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.
aged 18+
self-reported difference between sex assigned at birth and gender identity
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)
desire to stop using tobacco products (defined by ≥5 on the Motivational Aspects of Smoking Cessation Questionnaire)
unable to provide informed consent
current interfering untreated or unstable major health condition (e.g., bipolar, current psychosis)
current use of psychotherapy for smoking cessation
participation in Aim 1a procedures.
Parallel
PRIDE QUIT
BehavioralThis is an adapted behavioral intervention based on the integrated treatment for smoking cessation, anxiety, and depressed mood, known as QUIT, for persons with HIV. Through our treatment adaption process of QUIT (guided by Aim 1 and 2 data), PRIDE QUIT will be a Cognitive-Behavioral therapy-based intervention tailored for transgender and gender diverse (TGD) individuals, aimed at to helping participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance. There will be three major assessments: baseline (T1), at the end of the intervention (T2), and a three-month follow-up visit (T3). This intervention group will receive a pre-randomization general educational session (session 0) followed by 5 weekly sessions and a booster sessions 4 weeks after T2, with the quit day set between sessions 3 and 4.
Enhanced Treatment As Usual (ETAU)
BehavioralBrief counseling, American Cancer Society cessation resources (palm card with information on how to access the American Cancer Society website) after pre-randomization educational session (session 0,) the option of nicotine replacement therapy, and referral to the Quit Line.
Acceptability
Acceptability will be assessed via the Client Satisfaction Questionnaire-4 (CSQ-4) which will be completed after every other treatment session. Items are scored using a 4-point Likert scale with (1) quite dissatisfied; (2) dissatisfied; (3) satisfied; (4) quite satisfied. The questions include: (1) To what extent has our program met your needs?; (2) Have the services you received helped you to deal more effectively with your problems?; (3) In an overall, general sense, how satisfied are you with the service you have received?; (4) If you were to seek help again, would you come back to our program? The intervention will be deemed acceptable if at least 75% of the participants rate 4+ items on the acceptability questionnaires with a 3 or a 4 on the Likert-style scale.
Feasibility of the Intervention
Feasibility of the intervention is a primary outcome measure that will be calculated based on three assessments: (1) interventionist fidelity to the protocol (via a review of 10% of session recordings to determine whether key themes were addressed), (2) session attendance, and (3) participant retention at follow-up. Feasibility will be demonstrated if at least (1) 80% of the reviewed sessions address all key themes, (2) 75% of the participants attend at least half of all treatment sessions; and (3) 70% of the participants complete the 3-month follow-up.
7-Day Point Prevalence Abstinence
7-day point prevalence abstinence will be verified via expired-air carbon monoxide (CO) assessed with a Smokerlyzer, with 5ppm indicating abstinence (24 hours to two weeks). Because CO expired-air readings are significantly lower among users of e-cigarettes, abstinence for those using mostly e-cigarettes at baseline will be verified by cotinine assessment via a NicConfirm Mouth Swab Cotinine test (30 ng/ml indicates abstinence of 1-4 days).
Gender Minority Stress
Gender minority stress will be measured via the internal experience subscales of the Gender Minority Stress and Resilience Measure (GMSRM), including non-affirmation of gender identity, internalized transphobia, negative expectations, nondisclosure, community connectedness, and pride. Participants respond to each statement using a five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree."
Average Number of Cigarettes Smoked Per Day in the Past Week
Average number of cigarettes smoked per day in the past week, assessed via self-report.
Anxiety Symptoms
1\. Anxiety symptoms will be assessed by the Generalized Anxiety Disorder 7-item (GAD-7). Likert style: Not at all (0) to Nearly every day (3); scores range from 0 to 21, with higher scores indicating greater levels of symptomatology. 2. Participants will also be asked to rate their anxiety on a scale from 0 to 10, with 0 being no anxiety and 10 being the worst possible anxiety.
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Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
