- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03027466
Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging
Background:
Quitting smoking is hard. It is easy to relapse. Smokers may think of temptation to smoke as a threat if they think it suggests that they are unable to meet the challenges of stopping. When people feel such a threat to their sense of self-identity, they may get defensive. They may want to downplay the importance of quitting. This could make them try to quit less. Self-affirmation is a process of focusing on strengths and values. This can offset threats to the self and promote healthier behavior.
Objective:
To explore people s values, smoking attitudes, and smoking behavior.
Eligibility:
People ages 18 and older who smoke
Design:
The study takes place entirely on a mobile device.
Participants will give their age, gender, data about their smoking habits, and desired quit date.
Then they will get different texts about quitting.
Participants will answer follow-up surveys 1 and 3 months later.
...
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20892
- National Cancer Institute (NCI)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
- INCLUSION/EXCLUSION:
- Because the app is designed to assist with smoking cessation, all smokers are eligible to participate.
- Subjects are eligible if they are 18+ years of age.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Baseline Affirmation and Affirmation Texts
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study and will receive affirmation text messages throughout the study
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Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below).
Those in the control condition will receive no changes to the app (standard of care control condition).
Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving.
These will show up in a screen that shows Tips.
We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
|
활성 비교기: Baseline Affirmation and No Affirmation Texts
Participants will be given a "Baseline Affirmation" Quiz at the beginning of the study but will not receive affirmation text messages throughout the study
|
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below).
Those in the control condition will receive no changes to the app (standard of care control condition).
Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving.
These will show up in a screen that shows Tips.
We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
|
활성 비교기: No Baseline Affirmation and Affirmation Texts
Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study
|
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below).
Those in the control condition will receive no changes to the app (standard of care control condition).
Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving.
These will show up in a screen that shows Tips.
We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
|
위약 비교기: No Baseline Affirmation and No Affirmation Texts
Participants will experience the Smoke Free United Kingdom (UK) app without any affirmation content Smoke Free UK app (no baseline affirmation quiz and no affirmation text messages)
|
Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below).
Those in the control condition will receive no changes to the app (standard of care control condition).
Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving.
These will show up in a screen that shows Tips.
We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Reporting a Quit Attempt Within the Past Week at 1 Month and 3 Months
기간: 1 month and 3 months
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Participants were asked to report the number of times they attempted to quit smoking at 1 month and 3 months.
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1 month and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Days Participants Remained Smoke-free at the 1 and 3 Month Follow-up
기간: 1 month and 3 months follow-up
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Participants were asked the number of days they have remained smoke-free at the 1 and 3 month follow-up.
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1 month and 3 months follow-up
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Type of Tobacco Products
기간: 1 month and 3 months follow-up
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Participants will be asked the type of tobacco products they use at the 1 and 3 month follow-up.
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1 month and 3 months follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: William M Klein, Ph.D., National Cancer Institute (NCI)
간행물 및 유용한 링크
일반 간행물
- Armitage CJ, Harris PR, Hepton G, Napper L. Self-affirmation increases acceptance of health-risk information among UK adult smokers with low socioeconomic status. Psychol Addict Behav. 2008 Mar;22(1):88-95. doi: 10.1037/0893-164X.22.1.88.
- Spohr SA, Nandy R, Gandhiraj D, Vemulapalli A, Anne S, Walters ST. Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. J Subst Abuse Treat. 2015 Sep;56:1-10. doi: 10.1016/j.jsat.2015.01.011. Epub 2015 Feb 2.
- Cohen GL, Garcia J, Purdie-Vaughns V, Apfel N, Brzustoski P. Recursive processes in self-affirmation: intervening to close the minority achievement gap. Science. 2009 Apr 17;324(5925):400-3. doi: 10.1126/science.1170769.
- Seaman EL, Robinson CD, Crane D, Taber JM, Ferrer RA, Harris PR, Klein WMP. Association of Spontaneous and Induced Self-Affirmation With Smoking Cessation in Users of a Mobile App: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 5;23(3):e18433. doi: 10.2196/18433.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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