A clinical trial to study the effects of two methods, a behavioral support intervention and only brief advice for persons with severe mental illness and tobacco use disorder

The SCIMITAR South Asia programme to address tobacco related multiple long term conditions in Severe Mental Illness - SCIMITAR-SA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080243

Enrollment

1450

Registered

2025-02-10

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: F317- Bipolar disorder, currently in remission Health Condition 2: F333- Major depressive disorder, recurrent, severe with psychotic symptoms Health Condition 3: F172- Nicotine dependence Health Condition 4: F200- Paranoid schizophrenia Health Condition 5: F250- Schizoaffective disorder, bipolartype

Interventions

Intervention1: SCIMITAR SA Intervention: The behavioural support offered in SCIMITAR SA will comprise up to 15 one-to-one counselling sessions with a trained healthcare worker, over three months. Each

Eligibility

Inclusion criteria

Inclusion criteria: Adults (more than or equal to 18 years) receiving outpatient care at the study site Confirmed diagnosis of one or more SMI (schizophrenia, schizoaffective disorder, bipolar affective disorder, psychosis, severe depression with psychosis) by healthcare staff self reported current users of smoking (including cigarettes, bidis, waterpipe) and/or smokeless forms of tobacco (such as betel-quid, naswar, gutkha, zarda) for at least six months. Mentally stable at the time of recruitment and able to provide informed consent Willing to quit tobacco use and able to attend up to 10 face to face or telephone based counselling sessions with trained healthcare staff.

Exclusion criteria

Exclusion criteria: We will restrict trial participation to one member per household (to avoid contamination) and exclude those with comorbid drug and/or alcohol use (ascertained by the mental health specialist), as these individuals would require more specific intervention. We will also exclude those who are currently under treatment for tobacco dependence.

Design outcomes

Primary

Measure	Time frame
The primary trial outcome is biochemically verified, continuous abstinence from all tobacco products at six months post-randomisation.Timepoint: Data will be collected at baseline, three and six months	—

Secondary

Measure	Time frame
Secondary outcomes include self-reported abstinence at 12 months, and changes in physical health, mental health, and quality of life at six and 12 months.Timepoint: Data will be collected at baseline, three, six and twelve months	—

Countries

Bangladesh, India, Pakistan

Contacts

Public ContactProf Pratima Murthy

NIMHANS, Bengaluru

pratimamurthy@gmail.com08026995001

Outcome results

None listed

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