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Clinical Trials/NCT06654414
NCT06654414TerminatedNot Applicable

Project QUIT+: Adapting and Testing a Smoking Cessation Intervention for Transgender and Gender Expansive Individuals

Massachusetts General Hospital6 sites in 1 country3 target enrollmentStarted: September 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
3
Locations
6
Primary Endpoint
Acceptability

Study Overview

Brief Summary

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.

Detailed Description

Despite the substantial decrease in the prevalence of smoking over the past 50 years, there are persistent and significant disparities in tobacco use among transgender and gender diverse (TGD) individuals. The prevalence of cigarette use in TGD individuals is 45.7 - 62.3%, compared to 39.8% in cisgender individuals. There are also disparities in e-cigarette use among TGD people relative to cisgender adults (26.5% vs. 5.5% in transgender and cisgender men, respectively). Transgender individuals may be particularly vulnerable to the consequences of tobacco use, as hormone therapy among those who smoke increases heart disease risk, and smoking may hinder recovery from gender-affirming surgeries. Stigma, discrimination, gender dysphoria, and other gender minority stressors contribute to tobacco use disparities. Enacted stigma and discrimination toward TGD individuals are common (reported by over 75% of participants in some samples), and experiencing stigma or discrimination increases the odds of current cigarette smoking, e-cigarette use/vaping, and dual use among TGD people. Gender dysphoria and gender minority stress may also lead to and/or exacerbate disparities in anxiety and depression, which are major impediments to smoking cessation that are more prevalent among TGD than cisgender individuals. 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 individuals who smoke than among those who do not, are associated with reduced odds of cessation. Therefore, gender minority stress and high prevalence rates of anxiety and depression render TGD individuals particularly vulnerable to smoking cessation difficulties. A tailored smoking cessation intervention that builds cognitive behavioral skills for cessation as well as reduces gender minority stress and associated anxiety and depression symptoms has strong potential to mitigate tobacco use disparities among TGD individuals. The investigators propose to adapt an existing smoking cessation intervention (known as QUIT) to address the unique needs of TGD people. In focus groups with TGD individuals who use tobacco (N = up to 32) and providers (N = 8), the investigators will explore the ways in which gender minority stressors and associated anxiety/depression compromise cessation as well as identify content in the current version of the QUIT intervention that does and does not meet their needs. Providers will also comment on anticipated implementation barriers. Following the ADAPT-ITT model, the qualitative data will inform the adaptation of the intervention. The investigators will then test the feasibility and acceptability of the adapted intervention (QUIT+) in a pilot RCT (N = 60); the investigators will also assess for signals of clinically meaningful change in biologically verified 7-day point prevalence abstinence, average number of cigarettes smoked, gender minority stress, anxiety and depression symptoms, and distress tolerance. If deemed to be feasible and acceptable, the intervention will be ready for a hybrid efficacy/effectiveness trial.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • self-reported difference between sex assigned at birth and gender identity
  • current use of combustible cigarettes OR recent use of combustible cigarettes (defined as at least 5 cigarettes-per-day at some point within the past 6 months) OR current use of nicotine-containing e-cigarettes with use of combustible cigarettes in the past 6 months (defined as 5 cigarettes-per-day)
  • English-speaking.

Exclusion Criteria

  • unable to provide informed consent
  • current interfering untreated or unstable major health condition that is event during screening (e.g., active mania, current psychosis)

Arms & Interventions

PRIDE QUIT

Experimental

Participants in this adapted intervention arm (n=30) will receive empirically-based, Cognitive-Behavioral therapy-based strategies, tailored for transgender and gender diverse (TGD) individuals, which aims to help participants quit smoking and address gender minority stressors, anxiety, depression, and improve distress tolerance.

This intervention group will likely receive 6-10 active weekly sessions, with the quit day set around session 4-6. They will also receive transdermal nicotine patches (TNP) for a period of 8 weeks prior to the quit session.

Intervention: PRIDE QUIT (Behavioral)

Enhanced Treatment As Usual (ETAU)

Active Comparator

Participants in this arm (n=30) will receive enhanced treatment as usual at Fenway Health. These participants will attend one session (brief counseling), will come to the clinic for weekly assessments only, and receive the option of transdermal nicotine patch (TNP) and referral to the Quit Line.

Intervention: Enhanced Treatment As Usual (ETAU) (Behavioral)

Outcomes

Primary Outcomes

Acceptability

Time Frame: Through the end of treatment intervention, approximately 10 weeks

Acceptability will be assessed via a questionnaire, completed after every other treatment session, that measures the 7 constructs of the acceptability of health care interventions framework: affective attitude, burden, ethicality, coherence, opportunity costs, perceived effectiveness, and self-efficacy. The intervention will be deemed acceptable if at least 75% of the participants rate 4+ items on the acceptability questionnaires with a 4 or a 5 on the Likert-style scale.

Feasibility

Time Frame: Through participants' enrollment, approximately 6 months

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.

Feasibility of the Intervention

Time Frame: Through participants' enrollment, approximately 6 months

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.

Secondary Outcomes

  • 7-Day Point Prevalence Abstinence(At the end of treatment intervention (approx. 10 weeks post-baseline) and at 3-month follow-up (T3; approx. 6 months post-baseline))
  • Gender Minority Stress(At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline))
  • Average Number of Cigarettes Smoked Per Day In The Past Week(At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline))
  • Nonbinary Distal Stress (Nbi-DMSS )(At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline))
  • Proximal Minority Stress (Nbi-PMSS)(At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline))
  • Nonbinary Resilience (Nbi-RS)(At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline))
  • Severity of Nicotine Dependence(At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline))
  • Anxiety and Depressive Symptoms(At baseline assessment, end of treatment intervention (approx. 10 weeks post-baseline), and 3-month follow-up (T3; approx. 6 months post-baseline))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Conall O'Cleirigh

Director of Behavioral Medicine Program/Associate Professor

Massachusetts General Hospital

Study Sites (6)

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