Evaluation of Community Health Worker Support to Help People With Serious Mental Illness to Quit Smoking
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 937 people, planned
- Started
- 1 Oct 2026
- Expected to end
- Oct 2030
- Type of study
- Interventional, 2 groups
- Treatments tested
- Integrated CHW Support intervention
- Enhanced usual care (EUC)
- Record updated
- 27 August 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Age 18-75, inclusive
- Have been diagnosed with SMI that has qualified them for Medicaid behavioral health services (i.e., mood, anxiety, traumatic, and psychotic disorders with or without functional impairment) and receive care through the community human services organizations in Massachusetts
- Self-report of past year daily tobacco smoking
- Able to understand study procedures and communicate in English or Spanish
- Willingness to participate in a biannual interview with a research coordinator and to meet with a CHW if assigned to one
- Competent and willing to provide informed consent
Who cannot take part
- Have dementia or intellectual disability (estimated IQ< 70)
- Unstable medical condition that compromises ability to safely participate, in the investigator's opinion
- Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol
- Not able to communicate in English or Spanish
- Evidence of active problem substance use severe enough to compromise ability to safely participate, in the investigator's opinion
- Unwilling to participate in study procedures
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in United States
- Center for Addiction Medicine, Massachusetts General HospitalBoston, United StatesContact: Gladys Pachas, MD, MPHNot yet recruiting
About the trial
What the trial wants to find out
The purpose of this study is to learn whether providing additional smoking cessation support through specially trained members of behavioral healthcare team helps people quit smoking and improve their health. Participants ages 18-75 who receive mental health services and smoke cigarettes every day may qualify for this study looking at new ways to help people quit smoking.
The 2 groups in the trial
- Integrated CHW support interventionTreatment being tested
The randomization will be at the level of intensive care managers (ICM). Randomization will be stratified by care team. ICMs in this arm will be assigned to receive CHW and Tobacco Treatment Specialist certificate training (ICM-T) . Participants receive support from their ICM who has received CHW and TTS (ICM-T) training
- Enhanced usual care (EUC)Other group
The randomization will be at the level of intensive care managers (ICM). Randomization will be stratified by care team. ICMs in this arm (active-controlled) will not receive CHW and TTS training, participants will receive enhanced usual care (EUC) e.g. continue to receive ICM care.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Community Health Worker Support to Improve Tobacco Use Disorder Outcomes in Medicaid Beneficiaries With Serious Mental Illness
- Fit questions
- Built from NCT07789132, who can take part
- Record updated
- 27 August 2026