- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04461288
Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment
Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Participants (N=136) will be randomized to one of three conditions: (1) Pride Posts, a Facebook-delivered smoking cessation intervention (including daily posts, and weekly live group sessions, tailored to sexual and gender minority (SGM) adults; (2) Pride Posts Plus, the Facebook-delivered smoking cessation intervention plus a gamification element, or (2) a usual care condition which includes referral to smokefree.gov, a federally-developed web-based intervention which includes similar digital treatment elements. All participants will have access to up to six months of nicotine replacement therapy (NRT).
Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to provide biochemical verification of smoking status using a portable carbon monoxide measurement tool. All intervention and assessment procedures will be conducted digitally.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
California
-
San Francisco, California, Yhdysvallat, 94143
- University of California, San Francisco
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Daily smoker
- Self-identify as sexual and/or gender minority
- Interested in quitting in next 6 months
- 6 months of Facebook experience
- English-speaking
Exclusion Criteria:
- Contraindications to nicotine replacement therapy
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Pride Posts
This six month intervention will be conducted on the Facebook platform.
Participants will receive regular social media posts tailored to the sexual and gender minority communities (LGBTQ+).
Weekly live sessions with a tobacco expert will be available.
Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge).
Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
|
This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers.
The intervention is group-based and includes daily posts and weekly live sessions during the initial three months.
Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.
Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette. |
|
Kokeellinen: Pride Posts Plus
This six month intervention will include all elements of the Pride Posts arm.
In addition, the intervention will include gamification, gaming elements designed to encourage participation in the program and behavior change.
Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge).
Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
|
This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers.
The intervention is group-based and includes daily posts and weekly live sessions during the initial three months.
Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.
Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette.
Gaming elements designed to encourage participation in the program and behavior change.
|
|
Active Comparator: Usual Care Condition
Participants in this arm will be provided with a referral to smokefree.gov,
a federally-funded website which provides support and digital-based interventions to assist in smoking cessation activities.
Participants will also have access to up to six months of nicotine replacement therapy (patch + gum/lozenge).
Dosage will be based manufacturer's recommendations which are based on self-reported smoking behaviors.
|
Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors. In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months
Aikaikkuna: 3 months
|
Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 3 month assessment.
|
3 months
|
|
Number of Participants With Reported 7-day Biochemically Verified Abstinence at 6 Months
Aikaikkuna: 6 months
|
Abstinence is defined by all participants who report no smoking within the last 7 days will use a breathalyzer to measure carbon monoxide levels in the breath to verify smoking abstinence prior to the 6 month assessment.
|
6 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
Aikaikkuna: 3 to 6 months
|
Participants will report intentional quit attempts lasting at least 24 hours since treatment initiation or previous assessment
|
3 to 6 months
|
|
Responses to the Thoughts About Abstinence Questionnaire Over Time
Aikaikkuna: 3 to 6 months
|
The Thoughts About Abstinence Questionnaire is a 5 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty.
|
3 to 6 months
|
|
Frequency of social media posts
Aikaikkuna: 3 to 6 months
|
Treatment engagement as measured by frequency of social media posts
|
3 to 6 months
|
|
Frequency of participation in live group sessions
Aikaikkuna: 3 to 6 months
|
Treatment engagement as measured by participation in live group sessions
|
3 to 6 months
|
|
Duration of Active Participation
Aikaikkuna: 3 to 6 months
|
Treatment engagement as measured by duration of active participation in intervention.
|
3 to 6 months
|
Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Gary Humfleet, PhD, University of California, San Francisco
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Mielenterveyshäiriöt
- Kemiallisesti aiheutetut häiriöt
- Aineisiin liittyvät häiriöt
- Tupakan käyttöhäiriö
- Huumeiden fysiologiset vaikutukset
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Autonomiset agentit
- Ääreishermoston aineet
- Kolinergiset aineet
- Ganglioniset stimulantit
- Nikotiiniagonistit
- Kolinergiset agonistit
- Nikotiini
Muut tutkimustunnusnumerot
- TRDRP - T29IP0461
Yksittäisten osallistujien tietojen suunnitelma (IPD)
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