<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/NCT02212236</url>
  </required_header>
  <id_info>
    <org_study_id>14069</org_study_id>
    <nct_id>NCT02212236</nct_id>
  </id_info>
  <brief_title>Psychological Intervention for Distress During HSCT</brief_title>
  <official_title>Development and Evaluation of a Psychological Intervention to Alleviate Distress During Haematopoietic Stem-cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase II trial aims to evaluate a new psychological intervention to alleviate distress&#xD;
      during haematopoietic stem cell transplantation (HSCT) together with examining feasibility.&#xD;
&#xD;
      HSCT is a complex procedure aimed at a range of haematological and autoimmune illnesses. Over&#xD;
      3,000 individuals undergo the procedure every year in the UK with substantial benefits.&#xD;
      However, it is very costly, intensive, and has a range of debilitating side effects.&#xD;
      Consequently, patients often experience considerable distress, which can impede recovery.&#xD;
&#xD;
      A 90-minute, group-based intervention has been developed to address this need based on&#xD;
      psychological theory of adjustment to illness-related difficulties. It is delivered by the&#xD;
      transplant team and involves provision of information to foster more helpful perceptions&#xD;
      about HSCT and facilitating more helpful coping with its difficulties. To evaluate the&#xD;
      effectiveness of the intervention in alleviating distress, 60 patients about to undergo HSCT&#xD;
      at two sites (Sheffield &amp; Nottingham) will be randomly allocated into two groups. Patients in&#xD;
      the intervention group will receive the new intervention prior to transplantation together&#xD;
      with treatment as usual (TAU) while patients in the control group will receive TAU alone.&#xD;
      Participants and the researcher collecting the data will be blind to the allocation.&#xD;
&#xD;
      Demographic and relevant clinical information will be recorded at the end of participation to&#xD;
      ensure effectiveness of randomisation. For both groups, resilience, distress, coping, and&#xD;
      procedure-related perceptions will be measured at four time points: (i) prior to the&#xD;
      intervention/transplantation, (ii) day of transplant, (iii) two weeks following the&#xD;
      transplant, and (iv) four weeks following the transplant. It is hypothesised that patients in&#xD;
      the intervention group will experience higher resilience and lower distress compared to&#xD;
      controls and that this difference will be mediated by procedure-related perceptions and&#xD;
      coping. A subgroup of participants of those randomised to the group intervention will be&#xD;
      invited to participate in a feedback interview at the end.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression Anxiety Stress Scales (DASS-21)</measure>
    <time_frame>Baseline</time_frame>
    <description>Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression Anxiety Stress Scales (DASS-21)</measure>
    <time_frame>Day 0 (transplant day)</time_frame>
    <description>Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression Anxiety Stress Scales (DASS-21)</measure>
    <time_frame>Day 14</time_frame>
    <description>Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression Anxiety Stress Scales (DASS-21)</measure>
    <time_frame>Day 28</time_frame>
    <description>Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brief Resilience Scale (BRS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Assesses resilience; 6 items, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Resilience Scale (BRS)</measure>
    <time_frame>Day 0 (transplant day)</time_frame>
    <description>Assesses resilience; 6 items, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Resilience Scale (BRS)</measure>
    <time_frame>Day 14</time_frame>
    <description>Assesses resilience; 6 items, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Resilience Scale (BRS)</measure>
    <time_frame>Day 28</time_frame>
    <description>Assesses resilience; 6 items, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Coping with Problems Experienced scale (COPE)</measure>
    <time_frame>Baseline</time_frame>
    <description>Assesses coping styles; 28-item, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Coping with Problems Experienced scale (COPE)</measure>
    <time_frame>Day 0 (transplant day)</time_frame>
    <description>Assesses coping styles; 28-item, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Coping with Problems Experienced scale (COPE)</measure>
    <time_frame>Day 14</time_frame>
    <description>Assesses coping styles; 28-item, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Coping with Problems Experienced scale (COPE)</measure>
    <time_frame>Day 28</time_frame>
    <description>Assesses coping styles; 28-item, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Illness Perceptions Questionnaire (IPQ)</measure>
    <time_frame>Baseline</time_frame>
    <description>Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Illness Perceptions Questionnaire (IPQ)</measure>
    <time_frame>Day 0 (transplant day)</time_frame>
    <description>Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Illness Perceptions Questionnaire (IPQ)</measure>
    <time_frame>Day 14</time_frame>
    <description>Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Illness Perceptions Questionnaire (IPQ)</measure>
    <time_frame>Day 28</time_frame>
    <description>Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Psychological Distress</condition>
  <condition>Haematopoietic Stem Cell Transplantation</condition>
  <condition>Bone Marrow Transplantation</condition>
  <arm_group>
    <arm_group_label>Psychological preparation + TAU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAU=treatment as usual</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care including medication, nursing, and psychologist support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychological preparation</intervention_name>
    <description>Ninety-minute, group-based psychological preparation delivered prior to haematopoietic stem cell transplantation aiming at alleviating psychological distress during the procedure by enhancing perceptions of the procedure and fostering more helpful coping.</description>
    <arm_group_label>Psychological preparation + TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients referred for HSCT as treatment for haematological malignancy&#xD;
&#xD;
          -  age of 18 years or older&#xD;
&#xD;
          -  sufficient command of the English language or access to suitable support to comprehend&#xD;
             materials and participate in the group and data collection over the telephone&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  permission will also be sought by the patient's Consultant Haematologist once clients&#xD;
             have consented&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Consent withdrawn&#xD;
&#xD;
          -  Consultant Haematologist raises concern regarding participation&#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>Thomas Schröder, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nottingham City Hospital</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>October 27, 2015</last_update_submitted>
  <last_update_submitted_qc>October 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Distress</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Stress</keyword>
  <keyword>Coping</keyword>
  <keyword>Illness perceptions</keyword>
  <keyword>Stem cell transplantation</keyword>
  <keyword>Bone marrow transplantation</keyword>
  <!-- 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/NCT02212236
org study id: 14069
nct id: NCT02212236
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This Phase II trial aims to evaluate a new psychological intervention to alleviate distress
      during haematopoietic stem cell transplantation (HSCT) together with examining feasibility.

      HSCT is a complex procedure aimed at a range of haematological and autoimmune illnesses. Over
      3,000 individuals undergo the procedure every year in the UK with substantial benefits.
      However, it is very costly, intensive, and has a range of debilitating side effects.
      Consequently, patients often experience considerable distress, which can impede recovery.

      A 90-minute, group-based intervention has been developed to address this need based on
      psychological theory of adjustment to illness-related difficulties. It is delivered by the
      transplant team and involves provision of information to foster more helpful perceptions
      about HSCT and facilitating more helpful coping with its difficulties. To evaluate the
      effectiveness of the intervention in alleviating distress, 60 patients about to undergo HSCT
      at two sites (Sheffield & Nottingham) will be randomly allocated into two groups. Patients in
      the intervention group will receive the new intervention prior to transplantation together
      with treatment as usual (TAU) while patients in the control group will receive TAU alone.
      Participants and the researcher collecting the data will be blind to the allocation.

      Demographic and relevant clinical information will be recorded at the end of participation to
      ensure effectiveness of randomisation. For both groups, resilience, distress, coping, and
      procedure-related perceptions will be measured at four time points: (i) prior to the
      intervention/transplantation, (ii) day of transplant, (iii) two weeks following the
      transplant, and (iv) four weeks following the transplant. It is hypothesised that patients in
      the intervention group will experience higher resilience and lower distress compared to
      controls and that this difference will be mediated by procedure-related perceptions and
      coping. A subgroup of participants of those randomised to the group intervention will be
      invited to participate in a feedback interview at the end.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Depression Anxiety Stress Scales (DASS-21)
time frame: Baseline
description: Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
measure: Depression Anxiety Stress Scales (DASS-21)
time frame: Day 0 (transplant day)
description: Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
measure: Depression Anxiety Stress Scales (DASS-21)
time frame: Day 14
description: Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
measure: Depression Anxiety Stress Scales (DASS-21)
time frame: Day 28
description: Assesses presence of depression, anxiety, stress, and overall distress; 21 items, Likert-type.
measure: Brief Resilience Scale (BRS)
time frame: Baseline
description: Assesses resilience; 6 items, Likert-type.
measure: Brief Resilience Scale (BRS)
time frame: Day 0 (transplant day)
description: Assesses resilience; 6 items, Likert-type.
measure: Brief Resilience Scale (BRS)
time frame: Day 14
description: Assesses resilience; 6 items, Likert-type.
measure: Brief Resilience Scale (BRS)
time frame: Day 28
description: Assesses resilience; 6 items, Likert-type.
measure: Brief Coping with Problems Experienced scale (COPE)
time frame: Baseline
description: Assesses coping styles; 28-item, Likert-type.
measure: Brief Coping with Problems Experienced scale (COPE)
time frame: Day 0 (transplant day)
description: Assesses coping styles; 28-item, Likert-type.
measure: Brief Coping with Problems Experienced scale (COPE)
time frame: Day 14
description: Assesses coping styles; 28-item, Likert-type.
measure: Brief Coping with Problems Experienced scale (COPE)
time frame: Day 28
description: Assesses coping styles; 28-item, Likert-type.
measure: Brief Illness Perceptions Questionnaire (IPQ)
time frame: Baseline
description: Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
measure: Brief Illness Perceptions Questionnaire (IPQ)
time frame: Day 0 (transplant day)
description: Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
measure: Brief Illness Perceptions Questionnaire (IPQ)
time frame: Day 14
description: Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
measure: Brief Illness Perceptions Questionnaire (IPQ)
time frame: Day 28
description: Assesses illness perceptions, adapted for haematopoietic stem cell transplantation; 9-item, Likert-type.
arm group label: Psychological preparation + TAU
arm group type: Experimental
description: TAU=treatment as usual
arm group label: Treatment as usual
arm group type: No Intervention
description: Usual care including medication, nursing, and psychologist support.
intervention type: Other
intervention name: Psychological preparation
description: Ninety-minute, group-based psychological preparation delivered prior to haematopoietic stem cell transplantation aiming at alleviating psychological distress during the procedure by enhancing perceptions of the procedure and fostering more helpful coping.
arm group label: Psychological preparation + TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Schröder, PhD
role: Principal Investigator
affiliation: University of Nottingham
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor