NCT03405220

Brief Summary

The aim of these studies is to adapt the self-affirmation kindness questionnaire for use in a mobile application. Two studies will be conducted to test hypotheses that simplifying and shortening the original questionnaire in systematic ways will result in comparable effectiveness (compared to the original version) in promoting reduced defensive avoidance, less reactance, greater yielding, and higher intentions to quit smoking among a sample of smokers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

January 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

January 5, 2018

Last Update Submit

May 18, 2018

Conditions

Keywords

smokingself-affirmationmobile applicationcessation

Outcome Measures

Primary Outcomes (4)

  • Defensive Avoidance

    Indicator of defensive information processing, 3 items (Witte)

    immediately post-intervention

  • Reactance

    Indicator of defensive information processing, 27 items (Hall et al., 2016)

    immediately post-intervention

  • Yielding

    Indicator of defensive information processing, 7 items (Brennan et al., 2011, 2014)

    immediately post-intervention

  • Intentions to quit smoking in the next 3 months

    Intentions to quit smoking, 3 items

    immediately post-intervention

Secondary Outcomes (7)

  • Cognitive perceived likelihood of developing smoking related disease

    immediately post-intervention

  • Perceived severity

    immediately post-intervention

  • Response efficacy of quitting smoking

    immediately post-intervention

  • Self-efficacy to quit smoking

    immediately post-intervention

  • Affective perceived likelihood

    immediately post-intervention

  • +2 more secondary outcomes

Study Arms (15)

Self-affirm, No examples, Study 1

EXPERIMENTAL

Behavioral: Self affirmation, 10 items, no examples

Behavioral: Self affirmation, 10 items, no examples

Self-affirm, Write examples, Study 1

ACTIVE COMPARATOR

Behavioral: Self affirmation, 10 items, written examples

Behavioral: Self affirmation, 10 items, written examples

Self-affirm, Imagine examples, Study 1

EXPERIMENTAL

Behavioral: Self affirmation, 10 items, imagined examples

Behavioral: Self affirmation, 10 items, imagined examples

Opinion survey, No examples, Study 1

NO INTERVENTION

No intervention: control. Participants will complete the 10 item personal opinion survey and will not be asked to provide examples for any items they respond "yes" to.

Opinion survey, Write examples, Study 1

NO INTERVENTION

No intervention: control. Participants will complete the 10 item personal opinion survey and will be asked to provide written examples for each item they respond "yes" to.

Opinion survey, Imagine examples, Study1

NO INTERVENTION

No intervention: control. Participants will complete the 10 item personal opinion survey and will be asked to imagine examples for each item they respond "yes" to.

Self-affirm, 10-item, No ex, Study 2

EXPERIMENTAL

Behavioral: Self affirmation, 10 items, no examples

Behavioral: Self affirmation, 10 items, no examples

Self-affirm, 5-item, No ex, Study 2

EXPERIMENTAL

Behavioral: Self affirmation, 5 items, no examples

Behavioral: Self affirmation, 5 items, no examples

Self-affirm, 3-item, No ex, Study 2

EXPERIMENTAL

Behavioral: Self affirmation, 3 items, no examples

Behavioral: Self affirmation, 3 items, no examples

Self-affirm, 10-item, Write ex, Study 2

ACTIVE COMPARATOR

Behavioral: Self affirmation, 10 items, written examples

Behavioral: Self affirmation, 10 items, written examples

Self-affirm, 5-item, Write ex, Study 2

EXPERIMENTAL

Behavioral: Self affirmation, 5 items, written examples

Behavioral: Self affirmation, 5 items, written examples

Self-affirm, 3-item, Write ex, Study 2

EXPERIMENTAL

Behavioral: Self affirmation, 3 items, written examples

Behavioral: Self affirmation, 3 items, written examples

Self-affirm, 10-item, Imagine ex, Study2

EXPERIMENTAL

Behavioral: Self affirmation, 10 items, imagined examples

Behavioral: Self affirmation, 10 items, imagined examples

Self-affirm, 5-item, Imagine ex, Study 2

EXPERIMENTAL

Behavioral: Self affirmation, 5 items, imagined examples

Behavioral: Self affirmation, 5 items, imagined examples

Self-affirm, 3-item, Imagine ex, Study 2

EXPERIMENTAL

Behavioral: Self affirmation, 3 items, imagined examples

Behavioral: Self affirmation, 3 items, imagined examples

Interventions

Participants will complete the 10 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to.

Self-affirm, 10-item, Write ex, Study 2Self-affirm, Write examples, Study 1

Participants will complete the 10 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to.

Self-affirm, 10-item, No ex, Study 2Self-affirm, No examples, Study 1

Participants will complete the 10 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to.

Self-affirm, 10-item, Imagine ex, Study2Self-affirm, Imagine examples, Study 1

Participants will complete a 5 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to.

Self-affirm, 5-item, Write ex, Study 2

Participants will complete a 5 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to.

Self-affirm, 5-item, No ex, Study 2

Participants will complete a 5 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to.

Self-affirm, 5-item, Imagine ex, Study 2

Participants will complete a 3 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond "yes" to.

Self-affirm, 3-item, Write ex, Study 2

Participants will complete a 3 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond "yes" to.

Self-affirm, 3-item, No ex, Study 2

Participants will complete a 3 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond "yes" to.

Self-affirm, 3-item, Imagine ex, Study 2

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently live in the US
  • years (several states have 21 as minimum legal age to smoke)
  • self-identified every day or some day smoker
  • no prior diagnosis of lung cancer, chronic obstructive pulmonary disease, or emphysema (the most common and well-known smoking-related diseases

You may not qualify if:

  • Not currently living in the US
  • Less than 21 years of age or older than 65
  • Nonsmoker
  • Prior diagnosis of lung cancer, chronic obstructive pulmonary disease, or emphysema (the most common and well-known smoking-related diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kent State University

Kent, Ohio, 44242, United States

Location

Related Publications (1)

  • Reed, M. B., & Aspinwall, L. G. (1998). Self-affirmation reduces biased processing of health-risk information. Motivation and Emotion, 22(2), 99-132.

    BACKGROUND

MeSH Terms

Conditions

SmokingSmoking CessationTobacco Smoking

Condition Hierarchy (Ancestors)

BehaviorHealth BehaviorTobacco Use

Study Officials

  • Jennifer M Taber, PhD

    Kent State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Study 1 will use a 2 (self-affirmation: self-affirmation, control) X 3 (Mode of example: none, write, imagine) experimental design. In the self-affirmation condition, participants will complete the self-affirmation kindness quiz (10 questions) and in the control condition they will complete a personal opinion survey (10 questions). Depending on the mode of example condition, participants will not be asked to provide examples, asked to write examples for each of the 10 questions, or asked to imagine examples for each of the 10 questions. Based on examination of data from Study 1 (i.e., which items receive more "yes" responses and for which items examples are provided), in Study 2 we will test whether using fewer self-affirmation items influences dependent variables. Study 2 will use a 3 (Number of questions: 10, 5, 3) X 3 (Mode of example: none, write, imagine) experimental design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 23, 2018

Study Start

January 16, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations