Smoking cessation in persons with severe mental illness Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 15/04/2021:
Those eligible participants who consent will be randomly assigned to one of the trial arms using a computer-generated blocked stratified (by country) allocation
Sponsors
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/04/2021: 1. Adults (=18 years old) with SMI (i.e. schizophrenia, schizoaffective disorder, bipolar affective disorder, psychosis, severe depression with psychosis) 2. Considered to be stable by the mental health clinical team 3. Self-reported current smoker of any form of smoked tobacco product (including cigarettes, bidis, waterpipe etc) for at least 6 months 4. Smoking on >25 days in the past month 5. Able to provide informed consent 6. Attending/remotely accessing services from included institutions during the study period 7. Willing to cut down or quit smoking 8. Willing and able to attend up to 15 face-to-face and/or remotely delivered counselling sessions 9. Living in the Rawalpindi district in Pakistan, and in Bangalore urban and rural, nearby/neighbouring districts in India. Previous inclusion criteria: 1. Adults (=18 years old) with SMI (i.e. schizophrenia, schizoaffective disorder, bipolar affective disorder, psychosis, severe depression with psychosis) 2. Considered to be stable by the mental health clinical team 3. Self-reported current smoker of any form of smoked tobacco product (including cigarettes, bidis, waterpipe etc) for at least 6 months 4. Smoking on > 25 days in the past month 5. Able to provide informed consent 6. Attending included institutions during the study period 7. Willing to cut down or quit smoking 8. Willing and able to attend up to 10 face-to-face counselling sessions 9. Living in the Rawalpindi district in Pakistan, and in Bangalore urban and rural districts in India
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women 2. Comorbid drug and/or alcohol problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 15/04/2021: 1. Recruitment rates: Quantitative assessment of the acceptability of the research will be assessed by numbers screened, number eligible and those agreeing to participate. 2. Reasons for ineligibility/non-participation/non-consent of participants. 3. Length of time required to achieve the required sample size. 4. Retention in study: Assessed as a proportion of those enrolled in the study who are successfully followed-up at six months. 5. Retention in treatment: Evaluated by number of study intervention sessions attended as one measure of the feasibility and acceptability of the trial interventions to participants. 6. Intervention fidelity during the delivery of the behavioural support within the IMPACT 4S intervention, as well as for brief advice (BA), assessed as one measure of feasibility of intervention delivery. 7. Smoking cessation pharmacotherapy adherence: For those in the IMPACT 4S arm, adherence to smoking cessation pharmacotherapy will be assessed as one measure of the feasibility and acceptability of the smoking cessation pharmacotherapies to participants. 8. Data completeness: Data will be checked for completeness as another measure of acceptability and feasibility of data collection methods, and to identify problem areas and solutions. Previous primary outcome measures: Feasibility outcomes: 1. Recruitment rates: Quantitative assessment of the acceptability of the research will be assessed by numbers screened, number eligible and those agreeing to participate 2. Reasons for ineligibility/non-participation/non-consent of participants measured using patient records 3. Length of time required to achieve the required sample size 4. Retention in study: assessed as a proportion of those enrolled in the study who are successfully followed-up at six months 5. Retention in treatment: Retention in treatment will be evaluated by number of study intervention sessions attended as one measure of the feasibility and | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/04/2021: 1. Self-reported or family/carer reported continuous smoking abstinence for at least 6 months (only five instances of smoking allowed during the total 6 months) which is biochemically verified by CO concentration (CO concentration <7 ppm) at 6 months follow-up. This will be assessed at the longest possible follow-up point for those participants where it might not be possible to have a 6 months follow-up. 2. Point abstinence, defined as a self-report or family/carer report of not smoking in the previous 7 days, assessed at 1, 3 and 6 months follow-up. This will be assessed at the longest possible follow-up point for those participants where it might not be possible to have a 6 months follow-up. 3. Cost of delivering the IMPACT 4S and the BA interventions. Previous secondary outcome measures: 1. Self-reported or family/carer reported continuous smoking abstinence for at least 6 months (only five instances of smoking allowed during the total 6 months) which is biochemically verified by CO concentration (CO concentration <7 ppm) at 6 months follow-up. 2. Point abstinence, defined as a self-report or family/carer report of not smoking in the previous 7 days, assessed at 1, 3 and 6 months follow-up. 3. Cost of delivering the IMPACT 4S and the BA interventions. | — |
Countries
England, India, Pakistan, United Kingdom
Outcome results
None listed