<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/NCT04450862</url>
  </required_header>
  <id_info>
    <org_study_id>034442</org_study_id>
    <nct_id>NCT04450862</nct_id>
  </id_info>
  <brief_title>Anxiety Self-management Intervention for Pulmonary Hypertension</brief_title>
  <official_title>Development and Pilot Randomised Controlled Trial of a Self-management Intervention to Help Individuals With Pulmonary Hypertension Live Better With Anxiety</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>
      Pulmonary hypertension (PH) is a disorder of high blood pressure that impacts the heart and&#xD;
      lungs. Approximately, 50% of individuals with PH experience anxiety or panic disorders. There&#xD;
      is limited evidence on psychological treatments for anxiety in PH; however, results support&#xD;
      the use of Cognitive Behavioural Therapy (CBT). Despite the prevalence and impact of anxiety&#xD;
      in PH; there are no widely available and/or disease specific pathways, thus highlighting an&#xD;
      unmet need in this population. This project aims to develop and pilot, using randomised&#xD;
      control trial methodology, a self-management intervention for individuals with PH based on&#xD;
      principles of CBT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Project Objectives The primary aim of this study is to develop a self-management intervention&#xD;
      in collaboration with patient, public involvement, which will consist of experts by&#xD;
      experience and experts by education. The intervention is aimed at helping individuals with PH&#xD;
      to manage symptoms of anxiety.&#xD;
&#xD;
      A secondary aim of the project is to conduct a pilot randomised controlled trial&#xD;
      investigating the aforementioned self-management intervention. More specifically, the project&#xD;
      will explore acceptability and feasibility of the intervention itself and research&#xD;
      methodology proposed to test its effectiveness. Qualitative and quantitative data will be&#xD;
      collected for this purpose which will focus on: attrition rates; adherence to the&#xD;
      intervention; participant's acceptability of the intervention and research methodology (i.e.&#xD;
      eligibility, randomisation, emotional response, perceptions); outcome measures; recruitment&#xD;
      and data collection procedures; and any adverse effects. Moreover, this project will&#xD;
      investigate the preliminary efficacy of the intervention on a series of primary (anxiety&#xD;
      symptoms - Generalised Anxiety Disorder -7) and secondary measures (depression - PHQ9);&#xD;
      HRQoL- emphasis10); dyspnoea - dyspnoea12; perception of coping - self-mastery questionnaire;&#xD;
      and cognitive and behavioural processes (Cognitive Behavioural Processes Questionnaire&#xD;
      (CBPQ), so that effect sizes can be calculated and used to inform sample sizes of any future&#xD;
      definitive trials.&#xD;
&#xD;
      Design The study will be a pilot randomised superiority trial. Participants will be&#xD;
      randomised on a 1:1 basis to either one of two groups, (1) CBT informed self-management&#xD;
      intervention to help manage anxiety in PH or a (2) controlled waiting-list condition. A&#xD;
      control condition is required to control for any therapeutic gains associated with being&#xD;
      involved in a trial. Participants will be asked to complete a series of measures pre-, post-&#xD;
      and one month following completion of the intervention. As such, a 2 (cognitive-behavioural&#xD;
      informed intervention or control waiting list) x 3 (pre-, post- and intervention) research&#xD;
      design will be used. Participants or researchers will not be blinded to condition allocation&#xD;
      (i.e. participants will be aware they may be randomised to a waiting list condition, and&#xD;
      researchers may be contacting participants during the intervention for feedback on adherence&#xD;
      and acceptability).&#xD;
&#xD;
      Procedure From the study advert promoted by the Pulmonary Hypertension Association,&#xD;
      participants will be directed to a dedicated webpage for the proposed project.&#xD;
&#xD;
      From there, participants will be able to read the participant information sheet. Participants&#xD;
      interested in talking part will be asked to click on a link that will take them to a series&#xD;
      of questionnaire hosted by Qualtrics. Participants will first be asked to complete an&#xD;
      eligibility form. Based on their responses, if participants are not eligible they will be&#xD;
      informed immediately that they are unable to participate in the study. If participants are&#xD;
      eligible, they will be asked to complete a consent form and a series of questionnaires (see&#xD;
      below). All data entered on this page will be recorded, as it will help to inform feasibility&#xD;
      of the inclusion/exclusion criteria (i.e. is the study excluding a large percentage of people&#xD;
      based on a certain factor).&#xD;
&#xD;
      Participants will also be informed on the advert promoted by the Pulmonary Hypertension&#xD;
      Association, that they can contact the lead researcher (Gregg Rawlings) to ask any additional&#xD;
      questions about the project prior to completing the eligibility form, consent form and/or&#xD;
      questionnaires.&#xD;
&#xD;
      Eligible participants will be randomised, using an online randomiser, to either of the two&#xD;
      arms. The programme used to randomise will be Random.org. Those randomised to the wait-list&#xD;
      condition will be informed that they will be contacted again in four weeks asking them to&#xD;
      complete a series of questionnaires and again in an additional month (see below). Those in&#xD;
      the intervention condition will be sent the CBT intervention.&#xD;
&#xD;
      Participants in the intervention condition will be instructed to work systematically through&#xD;
      the intervention. Two weeks after the intervention is sent to participants, participants will&#xD;
      be contacted by the lead researcher (Gregg Rawlings) to check on adherence and acceptability&#xD;
      of the intervention using a mixed-methods structured questionnaire. Participants will be&#xD;
      attempted to be contacted a maximum of three times. Participants will have provided prior&#xD;
      consent to be contacted.&#xD;
&#xD;
      Four weeks following the intervention being received and one month thereafter participants&#xD;
      will be contacted asking them to complete the outcome measures (see below). During this time,&#xD;
      participants will be contacted asking them to complete a quantitative and qualitative&#xD;
      questionnaire on their views of participating in the intervention. This will be hosted by&#xD;
      Qualitrics. Participants will have provided consent to be contacted for this purpose.&#xD;
&#xD;
      Data analysis&#xD;
&#xD;
      Quantitative data:&#xD;
&#xD;
        -  Descriptive statistics, and a series of independent T-tests for continuous data and chi&#xD;
           square tests for categorical data will be used to compare participants in the two&#xD;
           intervention arms at baseline. This will help to indicate whether randomisation was&#xD;
           effective and inform additional analyses i.e. certain variables may need to be&#xD;
           controlled for using ANCOVAs or ANCOVA.&#xD;
&#xD;
        -  A series of independent T-tests for continuous data and chi square tests for categorical&#xD;
           data will be used to compare participants who have dropped out versus those who&#xD;
           completed the study. This will help to further understand acceptability and reasons for&#xD;
           attrition.&#xD;
&#xD;
        -  Descriptive statistics will be reported for rates of attrition and data collected from&#xD;
           the feedback questionnaires.&#xD;
&#xD;
        -  To explore the potential effectiveness of the intervention, a mixed ANOVA or ANCOVA&#xD;
           analysis will be conducted with assessment (pre-, post-intervention and one-month&#xD;
           follow) being the within subjects factors and intervention arm (self-help intervention&#xD;
           or waitlist) being the between subject factor. This will be conducted for the primary&#xD;
           measure and each of the secondary measures. As this is a pilot study and not testing&#xD;
           effectiveness specifically, intent to treat analysis and Bonferroni corrections will not&#xD;
           be performed. Cohen's d will be used to interpret observed effect sizes using the&#xD;
           parameters discussed above. A significance level of alpha (0.05) will be adopted for all&#xD;
           statistical analysis reported. SPSS25 will be used for all statistical analysis.&#xD;
&#xD;
        -  To calculate the post-hoc power analysis to inform sample sizes of future definitive&#xD;
           randomised controlled trials, G*Power software will be used utilising the same&#xD;
           parameters as above (i.e. two-tailed, alpha level and 80% power) - given the assumptions&#xD;
           of the ANOVA or ANCOVA were met and therefore the effect size is valid. This will be&#xD;
           conducted using the results from the primary outcome measure (GAD-7) and an average size&#xD;
           of secondary measures.&#xD;
&#xD;
      Qualitative data: Qualitative data gathered from the feedback questionnaires will be analysed&#xD;
      using a descriptive version of thematic analysis. This will adhere to the stages outline by&#xD;
      Braun and Clarke:&#xD;
&#xD;
        1. Become familiar with the transcripts through repeated readings - participant's responses&#xD;
           will already be in electronic format as it is collected via Qualtrics and so&#xD;
           transcriptions will not be needed.&#xD;
&#xD;
        2. Undertake iterative coding of each transcript re-coding each narrative as new codes&#xD;
           emerge.&#xD;
&#xD;
        3. Collate and contrast codes to create main- and sub-themes.&#xD;
&#xD;
        4. Review the themes and discuss the findings with members of the research team.&#xD;
&#xD;
        5. Final refinement of themes identifying clear titles and selecting appropriate quotations&#xD;
           in support of each theme.&#xD;
&#xD;
        6. Write up the report making the outcome of the analysis coherent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 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>Randomised controlled trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Generalised Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>pre intervention, post intervention (4 weeks after) and 1 month follow up</time_frame>
    <description>The Generalised Anxiety Disorder-7 (GAD-7) is a seven-item scale, self-administered screening tool and anxiety severity measure for anxiety disorders including, generalised anxiety disorder, social anxiety and panic disorder. Scores range from 0-21. A score of 0-4 indicates &quot;no difficulties&quot;, 5-9 &quot;mild&quot;, 10-14 &quot;moderate&quot; and 15-21 &quot;severe&quot; levels. A higher score suggests greater anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Patient Health Questionnaire-9 (PHQ9)</measure>
    <time_frame>pre intervention, post intervention (4 weeks after) and 1 month follow up</time_frame>
    <description>The Patient Health Questionnaire-9 (PHQ9) is a nine-item, self-administered tool to examine severity of depression. Scores range from 0-27. A score of 0-4 indicates &quot;no difficulties&quot;, 5-9 &quot;mild&quot;, 10-14 &quot;moderate&quot;, 15-19 &quot;moderately severe&quot; and 20 or higher &quot;severe depression&quot;. A higher score suggests greater depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in emPHasis-10</measure>
    <time_frame>pre intervention, post intervention (4 weeks after) and 1 month follow up</time_frame>
    <description>This is a disease-specific, health-related quality of life measure asking respondents to rate ten difficulties commonly associated with PH. Scores can range form 0-50, with a higher score indicating lower quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dyspnoea 12 (D12)</measure>
    <time_frame>pre intervention, post intervention (4 weeks after) and 1 month follow up</time_frame>
    <description>The Dyspnoea 12 (D12) will be used to examine participant's breathlessness severity. Total scores range from 0-36 with a higher score indicating worse functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mastery Scale</measure>
    <time_frame>pre intervention, post intervention (4 weeks after) and 1 month follow up</time_frame>
    <description>The Mastery Scale will be used to investigate participant's perception of their own ability of coping. Total scores range from 7-49 with a higher score suggesting the individual perceives himself or herself as having a greater capacity to cope</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cognitive Behavioural Processes Questionnaire (CBPQ)</measure>
    <time_frame>pre intervention, post intervention (4 weeks after) and 1 month follow up</time_frame>
    <description>The Cognitive Behavioural Processes Questionnaire (CBPQ) will be used to examine participant's responses to negative cognitions, emotions and behaviours that may themselves underlie anxiety disorders. Scores range from 0-120, with higher scores suggesting lower engagement in cognitive and behavioural processes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Pulmonary Hypertension</condition>
  <condition>Pulmonary Arterial Hypertension</condition>
  <condition>Anxiety</condition>
  <condition>Anxiety Disorders</condition>
  <arm_group>
    <arm_group_label>Intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomised to the intervention arm will receive a CBT informed, self-help intervention for anxiety in PH. This will be based on the four factor model, which is a trans-diagnostic approach to help understanding and identify behaviour change methods (Padesky &amp; Mooney, 1990).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A waiting-list will be used as a control condition. If the self-management intervention is found to be acceptable and not associated with any risk, then participants in the control condition will receive the intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive Behavioural therapy self help intervention for anxiety</intervention_name>
    <description>The intervention will involve five key components:&#xD;
Psychoeducation - Increase awareness of how PH may affect emotional health, normalisation of difficulties, and discussion of how symptoms associated with anxiety may add to the burden of the disease.&#xD;
Cognitions - Identify and challenge negative automatic thoughts associated with anxiety.&#xD;
Coping skills - Educate and practice a range of behavioural coping methods to help participants better manage their physical symptoms associated with anxiety in PH.&#xD;
Exposure - Replace avoidance of anxiety provoking situations and activities using graded exposure.&#xD;
Relapse prevention - Focus on relapse prevention with implementation intentions and promotion of problem solving.</description>
    <arm_group_label>Intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Aged 18 years or over&#xD;
&#xD;
               -  Diagnosis of pulmonary hypertension - participants will be asked to self-report&#xD;
                  this information&#xD;
&#xD;
               -  Able to complete the self-report questionnaires without help from others&#xD;
&#xD;
               -  Able to give informed consent - given that participants need to be proactive in&#xD;
                  entering the study, this will be assumed.&#xD;
&#xD;
               -  Literate in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Significant risk issues (participants will be asked to self-report this&#xD;
             information), for example, experiencing current thoughts of self-harm or suicide.&#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>Gregg H Rawlings, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sheffield</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gregg H Rawlings, PhD</last_name>
    <phone>(+44) (0)114 2226610</phone>
    <email>ghrawlings1@sheffield.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amrit Sinha</last_name>
    <phone>0114 2226650</phone>
    <email>a.sinha@sheffield.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinical Psychology Unit</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S1 2LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amrit Sinha</last_name>
      <phone>0114 2226650</phone>
      <email>A.Sinha@sheffield.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Nigel Beail, Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Thompson, Prof</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Iain Armstrong, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinical Psychology Unit</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amrit Sinha</last_name>
    </contact>
    <contact_backup>
      <email>a.sinha@sheffield.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.</citation>
    <PMID>16717171</PMID>
  </reference>
  <reference>
    <citation>Yorke J, Corris P, Gaine S, Gibbs JS, Kiely DG, Harries C, Pollock V, Armstrong I. emPHasis-10: development of a health-related quality of life measure in pulmonary hypertension. Eur Respir J. 2014 Apr;43(4):1106-13. doi: 10.1183/09031936.00127113. Epub 2013 Nov 14.</citation>
    <PMID>24232702</PMID>
  </reference>
  <reference>
    <citation>Yorke J, Moosavi SH, Shuldham C, Jones PW. Quantification of dyspnoea using descriptors: development and initial testing of the Dyspnoea-12. Thorax. 2010 Jan;65(1):21-6. doi: 10.1136/thx.2009.118521. Epub 2009 Dec 8.</citation>
    <PMID>19996336</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>November 6, 2020</last_update_submitted>
  <last_update_submitted_qc>November 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</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>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Participant's data will not be shared with researchers outside of the research team. Participants will be anonymised in all publications.</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/NCT04450862
org study id: 034442
nct id: NCT04450862
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulmonary hypertension (PH) is a disorder of high blood pressure that impacts the heart and
      lungs. Approximately, 50% of individuals with PH experience anxiety or panic disorders. There
      is limited evidence on psychological treatments for anxiety in PH; however, results support
      the use of Cognitive Behavioural Therapy (CBT). Despite the prevalence and impact of anxiety
      in PH; there are no widely available and/or disease specific pathways, thus highlighting an
      unmet need in this population. This project aims to develop and pilot, using randomised
      control trial methodology, a self-management intervention for individuals with PH based on
      principles of CBT.
Project Objectives The primary aim of this study is to develop a self-management intervention
      in collaboration with patient, public involvement, which will consist of experts by
      experience and experts by education. The intervention is aimed at helping individuals with PH
      to manage symptoms of anxiety.

      A secondary aim of the project is to conduct a pilot randomised controlled trial
      investigating the aforementioned self-management intervention. More specifically, the project
      will explore acceptability and feasibility of the intervention itself and research
      methodology proposed to test its effectiveness. Qualitative and quantitative data will be
      collected for this purpose which will focus on: attrition rates; adherence to the
      intervention; participant's acceptability of the intervention and research methodology (i.e.
      eligibility, randomisation, emotional response, perceptions); outcome measures; recruitment
      and data collection procedures; and any adverse effects. Moreover, this project will
      investigate the preliminary efficacy of the intervention on a series of primary (anxiety
      symptoms - Generalised Anxiety Disorder -7) and secondary measures (depression - PHQ9);
      HRQoL- emphasis10); dyspnoea - dyspnoea12; perception of coping - self-mastery questionnaire;
      and cognitive and behavioural processes (Cognitive Behavioural Processes Questionnaire
      (CBPQ), so that effect sizes can be calculated and used to inform sample sizes of any future
      definitive trials.

      Design The study will be a pilot randomised superiority trial. Participants will be
      randomised on a 1:1 basis to either one of two groups, (1) CBT informed self-management
      intervention to help manage anxiety in PH or a (2) controlled waiting-list condition. A
      control condition is required to control for any therapeutic gains associated with being
      involved in a trial. Participants will be asked to complete a series of measures pre-, post-
      and one month following completion of the intervention. As such, a 2 (cognitive-behavioural
      informed intervention or control waiting list) x 3 (pre-, post- and intervention) research
      design will be used. Participants or researchers will not be blinded to condition allocation
      (i.e. participants will be aware they may be randomised to a waiting list condition, and
      researchers may be contacting participants during the intervention for feedback on adherence
      and acceptability).

      Procedure From the study advert promoted by the Pulmonary Hypertension Association,
      participants will be directed to a dedicated webpage for the proposed project.

      From there, participants will be able to read the participant information sheet. Participants
      interested in talking part will be asked to click on a link that will take them to a series
      of questionnaire hosted by Qualtrics. Participants will first be asked to complete an
      eligibility form. Based on their responses, if participants are not eligible they will be
      informed immediately that they are unable to participate in the study. If participants are
      eligible, they will be asked to complete a consent form and a series of questionnaires (see
      below). All data entered on this page will be recorded, as it will help to inform feasibility
      of the inclusion/exclusion criteria (i.e. is the study excluding a large percentage of people
      based on a certain factor).

      Participants will also be informed on the advert promoted by the Pulmonary Hypertension
      Association, that they can contact the lead researcher (Gregg Rawlings) to ask any additional
      questions about the project prior to completing the eligibility form, consent form and/or
      questionnaires.

      Eligible participants will be randomised, using an online randomiser, to either of the two
      arms. The programme used to randomise will be Random.org. Those randomised to the wait-list
      condition will be informed that they will be contacted again in four weeks asking them to
      complete a series of questionnaires and again in an additional month (see below). Those in
      the intervention condition will be sent the CBT intervention.

      Participants in the intervention condition will be instructed to work systematically through
      the intervention. Two weeks after the intervention is sent to participants, participants will
      be contacted by the lead researcher (Gregg Rawlings) to check on adherence and acceptability
      of the intervention using a mixed-methods structured questionnaire. Participants will be
      attempted to be contacted a maximum of three times. Participants will have provided prior
      consent to be contacted.

      Four weeks following the intervention being received and one month thereafter participants
      will be contacted asking them to complete the outcome measures (see below). During this time,
      participants will be contacted asking them to complete a quantitative and qualitative
      questionnaire on their views of participating in the intervention. This will be hosted by
      Qualitrics. Participants will have provided consent to be contacted for this purpose.

      Data analysis

      Quantitative data:

        -  Descriptive statistics, and a series of independent T-tests for continuous data and chi
           square tests for categorical data will be used to compare participants in the two
           intervention arms at baseline. This will help to indicate whether randomisation was
           effective and inform additional analyses i.e. certain variables may need to be
           controlled for using ANCOVAs or ANCOVA.

        -  A series of independent T-tests for continuous data and chi square tests for categorical
           data will be used to compare participants who have dropped out versus those who
           completed the study. This will help to further understand acceptability and reasons for
           attrition.

        -  Descriptive statistics will be reported for rates of attrition and data collected from
           the feedback questionnaires.

        -  To explore the potential effectiveness of the intervention, a mixed ANOVA or ANCOVA
           analysis will be conducted with assessment (pre-, post-intervention and one-month
           follow) being the within subjects factors and intervention arm (self-help intervention
           or waitlist) being the between subject factor. This will be conducted for the primary
           measure and each of the secondary measures. As this is a pilot study and not testing
           effectiveness specifically, intent to treat analysis and Bonferroni corrections will not
           be performed. Cohen's d will be used to interpret observed effect sizes using the
           parameters discussed above. A significance level of alpha (0.05) will be adopted for all
           statistical analysis reported. SPSS25 will be used for all statistical analysis.

        -  To calculate the post-hoc power analysis to inform sample sizes of future definitive
           randomised controlled trials, G*Power software will be used utilising the same
           parameters as above (i.e. two-tailed, alpha level and 80% power) - given the assumptions
           of the ANOVA or ANCOVA were met and therefore the effect size is valid. This will be
           conducted using the results from the primary outcome measure (GAD-7) and an average size
           of secondary measures.

      Qualitative data: Qualitative data gathered from the feedback questionnaires will be analysed
      using a descriptive version of thematic analysis. This will adhere to the stages outline by
      Braun and Clarke:

        1. Become familiar with the transcripts through repeated readings - participant's responses
           will already be in electronic format as it is collected via Qualtrics and so
           transcriptions will not be needed.

        2. Undertake iterative coding of each transcript re-coding each narrative as new codes
           emerge.

        3. Collate and contrast codes to create main- and sub-themes.

        4. Review the themes and discuss the findings with members of the research team.

        5. Final refinement of themes identifying clear titles and selecting appropriate quotations
           in support of each theme.

        6. Write up the report making the outcome of the analysis coherent.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised controlled trial
primary purpose: Other
masking: None (Open Label)
measure: Change in Generalised Anxiety Disorder-7 (GAD-7)
time frame: pre intervention, post intervention (4 weeks after) and 1 month follow up
description: The Generalised Anxiety Disorder-7 (GAD-7) is a seven-item scale, self-administered screening tool and anxiety severity measure for anxiety disorders including, generalised anxiety disorder, social anxiety and panic disorder. Scores range from 0-21. A score of 0-4 indicates "no difficulties", 5-9 "mild", 10-14 "moderate" and 15-21 "severe" levels. A higher score suggests greater anxiety.
measure: Change in Patient Health Questionnaire-9 (PHQ9)
time frame: pre intervention, post intervention (4 weeks after) and 1 month follow up
description: The Patient Health Questionnaire-9 (PHQ9) is a nine-item, self-administered tool to examine severity of depression. Scores range from 0-27. A score of 0-4 indicates "no difficulties", 5-9 "mild", 10-14 "moderate", 15-19 "moderately severe" and 20 or higher "severe depression". A higher score suggests greater depression.
measure: Change in emPHasis-10
time frame: pre intervention, post intervention (4 weeks after) and 1 month follow up
description: This is a disease-specific, health-related quality of life measure asking respondents to rate ten difficulties commonly associated with PH. Scores can range form 0-50, with a higher score indicating lower quality of life.
measure: Change in Dyspnoea 12 (D12)
time frame: pre intervention, post intervention (4 weeks after) and 1 month follow up
description: The Dyspnoea 12 (D12) will be used to examine participant's breathlessness severity. Total scores range from 0-36 with a higher score indicating worse functioning
measure: Change in Mastery Scale
time frame: pre intervention, post intervention (4 weeks after) and 1 month follow up
description: The Mastery Scale will be used to investigate participant's perception of their own ability of coping. Total scores range from 7-49 with a higher score suggesting the individual perceives himself or herself as having a greater capacity to cope
measure: Change in Cognitive Behavioural Processes Questionnaire (CBPQ)
time frame: pre intervention, post intervention (4 weeks after) and 1 month follow up
description: The Cognitive Behavioural Processes Questionnaire (CBPQ) will be used to examine participant's responses to negative cognitions, emotions and behaviours that may themselves underlie anxiety disorders. Scores range from 0-120, with higher scores suggesting lower engagement in cognitive and behavioural processes.
arm group label: Intervention arm
arm group type: Experimental
description: Participants randomised to the intervention arm will receive a CBT informed, self-help intervention for anxiety in PH. This will be based on the four factor model, which is a trans-diagnostic approach to help understanding and identify behaviour change methods (Padesky & Mooney, 1990).
arm group label: Control arm
arm group type: No Intervention
description: A waiting-list will be used as a control condition. If the self-management intervention is found to be acceptable and not associated with any risk, then participants in the control condition will receive the intervention.
intervention type: Other
intervention name: Cognitive Behavioural therapy self help intervention for anxiety
description: The intervention will involve five key components:
Psychoeducation - Increase awareness of how PH may affect emotional health, normalisation of difficulties, and discussion of how symptoms associated with anxiety may add to the burden of the disease.
Cognitions - Identify and challenge negative automatic thoughts associated with anxiety.
Coping skills - Educate and practice a range of behavioural coping methods to help participants better manage their physical symptoms associated with anxiety in PH.
Exposure - Replace avoidance of anxiety provoking situations and activities using graded exposure.
Relapse prevention - Focus on relapse prevention with implementation intentions and promotion of problem solving.
arm group label: Intervention arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gregg H Rawlings, PhD
role: Principal Investigator
affiliation: University of Sheffield
last name: Gregg H Rawlings, PhD
phone: (+44) (0)114 2226610
email: ghrawlings1@sheffield.ac.uk
last name: Amrit Sinha
phone: 0114 2226650
email: a.sinha@sheffield.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PMID: 16717171
citation: Yorke J, Corris P, Gaine S, Gibbs JS, Kiely DG, Harries C, Pollock V, Armstrong I. emPHasis-10: development of a health-related quality of life measure in pulmonary hypertension. Eur Respir J. 2014 Apr;43(4):1106-13. doi: 10.1183/09031936.00127113. Epub 2013 Nov 14.
PMID: 24232702
citation: Yorke J, Moosavi SH, Shuldham C, Jones PW. Quantification of dyspnoea using descriptors: development and initial testing of the Dyspnoea-12. Thorax. 2010 Jan;65(1):21-6. doi: 10.1136/thx.2009.118521. Epub 2009 Dec 8.
PMID: 19996336
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Pulmonary Arterial Hypertension
mesh term: Hypertension
mesh term: Anxiety Disorders
sharing ipd: No
ipd description: Participant's data will not be shared with researchers outside of the research team. Participants will be anonymised in all publications.