- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05964296
중독으로 고통받는 사람들에게 MAURISSE 응용 프로그램 사용의 영향. (ALMA)
MAURISSE 응용 프로그램을 사용한 중독자의 치료 제휴에 미치는 영향 연구.
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Toulouse, 프랑스, 31059
- University Hospital of Toulouse
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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 |
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활성 비교기: 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). |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The therapeutic alliance score assessed by the Working Alliance Inventory Short Revised scale (WAI-SR).
기간: 2 months
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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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공동 작업자 및 조사자
수사관
- 수석 연구원: Juliette SALLES, University Hospital, Toulouse
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .