CompletedInterventional

Smoking cessation support for people with severe mental illness in South Asia

People living with severe mental illnesses, such as bipolar disorder or schizophrenia, are much more likely to smoke and often find it very hard to quit. This can lead to serious physical health problems and shorter life spans. Standard stop-smoking advice often does not offer enough support. This study, taking place in India and Pakistan, tests a tailored support programme called IMPACT 4S. It aims to see if combining regular one-to-one counselling with free stop-smoking medicines (such as bupropion, nicotine gum, or nicotine patches) helps people quit or cut down. A total of 172 adults are taking part. Half receive a short, one-off advice session, while the other half take part in up to 15 support sessions alongside medicine. Researchers check in with everyone over six months to see how well the support works.

At a glance

Status

Completed

Sponsor

University of York

Enrolment target

172

Start

15 Apr 2021

Estimated completion

07 Sep 2021

Smoking cessation in persons with severe mental illness

What is this study about?

People living with severe mental health conditions—such as schizophrenia, bipolar disorder, or severe depression—often face major physical health challenges. On average, their life expectancy is 10 to 25 years shorter than that of the general population. A large part of this difference is linked to smoking. People with severe mental illness are more likely to smoke, tend to smoke more heavily, and often find it much harder to stop using typical support methods.

Stop-smoking medicines and talking therapies have been shown to be safe and helpful when used together. However, most support programmes designed specifically for people with mental health conditions have only been tested in higher-income countries. This trial tests whether an adapted programme, called IMPACT 4S, is practical and helpful for adults attending mental health clinics in India (Bangalore) and Pakistan (Rawalpindi).

By comparing this intensive support to a short advice session, researchers want to see if the combined programme helps people reduce or stop smoking for good. If the results are positive, this approach could be rolled out more widely, helping to protect heart and lung health for many more people across South Asia.

Key takeaways

Tests a combined support programme of counselling and medicine to help people with severe mental illness quit smoking.
Takes place at mental health centres in Bangalore (India) and Rawalpindi (Pakistan).
Participants receive either a short advice session or up to 15 counselling sessions with free stop-smoking medication.
Health, wellbeing, and smoking habits are followed up over a six-month period.
Participation is entirely voluntary and does not affect your regular medical treatment.

Who may be eligible?

This study is open to adults aged 18 and older who have a diagnosed severe mental illness, such as schizophrenia, schizoaffective disorder, bipolar disorder, psychosis, or severe depression with psychotic symptoms. A person's mental health team must consider their condition to be stable before they can join.

Participants must be regular smokers who have smoked tobacco on at least 25 days over the past month, have smoked for at least six months, and want to cut down or quit. They also need to live in or near Bangalore in India or Rawalpindi in Pakistan, and be willing to attend support sessions in person or remotely.

This trial is not suitable for women who are pregnant or breastfeeding. It is also not suitable for people who currently have severe problems with alcohol or illegal drug misuse.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years of age or older?
Do you live with a severe mental illness, and is your condition currently stable?
Have you smoked tobacco on 25 or more days during the past month?
Do you want to cut down or stop smoking completely?
Do you live in or near Bangalore (India) or Rawalpindi (Pakistan)?
Are you not currently pregnant, breastfeeding, or struggling with drug or alcohol addiction?

Answer every question to see your result.

What does participation involve?

Taking part in the study lasts for about six months. At the start, participants complete an interview lasting roughly 30 minutes to discuss their smoking, general health, wellbeing, and lifestyle. Height and weight are also checked. A computer then randomly assigns each person to one of two groups by chance. One group receives a single, five-minute advice chat on stopping smoking. The other group receives the IMPACT 4S programme, which includes up to 15 individual counselling sessions (lasting 15 to 40 minutes each), breath tests to check carbon monoxide levels, and free stop-smoking medicines such as bupropion tablets, nicotine patches, or nicotine gum. Everyone attends follow-up check-ups at one, three, and six months to repeat health measurements and questionnaires. A small number of participants may also be invited to a private interview at three months to share feedback on their experience.

Potential risks and benefits

Participants may benefit from receiving dedicated support and free stop-smoking medicines to help them quit or cut down, which can greatly improve breathing and general health over time. However, direct benefits cannot be promised. Answering personal questions about mental health and smoking habits may sometimes feel uncomfortable. The medicines used can also cause mild side effects; bupropion may lead to dry mouth, difficulty sleeping, nausea, or headaches, while nicotine patches or gum can cause mild skin redness, throat irritation, or dizziness. Doctors check with each participant's mental health team before prescribing any medication. Taking part is completely voluntary, and participants can leave the study at any time without their usual medical care being affected.

Locations (3)

University of York
Approximate
York, England
National Institute of Mental Health and Neurosciences (NIMHANS)
City only
Bangalore, India
Institute of Psychiatry
City only
Rawalpindi, Pakistan

Common questions

Do I have to pay for the stop-smoking medicines or counselling?

No. All counselling sessions, health checks, and stop-smoking medicines provided in the study are completely free.

Can I choose whether I receive the full programme or brief advice?

No. A computer puts participants into groups at random, like flipping a coin. This ensures the research findings are fair and unbiased.

Will my usual mental health doctor know I am taking part?

Yes. The study team will consult your mental health doctors to make sure you are stable and that any medicines prescribed are safe alongside your regular treatments.

What happens if I try to quit but cannot stop completely?

You will still receive full support. The study is designed to help people cut down as well as quit, and every step toward reducing smoking is valued.

Can I leave the study if I change my mind?

Yes. You can withdraw at any time for any reason. Leaving the study will never affect the standard healthcare or mental health support you receive.

How to find out more

Pratima Murthy

pratimamurthy@gmail.com +91 (0)8026995250 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.