Adapted Intervention for Smoking Cessation

Palo Alto (17 mi)

Overseen byConall O'Cleirigh, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for transgender and gender diverse individuals who are dealing with nicotine addiction, possibly alongside depression, anxiety, or gender dysphoria. Participants should be interested in quitting smoking and willing to try new cessation methods.

Inclusion Criteria

I speak English.

My gender identity differs from the sex I was assigned at birth.

Exclusion Criteria

I am unable to understand or sign the consent form.

I do not have any untreated major health issues like active mania or psychosis.

Treatment Details

The study tests two approaches: 'Enhanced Treatment As Usual' (ETAU), which is the standard support for quitting smoking, against 'PRIDE QUIT', a tailored intervention considering the unique stressors faced by transgender and gender expansive individuals.

2Treatment groups

Experimental Treatment

Active Control

Group I: PRIDE QUITExperimental Treatment1 Intervention

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.

Group II: Enhanced Treatment As Usual (ETAU)Active Control1 Intervention

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.