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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

IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S): a protocol for a randomised controlled pilot and feasibility trial for a combined behavioural and pharmacological support intervention - IMPACT 4S

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021685
Enrollment
172
Registered
2019-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: F172- Nicotine dependence Health Condition 3: F200- Paranoid schizophrenia Health Condition 4: F250- Schizoaffective disorder, bipolartype

Interventions

Intervention1: Combined behavioural and pharmacological support intervention (IMPACT 4S intervention): Combined behavioural and pharmacological support intervention (IMPACT 4S intervention): Up to 10,

Sponsors

Prof Pratima Murthy
Lead Sponsor
Dr Krishna Prasad M
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Pregnant or breastfeeding women ï?· Comorbid drug and/or alcohol problems Epilepsy

Design outcomes

Primary

MeasureTime frame
Primary Outcomes 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 Timepoint: Data will be measured and collected from participants and carers at baseline, one, three and six months.

Secondary

MeasureTime frame
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.

Countries

India, Pakistan

Contacts

Public ContactProf Pratima Murthy

NIMHANS

pratimamurthy@gmail.com08026995250

Outcome results

None listed

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