[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566379":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":48,"studyPopulation":41,"armGroups":49,"interventions":62,"overallOfficials":70,"centralContacts":78,"locations":87,"responsibleParty":123,"collaborators":126,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":41,"eligibilityCriteria":135,"healthyVolunteers":132,"sex":136,"minAge":137,"maxAge":41,"enrollmentInfo":138,"targetDuration":41,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":150,"overallStatus":110,"whyStopped":41,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":41},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","Through the end of treatment intervention, approximately 6 weeks",{"measure":14,"description":15,"timeFrame":16},"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.","Through participants' enrollment, approximately 6 months",[18,22,26,30,34,38],{"measure":19,"description":20,"timeFrame":21},"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\u002Fml indicates abstinence of 1-4 days).","At the 3-month follow-up and 6-month follow-up",{"measure":23,"description":24,"timeFrame":25},"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.\"","At baseline assessment, 3-month follow-up, and 6-month follow-up",{"measure":27,"description":28,"timeFrame":29},"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.","At baseline assessment, end of each treatment session (weekly for 5 weeks post-baseline), 3-month follow-up, and 6-month follow up",{"measure":31,"description":32,"timeFrame":33},"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.","(1) At baseline assessment, 3-month follow-up, and 6-month follow-up. (2) At baseline assessment, after each intervention session, 3-month follow-up, and 6-month follow-up",{"measure":35,"description":36,"timeFrame":37},"Depression Symptoms","1\\. Depressive symptoms will be assessed by the Patient Health Questionnaire 8-item scale (PHQ-8). Likert style: Not at all (0) to Nearly every day (3); scores range from 0 to 24, with higher scores indicating greater levels of symptomatology. 2. Participants will also be asked to rate their depressive symptoms on a scale from 0 to 10, with 0 being no depressed mood and 10 being the worst possible depressed mood.","(1) At baseline assessment, 3-month follow-up, and 6-month follow-up. (2) At baseline assessment, after each intervention session, 3-month follow-up, and 6-month follow-up.",{"measure":39,"description":40,"timeFrame":25},"Distress Tolerance","Distress tolerance will be assessed using the Distress Tolerance Scale (DTS). Likert style: Strongly Agree (1) to Strongly Disagree (5); scores range from 16-80, with higher scores indicating greater levels of distress tolerance.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":41,"whoMasked":41},"NONE","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\u002Fdepression 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\u002Feffectiveness 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).",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"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 receive a general educational session (session 0) followed by 5 active weekly sessions and a booster session 4 weeks after T2 (approx. 14 weeks post-baseline), with the quit day set between sessions 3 and 4.",[55],"Behavioral: PRIDE QUIT",{"label":57,"type":58,"description":59,"interventionNames":60},"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 referral to the Quit Line.",[61],"Behavioral: Enhanced Treatment As Usual (ETAU)",[63,67],{"type":64,"name":51,"description":65,"armGroupLabels":66,"otherNames":41},"BEHAVIORAL","This 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.",[51],{"type":64,"name":57,"description":68,"armGroupLabels":69,"otherNames":41},"Brief 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.",[57],[71,75],{"name":72,"affiliation":73,"role":74},"Conall M O'Cleirigh, PhD","Massachusetts General Hospital, Behavioral Medicine Program","PRINCIPAL_INVESTIGATOR",{"name":76,"affiliation":77,"role":74},"Amelia Stanton, PhD","Boston University",[79,83],{"name":72,"role":80,"phone":81,"phoneExt":41,"email":82},"CONTACT","617-643-0385","cocleirigh@mgh.harvard.edu",{"name":76,"role":80,"phone":84,"phoneExt":85,"email":86},"617-724-6300","111-136-0063","stantona@bu.edu",[88,102,108],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":41},"Massachusetts General Hopsital","ACTIVE_NOT_RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-71.05977,42.35843,{"lat":100,"lon":99},{"facility":103,"status":90,"city":91,"state":92,"zip":104,"country":94,"countryCode":95,"cosmosGeoPoint":105,"geoPoint":107,"contacts":41},"Boston University - Charles River Campus","02215",{"type":97,"coordinates":106},[99,100],{"lat":100,"lon":99},{"facility":109,"status":110,"city":91,"state":92,"zip":104,"country":94,"countryCode":95,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"Fenway Health","RECRUITING",{"type":97,"coordinates":112},[99,100],{"lat":100,"lon":99},[115,119,122],{"name":116,"role":80,"phone":117,"phoneExt":41,"email":118},"Elizabeth Loynd","617-927-6216","eloynd@fenwayhealth.org",{"name":120,"role":80,"phone":41,"phoneExt":41,"email":121},"Elliott Weinstein, PhD","ERWEINSTEIN@mgh.harvard.edu",{"name":76,"role":74,"phone":41,"phoneExt":41,"email":41},{"type":74,"investigatorFullName":124,"investigatorTitle":125,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Conall O'Cleirigh","Director of Behavioral Medicine Program\u002FAssociate Professor",[127],{"name":128,"class":129},"National Cancer Institute (NCI)","NIH","100566379","project-quit-adapting-and-testing-a-smoking-cessation-intervention-for-transgender-and-gender-expansive-individuals-100566379",false,"NCT06654414","Adapting and Pilot Testing a Skills-based Smoking Cessation Intervention to Address Developmental and Health-related Stress Among Adults Who Smoke","Inclusion Criteria:\n\n1. aged 18+\n2. self-reported difference between sex assigned at birth and gender identity\n3. 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\u002FmL) with use of combustible cigarettes (5 cigarettes per day in any week in the past month)\n4. desire to stop using tobacco products (defined by ≥5 on the Motivational Aspects of Smoking Cessation Questionnaire)\n5. English-speaking.\n\nExclusion Criteria:\n\n1. unable to provide informed consent\n2. current interfering untreated or unstable major health condition (e.g., bipolar, current psychosis)\n3. current use of psychotherapy for smoking cessation\n4. participation in Aim 1a procedures.","ALL","18 Years",{"count":139,"type":140},100,"ESTIMATED","INTERVENTIONAL",[143],"NA","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.",[146,147,148,149,23],"Smoking Cessation","Depression","Anxiety","Nicotine Dependence",[146,151,152,153,154,155,148,147,156,157,23,39,158,159],"Smoking","Tobacco Use","Tobacco Use Disorder","Substance-Related Disorder","Nicotine","Transgender Individuals","Gender Expansive Individuals","Quitting","Cognitive Behavioral Therapy","2026-10-05",{"date":162,"type":163},"2026-10-08","ACTUAL",{"date":165,"type":163},"2024-09-01",{"date":167,"type":140},"2027-08-31",{"name":5,"class":6},3]