Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment
Social Media-Based Treatment: Engaging Sexual and Gender Minority Smokers
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
San Francisco、California、アメリカ、94143
- University of California, San Francisco
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
実験的：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.
|
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Reported 7-day Biochemically Verified Abstinence at 3 Months
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment
時間枠：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
時間枠：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
時間枠：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
時間枠：3 to 6 months
|
Treatment engagement as measured by participation in live group sessions
|
3 to 6 months
|
|
Duration of Active Participation
時間枠：3 to 6 months
|
Treatment engagement as measured by duration of active participation in intervention.
|
3 to 6 months
|
協力者と研究者
捜査官
- 主任研究者：Gary Humfleet, PhD、University of California, San Francisco
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TRDRP - T29IP0461
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。