N/A
N=1,165
Integrated Smoking Cessation Treatment for Smokers With Serious Mental Illness
Cigarette Smoking · Schizophrenia · Bipolar Disorder · Depressive Disorder, Major · Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT02845440 ↗Enrolled (actual)
1,165
Serious AEs
31.5%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1 — 13; 32; 19 Participants — p=0.013
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Academic Detailing (Other); Community Health Worker (Other); Treatment as Usual (TAU) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohort 1 |
13; 32; 19 | 0.013 sig |
| SECONDARY Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohort 1 |
112; 121; 83; 152; 138; 181 | 0.174 |
| SECONDARY Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessment in Cohort 1 |
34; 72; 30; 230; 187; 234 | <0.001 sig |
| SECONDARY Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 |
5; 24; 7; 8; 8; 12 | 0.056 |
| SECONDARY Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohort 1 |
1; 17; 4; 12; 15; 15 | 0.012 sig |
| SECONDARY Number of Participants Who Are Abstinent at the Intervention Year 2 Assessment in Cohorts 1 and 2 |
13; 32; 19; 11; 8 | 0.032 sig |
| SECONDARY Number of Participants Who Use of Any First Line, Evidence-based TUD Medication at the Intervention Year 1 or 2 Assessment in Cohorts 1 and 2 |
112; 121; 83; 30; 24; 152 | <0.001 sig |
| SECONDARY Number of Participants Who Use Varenicline at the Intervention Year 1 or 2 Assessments in Cohorts 1 and 2 |
34; 72; 30; 15; 6; 230 | <0.001 sig |
| SECONDARY Effect of Use of Any TUD Medication on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 |
5; 24; 7; 7; 2; 8 | 0.158 |
| SECONDARY Effect of Varenicline Use on Number of Participants Who Are Abstinence at the Intervention Year 2 Assessment in Cohorts 1 and 2 |
1; 17; 4; 5; 0; 12 | 0.013 sig |
| SECONDARY Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohort 1 |
3.02; 3.13; 3.08 | 0.505 |
| SECONDARY Health-related Quality of Life Single-item Assessment at the Intervention Year 2 Assessment in Cohorts 1 and 2 |
3.02; 3.13; 3.08; 3.11; 3.35 | 0.937 |
Summary
The overall aim of this study is to test the effect of academic detailing (i.e. provider-level educational intervention focused on evidence-based smoking cessation treatment for those with psychiatric illness) and community health worker (CHW) support on the provision and utilization of standard of care smoking cessation treatment to those with serious mental illness (SMI) and smoking cessation rates for adults with SMI who smoke.
Eligibility Criteria
Inclusion:
- adult (18+ years)
- current smoker
- current diagnosis of SMI (e.g. schizophrenia, bipolar disorder, major depressive disorder, etc...)
- currently receiving psychiatric rehabilitation services through CBFS and ACT programs at Bay Cove Human Services and Vinfen Corporation
Exclusion:
- intellectual disability (IQ<70)
Data sourced from ClinicalTrials.gov (NCT02845440). 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.