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

September 11, 2023 updated by: University Hospital, Toulouse

Study of Impact on Therapeutic Alliance in People With Addiction Using the MAURISSE Application.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Contact Backup

Study Locations

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:

  • 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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Application group
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
Other: The MAURISSE application use
  • 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.
Active Comparator: Standard-of-care group
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).
Other: Usual care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The therapeutic alliance score assessed by the Working Alliance Inventory Short Revised scale (WAI-SR).
Time Frame: 2 months
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
2 months

Collaborators and Investigators

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

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Juliette SALLES, Toulouse University Hospital

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)

September 7, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/21/0540

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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