NCT06806943

Brief Summary

The goal of this study is to investigate whether the use of artificial intelligence platforms can promote the retrieval of specific positive autobiographical memories.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 27, 2025

Last Update Submit

January 30, 2025

Conditions

Substance Use Disorder (SUD)

Keywords

autobiographical memorysubstance use disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Specific Autobiographical Memory Recall

    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 Outcomes (3)

  • Latency of Autobiographical Memory Recall

    During the intervention sessions for both conditions (avatar-based and face-to-face).

  • Pleasantness of Autobiographical Memories Recalled

    During the intervention sessions for both conditions (avatar-based and face-to-face).

  • Change in Age Memory Recall

    During the intervention sessions for both conditions (avatar-based and face-to-face).

Study Arms (1)

Avatar / Face-to-face

EXPERIMENTAL

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

Interventions

avatar-based interactionsDEVICE

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.

Avatar / Face-to-face

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous neurological pathologies
  • Previous cognitive deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le.L.A.T. Lega Lotta Aids E Tossicodipendenza

Messina, 98124, Italy

Location

Related Publications (10)

  • 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.

    PMID: 28756101BACKGROUND

  • 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.

    PMID: 28556207BACKGROUND

  • 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.

    PMID: 36950753BACKGROUND

  • 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.

    PMID: 26990362BACKGROUND

  • 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.

    PMID: 34401366BACKGROUND

  • 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.

    PMID: 39463396BACKGROUND

  • 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.

    PMID: 37972046BACKGROUND

  • 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.

    PMID: 38717129BACKGROUND

  • 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.

    PMID: 25307577BACKGROUND

  • 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.

    PMID: 10789197BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Fabio Frisone, PhD

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: within-subject design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 4, 2025

Study Start

July 1, 2024

Primary Completion

December 15, 2024

Study Completion

December 15, 2024

Last Updated

February 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
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.
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.
More information

Locations

IT(1)