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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05964296
Other study ID # RC31/21/0540
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 7, 2023
Est. completion date March 2025

Study information

Verified date September 2023
Source University Hospital, Toulouse
Contact Juliette SALLES
Phone 05 61 77 73 07
Email salles.j@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
France University Hospital of Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 months
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