Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04345302
Status:
UNKNOWN
Last Update Posted:
2022-01-11
First Post:
2020-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brief Motivational Therapy Versus Usual Care for Alcohol Use Disorders in Primary Care.
Sponsor:
Nicolás Barticevic
Organization:
Study Overview
Official Title:
Brief Motivational Therapy Versus Enhanced Usual Care for Alcohol Use Disorder in Primary Care in Chile, an Exploratory Randomised Trial
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Harmful alcohol use is a leading cause of global disability and death. However increased detection and brief intervention capacity of more severe alcohol use disorders (AUD) has not been accompanied by increased availability of treatment services. Incorporating treatment for such disorders into primary care (PC) is of paramount importance for improving access and health outcomes. This study aims to estimate the effectiveness of a Brief Motivational Treatment (BMT) applied in primary care for treatment of these disorders.
This trial aims to test the superiority of BMT over enhanced usual care with a reasonable margin, over which the BMT could be further considered for incorporation into PC in Chile. Its pragmatic approach ultimately aims to inform policymakers about the benefit of including a brief psychosocial treatment into PC.
This trial aims to test the superiority of BMT over enhanced usual care with a reasonable margin, over which the BMT could be further considered for incorporation into PC in Chile. Its pragmatic approach ultimately aims to inform policymakers about the benefit of including a brief psychosocial treatment into PC.
Detailed Description:
This exploratory trial aims to estimate the effectiveness of a BMT for AUD provided in PC. The underlying question is whether Chilean PC should incorporate this treatment among its regular programs based on its effectiveness.
To answer this question, a randomised comparison between the manualized BMT and EUC will be undertaken. The main hypothesis is a superiority one:
• Participants under BMT will perform better than EUC in the reduction of alcohol consumption.
Also, there are ancillary questions that deserve special attention. The following hypotheses will help with the explanation of the results:
* Active BMT components (i.e., the working alliance and fidelity to the MI strategies) mediate the effect.
* Participant´s AUD severity mediates the effect.
* Participants under BMT will receive a higher amount of additional care (physician consultations, social worker consultations, participation in alcoholic anonymous, and others).
To answer this question, a randomised comparison between the manualized BMT and EUC will be undertaken. The main hypothesis is a superiority one:
• Participants under BMT will perform better than EUC in the reduction of alcohol consumption.
Also, there are ancillary questions that deserve special attention. The following hypotheses will help with the explanation of the results:
* Active BMT components (i.e., the working alliance and fidelity to the MI strategies) mediate the effect.
* Participant´s AUD severity mediates the effect.
* Participants under BMT will receive a higher amount of additional care (physician consultations, social worker consultations, participation in alcoholic anonymous, and others).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: