| CTRI Number |
CTRI/2024/03/064241 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Integrated Care for Alcohol Problems |
|
Scientific Title of Study
|
Advancing Research to Reduce Alcohol-Related Harms - Lessons for Policy, Practice and Sustainable Development in India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhijit Nadkarni |
| Designation |
Co-Director |
| Affiliation |
Sangath |
| Address |
Department-Addictions and Related Research Grou
Institution-Sangath
Socorro
Porvorim
North Goa
GOA
403501
India |
| Phone |
7798889723 |
| Fax |
- |
| Email |
abhijit.nadkarni@lshtm.ac.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhijit Nadkarni |
| Designation |
Co-Director |
| Affiliation |
Sangath |
| Address |
Department-Addictions and Related Research Grou
Institution-Sangath
Socorro
Porvorim
NA
GOA
403501
India |
| Phone |
7798889723 |
| Fax |
- |
| Email |
abhijit.nadkarni@lshtm.ac.uk |
|
Details of Contact Person
Public Query
|
| Name |
Abhijit Nadkarni |
| Designation |
Co-Director |
| Affiliation |
Sangath |
| Address |
Department-Addictions and Related Research Grou
Institution-Sangath
Socorro
Porvorim
NA
GOA
403501
India |
| Phone |
7798889723 |
| Fax |
- |
| Email |
abhijit.nadkarni@lshtm.ac.uk |
|
|
Source of Monetary or Material Support
|
| National Institute for Health and Care Research (NIHR)
Global Health Research Programme
NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC)
University of Southampton
Alpha House, Enterprise Road,
Chilworth
Southampton
United Kingdom
SO16 7NS |
| Sangath, H no 451(168), Socorro, Bhatkar Waddo, Bardez, Porvorim Goa 403501
|
|
|
Primary Sponsor
|
| Name |
London School of Hygiene & Tropical Medicine |
| Address |
Keppel Street
London
|
| Type of Sponsor |
Research institution |
|
|
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 |
| Abhijit Nadkarni |
Sangath |
Department-Addictions and Related Research Group
Institution-Sangath
Socorro
Porvorim
North Goa
GOA |
7798889723
abhijit.nadkarni@lshtm.ac.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangath IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F101||Alcohol abuse, (2) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alcohol Problems Treatment Plus (APT+) |
APT+ will be made up of four components which will be delivered as per the requirements of the participant i.e. based on the severity of drinking problem.
Component 1 (AMBIT)for hazardous drinkers:This is a mobile based-brief intervention delivered through SMS messages twice or thrice a week delivered for a duration of 8 weeks. SMS messages will be sent automatically to participants as per schedule. Each week messages are focused on specific content areas. Content areas include self-awareness messages, self-reflection messages, motivational messages, messages on safe drinking, alcohol reduction, drinking management, risk management, craving management and drinking alternatives, health education messages, personalised feedback and information, and goal setting. The messages will be in English or the vernacular language based on the choice of the participants. The messages will predominantly ‘push’ messages (not requiring a response from the recipient) with a few ‘pull’ messages (requiring a response from recipient).
Component 2 (Counselling for Alcohol Problems-CAP) for harmful drinkers:CAP is a manualised psychological treatment delivered in three phases over a maximum of four sessions (each lasting approximately 30–45 min) at weekly to fortnightly intervals. The initial phase involves detailed assessment followed by personalised feedback; the middle phase involves helping the patient to develop cognitive and behavioural skills and techniques, consisting of drink refusal skills, handling of peer pressure, problem-solving skills, and handling of difficult emotions; and the ending phase involves the patient learning how to manage potential or actual relapses using the skills acquired in the middle phase.
Component 3 (CONTAD) for dependent drinkers:This involves relapse prevention counseling commenced on completion of detoxification or as soon as the patient is physically comfortable during the course of the detoxification. The counseling will be delivered over 4-8 weeks through up to four sessions, each lasting 30 to 60 minutes. The content of the sessions includes reviewing the patients drinking history and presenting personalized feedback, preparing to avoid a lapse by learning how to identify and deal with triggers, learning how to deal with a lapse, and learning what to do if a lapse turns into a relapse.
Component 4 (SAFE) for family members of men with drinking problems: Based on the 5-step method, SAFE is a psychosocial intervention based on the principles of the Stress–Strain- Coping Support model. The 5 steps include the following: (1) Exploring stresses and strains, (2) Providing relevant information, (3) Exploring and discussing coping behaviours, (4) Exploring and enhancing social support and (5) Exploring additional needs, and further sources of help and ending the intervention. The intervention is delivered over five sessions with a frequency of one session every 1–2 weeks. |
| Comparator Agent |
Enhanced Usual Care |
In the EUC group, usual care (consultation with the PHC physician) will be enhanced by provision of the screening results to the PHC physician and provision of a
contextualised version of the WHO Mental Health Gap Action Programme guidelines for drinking problems, including when and where to refer patients for specialist care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Screen positive for hazardous and harmful drinking (score >8) on the Alcohol Use Disorders Identification Test (AUDIT) |
|
| ExclusionCriteria |
| Details |
Severe mental disorder
Requiring emergency medical treatment |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Alcohol (gms) consumed in the past week measured using measured using the Time Line Follow Back (TLFB), a calendar tool supplemented by memory aids to obtain retrospective estimates of daily drinking over a specified time period. The TLFB is a validated instrument (Sobell & Sobell, 1992) that has been used in the study setting (Nadkarni, Weobong, et al., 2017). |
3 months post randomisation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Alcohol (gms) consumed in the past week |
12 months |
Percentage days abstinent (PDA)
|
3 months and 12 months |
| Percentage days heavy drinking (PDHD) |
3 months and 12 months |
Abstinence
|
3 months and 12 months |
| Remission (score <8) |
3 months and 12 months |
| Recovery (Remission at 3 and 12 months) |
3 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="491"
Sample Size from India="491"
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 3 |
|
Date of First Enrollment (India)
|
02/12/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Using systematic and evidence-based intervention development processes I will integrate interventions developed in the study setting into a single integrated intervention (APT+). The process will include consultations with various stakeholders such as expert clinicians, individuals with drinking problems, and family members; followed by evaluation of acceptability and feasibility through treatment cohorts using process evaluation and in-depth interviews with the various stakeholders. Through a hybrid effectiveness-implementation RCT with two arms I will compare enhanced usual care (EUC) with APT+. |