NCT05964296

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 7, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

July 18, 2023

Last Update Submit

September 11, 2023

Conditions

Keywords

eHealthmHealthapplicationsubstance use disorderspersonality disorderscare observancetherapeutic alliance

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Application group

EXPERIMENTAL

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

Standard-of-care group

ACTIVE COMPARATOR

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

Interventions

* 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.

Application group

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.

Standard-of-care group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersPersonality Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Juliette SALLES

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas NAVARRO

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 27, 2023

Study Start

September 7, 2023

Primary Completion

November 1, 2024

Study Completion

March 1, 2025

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations