Users of smoked and/or smokeless tobacco with a confirmed diagnosis of one or more Severe mental illness Other
Conditions
Interventions
Intervention Group: Participants in the intervention arm will also receive the SCIMITAR-SA intervention. The behavioural support offered in the SCIMITAR-SA intervention will comprise up to seven one-t
Sponsors
University of York
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adults (=18 years) receiving outpatient mental healthcare at any of the aforementioned trial facilities. 2. Confirmed diagnosis of one or more SMI (i.e. schizophrenia, schizoaffective disorder, bipolar affective disorder, psychosis, severe depression with or without psychosis) by healthcare staff. 3. Self-reported daily users of smoked products (including cigarettes, bidis, waterpipe) and/or users of smokeless forms of tobacco (such as betel-quid, naswar, gutkha, khaini, zarda, paan, pan-masala, gul, shada pata ) for the last six months (daily or non-daily) and >=25 days in the last month. 4. Confirmed to be clinically stable* by the healthcare staff at the time of recruitment and able to provide informed consent. 5. One member per household is eligible for trial participation (to avoid contamination). 6. Willing to quit all forms of tobacco use in the next 30 days and able to attend up to seven face-to-face counselling sessions with trained mental healthcare staff. 7. Living within the catchment area for the study facility that is defined by the district/administrative jurisdiction** in respective countries. *Patients will be considered clinically stable based on the assessment conducted by the treating clinician (Psychiatrist), with less than 25% change in the dosage of the medication and no administration of Electroconvulsive Therapy (ECT) or other neurostimulation treatments within the preceding three months. **The trial facilities will maintain a record of patients with their consent, including their addresses and contact information, who will be excluded from the feasibility trial due to residing outside the district or administrative jurisdiction in which the trial facilities are located. This record will be reviewed prior to initiating the main effectiveness trial and will serve as a reference for reassessing and refining the eligibility criteria for inclusion/exclusion moving forward.
Exclusion criteria
Exclusion criteria: 1. Self reported use of Electronic Nicotine Delivery Systems and Electronic Non-Nicotine Delivery Systems (ENDS/ENNDS), Heated Tobacco 2. Products (also known as Heat-Not-Burn products) (HTP/HNBs), noncombustible nicotine products, known as Oral Nicotine Pouches (ONPs) and/or in combination with either smoking and/or smokeless forms of tobacco in the past 30 days. 3. Individuals with comorbid drug or alcohol use disorder (as ascertained by the SCIMITAR-SA research team), personality disorders, eating disorders, autism spectrum disorders, disorders of intellectual development, Post Traumatic Stress Disorder (PTSD) as ascertained clinically by the treating psychiatrist. 4. Individuals who have received any pharmacotherapy (including nicotine replacement therapy) or psychosocial intervention except brief advice for tobacco cessation in the past 30 days. 5. Dual users who are willing to quit only one form of tobacco use/ product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment, retention, acceptability 1.1. Recruitment rates, assessed as the number of participants eligible, consenting and randomised, out of those screened. 1.2. Reasons for ineligibility/non-participation/non-consent of participants where provided. 1.3. Retention in the study, assessed as the number of participants randomised who are successfully followed up at four and seven months 4 post randomisation with details of withdrawals and loss to follow-up where available. 2. Intervention Delivery 2.1. Retention in intervention reported as the total number of sessions attended out of the total number of sessions offered. 2.2. Qualitative feedback from research staff, health facility staff and trial participants on trial processes. 2.3. Qualitative feedback from tobacco dependence advisors, mental health facility staff and trial participants on delivery, implementation and receipt of the SCIMITAR-SA intervention. 3. Data completion 3.1. Completeness of data for baseline assessments, outcome measures for the definitive trial and data on health resource use at 4 and 7 months. 3.2. Data completeness of self-reported and biochemically verified continuous abstinence from all tobacco products at 7 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Bangladesh, India, Pakistan
Contacts
Public ContactGarima Bhatt
Outcome results
None listed