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The Impact of the Use of the MAURISSE Application in People Suffering From an Addiction. (ALMA)

Primary Purpose

Substance Related Disorder, Personality Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
The MAURISSE application use
Usual care
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance Related Disorder focused on measuring eHealth, mHealth, application, substance use disorders, personality disorders, care observance, therapeutic alliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient over 18 years old, Starting specialized treatment for addiction (addiction to substance and behavioral addiction too as money games addiction). Suffering from any type of addiction, with an active addiction requiring weekly monitoring of substance use. possessing a smartphone or having access to a smartphone and having access to an internet connection. Able to read and understand French. Affiliated or beneficiary of a social security scheme. Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: Patient with cognitive or psychiatric disorders that may affect their ability to consent. Participation in another protocol involving a modification of the treatment for addiction. Known or suspected pregnancy. Person under legal protection.

Sites / Locations

  • University Hospital of ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Application group

Standard-of-care group

Arm Description

Patients randomized to the digital application arm will benefit from treatment as usual and will have access to the MAURISSE application, allowing them to communicate with the healthcare team using a messaging system, to report and follow substance use, to access a To-do list, to access personal multimedia contents helping with the treatment, to report a feeling of boredom (these moments presenting a risk of relapse) and finally to access a list of propositions in order to fight this feeling

These patients will benefit from the usual care within the center (appointments with doctors; regular follow-up meetings with nurses, psychologists, social workers, therapeutic groups depending on the evaluation).

Outcomes

Primary Outcome Measures

The therapeutic alliance score assessed by the Working Alliance Inventory Short Revised scale (WAI-SR).
The Working Alliance Inventory-Short Revised is a scale that consists of two questionnaires. A 12-question questionnaire for patients and a 10-question questionnaire for caregivers. The questions are scored using a Likert scale ranging from 1 to 5

Secondary Outcome Measures

Full Information

First Posted
July 18, 2023
Last Updated
September 11, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05964296
Brief Title
The Impact of the Use of the MAURISSE Application in People Suffering From an Addiction.
Acronym
ALMA
Official Title
Study of Impact on Therapeutic Alliance in People With Addiction Using the MAURISSE Application.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Substance Use Disorders (SUD) are associated with cognitive schemas that lead to care attrition and mistrust towards care. Considering this, establishing a strong, trustful relationship between the patient and the healthcare team is important to promote patient engagement within SUD management. However, it requires an important availability of the healthcare team, allowing for frequent interactions at all times, including at night and during days off. We postulated that a mobile application called MAURISSE, which aims to help the caregivers maintaining a link with the patient in order to facilitate trust in the relationship, could foster patient engagement as well as the therapeutic alliance. This research aims to compare the effect of the application MAURISSE on the therapeutic alliance in a population of patients treated for a disorder related to substance use at the Toulouse University Hospital.
Detailed Description
Substance Use Disorders (SUD) are frequently associated with other mental disorders, especially Borderline Personality Disorder, thus defining co-occurring substance use and mental disorders with borderline and anti-social personality disorders that is often associated with cognitive schemas leading to care attrition and mistrust towards care. The goal of the care intervention within Substance Use Disorders management is therefore to help the patient reduce the use of dysfunctional coping strategies involving substance use. Indeed, the establishment of a trustful relation between the patient and the care team leads the patient into building a secure attachment towards care that could secondly be generalized in other situations. We designed an application called MAURISSE, which aims to help the caregivers maintaining a link with the patient in order to facilitate a more secure attachment, thus enabling trust in the relationship as well as fostering patient engagement in the care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Related Disorder, Personality Disorders
Keywords
eHealth, mHealth, application, substance use disorders, personality disorders, care observance, therapeutic alliance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Application group
Arm Type
Experimental
Arm Description
Patients randomized to the digital application arm will benefit from treatment as usual and will have access to the MAURISSE application, allowing them to communicate with the healthcare team using a messaging system, to report and follow substance use, to access a To-do list, to access personal multimedia contents helping with the treatment, to report a feeling of boredom (these moments presenting a risk of relapse) and finally to access a list of propositions in order to fight this feeling
Arm Title
Standard-of-care group
Arm Type
Active Comparator
Arm Description
These patients will benefit from the usual care within the center (appointments with doctors; regular follow-up meetings with nurses, psychologists, social workers, therapeutic groups depending on the evaluation).
Intervention Type
Other
Intervention Name(s)
The MAURISSE application use
Intervention Description
Exchanges with the care team via the messaging system, Postponement of consumption, Monitoring of consumption, Access to information on the To Do List, Access to personal content to help with management (Socio-professional situation, type of life, personal history..). Postponement of a feeling of boredom, Access to proposals to fight against this feeling.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
The usual care within the center will consist of appointments with doctors; regular follow-up meetings with nurses, psychologists, social workers, therapeutic groups depending on the evaluation.
Primary Outcome Measure Information:
Title
The therapeutic alliance score assessed by the Working Alliance Inventory Short Revised scale (WAI-SR).
Description
The Working Alliance Inventory-Short Revised is a scale that consists of two questionnaires. A 12-question questionnaire for patients and a 10-question questionnaire for caregivers. The questions are scored using a Likert scale ranging from 1 to 5
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient over 18 years old, Starting specialized treatment for addiction (addiction to substance and behavioral addiction too as money games addiction). Suffering from any type of addiction, with an active addiction requiring weekly monitoring of substance use. possessing a smartphone or having access to a smartphone and having access to an internet connection. Able to read and understand French. Affiliated or beneficiary of a social security scheme. Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: Patient with cognitive or psychiatric disorders that may affect their ability to consent. Participation in another protocol involving a modification of the treatment for addiction. Known or suspected pregnancy. Person under legal protection.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliette SALLES
Phone
05 61 77 73 07
Email
salles.j@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas NAVARRO
Email
navarro.ni@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliette SALLES
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette SALLES
Email
salles.j@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Valérie MALLARD
Email
mallard.v@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Juliette SALLES
First Name & Middle Initial & Last Name & Degree
Nicolas NAVARRO

12. IPD Sharing Statement

Learn more about this trial

The Impact of the Use of the MAURISSE Application in People Suffering From an Addiction.

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