A clinical trial to study the effects of two methods, a behavioral and drug treatment based support intervention and only brief advice for persons with severe mental illness and smoking problem
- Conditions
- Health Condition 1: F317- Bipolar disorder, currently in remissionHealth Condition 2: F172- Nicotine dependenceHealth Condition 3: F200- Paranoid schizophreniaHealth Condition 4: F250- Schizoaffective disorder, bipolartype
- Registration Number
- CTRI/2019/10/021685
- Lead Sponsor
- Prof Pratima Murthy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Adults (>=18 years old) with SMI (i.e. schizophrenia, schizoaffective disorder, bipolar affective disorder, psychosis, severe depression with psychosis) ï?·
Considered to be stable by the mental health clinical team ï?·
Self-reported current smoker of any form of smoked tobacco product (including cigarettes, bidis, waterpipe etc) for at least 6 months ï?· Smoking on >25 days in the past month ï?·
Able to provide informed consent ï?·
Attending included institutions during the study period ï?·
Willing to cut down or quit smoking ï?·
Willing and able to attend up to 10 face-to-face counselling sessions ï?·
Living in Bangalore urban and rural districts in India
Pregnant or breastfeeding women ï?·
Comorbid drug and/or alcohol problems
Epilepsy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcomes <br/ ><br>1.Recruitment rates 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 5. Retention in treatment 6. Intervention fidelity 7. Smoking cessation pharmacotherapy adherence 8. Data completeness <br/ ><br>Timepoint: Data will be measured and collected from participants and carers at baseline, one, three and six months.
- Secondary Outcome Measures
Name Time Method 9. Self-reported or family/carer reported continuous smoking abstinence for at least six months (only five instances of smoking allowed during the total six months) which is biochemically verified by CO concentration (CO concentration 7ppm) at six months follow-up. 10. Point abstinence, defined as a self-report or family/carer report of not smoking in the previous seven days, assessed at one, three and six months follow-up. 11. Cost of delivering the IMPACT 4S and the BA interventions.Timepoint: Data will be measured and collected from participants and carers at baseline, one, three and six months.