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NOT YET RECRUITING

NCT06602076

EARLY_PHASE1

Developing Empowering Smoking Cessation

Sponsor: University of Oklahoma

View on ClinicalTrials.gov

Summary

Problem: Despite encouraging use declines in the U.S. population, tobacco is still a leading cause of preventable disease and death. Current cessation treatments have limited success; two-thirds relapse within 6 months of a quit attempt. Existing smoking cessation interventions overwhelmingly focus on within-person processes of behavior change rather than socioenvironmental influences on cessation success. Cessation interventions based on evidence linking social stress to increased nicotine dependence and relapse risk are needed to address the stressors people who smoke encounter while navigating their social environments (i.e., social stress). Effective empowering approaches for infectious disease prevention and youth tobacco use suggest that Empowerment Theory may also enhance smoking cessation assistance for people experiencing high levels of social stress. Hypothesis: Our hypothesis is that when people participate in community-serving volunteer activities, they may also experience cognitive and behavioral changes (i.e., enhanced stress coping, social support, self-worth, prosociality) that ameliorate the effects of social stress, thereby supporting smoking cessation. Importance: Empowerment Theory-informed health behavior change approaches have worked for infectious disease prevention and youth tobacco interventions. Our pretest (N=20; Oklahoma) demonstrated the feasibility and acceptability of volunteer activity participation as an adjunct to standard smoking cessation treatment. This novel smoking cessation intervention uses an innovative, theory-based, local-yet-scalable approach to enhance individual outcomes through community engagement. To ensure scalability and accessibility of this remotely delivered intervention, we will utilize the NIH-supported Dissemination and Implementation (D\&I) science framework, the Practical, Robust Implementation and Sustainability Model (PRISM), which is the contextually expanded version of RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance). This project will advance efforts to understand and address high tobacco use among people experiencing high levels of social stress and will inform a future R01 application for a fully-powered, multi-site RCT of ECHO aiming to end tobacco use across the U.S. while supporting community connectedness.

Official title: Developing an Empowerment Theory-Based Smoking Cessation Intervention for People With High Levels of Social Stress

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08

Completion Date

2027-07

Last Updated

2025-08-19

Healthy Volunteers

Yes

Conditions

Smoking Cessation

Interventions

BEHAVIORAL

ECHO (Empowering Our Community & Health Outcomes)

Additive intervention design wherein study participants receive remotely-delivered standard smoking cessation support (i.e., behavioral support plus nicotine replacement therapy) and engage in community-serving volunteer activities.

Inclusion/exclusion criteria (All Aims): * Sexual and/or gender minority (SGM)-identified * Adults (i.e., ≥ 18 years old) * Currently smoking cigarettes * Living in a high stigma environment in the U.S. * Able to read English at \> 6th-grade level Individuals with serious psychological distress (i.e., score of 13 ≥ 18 on the Kessler PD Scale-6 19) will be excluded from all Aims because of likelihood of functional impairments that substantially interfere with one or more major life activities. Aim 3 (Pilot RCT) inclusion criteria will be: * (1) ≥ 18 years old * (2) sexual and/or gender minority-identified (see definition above) * (3) living in Oklahoma or one of the 8 counties in San Joaquin Valley, California (verified by address) * (4) a current cigarette smoker (see definition above) * (5) willing to quit smoking within 30 days of enrollment (see definition above) * (6) own a smartphone * (7) ability to read English at \> 6th-grade level (see definition above) * have no NRT contraindications * (8) ≥ weekly internet access * (9) willing and able to participate in SGM-serving volunteer activities. Aim 3 (Pilot RCT) exclusion criteria: Individuals will be excluded if currently using other smoking cessation treatments. Sexual minority identity will be indicated by selecting any non-heterosexual response option(s) from: Heterosexual (Straight); Gay or Lesbian; Bisexual; Something else (please state)." Participants will indicate the sex assigned on their birth certificate (i.e., natal sex). Gender minority identity will be indicated by "Trans male/Trans man;" "Trans female/Trans woman;" "Gender queer/Gender non-conforming;" "Different identity (please state)" or a binary identity (male or female) non-concordant with natal sex. Current cigarette smoking will be indicated by ≥100 lifetime cigarettes and currently smoking cigarettes "every day" or "some days". High SGM stigma states are defined as the 22 states wherein ˂60% of the population 'thinks that homosexuality should be accepted'.21 High SGM stigma municipalities are defined as one of the 246 U.S. municipalities (out of the 496 scored from all U.S. states) that scored below the median (71) on the HRC Municipal Equality Index. Willingness to quit smoking will be assessed with a single item: "Are you willing to quit smoking cigarettes within 30 days after enrolling in this study? (yes/no)". To be classified as 'ready to quit smoking,' participants will report readiness to quit in the next 30 days and at least 1 past-year quit attempt (i.e., in the "Preparation" stage of change). An equal number of female and male participants (i.e., natal sex) will be recruited so as to examine sex as a biological factor. Recruitment targets will aim to reflect the racial/ethnic composition of the populations from which the samples are drawn.