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Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke

Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke

Recruiting
18 years and older
All
Phase N/A

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Overview

Smoking remains the leading preventable cause of death in the United States, and there are persistent and significant disparities in tobacco use among transgender and gender diverse (TGD) individuals. Stigma, discrimination, gender dysphoria, and other gender minority stressors likely contribute to these disparities, and the increased burden of gender minority stress may also be driving higher prevalence rates of anxiety and depression, both of which are more common among TGD individuals and among those who smoke relative to comparison samples. This study will (1) explore the ways in which gender minority stressors and associated anxiety and depression compromise smoking cessation among TGD individuals, identifying elements in an existing smoking cessation intervention that need to be adjusted to meet their unique needs; (2) adapt an existing smoking cessation intervention for TGD individuals; and (3) evaluate the feasibility and acceptability of the adapted intervention in a pilot randomized controlled trial.

Description

Despite the substantial decrease in smoking prevalence over the past 50 years, persistent and significant disparities in tobacco use remain among clinical and non-clinical populations of adults who smoke. Cigarette use among clinical populations, including patients with HIV and those with significant developmental stress, ranges from approximately 40-70%, compared with 10-12% among non-clinical populations. Clinical populations with HIV and developmental stressors also show dramatically higher rates of e-cigarette use relative to non-clinical populations (26.5% vs. 5.5% in some samples of adults who smoke). Adults managing HIV and developmental stressors may be particularly vulnerable to the consequences of tobacco use through increased heart disease risk, and smoking may hinder recovery from HIV and other related illnesses. Differential responses to developmental stressors, the stress of managing HIV and its treatment, and co-occurring clinical concerns such as anxiety and depression further contribute to these differences in tobacco use. Anxiety and depression are major impediments to smoking cessation and are more prevalent among people with developmental stress and people living with HIV than in non-clinical samples. Anxiety symptoms co-occur with smoking at high rates and significantly impair cessation success. Similarly, depressed mood and major depressive disorder-both more common among people who smoke than among those who do not-are associated with reduced odds of cessation. The high prevalence of anxiety and depression among clinical populations of adults who smoke therefore leaves these individuals particularly vulnerable to cessation difficulties. A tailored smoking cessation intervention that builds cognitive-behavioral skills for cessation while also reducing stress and associated anxiety and depression symptoms has strong potential to mitigate tobacco use. We propose to adapt an existing smoking cessation intervention, QUIT, to address the unique needs of adults with developmental stress who smoke. In focus groups with individuals who use tobacco (N ≤ 32) and providers (N ≤ 8), we will explore the ways in which stress and associated anxiety/depression compromise cessation, and identify content in the current version of QUIT that does and does not meet participants' needs. Providers will also comment on anticipated implementation barriers. Following the ADAPT-ITT model, these qualitative data will inform adaptation of the intervention. We will then test the feasibility and acceptability of the adapted intervention (QUIT 2.0) in a pilot randomized controlled trial (RCT; N = 60), assessing for signals of clinically meaningful change in biologically verified 7-day point-prevalence abstinence, average number of cigarettes smoked, and stress, anxiety, depression, and distress tolerance. If QUIT 2.0 is feasible and acceptable, it will be ready for a hybrid efficacy/effectiveness trial. We will also include a non-randomized, retrospective comparison group-matched on age, sex, and average number of cigarettes smoked per day in the past week-consisting of adults with HIV who completed the original, un-adapted intervention (QUIT 1.0).

Eligibility

Inclusion Criteria:

  1. aged 18+
  2. self-reported difference between sex assigned at birth and gender identity
  3. current use of combustible cigarettes (defined as self-reported 5 combustible cigarettes per day in any week in the past month and a carbon monoxide \[CO\] expired-air reading of ≥8ppm) OR current use of nicotine-containing e-cigarettes (defined by saliva cotinine level of ≥30ng/mL) with use of combustible cigarettes (5 cigarettes per day in any week in the past month)
  4. desire to stop using tobacco products (defined by ≥5 on the Motivational Aspects of Smoking Cessation Questionnaire)
  5. English-speaking.

Exclusion Criteria:

  1. unable to provide informed consent
  2. current interfering untreated or unstable major health condition (e.g., bipolar, current psychosis)
  3. current use of psychotherapy for smoking cessation
  4. participation in Aim 1a procedures.

Study details
    Smoking Cessation
    Depression
    Anxiety
    Nicotine Dependence
    Gender Minority Stress

NCT06654414

Massachusetts General Hospital

21 October 2026

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