<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/NCT03749382</url>
  </required_header>
  <id_info>
    <org_study_id>0245</org_study_id>
    <nct_id>NCT03749382</nct_id>
  </id_info>
  <brief_title>Testing Smoking Interventions in Women</brief_title>
  <official_title>A Randomized Controlled Trial of Smoking Interventions in Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester Metropolitan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Manchester Metropolitan University</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>
      The study is a randomised controlled trial (RCT) designed to test two tailored conditions of&#xD;
      an appearance-based intervention for smoking in female smokers, compared to a control group&#xD;
      administered a general stop smoking intervention.&#xD;
&#xD;
      The intervention delivery is being tested to assess whether the level of physiological&#xD;
      arousal evoked by the intervention and the instruction type has an influence on the outcome&#xD;
      measures. To do this one condition will receive the intervention with a neutral instruction&#xD;
      and the other the intervention with additional instructions, measures of physiological stress&#xD;
      reactivity will be used to measure level of stress evoked by the intervention and delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Despite health-related smoking cessation campaigns, still one in five of adults in the UK&#xD;
      smokes and it is estimated that half of all regular smokers will eventually die from&#xD;
      smoking-related diseases. Innovative smoking cessation campaigns are needed to reach the&#xD;
      remaining smoker population and prevent smoking-related diseases.&#xD;
&#xD;
      Smoking interventions have previously focused on smoking impact on health. However, besides&#xD;
      health-related diseases, smoking causes aging effects to the skin and recent research&#xD;
      suggests that smoking interventions based on threats to appearance may be more effective.&#xD;
      Further research using an age-appearance facial morphing intervention for smoking, which&#xD;
      shows women realistic images of the effects of smoking on their own face, research found that&#xD;
      female smokers aged 18-34 reported increased motivation to quit after the intervention.&#xD;
      Quantitative results from a randomised control trial support the interventions effectiveness&#xD;
      .&#xD;
&#xD;
      The previous research on appearance-based interventions for smoking show promising results&#xD;
      however these studies had report small sample sizes and differences in the age range of&#xD;
      participants. Additionally, previous research has focused on the primary outcome measures of&#xD;
      smoking including smoking cognitions, behaviours and CO readings and have not investigated&#xD;
      further moderating variables such as, anxiety, depression, appearance orientation and stage&#xD;
      of change.&#xD;
&#xD;
      In previous research participants have consistently reported a 'shock' reaction, and findings&#xD;
      from a pilot and feasibility study (unpublished) suggest that this 'shock' reaction as&#xD;
      measured by physiological reactivity to the intervention could mediate smoking outcomes.&#xD;
      Therefore, the present research proposes to assess facial morphing intervention effectiveness&#xD;
      in relation to individual's physiological shock reactions to viewing the morphed images and&#xD;
      moderator variables in a large sample of women across a broad age range.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      Primary Objectives- To assess effectiveness of an appearance-based intervention on smoking&#xD;
      outcomes in a female population (18-55 years old) immediately after the intervention session&#xD;
      and at 1, 3 and 6 months post intervention session. In addition to compare the results to&#xD;
      that of a standard stop smoking intervention.&#xD;
&#xD;
      An additional primary objective will be to compare the primary outcome measures for both&#xD;
      appearance-based intervention instruction conditions (neutral vs additional) immediately&#xD;
      after the intervention and at 1, 3 and 6 months after to assess which instruction type is&#xD;
      more effective in reducing smoking behaviour.&#xD;
&#xD;
      Other objectives-&#xD;
&#xD;
        1. Investigate the mediating effects of physiological arousal [measured during the&#xD;
           intervention by electro dermal activity and beats per a minute (BPM, derived from pulse&#xD;
           rate)] on the intervention efficacy as measured by the primary and secondary outcome&#xD;
           measures.&#xD;
&#xD;
        2. Investigate the impact of moderating variables on the primary outcome measures.&#xD;
&#xD;
      Measures&#xD;
&#xD;
      Outcome measures -&#xD;
&#xD;
        1. The primary outcomes will be smoking intentions measured pre, immediately after and at&#xD;
           1, 3 and 6 months post intervention.&#xD;
&#xD;
        2. Secondary outcome measures will be smoking cognitions (attitudes, subjective norms and&#xD;
           perceived behavioural control), nicotine dependence and self-reported smoking behaviour&#xD;
           measured pre, immediately after and at 1, 3 and 6 month post the intervention.&#xD;
&#xD;
      Participants:&#xD;
&#xD;
      Current female smokers aged 18-55 will be recruited and randomised into one of three&#xD;
      conditions. (1) Appearance-based intervention neutral, (2) Appearance-based intervention&#xD;
      additional instructions, (3) Control general stop smoking intervention. Participants are&#xD;
      eligible to take part if they are a female between the ages of 18-55 and that they smoke at&#xD;
      least one cigarette a week. Participants are informed to withhold from taking part if they&#xD;
      have any mental health issues that may be affected by appearance-based imagery.&#xD;
&#xD;
      Randomisation will be achieved through using SPSS (V25) to create two sets of randomisation&#xD;
      one for participants over the age of 35 and another for women under the age 35 to allow an&#xD;
      equal distribution of ages into each condition.&#xD;
&#xD;
      Protocol:&#xD;
&#xD;
      At the start of the intervention session participants will be asked to provide informed&#xD;
      consent, immediately after electrodes and a light sensor will be placed on the participants&#xD;
      non-dominant hand. Participants are then asked to fill in a self-report questionnaire&#xD;
      including demographic questions and stress confounders, smoking behaviour, cognitions and&#xD;
      quit attempts, levels of anxiety and depression, how much they consider their future&#xD;
      consequences and how they view their appearance.&#xD;
&#xD;
      Participants in the two appearance-based interventions groups will then have a photo taken of&#xD;
      their face and aged with the effects of smoking in a range of morphing sequences and then&#xD;
      given a general stop smoking booklet alternatively participants allocated to the control&#xD;
      condition will be asked to only read a general stop smoking intervention booklet. All three&#xD;
      conditions will then be asked to provide carbon monoxide breath reading using a hand held&#xD;
      battery operated device. The participants smoking cognitions and behaviours will then be&#xD;
      measured again immediately and longer term at 1, 3 and 6 months post intervention.&#xD;
&#xD;
      Sample size calculation:&#xD;
&#xD;
      In a previous randomized controlled trial (RCT) on an appearance-based intervention for&#xD;
      female smokers , 35 women were allocated to one of two conditions (control group or&#xD;
      intervention) with a reported effect size of d=.63 for nicotine dependence at 4 weeks&#xD;
      post-intervention. Based on previous research and to account for a 30% dropout at six-month&#xD;
      follow up 50 participants per group is required in the current study. Additionally, an a&#xD;
      priori power analysis has been conducted using GPower which supports the specified number of&#xD;
      participants per group. Specifically, to obtain a medium effect of .25 and a power of .80 at&#xD;
      alpha .05, a total sample of 158 is required (52 per group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">August 20, 2020</completion_date>
  <primary_completion_date type="Actual">August 20, 2020</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>
    <intervention_model_description>Parallel assignment</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will receive a brief description of both the appearance-based intervention and general stop smoking intervention. Participants will not know prior to taking part which condition they will be randomised into, on completion of the intervention it will become apparent whether they received the appearance-based intervention or general intervention. For participants randomised to the appearance intervention the instruction type will remain concealed. The investigator will not be blind throughout.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Smoking Intentions</measure>
    <time_frame>Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.</time_frame>
    <description>Smoking Intentions, which are intentions the participant has to quit smoking are measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Three items are each asked on a 13-point scale producing a combined score between 0-39. The score from each individual item is then averaged together to create a total score for smoking intentions. The higher the averaged score the more intention the participant has to quit smoking.The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Smoking Attitudes</measure>
    <time_frame>Measures obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.</time_frame>
    <description>Smoking Attitudes, is the attitude a participant has to smoking cessation, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Four items are each asked on a 13-point scale producing a score between 0-52. Scores from individual items are then averaged together to create a total score for Smoking Attitudes. The higher the averaged score the more positive the participants attitude is to smoking cessation. The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Smoking Subjective Norms</measure>
    <time_frame>Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.</time_frame>
    <description>Smoking Subjective Norms, is the perceived social pressure the participant feels to stop smoking, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Three items are each asked on a 13-point scale producing a combined score between 0-39. Scores from each individual item is then averaged together to create a total score for Smoking Subjective Norms. The higher the averaged score the more the participants feels it socially acceptable to quit smoking .The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Smoking Perceived Behavioural Control</measure>
    <time_frame>Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.</time_frame>
    <description>Smoking Subjective Perceived Behavioural Control, is the Perceived Control the participant has over their own smoking behaviour, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Four items are each asked on a 13-point scale producing a combined score between 0-52. Scores from each individual item is then averaged together to create a total score for Smoking Perceived Behavioural Control. The higher the averaged score the more control a participants feels they have over their own smoking behaviour. The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Nicotine dependence</measure>
    <time_frame>Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.</time_frame>
    <description>Nicotine dependence as measured by the Fagerstrom test for nicotine dependence (Heatherton et al.,1991) a validated instrument that determines the extent to which participants are physically addicted to nicotine. The measure includes six items that are summed to create a score between 0-10. Higher scores equate to a higher dependence to nicotine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-reported smoking behaviour</measure>
    <time_frame>Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.</time_frame>
    <description>Participants report the amount of cigarettes smoked each day for the week prior to each measurement time point, the cigarettes consumed on each day are summed to create a total cigarette consumption score for the week. The measure is administered to the participant as part of the Smoking Questionnaire (Grogan et al., 2011).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Intervention Neutral instructions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Appearance based intervention group delivered with neutral instructions from the investigator alongside general stop smoking intervention leaflet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Additional instructions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Appearance based intervention group delivered with neutral instructions with additional reassuring messages from the investigator alongside general stop smoking intervention leaflet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Neutral task plus the general stop smoking intervention in the form of a leaflet, administered by the investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AprilAge- facial morphing appearance based intervention for smoking</intervention_name>
    <description>Appearance-based intervention: The intervention is a software that ages an individual's face with and without the effects of smoking. Participants have their photo taken on a laptop webcam, they are then asked to report their age and ethnicity in order to calibrate the software, the participants picture is then matched to a stock image. The participants will see two images on the screen, on the left is there face aged without the effects of smoking and one the right aged with the effects of smoking. Participants will be led through a series of morphing sequences (1-5). In-between each of the morphing sequences (Morph1 to Morph5) the participant will be asked to comment on the differences they can see between the two images.&#xD;
General stop smoking intervention: The General stop smoking intervention comes in the form of a NHS stop smoking information leaflet. The participants will be given the leaflet on a laptop screen and asked to read through the whole document.</description>
    <arm_group_label>Intervention Additional instructions</arm_group_label>
    <arm_group_label>Intervention Neutral instructions</arm_group_label>
    <other_name>Appearance-based intervention</other_name>
    <other_name>Appearance orientated intervention</other_name>
    <other_name>Internet-based Photo aging intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Aged 18-55&#xD;
&#xD;
          -  Smoke at least 1 cigarette a week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Self-reported appearance related mental health issue&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Brooks Building</name>
      <address>
        <city>Manchester</city>
        <zip>M156GX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.</citation>
    <PMID>11832252</PMID>
  </reference>
  <reference>
    <citation>Borrelli B, Mermelstein R. The role of weight concern and self-efficacy in smoking cessation and weight gain among smokers in a clinic-based cessation program. Addict Behav. 1998 Sep-Oct;23(5):609-22. doi: 10.1016/s0306-4603(98)00014-8.</citation>
    <PMID>9768298</PMID>
  </reference>
  <reference>
    <citation>Cash, T. F. (2016) 'Multidimensional Body-Self Relations Questionnaire (MBSRQ).' In Wade, T. (ed.) Encyclopedia of Feeding and Eating Disorders. Singapore: Springer Singapore, pp. 1-4.</citation>
  </reference>
  <reference>
    <citation>DiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The process of smoking cessation: an analysis of precontemplation, contemplation, and preparation stages of change. J Consult Clin Psychol. 1991 Apr;59(2):295-304. doi: 10.1037//0022-006x.59.2.295.</citation>
    <PMID>2030191</PMID>
  </reference>
  <reference>
    <citation>Flett K, Clark-Carter D, Grogan S, Davey R. How effective are physical appearance interventions in changing smoking perceptions, attitudes and behaviours? A systematic review. Tob Control. 2013 Mar;22(2):74-9. doi: 10.1136/tobaccocontrol-2011-050236. Epub 2012 May 9.</citation>
    <PMID>22573734</PMID>
  </reference>
  <reference>
    <citation>Flett K, Grogan S, Clark-Carter D, Gough B, Conner M. Male smokers' experiences of an appearance-focused facial-ageing intervention. J Health Psychol. 2017 Mar;22(4):422-433. doi: 10.1177/1359105315603477. Epub 2016 Jul 10.</citation>
    <PMID>26338489</PMID>
  </reference>
  <reference>
    <citation>Grogan S, Flett K, Clark-Carter D, Gough B, Davey R, Richardson D, Rajaratnam G. Women smokers' experiences of an age-appearance anti-smoking intervention: a qualitative study. Br J Health Psychol. 2011 Nov;16(4):675-89. doi: 10.1348/2044-8287.002006. Epub 2010 Dec 6.</citation>
    <PMID>21199543</PMID>
  </reference>
  <reference>
    <citation>Grogan S, Flett K, Clark-Carter D, Conner M, Davey R, Richardson D, Rajaratnam G. A randomized controlled trial of an appearance-related smoking intervention. Health Psychol. 2011 Nov;30(6):805-9. doi: 10.1037/a0024745. Epub 2011 Jul 18.</citation>
    <PMID>21767016</PMID>
  </reference>
  <reference>
    <citation>Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011 Jul;2(3):109-12. doi: 10.4103/2229-3485.83221.</citation>
    <PMID>21897887</PMID>
  </reference>
  <reference>
    <citation>Koh JS, Kang H, Choi SW, Kim HO. Cigarette smoking associated with premature facial wrinkling: image analysis of facial skin replicas. Int J Dermatol. 2002 Jan;41(1):21-7. doi: 10.1046/j.1365-4362.2002.01352.x.</citation>
    <PMID>11895509</PMID>
  </reference>
  <reference>
    <citation>Strathman, A., Gleicher, F., Boninger, D. S. and Edwards, C. S. (1994) 'The consideration of future consequences: Weighing immediate and distant outcomes of behavior.' Journal of Personality and Social Psychology, 66(4) pp. 742-752.</citation>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Manchester Metropolitan University</investigator_affiliation>
    <investigator_full_name>Lucy Walker</investigator_full_name>
    <investigator_title>Prinical Investigator</investigator_title>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>Tobacco</keyword>
  <keyword>Cessation</keyword>
  <keyword>Intervention</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03749382
org study id: 0245
nct id: NCT03749382
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a randomised controlled trial (RCT) designed to test two tailored conditions of
      an appearance-based intervention for smoking in female smokers, compared to a control group
      administered a general stop smoking intervention.

      The intervention delivery is being tested to assess whether the level of physiological
      arousal evoked by the intervention and the instruction type has an influence on the outcome
      measures. To do this one condition will receive the intervention with a neutral instruction
      and the other the intervention with additional instructions, measures of physiological stress
      reactivity will be used to measure level of stress evoked by the intervention and delivery.
Background

      Despite health-related smoking cessation campaigns, still one in five of adults in the UK
      smokes and it is estimated that half of all regular smokers will eventually die from
      smoking-related diseases. Innovative smoking cessation campaigns are needed to reach the
      remaining smoker population and prevent smoking-related diseases.

      Smoking interventions have previously focused on smoking impact on health. However, besides
      health-related diseases, smoking causes aging effects to the skin and recent research
      suggests that smoking interventions based on threats to appearance may be more effective.
      Further research using an age-appearance facial morphing intervention for smoking, which
      shows women realistic images of the effects of smoking on their own face, research found that
      female smokers aged 18-34 reported increased motivation to quit after the intervention.
      Quantitative results from a randomised control trial support the interventions effectiveness
      .

      The previous research on appearance-based interventions for smoking show promising results
      however these studies had report small sample sizes and differences in the age range of
      participants. Additionally, previous research has focused on the primary outcome measures of
      smoking including smoking cognitions, behaviours and CO readings and have not investigated
      further moderating variables such as, anxiety, depression, appearance orientation and stage
      of change.

      In previous research participants have consistently reported a 'shock' reaction, and findings
      from a pilot and feasibility study (unpublished) suggest that this 'shock' reaction as
      measured by physiological reactivity to the intervention could mediate smoking outcomes.
      Therefore, the present research proposes to assess facial morphing intervention effectiveness
      in relation to individual's physiological shock reactions to viewing the morphed images and
      moderator variables in a large sample of women across a broad age range.

      Objectives:

      Primary Objectives- To assess effectiveness of an appearance-based intervention on smoking
      outcomes in a female population (18-55 years old) immediately after the intervention session
      and at 1, 3 and 6 months post intervention session. In addition to compare the results to
      that of a standard stop smoking intervention.

      An additional primary objective will be to compare the primary outcome measures for both
      appearance-based intervention instruction conditions (neutral vs additional) immediately
      after the intervention and at 1, 3 and 6 months after to assess which instruction type is
      more effective in reducing smoking behaviour.

      Other objectives-

        1. Investigate the mediating effects of physiological arousal [measured during the
           intervention by electro dermal activity and beats per a minute (BPM, derived from pulse
           rate)] on the intervention efficacy as measured by the primary and secondary outcome
           measures.

        2. Investigate the impact of moderating variables on the primary outcome measures.

      Measures

      Outcome measures -

        1. The primary outcomes will be smoking intentions measured pre, immediately after and at
           1, 3 and 6 months post intervention.

        2. Secondary outcome measures will be smoking cognitions (attitudes, subjective norms and
           perceived behavioural control), nicotine dependence and self-reported smoking behaviour
           measured pre, immediately after and at 1, 3 and 6 month post the intervention.

      Participants:

      Current female smokers aged 18-55 will be recruited and randomised into one of three
      conditions. (1) Appearance-based intervention neutral, (2) Appearance-based intervention
      additional instructions, (3) Control general stop smoking intervention. Participants are
      eligible to take part if they are a female between the ages of 18-55 and that they smoke at
      least one cigarette a week. Participants are informed to withhold from taking part if they
      have any mental health issues that may be affected by appearance-based imagery.

      Randomisation will be achieved through using SPSS (V25) to create two sets of randomisation
      one for participants over the age of 35 and another for women under the age 35 to allow an
      equal distribution of ages into each condition.

      Protocol:

      At the start of the intervention session participants will be asked to provide informed
      consent, immediately after electrodes and a light sensor will be placed on the participants
      non-dominant hand. Participants are then asked to fill in a self-report questionnaire
      including demographic questions and stress confounders, smoking behaviour, cognitions and
      quit attempts, levels of anxiety and depression, how much they consider their future
      consequences and how they view their appearance.

      Participants in the two appearance-based interventions groups will then have a photo taken of
      their face and aged with the effects of smoking in a range of morphing sequences and then
      given a general stop smoking booklet alternatively participants allocated to the control
      condition will be asked to only read a general stop smoking intervention booklet. All three
      conditions will then be asked to provide carbon monoxide breath reading using a hand held
      battery operated device. The participants smoking cognitions and behaviours will then be
      measured again immediately and longer term at 1, 3 and 6 months post intervention.

      Sample size calculation:

      In a previous randomized controlled trial (RCT) on an appearance-based intervention for
      female smokers , 35 women were allocated to one of two conditions (control group or
      intervention) with a reported effect size of d=.63 for nicotine dependence at 4 weeks
      post-intervention. Based on previous research and to account for a 30% dropout at six-month
      follow up 50 participants per group is required in the current study. Additionally, an a
      priori power analysis has been conducted using GPower which supports the specified number of
      participants per group. Specifically, to obtain a medium effect of .25 and a power of .80 at
      alpha .05, a total sample of 158 is required (52 per group).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel assignment
primary purpose: Other
masking: Single (Participant)
masking description: Participants will receive a brief description of both the appearance-based intervention and general stop smoking intervention. Participants will not know prior to taking part which condition they will be randomised into, on completion of the intervention it will become apparent whether they received the appearance-based intervention or general intervention. For participants randomised to the appearance intervention the instruction type will remain concealed. The investigator will not be blind throughout.
measure: Change in Smoking Intentions
time frame: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
description: Smoking Intentions, which are intentions the participant has to quit smoking are measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Three items are each asked on a 13-point scale producing a combined score between 0-39. The score from each individual item is then averaged together to create a total score for smoking intentions. The higher the averaged score the more intention the participant has to quit smoking.The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).
measure: Change in Smoking Attitudes
time frame: Measures obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
description: Smoking Attitudes, is the attitude a participant has to smoking cessation, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Four items are each asked on a 13-point scale producing a score between 0-52. Scores from individual items are then averaged together to create a total score for Smoking Attitudes. The higher the averaged score the more positive the participants attitude is to smoking cessation. The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).
measure: Change in Smoking Subjective Norms
time frame: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
description: Smoking Subjective Norms, is the perceived social pressure the participant feels to stop smoking, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Three items are each asked on a 13-point scale producing a combined score between 0-39. Scores from each individual item is then averaged together to create a total score for Smoking Subjective Norms. The higher the averaged score the more the participants feels it socially acceptable to quit smoking .The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).
measure: Change in Smoking Perceived Behavioural Control
time frame: Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention.
description: Smoking Subjective Perceived Behavioural Control, is the Perceived Control the participant has over their own smoking behaviour, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Four items are each asked on a 13-point scale producing a combined score between 0-52. Scores from each individual item is then averaged together to create a total score for Smoking Perceived Behavioural Control. The higher the averaged score the more control a participants feels they have over their own smoking behaviour. The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011).
measure: Change in Nicotine dependence
time frame: Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.
description: Nicotine dependence as measured by the Fagerstrom test for nicotine dependence (Heatherton et al.,1991) a validated instrument that determines the extent to which participants are physically addicted to nicotine. The measure includes six items that are summed to create a score between 0-10. Higher scores equate to a higher dependence to nicotine.
measure: Change in Self-reported smoking behaviour
time frame: Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention.
description: Participants report the amount of cigarettes smoked each day for the week prior to each measurement time point, the cigarettes consumed on each day are summed to create a total cigarette consumption score for the week. The measure is administered to the participant as part of the Smoking Questionnaire (Grogan et al., 2011).
arm group label: Intervention Neutral instructions
arm group type: Experimental
description: Appearance based intervention group delivered with neutral instructions from the investigator alongside general stop smoking intervention leaflet.
arm group label: Intervention Additional instructions
arm group type: Experimental
description: Appearance based intervention group delivered with neutral instructions with additional reassuring messages from the investigator alongside general stop smoking intervention leaflet.
arm group label: Control
arm group type: No Intervention
description: Neutral task plus the general stop smoking intervention in the form of a leaflet, administered by the investigator.
intervention type: Other
intervention name: AprilAge- facial morphing appearance based intervention for smoking
description: Appearance-based intervention: The intervention is a software that ages an individual's face with and without the effects of smoking. Participants have their photo taken on a laptop webcam, they are then asked to report their age and ethnicity in order to calibrate the software, the participants picture is then matched to a stock image. The participants will see two images on the screen, on the left is there face aged without the effects of smoking and one the right aged with the effects of smoking. Participants will be led through a series of morphing sequences (1-5). In-between each of the morphing sequences (Morph1 to Morph5) the participant will be asked to comment on the differences they can see between the two images.
General stop smoking intervention: The General stop smoking intervention comes in the form of a NHS stop smoking information leaflet. The participants will be given the leaflet on a laptop screen and asked to read through the whole document.
arm group label: Intervention Additional instructions
arm group label: Intervention Neutral instructions
other name: Appearance-based intervention
other name: Appearance orientated intervention
other name: Internet-based Photo aging intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
country: United Kingdom
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PMID: 11832252
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PMID: 9768298
citation: Cash, T. F. (2016) 'Multidimensional Body-Self Relations Questionnaire (MBSRQ).' In Wade, T. (ed.) Encyclopedia of Feeding and Eating Disorders. Singapore: Springer Singapore, pp. 1-4.
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PMID: 2030191
citation: Flett K, Clark-Carter D, Grogan S, Davey R. How effective are physical appearance interventions in changing smoking perceptions, attitudes and behaviours? A systematic review. Tob Control. 2013 Mar;22(2):74-9. doi: 10.1136/tobaccocontrol-2011-050236. Epub 2012 May 9.
PMID: 22573734
citation: Flett K, Grogan S, Clark-Carter D, Gough B, Conner M. Male smokers' experiences of an appearance-focused facial-ageing intervention. J Health Psychol. 2017 Mar;22(4):422-433. doi: 10.1177/1359105315603477. Epub 2016 Jul 10.
PMID: 26338489
citation: Grogan S, Flett K, Clark-Carter D, Gough B, Davey R, Richardson D, Rajaratnam G. Women smokers' experiences of an age-appearance anti-smoking intervention: a qualitative study. Br J Health Psychol. 2011 Nov;16(4):675-89. doi: 10.1348/2044-8287.002006. Epub 2010 Dec 6.
PMID: 21199543
citation: Grogan S, Flett K, Clark-Carter D, Conner M, Davey R, Richardson D, Rajaratnam G. A randomized controlled trial of an appearance-related smoking intervention. Health Psychol. 2011 Nov;30(6):805-9. doi: 10.1037/a0024745. Epub 2011 Jul 18.
PMID: 21767016
citation: Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011 Jul;2(3):109-12. doi: 10.4103/2229-3485.83221.
PMID: 21897887
citation: Koh JS, Kang H, Choi SW, Kim HO. Cigarette smoking associated with premature facial wrinkling: image analysis of facial skin replicas. Int J Dermatol. 2002 Jan;41(1):21-7. doi: 10.1046/j.1365-4362.2002.01352.x.
PMID: 11895509
citation: Strathman, A., Gleicher, F., Boninger, D. S. and Edwards, C. S. (1994) 'The consideration of future consequences: Weighing immediate and distant outcomes of behavior.' Journal of Personality and Social Psychology, 66(4) pp. 742-752.
responsible party type: Principal Investigator
investigator affiliation: Manchester Metropolitan University
investigator full name: Lucy Walker
investigator title: Prinical Investigator
sharing ipd: No