| 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
|
|
|
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
|
|
|
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 signiï¬cant 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. |