<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/NCT03004027</url>
  </required_header>
  <id_info>
    <org_study_id>147400</org_study_id>
    <nct_id>NCT03004027</nct_id>
  </id_info>
  <brief_title>Enhancing Psychological Self-help With Implementation Intentions</brief_title>
  <official_title>Enhancing Psychological Self-help With Implementation Intentions for Those With Visible Skin Difference and Fear of Negative Evaluation</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Individuals with visible conditions often report experiencing lowered social confidence and&#xD;
      encountering intrusive reactions from others, yet relatively few targeted psychosocial self&#xD;
      help interventions are available.&#xD;
&#xD;
      The investigators will conduct a randomised controlled trial to compare the efficacy of an&#xD;
      adapted form of an existing self-help intervention with an enhanced version of the same&#xD;
      intervention that incorporates if-then planning instructions (or 'implementation intentions')&#xD;
      and a control condition that will receive support as usual. Participants who self-identify as&#xD;
      having a visible condition affecting the skin or hair, or scarring to the skin that&#xD;
      negatively affects their social confidence will be allocated to one of three conditions:&#xD;
      augmented self-help, standard self help or control. The interventions will be delivered&#xD;
      online and participants will complete psychometric outcome measures at two time points, four&#xD;
      weeks apart.&#xD;
&#xD;
      It is hypothesised that participants who receive the augmented self help intervention will&#xD;
      have a statistically significant decrease in fear of negative evaluation in comparison to&#xD;
      both the standard self-help and support as usual control groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed research will take the form of a randomised controlled trial conducted in&#xD;
      accordance with CONSORT guidelines (http://www.consort-statement.org). Data will be collected&#xD;
      online using Qualtrics. Participants will be required to answer all fields on Qualtrics, as a&#xD;
      way of managing potential missing data.&#xD;
&#xD;
      Participants will be randomly allocated to one of three groups: (i) psychological self-help&#xD;
      augmented with implementation intentions, (ii) standard psychological self-help or (iii) a no&#xD;
      intervention waiting list control. Qualtrics will be used to randomly allocate participants&#xD;
      to one of the three groups.&#xD;
&#xD;
      A sample size analysis has been conducted and calculated assuming two measures, three groups,&#xD;
      an alpha of 0.05, a power of 0.8, and an effect size of 0.25; a total sample size of 120&#xD;
      participants would be needed (i.e. 40 per group). Allowing for an attrition rate of 20%, 144&#xD;
      participants would need to be recruited (i.e. 48 per group). Although participants will be&#xD;
      randomised to condition, it is best practice for any differences at baseline to be controlled&#xD;
      for in analyses and thus a between factors repeated measure analysis of variance (ANOVA) will&#xD;
      be conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Brief Fear of Negative Evaluation-II at four weeks (Carleton, Collimore, &amp; Asmundson, 2007)</measure>
    <time_frame>At baseline and four weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Generalised Anxiety Disorder 7 at four weeks</measure>
    <time_frame>At baseline and four weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Patient Health Questionnaire 9 at four weeks</measure>
    <time_frame>At baseline and four weeks</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">326</enrollment>
  <condition>Social Anxiety</condition>
  <arm_group>
    <arm_group_label>Enhanced</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>self help leaflet enhanced with implementation intentions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>self help leaflet standard (without implementation intentions)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Baseline measures administered only. self help intervention will be made available once the study has finished.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self help leaflet</intervention_name>
    <description>Self help leaflet entitled 'Building confidence in social situations: A guide for people living with a visible skin differences'</description>
    <arm_group_label>Enhanced</arm_group_label>
    <arm_group_label>Standard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants self-identify as having a visible skin difference&#xD;
&#xD;
          -  Participants will be aged 18 years or over&#xD;
&#xD;
          -  Participants will be fluent in the English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants will be excluded if they are currently receiving psychotherapy&#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>Jessica C Lane</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sheffield</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Sheffield</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S1 2LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.</citation>
    <PMID>17695343</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sheffield</investigator_affiliation>
    <investigator_full_name>Jessica Lane</investigator_full_name>
    <investigator_title>Trainee Clinical Psychologist</investigator_title>
  </responsible_party>
  <keyword>health behaviour change</keyword>
  <keyword>implementation intention</keyword>
  <keyword>if then plan</keyword>
  <keyword>skin condition</keyword>
  <keyword>visible difference</keyword>
  <keyword>self help</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Possibility that data will be used in future research. Individual participant data includes age, gender, description of visible skin difference and scores on the Brief Fear of Negative Evaluation, General Anxiety Disorder 7, Patient Health Questionnaire 9 questionnaires. Data will be obtained with agreement from the primary investigator Jessica Lane (jlane1@sheffield.ac.uk)</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/NCT03004027
org study id: 147400
nct id: NCT03004027
lead sponsor: 
has dmc: No
Individuals with visible conditions often report experiencing lowered social confidence and
      encountering intrusive reactions from others, yet relatively few targeted psychosocial self
      help interventions are available.

      The investigators will conduct a randomised controlled trial to compare the efficacy of an
      adapted form of an existing self-help intervention with an enhanced version of the same
      intervention that incorporates if-then planning instructions (or 'implementation intentions')
      and a control condition that will receive support as usual. Participants who self-identify as
      having a visible condition affecting the skin or hair, or scarring to the skin that
      negatively affects their social confidence will be allocated to one of three conditions:
      augmented self-help, standard self help or control. The interventions will be delivered
      online and participants will complete psychometric outcome measures at two time points, four
      weeks apart.

      It is hypothesised that participants who receive the augmented self help intervention will
      have a statistically significant decrease in fear of negative evaluation in comparison to
      both the standard self-help and support as usual control groups.
The proposed research will take the form of a randomised controlled trial conducted in
      accordance with CONSORT guidelines (http://www.consort-statement.org). Data will be collected
      online using Qualtrics. Participants will be required to answer all fields on Qualtrics, as a
      way of managing potential missing data.

      Participants will be randomly allocated to one of three groups: (i) psychological self-help
      augmented with implementation intentions, (ii) standard psychological self-help or (iii) a no
      intervention waiting list control. Qualtrics will be used to randomly allocate participants
      to one of the three groups.

      A sample size analysis has been conducted and calculated assuming two measures, three groups,
      an alpha of 0.05, a power of 0.8, and an effect size of 0.25; a total sample size of 120
      participants would be needed (i.e. 40 per group). Allowing for an attrition rate of 20%, 144
      participants would need to be recruited (i.e. 48 per group). Although participants will be
      randomised to condition, it is best practice for any differences at baseline to be controlled
      for in analyses and thus a between factors repeated measure analysis of variance (ANOVA) will
      be conducted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Brief Fear of Negative Evaluation-II at four weeks (Carleton, Collimore, & Asmundson, 2007)
time frame: At baseline and four weeks
measure: Change in Generalised Anxiety Disorder 7 at four weeks
time frame: At baseline and four weeks
measure: Change in Patient Health Questionnaire 9 at four weeks
time frame: At baseline and four weeks
arm group label: Enhanced
arm group type: Experimental
description: self help leaflet enhanced with implementation intentions
arm group label: Standard
arm group type: Active Comparator
description: self help leaflet standard (without implementation intentions)
arm group label: Waiting list control
arm group type: No Intervention
description: Baseline measures administered only. self help intervention will be made available once the study has finished.
intervention type: Other
intervention name: Self help leaflet
description: Self help leaflet entitled 'Building confidence in social situations: A guide for people living with a visible skin differences'
arm group label: Enhanced
arm group label: Standard
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jessica C Lane
role: Principal Investigator
affiliation: University of Sheffield
facility: 
country: United Kingdom
citation: Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PMID: 17695343
responsible party type: Principal Investigator
investigator affiliation: University of Sheffield
investigator full name: Jessica Lane
investigator title: Trainee Clinical Psychologist
sharing ipd: Undecided
ipd description: Possibility that data will be used in future research. Individual participant data includes age, gender, description of visible skin difference and scores on the Brief Fear of Negative Evaluation, General Anxiety Disorder 7, Patient Health Questionnaire 9 questionnaires. Data will be obtained with agreement from the primary investigator Jessica Lane (jlane1@sheffield.ac.uk)