Effectiveness of 5 As brief intervention in smokeless tobacco

Effectiveness of 5 As based Brief Intervention in Smokeless Tobacco dependence among patients with Common Mental Disorders: A Randomized open-label trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080982

Enrollment

118

Registered

2025-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders

Interventions

Intervention1: 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 int

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Primary outcome: Self-reported complete abstinence from SLT at the end of six weeksTimepoint: 6 weeks	—

Secondary

Measure	Time frame
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.Timepoint: 2 weeks and 4 weeks	—

Countries

India

Contacts

Public ContactDiptadhi Mukherjee

Lokopriya Gopinath Bordoloi Regional Institute of Mental Health

diptadhimukherjee@gmail.com9433780660

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026