| CTRI Number |
CTRI/2023/12/060856 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Using a Mobile application installed on their mobile phone.] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nurse-Conducted Brief Intervention Supplemented Mobile Intervention for Alcohol Relapse Prevention. |
|
Scientific Title of Study
|
Effectiveness of Nurse-Conducted Brief Intervention supplemented with Mobile-based Application for Monitoring and Relapse Prevention in Patients with Alcohol Use Disorders: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alvin Joseph |
| Designation |
Postgraduate Psychiatry Resident |
| Affiliation |
St. John’s Medical College and Hospital, Sarjapur Road, Bangalore |
| Address |
Department of Psychiatry, St. John’s Medical College and Hospital, Sarjapur Road, Bangalore - 560034, Karnataka, India. (Contact: 7009486397).
Bangalore
KARNATAKA
560034
India |
| Phone |
7009486397 |
| Fax |
|
| Email |
alvin.thoundassery@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Johnson Pradeep R |
| Designation |
Professor & Head, Department of Psychiatry |
| Affiliation |
St. John’s Medical College and Hospital, Sarjapur Road, Bangalore |
| Address |
Department of Psychiatry, St. John’s Medical College and Hospital, Sarjapur Road, Bangalore - 560034, Karnataka, India. (Contact: 7009486397).
Bangalore
KARNATAKA
560034
India |
| Phone |
08022065570 |
| Fax |
|
| Email |
johnson.pr@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Alvin Joseph |
| Designation |
Postgraduate Psychiatry Resident |
| Affiliation |
St. John’s Medical College and Hospital, Sarjapur Road, Bangalore |
| Address |
Department of Psychiatry, St. John’s Medical College and Hospital, Sarjapur Road, Bangalore - 560034, Karnataka, India. (Contact: 7009486397).
Bangalore
KARNATAKA
560034
India |
| Phone |
7009486397 |
| Fax |
|
| Email |
alvin.thoundassery@stjohns.in |
|
|
Source of Monetary or Material Support
|
| Approved for research grant from PRIIIA (Psychiatric Research Infrastructure for Intervention and Implementation in India) (Funded by Fogarty International Center at National Institute of Health of the United States of America). |
|
|
Primary Sponsor
|
| Name |
St. Johns Research Institute |
| Address |
St. Johns Research Institute
Sarjapur Road, Bangalore - 560034, Karnataka, India. (Contact: 7009486397). |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alvin Joseph |
St. John’s Medical College and Hospital, Bangalore |
Common Ward, Department of Gastroenterology, St. John’s Medical College and Hospital, Sarjapur Road,
Bangalore - 560034, Karnataka, India. (Contact: 7009486397).
Bangalore
KARNATAKA |
7009486397
alvin.thoundassery@stjohns.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nurse conducted brief intervention |
A trained nurse will conduct three individual sessions with the participant during the hospital stay, each lasting about 15–20 minutes. The sessions will focus on feedback, responsibility, advice, a menu of strategies, empathy, and self-efficacy principles, based on the WHO FRAMES model and Motivational Interviewing. The sessions will address participants alcohol use behavior and provide strategies to promote abstinence. One session will involve your family members in a group discussion. Total intervention duration 3 days for sessions, Total study duration including follow-up 3 months. |
| Intervention |
Nurse conducted brief intervention + Mobile Health Application Group |
The participant along with a Nurse conducted brief intervention will have access to a smartphone application designed to assist in monitoring and preventing relapse. The application will provide personalized recovery plans, goal setting, progress tracking, stress and craving management tools, educational resources, daily reflection prompts, personalized reminders, progress reports, and psychoeducational videos. Healthcare professionals will train the participant to effectively use the application, taking approximately 30-45 minutes. Participant will use the application regularly to track your progress, engage with features, and access resources. Total intervention duration including follow-up 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Male |
| Details |
Participants must be male, aged 18-59, diagnosed with alcohol dependence based on ICD-10 criteria to be eligible for the study, with an android smartphone. |
|
| ExclusionCriteria |
| Details |
Excluded from the study are females, individual below 18 or above 59, those with severe medical conditions, psychiatric disorders hindering participation, and those unable to provide consent. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome:Relapse (Lapse, Relapse, Abstinence)
Metric: Percentage of participants experiencing relapse, lapse, or maintaining abstinence |
Time point of Primary Interest: One month and Three months post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Outcomes: 1. Sociodemographic Factors: Metric: Collected using BIG proforma. 2. Severity of Alcohol Dependence: Severity of Alcohol Dependence Metric: Scored using the Severity of Alcohol Dependence Questionnaire (SADQ)3. Motivation to Reduce/Quit Alcohol: Motivation to abstain from alcohol Metric: Scored using the Readiness to Change Questionnaire. 4. Alcohol Use Disorders Identification: Alcohol Use Disorders Identification Metric: Scored using the Alcohol Use Disorders Identification Test (AUDIT) |
Time point of interest: Baseline, one month,Three months post-intervention |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary purpose of the
protocol is to investigate the effectiveness of a Nurse-Conducted Brief
Intervention (NCBI) supplemented with a Smart Mobile Health Application in
monitoring and preventing relapse among patients with Alcohol Use Disorders
(AUDs) within a Tertiary Care Center. The study aims to address the need for
effective interventions to prevent relapse and support patients in overcoming
alcohol addiction. Additionally, it seeks to bridge the gap between traditional
care and clinical need by utilizing modern technology for continuous
communication, monitoring, and relapse prevention strategies.
The study’s primary objective is
to determine the effectiveness of the combined approach of NCBI and a Mobile
Health Application in monitoring and preventing relapse for a three-month
period, compared to using only Nurse-Conducted Brief Intervention, in patients
with AUDs within a Tertiary Care Center.
The hypotheses to be tested are
as follows:
Null Hypotheses (H0): There is no
significant difference in relapse rates between the group receiving
Nurse-Conducted Brief Intervention (NCBI) supplemented with the Mobile Health
Application and the group receiving only Nurse-Conducted Brief Intervention
(NCBI). Alternative Hypotheses (Ha): There
is a significant difference in relapse rates between the group receiving
Nurse-Conducted Brief Intervention (NCBI) supplemented with the Mobile Health
Application and the group receiving only Nurse-Conducted Brief Intervention
(NCBI).
These hypotheses frame the main
comparison between the two groups in terms of their relapse rates, which is the
primary outcome measure of the study. The study is motivated by the
high morbidity and mortality associated with AUDs, and despite available
treatments, relapse rates remain a challenge. The existing literature supports
the effectiveness of brief psychological interventions like NCBI in managing
harmful drinking, but there is a need to enhance these interventions,
particularly in terms of relapse prevention. Mobile health technology,
including smartphone applications, has shown potential in providing consistent
support for individuals with AUDs, but its integration with traditional
interventions like NCBI needs exploration. |