuspended
-
Universidad Rey Juan CarlosCompleted
-
Saint-Joseph UniversityRecruitingAnxiety | Local Anesthesia | Fear | Pediatric DentistryLebanon
-
Akdeniz UniversityThe Scientific and Technological Research Council of TurkeyCompletedDeveloping the ABEP-H | Determining the Effect of ABEP-HTurkey
-
Fundació Sant Joan de DéuRecruitingSchizophrenia Disorders | Treatment Resistant HallucinationsSpain
-
Miami VA Healthcare SystemPfizerCompletedOveractive BladderUnited States
-
Ciusss de L'Est de l'Île de MontréalActive, not recruitingPsychotic Disorders | Mental Health Disorder | Cannabis Use DisorderCanada
-
Yonsei UniversitySeverance HospitalRecruitingRadiotherapy | Patient EducationSouth Korea