<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01668771</url>
  </required_header>
  <id_info>
    <org_study_id>999912162</org_study_id>
    <secondary_id>12-C-N162</secondary_id>
    <nct_id>NCT01668771</nct_id>
  </id_info>
  <brief_title>Self-Affirmation and Response to Health Risk Information</brief_title>
  <official_title>Self-Affirmation, Affect, and Implementation Intentions for Alcohol Cessation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Self-affirmation is the process of reflecting on values that a person considers important.&#xD;
      This process may encourage people to be more open to information about health risks. It may&#xD;
      also encourage them to change their behaviors or lifestyle to decrease these health risks.&#xD;
      Researchers want to look at the effect of self-affirmation on people s responses to new&#xD;
      health risk information. Because recent studies have linked alcohol consumption to increased&#xD;
      risk of breast cancer, the study will focus on alcohol s link to breast cancer.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      - To study how self-affirmation can change opinions following a message about a health risk.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Women at least 18 years of age who drink at least two alcoholic beverages per week and/or&#xD;
      at least three alcoholic beverages per sitting.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be recruited through an online panel. The study will be conducted&#xD;
           entirely online.&#xD;
&#xD;
        -  Participants will respond to two short studies. The first will ask about life events and&#xD;
           how they make people feel. The second will look at how people respond to information&#xD;
           about alcohol and breast cancer.&#xD;
&#xD;
        -  For the first study, participants will write a paragraph or two about an important event&#xD;
           in their lives. They will answer questions about how that event made them feel. They&#xD;
           will also write a paragraph about an important personal value.&#xD;
&#xD;
        -  For the second study, participants will read information about alcohol and breast cancer&#xD;
           risk. They will then answer questions about this information. They will also answer&#xD;
           questions about their beliefs about alcohol and breast cancer.&#xD;
&#xD;
        -  Participants will receive financial compensation for being in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to examine whether emotional state moderates the effect of self-affirmation&#xD;
      on intentions to engage in proactive behavior following a message about a health threat.&#xD;
      Specifically, we propose to examine whether self-affirmation a process by which individuals&#xD;
      reflect on cherished personal values differentially affects the persuasiveness of a message&#xD;
      about the link between alcohol and breast cancer depending on whether individuals are in a&#xD;
      particular emotional state. Previous evidence suggests that self affirmation may reduce&#xD;
      defensiveness to threatening health information, increasing openness to the message and&#xD;
      resulting in increased disease risk perceptions, disease-related worry, and intentions to&#xD;
      engage in preventive behavior. However, self-affirmation may be differentially effective&#xD;
      depending on the prior emotional state of the individual. Human subjects (women who report&#xD;
      having consumed one or more alcoholic beverages in the past month) will be randomly assigned&#xD;
      to write about an emotional event (something that made them happy, sad, angry, or hopeful) or&#xD;
      to a neutral emotion condition (writing about a room in their house). Then, they will be&#xD;
      randomly assigned to self-affirm (write about why a particular value is important to them) or&#xD;
      to be in a control condition (write about why a particular value might be important to&#xD;
      someone else). Following the autobiographical emotion task and self-affirmation, subjects&#xD;
      will read about the link between alcohol and breast cancer. Finally, they will be asked a&#xD;
      series of questions about their intentions to reduce drinking, their perceived risk of breast&#xD;
      cancer, and their worry about breast cancer. Drawing on previous research, we hypothesize&#xD;
      that self-affirmation will be most effective for those asked to recall a happy or angry&#xD;
      experience, and least effective for those asked to recall a sad or hopeful experience&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 11, 2012</start_date>
  <completion_date>May 13, 2013</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">1116</enrollment>
  <condition>Alcohol Drinking</condition>
  <condition>Emotions</condition>
  <condition>Ego</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Knowledge Networks panel respondents will be included if they are women who report&#xD;
             having consumed the equivalent of 2-3 or more alcoholic beverage per week and/ or 3 or&#xD;
             more alcoholic beverages in one sitting.&#xD;
&#xD;
          -  Women will be included if they report drinking 3 or more drinks on any occasion, or&#xD;
             more than 2-3 times per week.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Women will be excluded if they report never drinking alcohol or drinking monthly or&#xD;
             2-4 times per month, 1-2 drinks or less each time.&#xD;
&#xD;
          -  All men, and women who report a lower threshold of alcohol consumption, will be&#xD;
             excluded&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca A Ferrer, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Cancer Institute (NCI), 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>18298234</PMID>
  </reference>
  <reference>
    <citation>Cavanaugh LA, Cutright KM, Luce MF, Bettman JR. Hope, pride, and processing during optimal and nonoptimal times of day. Emotion. 2011 Feb;11(1):38-46. doi: 10.1037/a0022016.</citation>
    <PMID>21401223</PMID>
  </reference>
  <reference>
    <citation>Crocker J, Niiya Y, Mischkowski D. Why does writing about important values reduce defensiveness? Self-affirmation and the role of positive other-directed feelings. Psychol Sci. 2008 Jul;19(7):740-7. doi: 10.1111/j.1467-9280.2008.02150.x.</citation>
    <PMID>18727791</PMID>
  </reference>
  <verification_date>May 13, 2013</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <keyword>Self-Affirmation</keyword>
  <keyword>Affect</keyword>
  <keyword>Alcohol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01668771
org study id: 999912162
secondary id: 12-C-N162
nct id: NCT01668771
lead sponsor: 
Background:

      - Self-affirmation is the process of reflecting on values that a person considers important.
      This process may encourage people to be more open to information about health risks. It may
      also encourage them to change their behaviors or lifestyle to decrease these health risks.
      Researchers want to look at the effect of self-affirmation on people s responses to new
      health risk information. Because recent studies have linked alcohol consumption to increased
      risk of breast cancer, the study will focus on alcohol s link to breast cancer.

      Objectives:

      - To study how self-affirmation can change opinions following a message about a health risk.

      Eligibility:

      - Women at least 18 years of age who drink at least two alcoholic beverages per week and/or
      at least three alcoholic beverages per sitting.

      Design:

        -  Participants will be recruited through an online panel. The study will be conducted
           entirely online.

        -  Participants will respond to two short studies. The first will ask about life events and
           how they make people feel. The second will look at how people respond to information
           about alcohol and breast cancer.

        -  For the first study, participants will write a paragraph or two about an important event
           in their lives. They will answer questions about how that event made them feel. They
           will also write a paragraph about an important personal value.

        -  For the second study, participants will read information about alcohol and breast cancer
           risk. They will then answer questions about this information. They will also answer
           questions about their beliefs about alcohol and breast cancer.

        -  Participants will receive financial compensation for being in this study.
This study aims to examine whether emotional state moderates the effect of self-affirmation
      on intentions to engage in proactive behavior following a message about a health threat.
      Specifically, we propose to examine whether self-affirmation a process by which individuals
      reflect on cherished personal values differentially affects the persuasiveness of a message
      about the link between alcohol and breast cancer depending on whether individuals are in a
      particular emotional state. Previous evidence suggests that self affirmation may reduce
      defensiveness to threatening health information, increasing openness to the message and
      resulting in increased disease risk perceptions, disease-related worry, and intentions to
      engage in preventive behavior. However, self-affirmation may be differentially effective
      depending on the prior emotional state of the individual. Human subjects (women who report
      having consumed one or more alcoholic beverages in the past month) will be randomly assigned
      to write about an emotional event (something that made them happy, sad, angry, or hopeful) or
      to a neutral emotion condition (writing about a room in their house). Then, they will be
      randomly assigned to self-affirm (write about why a particular value is important to them) or
      to be in a control condition (write about why a particular value might be important to
      someone else). Following the autobiographical emotion task and self-affirmation, subjects
      will read about the link between alcohol and breast cancer. Finally, they will be asked a
      series of questions about their intentions to reduce drinking, their perceived risk of breast
      cancer, and their worry about breast cancer. Drawing on previous research, we hypothesize
      that self-affirmation will be most effective for those asked to recall a happy or angry
      experience, and least effective for those asked to recall a sad or hopeful experience
time perspective: Prospective
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rebecca A Ferrer, Ph.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
citation: 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.
PMID: 18298234
citation: Cavanaugh LA, Cutright KM, Luce MF, Bettman JR. Hope, pride, and processing during optimal and nonoptimal times of day. Emotion. 2011 Feb;11(1):38-46. doi: 10.1037/a0022016.
PMID: 21401223
citation: Crocker J, Niiya Y, Mischkowski D. Why does writing about important values reduce defensiveness? Self-affirmation and the role of positive other-directed feelings. Psychol Sci. 2008 Jul;19(7):740-7. doi: 10.1111/j.1467-9280.2008.02150.x.
PMID: 18727791
mesh term: Alcohol Drinking