<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/NCT04445974</url>
  </required_header>
  <id_info>
    <org_study_id>165478</org_study_id>
    <nct_id>NCT04445974</nct_id>
  </id_info>
  <brief_title>Testing a Body-functionality Intervention for Body Image in Individuals With Skin Conditions</brief_title>
  <official_title>Can a Brief Body-functionality Writing Intervention Improve Body Image in Individuals Living With a Skin Condition? A Randomised Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sheffield</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sheffield</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>
      'Expand Your Horizons', a self-help writing intervention that seeks to train individuals to&#xD;
      focus on what their body can do (functionality) rather than what it looks like (appearance),&#xD;
      has produced promising results in improving body image. However, it has not been adapted and&#xD;
      trialled in populations with conditions affecting skin appearance. This research therefore&#xD;
      seeks to evaluate the potential for 'Expand Your Horizons' to (1) improve body image, as&#xD;
      measured by body and functionality appreciation; and (2) improve skin-specific outcome, as&#xD;
      measure by skin-shame, dermatology and quality of life, in a population with dermatological&#xD;
      conditions, using a Randomised Control Trail.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Method of sampling/recruitment:&#xD;
&#xD;
      Recruitment from community sample, including: The University staff and student volunteers&#xD;
      lists; Psychology undergraduate credit systems, Social media/forums; Charities; Research&#xD;
      recruitment platforms, and a mailing lists.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      An apriori power analysis, based on an ANCOVA, with a medium effect for the primary outcome&#xD;
      (body appreciation) indicated a sample of 128 would be needed to achieve 80% power. Assuming&#xD;
      an attrition rate of 50%, the total number of participants required will be 256.&#xD;
&#xD;
      In line with recommendations for evaluating interventions, we will include an internal pilot&#xD;
      whereby we review the recruitment progress (completion) about 3 months into the trial and&#xD;
      could then consider whether we need to make any minor or major adjustments to the recruitment&#xD;
      strategy or study. If these substantial changes are needed, the pilot component will be&#xD;
      written up and analysed separately to inform the next phase.&#xD;
&#xD;
      Procedure:&#xD;
&#xD;
      Time-point 1: Participants asked to read information sheet and provide consent. Participants&#xD;
      will then be asked to complete the demographic measures and provide information on their skin&#xD;
      condition(s). Participants will then complete baseline measures of trait body appreciation,&#xD;
      body functionality, and, skin-specific quality of life, appearance anxiety with the order of&#xD;
      these questionnaires counterbalanced. The online system will then randomly allocate&#xD;
      individual meeting the exclusion criteria to either 'Expand Your Horizon' or an active&#xD;
      control, at a ratio of 1:1. Participants will then be asked to complete the first writing&#xD;
      activity and complete state measures&#xD;
&#xD;
      Time-point 2 (approximately 2 days later): Participants asked to complete the second writing&#xD;
      exercise, and rate their state measures.&#xD;
&#xD;
      Time-point 3 (approximately 1 week later): Participants will be asked to complete the final&#xD;
      writing task, before completing state measures and repeating the outcome measures given at&#xD;
      baseline. Participants in both conditions will then be asked to provide feedback on the&#xD;
      intervention.&#xD;
&#xD;
      Time-point 4 (One month later): Participants will be asked to repeat the outcome measures.&#xD;
      Participants will then be shown the debrief screen and told which group they were in.&#xD;
      Participants in the control condition will be offered a link to the intervention.&#xD;
&#xD;
      Analytic strategy:&#xD;
&#xD;
      The data will be initially assessed to check whether they meet the assumptions of the&#xD;
      statistical tests used.&#xD;
&#xD;
      Descriptive statistics will then be used to describe the sample, and to summarise information&#xD;
      on attrition at each point of the study and feedback on the intervention. Demographic and&#xD;
      skin disease-history variables will be assessed for covariance using t-tests, ANOVAs and&#xD;
      bivariate correlations as appropriate.&#xD;
&#xD;
      To assess whether randomisation of allocation to groups (intervention vs control) has been&#xD;
      effective, t-tests and ANOVAs will be used, as appropriate, to compare demographics baseline&#xD;
      measures.&#xD;
&#xD;
      T-tests will also be used to compare the levels of skin-specific appearance satisfaction,&#xD;
      appearance satisfaction and body-functionality satisfaction between participants in both the&#xD;
      intervention and control condition. This will include both intention-to-treat and completer&#xD;
      analyses.&#xD;
&#xD;
      The effectiveness of the intervention will be tested using a series of between group ANCOVAs.&#xD;
&#xD;
      The number of participants showing reliable and clinical change on measures of anxiety and&#xD;
      skin-specific quality of life will also be calculated for each group.&#xD;
&#xD;
      Change over time (Pre, post, one month follow up) for each group will be assessed using a&#xD;
      repeated measures ANOVA. If any significant covariates, are identified ANCOVAs will be used&#xD;
      instead.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2020</start_date>
  <completion_date type="Actual">August 5, 2021</completion_date>
  <primary_completion_date type="Actual">August 5, 2021</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>This study is an online single-blinded Randonmised Control Trial, which contains acceptability and feasibility components.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will not be told whether they have been allocated to intervention or control condition until the end of the study. The control condition is a series of creative writing tasks, which are framed as an intervention within the introduction to the first task. This replicates previous RCTs of the same intervention in different populations (Alleva et al., 2015).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body appreciation</measure>
    <time_frame>Baseline to 1 week</time_frame>
    <description>The Body Appreciation Scale 2 (BAS-2, Tylka &amp; Wood-Barcalow, 2015) will be used to measure body appreciation and contains 10 items, and will be used to measure trait levels of body appreciation. Each item is rated on a scale of 1 (never) to 5 (always). The average score is calculated by adding each item and divided by 10, and can range between 1 and 5 with higher numbers indicating higher levels of body appreciation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in body functionality appreciation</measure>
    <time_frame>Baseline to 1 week</time_frame>
    <description>The Functionality Appreciation Scale (FAS: Alleva, Tylka, &amp; Van Diest, 2017) will be used to measure body functionality appreciation. The FAS comprises of seven questions, and will be used to assess participants' trait levels of appreciation for their bodies' functionality (Appendix L). Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The average score is calculated by adding each item and dividing by 7, and can range between 1 and 5 with higher numbers indicating higher levels of function appreciation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in dermatology specific quality of life</measure>
    <time_frame>Baseline to 1 week</time_frame>
    <description>The Dermatology Quality of Life Index (DLQI: Finlay &amp; Khan, 1994) will be used to measure the impact of skin-conditions on participants' quality of life (Appendix M). The DLQI contains 10 questions scored from 0 (not at all/not relevant) to 3 (very much). Total scores range from 0 to 30, with lower scores indicating greater skin-specific quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dermatology specific quality of life at follow up</measure>
    <time_frame>Baseline to 1 month</time_frame>
    <description>The Dermatology Quality of Life Index (DLQI: Finlay &amp; Khan, 1994) will be used to measure the impact of skin-conditions on participants' quality of life (Appendix M). The DLQI contains 10 questions scored from 0 (not at all/not relevant) to 3 (very much). Total scores range from 0 to 30, with lower scores indicating greater skin-specific quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chance in skin-specific shame</measure>
    <time_frame>Baseline to 1 week</time_frame>
    <description>The Skin Shame Scale (SSS: Scott, 2004) will be used to measure levels of skin-specific shame. The SSS contains 24 items, which are rated on a scale from 1 (never) to 5 (always). Total scores can range from 24 to 120, with higher score indicating greater levels of shame.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chance in skin-specific shame at follow up</measure>
    <time_frame>Baseline to 1 month</time_frame>
    <description>The Skin Shame Scale (SSS: Scott, 2004) will be used to measure levels of skin-specific shame. The SSS contains 24 items, which are rated on a scale from 1 (never) to 5 (always). Total scores can range from 24 to 120, with higher score indicating greater levels of shame.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in appearance anxiety</measure>
    <time_frame>Baseline to 1 week</time_frame>
    <description>The Appearance Anxiety Index (AAI: Veale et al., 2014) will be used to measure appearance anxiety. The AAI contains 10 questions focused on cognitive and behavioural components of appearance-related anxiety, including avoidance and threat monitoring. Each item is scored on a five point Likert scale from 0 (not at all) to 4 (all the time). Total scores can range from 0 to 40, with higher scores indicating a greater level of appearance-related anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in appearance anxiety at follow up</measure>
    <time_frame>Baseline to 1 month</time_frame>
    <description>The Appearance Anxiety Index (AAI: Veale et al., 2014) will be used to measure appearance anxiety. The AAI contains 10 questions focused on cognitive and behavioural components of appearance-related anxiety, including avoidance and threat monitoring. Each item is scored on a five point Likert scale from 0 (not at all) to 4 (all the time). Total scores can range from 0 to 40, with higher scores indicating a greater level of appearance-related anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State appearance satisfaction</measure>
    <time_frame>Day 1</time_frame>
    <description>After writing exercise 1, participants will also be asked to rate their state satisfaction with their appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State appearance satisfaction</measure>
    <time_frame>Day 3 (approximately)</time_frame>
    <description>After writing exercise 2, participants will also be asked to rate their state satisfaction with their appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State appearance satisfaction</measure>
    <time_frame>1 week</time_frame>
    <description>After writing exercise 3, participants will also be asked to rate their state satisfaction with their appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State skin appearance satisfaction</measure>
    <time_frame>Day 1</time_frame>
    <description>After writing task 1, participants will also be asked to rate their satisfaction with their state skin appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State skin appearance satisfaction</measure>
    <time_frame>Day 3 (approximately)</time_frame>
    <description>After writing task 2, participants will also be asked to rate their satisfaction with their state skin appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State skin appearance satisfaction</measure>
    <time_frame>1 week</time_frame>
    <description>After writing task 3, participants will also be asked to rate their satisfaction with their state skin appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State functionality satisfaction</measure>
    <time_frame>Day 1</time_frame>
    <description>After writing task 1, participants will also be asked to rate their state satisfaction with their body functionality on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State functionality satisfaction</measure>
    <time_frame>Day 3 (approximately)</time_frame>
    <description>After writing task 2, participants will also be asked to rate their state satisfaction with their body functionality on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State functionality satisfaction</measure>
    <time_frame>1 week</time_frame>
    <description>After writing task 3, participants will also be asked to rate their state satisfaction with their body functionality on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body appreciation at follow up</measure>
    <time_frame>Baseline to 1 month</time_frame>
    <description>The Body Appreciation Scale 2 (BAS-2, Tylka &amp; Wood-Barcalow, 2015) will be used to measure body appreciation and contains 10 items, and will be used to measure trait levels of body appreciation. Each item is rated on a scale of 1 (never) to 5 (always). The average score is calculated by adding each item and divided by 10, and can range between 1 and 5 with higher numbers indicating higher levels of body appreciation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body functionality appreciation at follow up</measure>
    <time_frame>Baseline to 1 month</time_frame>
    <description>The Functionality Appreciation Scale (FAS: Alleva, Tylka, &amp; Van Diest, 2017) will be used to measure body functionality appreciation. The FAS comprises of seven questions, and will be used to assess participants' trait levels of appreciation for their bodies' functionality (Appendix L). Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The average score is calculated by adding each item and dividing by 7, and can range between 1 and 5 with higher numbers indicating higher levels of function appreciation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intervention evaluation</measure>
    <time_frame>1 week</time_frame>
    <description>Participants in the functionality intervention will be asked to complete a series of questions about their experience of the intervention, and given the option to add any further comments in a free text box.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence</measure>
    <time_frame>Through study completion (on average 1 week)</time_frame>
    <description>Adherence will be assessed by reviewing the content of participants writing and time-spent on the exercises and word count. Participant entries will also be rated, on a three-point scale, whether the content of participants writing conforms to the given instructions; if there is no relevant content, it will be scored 0, if instructions are partially followed, it will score 1, and if instruction are fully followed it will score a 2.&#xD;
to identify inappropriate responses. Previous studies evaluating the intervention have reported minimal information about how adherence was assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Attrition</measure>
    <time_frame>Through study completion (on average 1 week)</time_frame>
    <description>The number of participants that drop out across the study</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">454</enrollment>
  <condition>Body Image</condition>
  <condition>Psychological Distress</condition>
  <condition>Dermatologic Disease</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Expand Your Horizons: More than my skin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants allocated to the intervention condition will be asked to follow the adapted instructions for 'Expand Your Horizon'. Participants will be asked to complete three 15 min writing exercises over approximately six days. Participants who complete the first exercise on Qualtrics will be sent links to and asked to complete the second and third writing exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control writing activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the control condition will be asked to complete three 15 minute creative writing exercises online via Qualtucs over approximately six days. Participants completing the first writing exercise will be sent links to the second and third writing exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expand your horizons: More than my skin</intervention_name>
    <description>'Expand Your Horizon' is a self-help intervention which uses writing exercises to help individuals with poor body image practice focusing on their body-functionality rather than their physical appearance (Alleva et al., 2015). The materials for 'Expand Your Horizon' are freely available (Alleva et al., 2015), and permission has been granted to use and adapt the materials in this research. 'Expand Your Horizon' comprises of three 15 min writing exercises, typically completed over approximately six days. The intervention materials have been adapted for use with a population with skin diseases, and modified to use gender neutral language. Adaptions were made in consultation with experts by experience. The changes were reviewed and approved by the first author of the original intervention to ensure the materials were in keeping with the original intervention.</description>
    <arm_group_label>Expand Your Horizons: More than my skin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Creative writing activities</intervention_name>
    <description>In line with previous studies examining 'Expand Your Horizon' the active control condition will involve creative writing tasks (Alleva et al., 2015). Participants in the intervention condition will complete three 15 minute creative writing exercises, completed over six days.</description>
    <arm_group_label>Control writing activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with dermatological condition (including conditions that affect the skin,&#xD;
             hair and/or nails). This includes, but is not limited to, acne, eczema, alopecia,&#xD;
             psoriasis, vitiligo, rosacea, dermatitis, hyperpigmentation, hidradenitis suppurativa&#xD;
             (HS), hyperhidrosis, hirsutism, neurofibromatosis, onychomycosis, melasma, cysts,&#xD;
             herpes, ichthyosis, and lichen sclerosus.&#xD;
&#xD;
          -  Individuals self-reporting that their body image is affected by their skin condition.&#xD;
&#xD;
          -  Sufficient English to complete the measures and writing exercises&#xD;
&#xD;
          -  Access to the internet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  As the focus of this research is on skin disease, individuals living with visible&#xD;
             differences as a consequence of trauma (e.g. scarring from burns or scarring from&#xD;
             traumatic injury) are not eligible to participate in this study.&#xD;
&#xD;
          -  Individuals who do not feel their body image is affected by having a dermatological&#xD;
             condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul G Overton, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sheffield</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Psychology, University of Sheffield</name>
      <address>
        <city>Sheffield</city>
        <state>Choose Province</state>
        <zip>S1 2LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Alleva JM, Martijn C, Van Breukelen GJ, Jansen A, Karos K. Expand Your Horizon: A programme that improves body image and reduces self-objectification by training women to focus on body functionality. Body Image. 2015 Sep;15:81-9. doi: 10.1016/j.bodyim.2015.07.001. Epub 2015 Aug 14.</citation>
    <PMID>26280376</PMID>
  </reference>
  <reference>
    <citation>Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.</citation>
    <PMID>25462882</PMID>
  </reference>
  <reference>
    <citation>Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.</citation>
    <PMID>28822275</PMID>
  </reference>
  <reference>
    <citation>Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.</citation>
    <PMID>8033378</PMID>
  </reference>
  <reference>
    <citation>Scott, C. (2004). Understanding psychodermatological distress: constructing a skin shame scale (Doctoral dissertation, University of Sheffield, UK). Retrieved from http://etheses.whiterose.ac.uk/14863/1/412462.pdf</citation>
  </reference>
  <reference>
    <citation>Veale D, Eshkevari E, Kanakam N, Ellison N, Costa A, Werner T. The Appearance Anxiety Inventory: validation of a process measure in the treatment of body dysmorphic disorder. Behav Cogn Psychother. 2014 Sep;42(5):605-16. doi: 10.1017/S1352465813000556. Epub 2013 Jul 3.</citation>
    <PMID>23823485</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Participants will be asked as part of the consent form whether they would be willing for their anonymised data to be available to other researchers. Data won't be shared for participants who do not consent to this. Sharing of the remaining data will depend on sufficient participants consenting to this to not compromise anonymity or outcomes.</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/NCT04445974
org study id: 165478
nct id: NCT04445974
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
'Expand Your Horizons', a self-help writing intervention that seeks to train individuals to
      focus on what their body can do (functionality) rather than what it looks like (appearance),
      has produced promising results in improving body image. However, it has not been adapted and
      trialled in populations with conditions affecting skin appearance. This research therefore
      seeks to evaluate the potential for 'Expand Your Horizons' to (1) improve body image, as
      measured by body and functionality appreciation; and (2) improve skin-specific outcome, as
      measure by skin-shame, dermatology and quality of life, in a population with dermatological
      conditions, using a Randomised Control Trail.
Method of sampling/recruitment:

      Recruitment from community sample, including: The University staff and student volunteers
      lists; Psychology undergraduate credit systems, Social media/forums; Charities; Research
      recruitment platforms, and a mailing lists.

      Sample size:

      An apriori power analysis, based on an ANCOVA, with a medium effect for the primary outcome
      (body appreciation) indicated a sample of 128 would be needed to achieve 80% power. Assuming
      an attrition rate of 50%, the total number of participants required will be 256.

      In line with recommendations for evaluating interventions, we will include an internal pilot
      whereby we review the recruitment progress (completion) about 3 months into the trial and
      could then consider whether we need to make any minor or major adjustments to the recruitment
      strategy or study. If these substantial changes are needed, the pilot component will be
      written up and analysed separately to inform the next phase.

      Procedure:

      Time-point 1: Participants asked to read information sheet and provide consent. Participants
      will then be asked to complete the demographic measures and provide information on their skin
      condition(s). Participants will then complete baseline measures of trait body appreciation,
      body functionality, and, skin-specific quality of life, appearance anxiety with the order of
      these questionnaires counterbalanced. The online system will then randomly allocate
      individual meeting the exclusion criteria to either 'Expand Your Horizon' or an active
      control, at a ratio of 1:1. Participants will then be asked to complete the first writing
      activity and complete state measures

      Time-point 2 (approximately 2 days later): Participants asked to complete the second writing
      exercise, and rate their state measures.

      Time-point 3 (approximately 1 week later): Participants will be asked to complete the final
      writing task, before completing state measures and repeating the outcome measures given at
      baseline. Participants in both conditions will then be asked to provide feedback on the
      intervention.

      Time-point 4 (One month later): Participants will be asked to repeat the outcome measures.
      Participants will then be shown the debrief screen and told which group they were in.
      Participants in the control condition will be offered a link to the intervention.

      Analytic strategy:

      The data will be initially assessed to check whether they meet the assumptions of the
      statistical tests used.

      Descriptive statistics will then be used to describe the sample, and to summarise information
      on attrition at each point of the study and feedback on the intervention. Demographic and
      skin disease-history variables will be assessed for covariance using t-tests, ANOVAs and
      bivariate correlations as appropriate.

      To assess whether randomisation of allocation to groups (intervention vs control) has been
      effective, t-tests and ANOVAs will be used, as appropriate, to compare demographics baseline
      measures.

      T-tests will also be used to compare the levels of skin-specific appearance satisfaction,
      appearance satisfaction and body-functionality satisfaction between participants in both the
      intervention and control condition. This will include both intention-to-treat and completer
      analyses.

      The effectiveness of the intervention will be tested using a series of between group ANCOVAs.

      The number of participants showing reliable and clinical change on measures of anxiety and
      skin-specific quality of life will also be calculated for each group.

      Change over time (Pre, post, one month follow up) for each group will be assessed using a
      repeated measures ANOVA. If any significant covariates, are identified ANCOVAs will be used
      instead.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is an online single-blinded Randonmised Control Trial, which contains acceptability and feasibility components.
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants will not be told whether they have been allocated to intervention or control condition until the end of the study. The control condition is a series of creative writing tasks, which are framed as an intervention within the introduction to the first task. This replicates previous RCTs of the same intervention in different populations (Alleva et al., 2015).
measure: Change in body appreciation
time frame: Baseline to 1 week
description: The Body Appreciation Scale 2 (BAS-2, Tylka & Wood-Barcalow, 2015) will be used to measure body appreciation and contains 10 items, and will be used to measure trait levels of body appreciation. Each item is rated on a scale of 1 (never) to 5 (always). The average score is calculated by adding each item and divided by 10, and can range between 1 and 5 with higher numbers indicating higher levels of body appreciation.
measure: Change in body functionality appreciation
time frame: Baseline to 1 week
description: The Functionality Appreciation Scale (FAS: Alleva, Tylka, & Van Diest, 2017) will be used to measure body functionality appreciation. The FAS comprises of seven questions, and will be used to assess participants' trait levels of appreciation for their bodies' functionality (Appendix L). Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The average score is calculated by adding each item and dividing by 7, and can range between 1 and 5 with higher numbers indicating higher levels of function appreciation.
measure: Change in dermatology specific quality of life
time frame: Baseline to 1 week
description: The Dermatology Quality of Life Index (DLQI: Finlay & Khan, 1994) will be used to measure the impact of skin-conditions on participants' quality of life (Appendix M). The DLQI contains 10 questions scored from 0 (not at all/not relevant) to 3 (very much). Total scores range from 0 to 30, with lower scores indicating greater skin-specific quality of life.
measure: Change in dermatology specific quality of life at follow up
time frame: Baseline to 1 month
description: The Dermatology Quality of Life Index (DLQI: Finlay & Khan, 1994) will be used to measure the impact of skin-conditions on participants' quality of life (Appendix M). The DLQI contains 10 questions scored from 0 (not at all/not relevant) to 3 (very much). Total scores range from 0 to 30, with lower scores indicating greater skin-specific quality of life.
measure: Chance in skin-specific shame
time frame: Baseline to 1 week
description: The Skin Shame Scale (SSS: Scott, 2004) will be used to measure levels of skin-specific shame. The SSS contains 24 items, which are rated on a scale from 1 (never) to 5 (always). Total scores can range from 24 to 120, with higher score indicating greater levels of shame.
measure: Chance in skin-specific shame at follow up
time frame: Baseline to 1 month
description: The Skin Shame Scale (SSS: Scott, 2004) will be used to measure levels of skin-specific shame. The SSS contains 24 items, which are rated on a scale from 1 (never) to 5 (always). Total scores can range from 24 to 120, with higher score indicating greater levels of shame.
measure: Change in appearance anxiety
time frame: Baseline to 1 week
description: The Appearance Anxiety Index (AAI: Veale et al., 2014) will be used to measure appearance anxiety. The AAI contains 10 questions focused on cognitive and behavioural components of appearance-related anxiety, including avoidance and threat monitoring. Each item is scored on a five point Likert scale from 0 (not at all) to 4 (all the time). Total scores can range from 0 to 40, with higher scores indicating a greater level of appearance-related anxiety.
measure: Change in appearance anxiety at follow up
time frame: Baseline to 1 month
description: The Appearance Anxiety Index (AAI: Veale et al., 2014) will be used to measure appearance anxiety. The AAI contains 10 questions focused on cognitive and behavioural components of appearance-related anxiety, including avoidance and threat monitoring. Each item is scored on a five point Likert scale from 0 (not at all) to 4 (all the time). Total scores can range from 0 to 40, with higher scores indicating a greater level of appearance-related anxiety.
measure: State appearance satisfaction
time frame: Day 1
description: After writing exercise 1, participants will also be asked to rate their state satisfaction with their appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).
measure: State appearance satisfaction
time frame: Day 3 (approximately)
description: After writing exercise 2, participants will also be asked to rate their state satisfaction with their appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).
measure: State appearance satisfaction
time frame: 1 week
description: After writing exercise 3, participants will also be asked to rate their state satisfaction with their appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).
measure: State skin appearance satisfaction
time frame: Day 1
description: After writing task 1, participants will also be asked to rate their satisfaction with their state skin appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).
measure: State skin appearance satisfaction
time frame: Day 3 (approximately)
description: After writing task 2, participants will also be asked to rate their satisfaction with their state skin appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).
measure: State skin appearance satisfaction
time frame: 1 week
description: After writing task 3, participants will also be asked to rate their satisfaction with their state skin appearance on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).
measure: State functionality satisfaction
time frame: Day 1
description: After writing task 1, participants will also be asked to rate their state satisfaction with their body functionality on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).
measure: State functionality satisfaction
time frame: Day 3 (approximately)
description: After writing task 2, participants will also be asked to rate their state satisfaction with their body functionality on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).
measure: State functionality satisfaction
time frame: 1 week
description: After writing task 3, participants will also be asked to rate their state satisfaction with their body functionality on a 100 point visual analogue scale (100 = extremely satisfied and 0 = extremely dissatisfied).
measure: Change in body appreciation at follow up
time frame: Baseline to 1 month
description: The Body Appreciation Scale 2 (BAS-2, Tylka & Wood-Barcalow, 2015) will be used to measure body appreciation and contains 10 items, and will be used to measure trait levels of body appreciation. Each item is rated on a scale of 1 (never) to 5 (always). The average score is calculated by adding each item and divided by 10, and can range between 1 and 5 with higher numbers indicating higher levels of body appreciation.
measure: Change in body functionality appreciation at follow up
time frame: Baseline to 1 month
description: The Functionality Appreciation Scale (FAS: Alleva, Tylka, & Van Diest, 2017) will be used to measure body functionality appreciation. The FAS comprises of seven questions, and will be used to assess participants' trait levels of appreciation for their bodies' functionality (Appendix L). Each item is rated on a scale from 1 (strongly disagree) to 5 (strongly agree). The average score is calculated by adding each item and dividing by 7, and can range between 1 and 5 with higher numbers indicating higher levels of function appreciation.
measure: Intervention evaluation
time frame: 1 week
description: Participants in the functionality intervention will be asked to complete a series of questions about their experience of the intervention, and given the option to add any further comments in a free text box.
measure: Adherence
time frame: Through study completion (on average 1 week)
description: Adherence will be assessed by reviewing the content of participants writing and time-spent on the exercises and word count. Participant entries will also be rated, on a three-point scale, whether the content of participants writing conforms to the given instructions; if there is no relevant content, it will be scored 0, if instructions are partially followed, it will score 1, and if instruction are fully followed it will score a 2.
to identify inappropriate responses. Previous studies evaluating the intervention have reported minimal information about how adherence was assessed.
measure: Attrition
time frame: Through study completion (on average 1 week)
description: The number of participants that drop out across the study
arm group label: Expand Your Horizons: More than my skin
arm group type: Active Comparator
description: Participants allocated to the intervention condition will be asked to follow the adapted instructions for 'Expand Your Horizon'. Participants will be asked to complete three 15 min writing exercises over approximately six days. Participants who complete the first exercise on Qualtrics will be sent links to and asked to complete the second and third writing exercises.
arm group label: Control writing activity
arm group type: Experimental
description: Participants in the control condition will be asked to complete three 15 minute creative writing exercises online via Qualtucs over approximately six days. Participants completing the first writing exercise will be sent links to the second and third writing exercises.
intervention type: Behavioral
intervention name: Expand your horizons: More than my skin
description: 'Expand Your Horizon' is a self-help intervention which uses writing exercises to help individuals with poor body image practice focusing on their body-functionality rather than their physical appearance (Alleva et al., 2015). The materials for 'Expand Your Horizon' are freely available (Alleva et al., 2015), and permission has been granted to use and adapt the materials in this research. 'Expand Your Horizon' comprises of three 15 min writing exercises, typically completed over approximately six days. The intervention materials have been adapted for use with a population with skin diseases, and modified to use gender neutral language. Adaptions were made in consultation with experts by experience. The changes were reviewed and approved by the first author of the original intervention to ensure the materials were in keeping with the original intervention.
arm group label: Expand Your Horizons: More than my skin
intervention type: Behavioral
intervention name: Creative writing activities
description: In line with previous studies examining 'Expand Your Horizon' the active control condition will involve creative writing tasks (Alleva et al., 2015). Participants in the intervention condition will complete three 15 minute creative writing exercises, completed over six days.
arm group label: Control writing activity
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul G Overton, PhD
role: Principal Investigator
affiliation: University of Sheffield
facility: 
country: United Kingdom
citation: Alleva JM, Martijn C, Van Breukelen GJ, Jansen A, Karos K. Expand Your Horizon: A programme that improves body image and reduces self-objectification by training women to focus on body functionality. Body Image. 2015 Sep;15:81-9. doi: 10.1016/j.bodyim.2015.07.001. Epub 2015 Aug 14.
PMID: 26280376
citation: Tylka TL, Wood-Barcalow NL. The Body Appreciation Scale-2: item refinement and psychometric evaluation. Body Image. 2015 Jan;12:53-67. doi: 10.1016/j.bodyim.2014.09.006. Epub 2014 Oct 21.
PMID: 25462882
citation: Alleva JM, Tylka TL, Kroon Van Diest AM. The Functionality Appreciation Scale (FAS): Development and psychometric evaluation in U.S. community women and men. Body Image. 2017 Dec;23:28-44. doi: 10.1016/j.bodyim.2017.07.008. Epub 2017 Aug 17.
PMID: 28822275
citation: Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
PMID: 8033378
citation: Scott, C. (2004). Understanding psychodermatological distress: constructing a skin shame scale (Doctoral dissertation, University of Sheffield, UK). Retrieved from http://etheses.whiterose.ac.uk/14863/1/412462.pdf
citation: Veale D, Eshkevari E, Kanakam N, Ellison N, Costa A, Werner T. The Appearance Anxiety Inventory: validation of a process measure in the treatment of body dysmorphic disorder. Behav Cogn Psychother. 2014 Sep;42(5):605-16. doi: 10.1017/S1352465813000556. Epub 2013 Jul 3.
PMID: 23823485
responsible party type: Sponsor
mesh term: Skin Diseases
sharing ipd: No
ipd description: Participants will be asked as part of the consent form whether they would be willing for their anonymised data to be available to other researchers. Data won't be shared for participants who do not consent to this. Sharing of the remaining data will depend on sufficient participants consenting to this to not compromise anonymity or outcomes.