Phase 2
N=94
Proactive Outreach for Smoking Treatment
Smoking, Tobacco · Mental Illness
Bottom Line
View on ClinicalTrials.gov: NCT04988477 ↗Enrolled (actual)
94
Serious AEs
1.1%
Results posted
May 2025
Primary outcome: Primary: Study 3: Smoking Abstinence — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Study 3: Chronic care management (Behavioral); Study 2: Pilot trial (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sandra Japuntich
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study 3: Smoking Abstinence |
3 | — |
| PRIMARY Study 1: Perceived Feasibility of Intervention |
17 | — |
| PRIMARY Study 1: Perceived Acceptability of Intervention |
18 | — |
| PRIMARY Studies 2 & 3: Feasibility of Recruitment |
25; 49 | — |
| PRIMARY Studies 2 & 3: Feasibility of Retention |
41; 23 | — |
| PRIMARY Study 2: Perceived Acceptability of Intervention |
8 | — |
| SECONDARY Study 3: Smoking Abstinence |
3 | — |
| SECONDARY Study 3: Quit Attempts |
3.07 | — |
| SECONDARY Study 3: Cigarettes Per Day |
10.56 | — |
Summary
Tobacco use disorder is a chronic disease. This is particularly true for people living with mental illness, who are more likely to smoke and make more unsuccessful quit attempts than those without. The current study is designed to test a package of two chronic disease management strategies to treatment tobacco in community mental health centers: regular provider interventions during routine mental healthcare visits, and proactive outreach by community mental health center staff to offer connections to tobacco cessation treatment. In study 1 we will interview patients, providers and leaders across wo community healthcare systems, in study 2 we will pilot test the package of interventions in 25 patients at a community mental health center for feasibility and acceptability. in Study 3, 50 patients at a community mental health center will receive provider intervention at their regular visits as well as 3 outreach calls over 9 months from trained staff to offer to connect them with stop smoking treatment. The investigators will measure the effect of these interventions on tobacco use over the next year.
Eligibility Criteria
Inclusion Criteria
- daily cigarettes smokers (smoking >25 days/month)
- English speaking
- patient in one of the two community mental health center study sites.
Exclusion Criteria
- cognitive impairment
- judged by community mental health center staff as unable to participate in research
- no access to a telephone
- no mailing address.
Data sourced from ClinicalTrials.gov (NCT04988477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.