<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/NCT03295409</url>
  </required_header>
  <id_info>
    <org_study_id>Chun_1</org_study_id>
    <nct_id>NCT03295409</nct_id>
  </id_info>
  <brief_title>Testing Familial Self-affirmation for Smoking Cessation</brief_title>
  <official_title>Testing Familial Self-affirmation for Smoking Cessation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manchester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evidence suggests that affirming the self can help people to make changes in their health&#xD;
      behavior. Typically, people affirm a personally-important value, but evidence suggests that&#xD;
      affirming the values of family (&quot;familial self-affirmation&quot;) might exert stronger effects.&#xD;
      The aim of the present study is to examine the effects of familial self-affirmation versus&#xD;
      standard self-affirmation versus a control group on smoking cessation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking cessation</measure>
    <time_frame>1 month</time_frame>
    <description>Self-reported quitting</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quit attempts</measure>
    <time_frame>1 month</time_frame>
    <description>Self-reported quit attempts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nicotine dependence</measure>
    <time_frame>1 month</time_frame>
    <description>Self-reported nicotine dependence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Craving</measure>
    <time_frame>1 month</time_frame>
    <description>Self-reported cravings</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Habit</measure>
    <time_frame>1 month</time_frame>
    <description>Self-reported habit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-regulation</measure>
    <time_frame>1 month</time_frame>
    <description>Self-reported self-regulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective well-being</measure>
    <time_frame>1 month</time_frame>
    <description>Self-reported subjective well-being</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Experimental: Standard self-affirmation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are asked to form a self-affirming implementation intention at the end of a questionnaire:&#xD;
The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines below, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you.&#xD;
If I feel threatened or anxious, then I will…&#xD;
think about the things I value about myself&#xD;
remember things that I have succeeded in&#xD;
think about what I stand for&#xD;
think about things that are important to me&#xD;
If…___________________________________________________________________</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Familial self-affirmation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are asked to form a self-affirming implementation intention at the end of a questionnaire:&#xD;
The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines below, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you.&#xD;
If I feel threatened or anxious, then I will…&#xD;
think about the things my family and I value about ourselves&#xD;
remember things that my family and I have succeeded in&#xD;
think about what my family and I stand for&#xD;
think about things that are important to my family and me&#xD;
If…__________________________________________________________________</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants are asked to complete a questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-affirmation</intervention_name>
    <description>Participants are asked to complete a standard questionnaire and on the last page they are asked to form a self-affirming implementation intention by copying out a sentence.</description>
    <arm_group_label>Experimental: Familial self-affirmation</arm_group_label>
    <arm_group_label>Experimental: Standard self-affirmation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
          -  Unable or unwilling to complete questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HC Engineering Company</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perfect Match Wedding Service</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Christopher Armitage</investigator_full_name>
    <investigator_title>Professor of Health Psychology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Anonymised SPSS file</ipd_description>
  </patient_data>
  <!-- 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/NCT03295409
org study id: Chun_1
nct id: NCT03295409
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evidence suggests that affirming the self can help people to make changes in their health
      behavior. Typically, people affirm a personally-important value, but evidence suggests that
      affirming the values of family ("familial self-affirmation") might exert stronger effects.
      The aim of the present study is to examine the effects of familial self-affirmation versus
      standard self-affirmation versus a control group on smoking cessation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Smoking cessation
time frame: 1 month
description: Self-reported quitting
measure: Quit attempts
time frame: 1 month
description: Self-reported quit attempts
measure: Nicotine dependence
time frame: 1 month
description: Self-reported nicotine dependence
measure: Craving
time frame: 1 month
description: Self-reported cravings
measure: Habit
time frame: 1 month
description: Self-reported habit
measure: Self-regulation
time frame: 1 month
description: Self-reported self-regulation
measure: Subjective well-being
time frame: 1 month
description: Self-reported subjective well-being
arm group label: Experimental: Standard self-affirmation
arm group type: Experimental
description: Participants are asked to form a self-affirming implementation intention at the end of a questionnaire:
The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines below, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you.
If I feel threatened or anxious, then I will…
think about the things I value about myself
remember things that I have succeeded in
think about what I stand for
think about things that are important to me
If…___________________________________________________________________
arm group label: Experimental: Familial self-affirmation
arm group type: Experimental
description: Participants are asked to form a self-affirming implementation intention at the end of a questionnaire:
The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines below, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you.
If I feel threatened or anxious, then I will…
think about the things my family and I value about ourselves
remember things that my family and I have succeeded in
think about what my family and I stand for
think about things that are important to my family and me
If…__________________________________________________________________
arm group label: Control
arm group type: No Intervention
description: Participants are asked to complete a questionnaire.
intervention type: Behavioral
intervention name: Self-affirmation
description: Participants are asked to complete a standard questionnaire and on the last page they are asked to form a self-affirming implementation intention by copying out a sentence.
arm group label: Experimental: Familial self-affirmation
arm group label: Experimental: Standard self-affirmation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Christopher Armitage
investigator title: Professor of Health Psychology
sharing ipd: Undecided
ipd description: Anonymised SPSS file