Effectiveness of Nurse-Conducted Brief Intervention (NCBI) Supplemented With Mobile for Preventing Alcohol Use Disorders

NCT06652802 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY230900505D43TW009114-10
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is aimed to find out that combining Nurse-Conducted Brief Intervention (NCBI) with a Smart Mobile is better than Nurse-Conducted Brief Intervention (NCBI) only in preventing relapse among Alcohol Use Disorder patients. The high relapse rates among alcohol disorder patients may be benefitted by new technology using application for improved outcomes in managing and preventing alcohol addiction relapse.

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol Use Disorders (AUDs),; A Randomized controlled trial; Gastroenterology,; CIWA,; Nurse-Conducted Brief Intervention (NCBI)

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Nurse-Conducted Brief Intervention (NCBI) supplemented with a Mobile Health Application in preventing relapse among patients with Alcohol Use Disorders (AUDs

  The primary endpoint of the study is the effectiveness of Nurse-Conducted Brief Intervention (NCBI) supplemented with a Mobile Health Application in preventing relapse among patients with Alcohol Use Disorders (AUDs) over a three-month period. • The primary outcome measure will be the difference in relapse rates between the group receiving NCBI with the mobile application and the group receiving only NCBI.

  Three months period

Secondary Outcomes (4)

• Provide insight into the effectiveness and impact of the interventions: Sociodemographic

  Baseline

• Provide insight into the effectiveness and impact of the interventions: Severity of AUD

  Baseline

• Provide insight into the effectiveness and impact of the interventions:Lapse evaluation

  Baseline

• Provide insight into the effectiveness and impact of the interventions: comparison with sociodemographic factors

  Baseline

Study Arms (2)

Nurse-Conducted Brief Intervention (NCBI). supplemented with mobile based application

EXPERIMENTAL

Experimental group participants receive Nurse-Conducted Brief Intervention (NCBI). supplemented with mobile based application. Due to the availability of Nurse Conducted Brief intervention (NCBI) service in Gastroenterology department by trained nurse it was done in the gastroentrology department.

Behavioral: Nurse-Conducted Brief Intervention (NCBI). supplemented with mobile based application.

Nurse-Conducted Brief Intervention (NCBI)

ACTIVE COMPARATOR

Control group participants receive only Nurse-Conducted Brief Intervention (NCBI).

Behavioral: Nurse-Conducted Brief Intervention (NCBI)

Interventions

Nurse-Conducted Brief Intervention (NCBI). supplemented with mobile based application. BEHAVIORAL

* An interactive mobile based application will be developed with the following features to assist in monitoring and preventing relapse. * Purpose of the Mobile based application: The mobile application will be an interactive tool designed to assist in monitoring and preventing relapse of alcohol use disorder. It will provide various features to support users in their journey to sobriety, including personalized recovery plans, goal setting, progress tracking, stress and craving management tools, educational resources, daily reflection prompts, emergency assistance, personalized reminders, progress reports, and psychoeducational videos. * The Target population: 40 Male patients selected through randomized sampling, aged between 18 and 59 years, who have participated in Nurse-Conducted Brief Intervention (NCBI) for AUD in the Gastroenterology ward with diagnosis of alcohol dependence use disorder based on ICD-10 who have access to smartphone application and have the ability to use it.

Nurse-Conducted Brief Intervention (NCBI). supplemented with mobile based application

Nurse-Conducted Brief Intervention (NCBI) BEHAVIORAL

* Nurse-Conducted Brief Intervention (NCBI) is a feasible and acceptable model of care for males diagnosed with Alcohol Use Disorders (AUDs) in gastroenterology settings. The study found that the Nurse-Conducted Brief Intervention (NCBI) had a positive impact on promoting abstinence in patients with AUDs, and the preliminary findings demonstrate probable good outcomes. \[21\]. * It consists of a trained Nurse delivering three individual sessions with the patient over a span of two to three days (15 to 20 mins each) during their period of admission in the ward and one session with the family members.

Nurse-Conducted Brief Intervention (NCBI)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Gender Eligibility Details: • Female patients were excluded from the study. The decision to exclude women from the study is likely grounded in the consideration of potential gender-specific factors in the manifestation and treatment of Alcohol Use Disorders (AUDs). Research suggests that there are gender differences in the prevalence, patterns, and consequences of alcohol consumption, as well as in the response to interventions for alcohol-related issues, which will affect the outcome of the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients.
• Aged between 18 and 59 years.
• Diagnosis of alcohol dependence use disorder based on ICD-10 criteria.
• Patients with an Android smartphone and the ability to use mobile application.

You may not qualify if:

• Female patients
• Comorbid other substance abuse, except tobacco.
• Comorbid major mental illness /physical illness.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Fogarty International Center of the National Institute of Health: collaborator

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Vishwajit L Nimgaonkar, MD, PhD

  University of Pittburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Triptish Bhatia

CONTACT

09910107210; bhatiatriptish@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is designed as single-blind, meaning the outcome assessors and the data analysts will be blinded to the group allocations to reduce bias in the evaluation of the outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Human Genetics

Model Details: The study design is a randomized controlled trial. In this type of study, participants are randomly assigned to two different groups, i.e Group A and Group B. Group A participants receive only Nurse-Conducted Brief Intervention (NCBI). Whereas's Group B receives Nurse-Conducted Brief Intervention (NCBI). supplemented with mobile based application. The study is designed as single-blind, meaning the outcome assessors and the data analysts will be blinded to the group allocations to reduce bias in the evaluation of the outcomes

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 22, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year
• Access Criteria: The study should be ethically approved and scientifically sound,