| CTRI Number |
CTRI/2025/02/080982 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of 5 As brief intervention in smokeless tobacco |
|
Scientific Title of Study
|
Effectiveness of 5 As based Brief Intervention in Smokeless Tobacco dependence among patients with Common Mental Disorders: A Randomized open-label 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 |
Nivedita Mondal |
| Designation |
Post-graduate trainee, Department of Psychiatry |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of Psychiatry, SR Hostel, room no. 36, LGBRIMH, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
8250303778 |
| Fax |
|
| Email |
mnivedita690@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Diptadhi Mukherjee |
| Designation |
Assistant Professor, Department of Psychiatry |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of Psychiatry, Division - Addiction Medicine, Gate no. 7, Room no.1, LGBRIMH, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
9433780660 |
| Fax |
|
| Email |
diptadhimukherjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Diptadhi Mukherjee |
| Designation |
Assistant Professor, Department of Psychiatry |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of psychiatry, Division - Addiction medicine, Gate no. 7, Room no. 1, LGBRIMH, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
9433780660 |
| Fax |
|
| Email |
diptadhimukherjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Ex-police line road, Mahabhairab, Tezpur, Assam - 784001, India |
|
|
Primary Sponsor
|
| Name |
Nivedita Mondal |
| Address |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Ex-police line road, Tezpur, Assam - 784001, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Nivedita Mondal |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
Department of Psychiatry, Gate no. 1, Room no. 17
Sonitpur
ASSAM |
8250303778
mnivedita690@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, LGBRIMH, Tezpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5 As Brief intervention |
5 As Brief Intervention includes, Ask, Advice, Assess, Assist and Arrange. Patients will receive Nicotine Replacement Therapy (Nicotine gums) as part of the intervention, and called for follow up at 2 weeks and 4 weeks |
| Comparator Agent |
usual care provided along with an informational pamphlet to quit SLT. |
5 A’s based Brief Intervention will be compared to the usual care provided along with an informational pamphlet to quit SLT. It is a waitlist control, which means that after the study period, the control group will be offered NRT.
Patients from this group, those who have not quit at six weeks will be provided with 5 A’s and the pharmacotherapy until as per the waitlist number and availability of slots. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to participate in the study with a written consent
2. Patients using SLT in dependence pattern (as determined by FTND-ST score 3 or more)
3. Patients diagnosed with common mental disorders (CMDs) – depression, anxiety, stress-related and somatoform disorders (diagnosed by ICD-10) |
|
| ExclusionCriteria |
| Details |
1. Patients also consuming tobacco in smoking form having FTND score more than/equal to 3
2. Any patient with a diagnosis of obsessive-compulsive disorder (F42) or Severe Depressive Episode (F32.2 and F32.3) will be excluded from the study.
3. Patients with substance dependence other than tobacco
4. Patients with severe mental illness (SMI) (conditions outside the defined CMD scope (e.g., psychotic disorders, Bipolar mood disorder, Dementia or substance dependence other than tobacco) or severe physical illness who are not amenable for interview will also be excluded.
5. Patients who are receiving Medications like Bupropion/ Nortriptyline for their CMD.
6. Patients whose circumstances might contra-indicate NRT use, such as pregnancy and/ or breastfeeding women |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome: Self-reported complete abstinence from SLT at the end of six weeks |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome:
1. Self-reported Partial abstinence: At least 50% reduction in SLT use.
2. Reduction in FTND-ST score
3. The proportion of patients initiated on tobacco cessation pharmacotherapy in the intervention group. |
2 weeks and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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 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
|
Background: Smokeless tobacco (SLT) use is a critical public health issue in India, particularly in the Northeastern states where its prevalence exceeds the national average. SLT contributes to severe health problems, including oral cancers, cardiovascular diseases, and adverse pregnancy outcomes. Despite these risks, SLT cessation interventions are limited, especially in resource-constrained settings like Northeast India. Compounding this issue is the high burden of Common Mental Disorders (CMDs) in India, which include mood, neurotic, stress-related, and somatoform disorders. Individuals with CMDs often engage in substance use, including SLT, as a means of self-medication for symptoms such as anxiety and low mood. Primary Objective: To determine the effectiveness of 5 A’s based Brief Intervention in cessation of smokeless tobacco in patients diagnosed with common mental disorders. Secondary Objectives: (i) To determine prevalence and pattern of smokeless tobacco use in patients with common mental disorders. (ii) To assess changes in SLT consumption patterns after intervention. (iii) To assess the temporal relation between SLT consumption and mental disorder symptoms after intervention. (iv) To determine the effectiveness of 5As in NRT uptake. Methodology: Proposed study is a randomized controlled trial in the setting of Out Patient Department of LGBRIMH, with a sample size of 118 participants. Patients diagnosed with Common Mental Disorders (CMD) will be recruited according to the selection criteria, and severity of SLT consumption will be assessed by Fagerstrom Test for Nicotine Dependence - Smokeless Tobacco (FTND-ST) score, along with severity of mental disorder symptoms using PHQ-9, GAD-7 and PHQ-15 scales. They will be randomized to either the intervention (5A’s brief intervention with Nicotine Replacement Therapy) group (n = 59) or the waitlist control group (n = 59), and followed up at 2 weeks and 6 weeks for medication adherence, partial/complete abstinence from SLT, and symptom reduction. Statistical Analysis: Chi-square test will be used to compare the complete and partial abstinence rates between the two groups, paired t-tests to assess within-group FTND-ST score reduction, and independent t-tests to compare between groups. |