<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/NCT03035110</url>
  </required_header>
  <id_info>
    <org_study_id>205350</org_study_id>
    <nct_id>NCT03035110</nct_id>
  </id_info>
  <brief_title>A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings</brief_title>
  <official_title>A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Essex</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Essex</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current research is being undertaken as part of a professional doctorate in clinical&#xD;
      psychology, which aims to evaluate the feasibility of a group programme to address self-harm&#xD;
      within 23 days, to provide evidence for a controlled trial. The intervention will include&#xD;
      four group sessions conducted over 2 weeks, based on Dialectical Behavioural Therapy.&#xD;
      Specifically the aims are to determine 1) means and a standard deviation for two pre and post&#xD;
      treatment outcome measures in order to estimate sample size for the main study, 2) the need&#xD;
      for an inpatient intervention for self-harm measured by number of participants eligible and&#xD;
      accepting of the treatment, 3) retention of participants for 4 groups given the predicted&#xD;
      short stays of patients on wards, and 4) the acceptability of the research process for this&#xD;
      client group through feedback.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Actual">May 15, 2018</completion_date>
  <primary_completion_date type="Actual">May 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Inventory of Statements About Self-Injury (ISAS)</measure>
    <time_frame>23 days</time_frame>
    <description>ISAS is a self-report measure designed to assess the function and frequency of deliberate self-harm. It will be administered pre- and post-intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Distress Tolerance Scale (DTS)</measure>
    <time_frame>23 days</time_frame>
    <description>The DTS consists of 15 items, which measure a person's appraisal of their emotional distress, their ability to tolerate this distress and any regulation efforts to alleviate it. It will be administered pre- and post-intervention.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Self-Injurious Behavior</condition>
  <arm_group>
    <arm_group_label>Dialectical Behavioural Therapy (DBT) skills group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four group sessions, based on DBT, over two weeks, with a group of four to eight participants in attendance located on the hospital ward where the participant is a patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dialectical Behavioural Therapy (DBT) based skills groups</intervention_name>
    <description>Dialectical Behavioural Therapy (DBT) involves skills that help people manage their emotions and tolerate distress. This therapy is found effective in reducing self-harm behaviour for outpatients with Borderline Personality Disorder.</description>
    <arm_group_label>Dialectical Behavioural Therapy (DBT) skills group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be screened by their allocated clinician and included if they are&#xD;
             aged between 18-65&#xD;
&#xD;
          -  admitted to hospital&#xD;
&#xD;
          -  have a history of or engaged in at least one episode of self-harm, iv) have capacity&#xD;
             to understand the information sheet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants will be screened by clinicians and they will exclude people if i) they&#xD;
             are Non-English speakers (due to translation costs)&#xD;
&#xD;
          -  they lack the capacity to give informed consent (assessed by their key clinician)&#xD;
&#xD;
          -  their symptoms prevent them from concentrating for an hour at a time (i.e. severe&#xD;
             thought disorder), and therefore not benefiting from the group (assessed by their key&#xD;
             clinician)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Goodmayes Hospital</name>
      <address>
        <city>Ilford</city>
        <state>Essex</state>
        <zip>IG3 8XJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>June 1, 2018</last_update_submitted>
  <last_update_submitted_qc>June 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2018</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>Self-Injurious Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03035110
org study id: 205350
nct id: NCT03035110
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current research is being undertaken as part of a professional doctorate in clinical
      psychology, which aims to evaluate the feasibility of a group programme to address self-harm
      within 23 days, to provide evidence for a controlled trial. The intervention will include
      four group sessions conducted over 2 weeks, based on Dialectical Behavioural Therapy.
      Specifically the aims are to determine 1) means and a standard deviation for two pre and post
      treatment outcome measures in order to estimate sample size for the main study, 2) the need
      for an inpatient intervention for self-harm measured by number of participants eligible and
      accepting of the treatment, 3) retention of participants for 4 groups given the predicted
      short stays of patients on wards, and 4) the acceptability of the research process for this
      client group through feedback.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: The Inventory of Statements About Self-Injury (ISAS)
time frame: 23 days
description: ISAS is a self-report measure designed to assess the function and frequency of deliberate self-harm. It will be administered pre- and post-intervention.
measure: The Distress Tolerance Scale (DTS)
time frame: 23 days
description: The DTS consists of 15 items, which measure a person's appraisal of their emotional distress, their ability to tolerate this distress and any regulation efforts to alleviate it. It will be administered pre- and post-intervention.
arm group label: Dialectical Behavioural Therapy (DBT) skills group
arm group type: Experimental
description: Four group sessions, based on DBT, over two weeks, with a group of four to eight participants in attendance located on the hospital ward where the participant is a patient.
intervention type: Behavioral
intervention name: Dialectical Behavioural Therapy (DBT) based skills groups
description: Dialectical Behavioural Therapy (DBT) involves skills that help people manage their emotions and tolerate distress. This therapy is found effective in reducing self-harm behaviour for outpatients with Borderline Personality Disorder.
arm group label: Dialectical Behavioural Therapy (DBT) skills group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Self-Injurious Behavior
sharing ipd: No