Integrating Use of Self-Affirmation Content Into a Mobile App to Promote Quit Attempts With Text-Based Smoking Cessation Intervention Messaging

NCT ID: NCT03027466

Last Updated: 2021-07-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7899 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-06

Study Completion Date

2019-09-01

Brief Summary

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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.

...

Detailed Description

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Quitting smoking is challenging and relapse is likely. Smokers may perceive temptation to smoke as threatening if they think it suggests that they are unable to meet the challenges of cessation. When individuals experience such a threat to their sense of self-identity (e.g., to their sense that they have integrity and/ or competence), they often respond defensively. Individuals have a tendency to react defensively to information that informs them that their behavior increases risk for a particular disease or negative health consequences. Self-affirmation a process through which individuals focus on their strengths and values can offset threats to the self and promote healthier behaviors, including smoking cessation. To the extent that relapse or difficulty quitting is perceived as a threat to self-identity, when individuals are presented with the opportunity to self-affirm they may perceive failure as less threatening, mitigating the motivation to downplay the importance of quitting. Preliminary evidence suggests that self-affirmation can be feasibly incorporated into an existing smoking cessation text message-based intervention, and may bolster cessation rates among users motivated to quit smoking. Here, we propose to extend that research by examining whether the addition of self-affirmation text messages to a smoking cessation app (Smoke Free United Kingdom (UK) promotes smoking cessation, compared to standard of care (i.e., existing app content only). Importantly, self-affirmation material will be incorporated into the current app and will not change the goals or nature of the original texting program. We predict that the individuals in the self-affirmation condition will be more likely to report being smoke-free at the 1-month and 3-month follow-ups.

Conditions

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Number of Quit Attempts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Self-affirmation induction

Intervention Type BEHAVIORAL

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.

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

Group Type ACTIVE_COMPARATOR

Self-affirmation induction

Intervention Type BEHAVIORAL

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.

No Baseline Affirmation and Affirmation Texts

Participants will not be given a "Baseline Affirmation Quiz" but will receive affirmation text messages throughout the study

Group Type ACTIVE_COMPARATOR

Self-affirmation induction

Intervention Type BEHAVIORAL

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.

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)

Group Type PLACEBO_COMPARATOR

Self-affirmation induction

Intervention Type BEHAVIORAL

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.

Interventions

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Self-affirmation induction

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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William Klein, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William M Klein, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

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National Cancer Institute (NCI)

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18298234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25720333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19372432 (View on PubMed)

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.

Reference Type RESULT
PMID: 33666561 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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17-C-N039

Identifier Type: -

Identifier Source: secondary_id

999917039

Identifier Type: -

Identifier Source: org_study_id

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