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CTRI Number  CTRI/2021/05/033418 [Registered on: 06/05/2021] Trial Registered Prospectively
Last Modified On: 06/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of tele-based interventions in maintaining abstinence in persons who had past deaddiction treatment 
Scientific Title of Study   Efficacy and feasibility of tele-based interventions in maintaining abstinence in persons who had past deaddiction treatment- a mixed methods study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sindhu 
Designation  post graduate  
Affiliation  sri ramachandra medical college and research institute 
Address  Department of Psychiatry Sri Ramachandra Medical College And research institute, Porur

Chennai
TAMIL NADU
600116
India 
Phone  07418999095  
Fax    
Email  sindhu.heureux@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Suvarna Jyothi Kantipudi 
Designation  Associate professor 
Affiliation  sri ramachandra medical college and research institute 
Address  Department of Psychiatry, Sri Ramachandra Medical College And research institute, Porur

Chennai
TAMIL NADU
600116
India 
Phone  9629745628  
Fax    
Email  suvarna.srmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sindhu 
Designation  post graduate  
Affiliation  sri ramachandra medical college and research institute 
Address  Department of Psychiatry Sri Ramachandra Medical College And research institute, Porur

Chennai
TAMIL NADU
600116
India 
Phone  07418999095  
Fax    
Email  sindhu.heureux@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Nagar, Porur 
 
Primary Sponsor  
Name  Sindhu Ponnusamy 
Address  Department of Psychiatry, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Nagar, Porur 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sindhu Ponnusamy  Sri Ramachandra Medical College and Research Institute  Department of Paychiatry Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Nagar, Porur
Chennai
TAMIL NADU 
7418999095

sindhu.heureux@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional research ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  behavioral interventions for 4weeks   Psychoeducation, motivation to change, helping to identify triggers, anger management, relapse prevention, reassurance and motivation to maintain abstinence. The interventions will be sent as audio and video files to the study arm. Each session will be a recorded file of 15-20mins and a total of 6 sessions with 1-2 sessions per week planned for 4 weeks. 
Comparator Agent  deaddiction  advised and follow up for detoxification and deaddiction. no tele-based behavioral interventions.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ICD – 10 criteria for alcohol dependence and underwent deaddiction in the past.
Willing to provide informed consent.

 
 
ExclusionCriteria 
Details  1. Patients with any other co-morbid substance use fulfilling criteria for dependence. (except tobacco)
2.Major psychiatric disorders (i.e., schizophrenia, bipolar disorder)
3.Patients who are unwilling to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To explore the effectiveness of telemedicine based interventions in maintaining abstinence in patients previously treated for deaddiction  baseline, 4 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To explore the effectiveness of telemedicine based interventions in reducing the craving of alcohol, addressing stress and improving the quality of life in these patients.   baselinw, 4 weeks and 12 weeks 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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   N/A 
Date of First Enrollment (India)   24/05/2021 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

COVID-19  pandemic poses vast challenges to population worldwide. First case of COVID-19 in India was confirmed on January 30th 2020. Since then the cases started rising up and the government started taking measures to control the spread. As a part of control measure, a nation-wide lockdown was announced on March 24th 2020. First, all non-emergency services were shut down. Second, patients suspected with COVID-19 were seen only in dedicated hospitals. Third, during the lockdown all states and union territories allowed basic amenities and banned alcohol. Lockdown had negative impact on mental health services as patients were treated on outpatient basis in many psychiatric clinics and emergency psychiatric facilities were only available in tertiary health care centers. Substance use disorders have been recognized as a major public health problem globally including India. Alcohol is a major contributor to mortality and morbidity in South Asian Region. There is already an existing huge treatment gap for alcohol problems (86%), the highest amongst all mental and substance use disorders, the lockdown had further restricted access to all face to face services that they were already accessing or wanted to access. Psychosocial factors play a major role in patient’s maintaining abstinence who had been treated for de-addiction for alcohol dependence. Social isolation, unemployment issues and income reductions result in psychological distress which eventually lead to increased substance use. The exacerbated anxiety and negative thinking that is inherent to the current experience of the pandemic and consequent lockdown can by itself be a significant trigger for relapse. The other mechanism suggests that due to tighter budget constraints, less money may be spent on alcohol use. Nation-wide lockdown was called off and access to alcohol was started on May 4th 2020. This lead to greater commotion in procuring alcohol. Even people who were maintaining abstinence during lockdown period due to inability to procure alcohol might have relapsed. Psychiatric services have been restricted in many hospitals and the access to inpatient treatment for alcohol de-addiction varies from place to place. Patients are also afraid to get access to tertiary care centers because of the high load of COVID-19 cases. This pandemic has caused uncertainty in treating the psychiatric illnesses and telemedicine based approaches are followed in many centers to treat the patients. This study aims to elucidate  the pattern of current alcohol use in previously treated patients for de-addiction during COVID-19 and also their craving for alcohol during this period. After assessing their alcohol use pattern, they will be recruited for telemedicine based interventions to know the feasibility of these interventions to reduce the craving and to motivate them to prevent relapses using psychoeducational programme.

AIM : To assess the pattern of alcohol use in alcohol dependent patients during COVID -19 and to explore the effectiveness of telemedicine based interventions in maintaining abstinence in these patients. 


 
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