<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/NCT02186730</url>
  </required_header>
  <id_info>
    <org_study_id>CITADAL</org_study_id>
    <nct_id>NCT02186730</nct_id>
  </id_info>
  <brief_title>Computerised Intervention/Treatment for Adolescent Depression and Low Mood:</brief_title>
  <acronym>CITADAL</acronym>
  <official_title>Computerised Intervention/Treatment for Adolescent Depression and Low Mood: Feasibility Phase 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leeds and York Partnership NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Leeds and York Partnership NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study forms the second phase of previous work to examine the effectiveness of&#xD;
      computerised Cognitive Behaviour Therapy (cCBT) to treat adolescents with low&#xD;
      mood/depression.&#xD;
&#xD;
      Depression affects around 2% of adolescents. Antidepressants are not recommended for this age&#xD;
      range as a first line treatment because of concerns about their usefulness and side effects.&#xD;
      Government guidelines have supported using Cognitive Behaviour Therapy (CBT), which is&#xD;
      effective and one of the main treatments recommended for depression. It has been suggested&#xD;
      that computerised versions of CBT (cCBT) may be effective for treating depression in young&#xD;
      people who may prefer this to seeing a therapist face-to-face, but little research exists to&#xD;
      date to support this. This study examines the feasibility of running a large scale randomised&#xD;
      controlled trial (RCT) to compare a promising cCBT program (Stressbusters) with self-help&#xD;
      websites for adolescents with low mood and depression (LMD).&#xD;
&#xD;
      Eligible and consenting participants will complete several questionnaires to assess their&#xD;
      mood before being randomly assigned to either cCBT (Stressbusters) or equivalent access to&#xD;
      selected websites providing self help for LMD. Participants will complete further mood&#xD;
      questionnaires 4 and 12 months after treatment completion/withdrawal. We have already&#xD;
      recruited 97 individuals to this trial but aim to recruit a further 48 participants to&#xD;
      collect further information.&#xD;
&#xD;
      We are also keen to find out whether sending participants text messages before sessions and&#xD;
      around follow up periods will increase attendance/completion. Therefore all trial&#xD;
      participants will receive text messages from the research team during their participation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2014</start_date>
  <completion_date type="Actual">August 1, 2016</completion_date>
  <primary_completion_date type="Actual">April 27, 2015</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>Changes on the Short Beck Depression Inventory from baseline to 4 and 12 months follow up</measure>
    <time_frame>baseline, 4 months follow up, 12 months follow up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes on the Mood and Feelings Questionnaire from baseline to 4 and 12 months follow up</measure>
    <time_frame>Baseline, 4 months follow up, 12 months follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Short Mood and Feelings Questionnaire</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes on the Spence Children's Anxiety Scale from baseline to 4 and 12 months follow up</measure>
    <time_frame>Baseline, 4 months follow up and 12 months follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health status measured by the EQ-5D-Y from baseline to 4 and 12 months follow up</measure>
    <time_frame>Baseline, 4 months follow up, 12 months follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in health status measured by the HUI2 from baseline to 4 and 12 months follow up</measure>
    <time_frame>Baseline, 4 months follow up and 12 months follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of health services used by participants between baseline, 4 months and 12 months follow up</measure>
    <time_frame>Baseline, 4 months follow up, 12 months follow up</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Further mental health support received during trial participation</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of self-harm episodes during trial participation</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of inpatient admissions during trial participation</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Stressbsuters</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computerised Cognitive Behaviour package consisting of eight 30-45 minute sessions of CBT designed for 12-18 year olds. Each Stressbusters session is an interactive presentation featuring narration synchronised with videos, animations, graphics and printouts.&#xD;
The programme has a narrator guiding individuals through each of the eight sessions in a linear progression. Each session builds on the knowledge gained in previous sessions and on tasks carried out at home. Sessions contain flexible &quot;add-ons&quot; such as written fact sheets (for example about bullying, sleep problems) which can be printed out and taken away together with home practice related handouts from the programme (for example mood diary sheets). Session topics include getting activated, relapse prevention, challenging negative thoughts and problem solving</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Websites</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Any individuals randomised to arm 2 of the trial will spend the equivalent time accessing currently available self help websites that provide information about low mood/depression. These four websites will be the same as those used in our initial feasibility study of which, based on our preliminary data, there is evidence for their usefulness.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stressbusters</intervention_name>
    <description>cCBT</description>
    <arm_group_label>Stressbsuters</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Websites</intervention_name>
    <description>Self help websites</description>
    <arm_group_label>Websites</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12 to 18 years&#xD;
&#xD;
          -  Low mood/depression&#xD;
&#xD;
          -  co-morbid physical illness or co-morbid non-psychotic functional disorders, such as&#xD;
             anxiety&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suicidality&#xD;
&#xD;
          -  Postnatally depressed&#xD;
&#xD;
          -  Suffering psychotic symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barry Wright</last_name>
    <role>Principal Investigator</role>
    <affiliation>LYPFT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Limetrees Child Adolescent and Family Unit</name>
      <address>
        <city>York</city>
        <state>North Yorkshire</state>
        <zip>YO30 5RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>June 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Computerised Cognitive Behaviour Therapy</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Depression</keyword>
  <keyword>Low Mood</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT02186730
org study id: CITADAL
nct id: NCT02186730
lead sponsor: 
has dmc: Yes
This study forms the second phase of previous work to examine the effectiveness of
      computerised Cognitive Behaviour Therapy (cCBT) to treat adolescents with low
      mood/depression.

      Depression affects around 2% of adolescents. Antidepressants are not recommended for this age
      range as a first line treatment because of concerns about their usefulness and side effects.
      Government guidelines have supported using Cognitive Behaviour Therapy (CBT), which is
      effective and one of the main treatments recommended for depression. It has been suggested
      that computerised versions of CBT (cCBT) may be effective for treating depression in young
      people who may prefer this to seeing a therapist face-to-face, but little research exists to
      date to support this. This study examines the feasibility of running a large scale randomised
      controlled trial (RCT) to compare a promising cCBT program (Stressbusters) with self-help
      websites for adolescents with low mood and depression (LMD).

      Eligible and consenting participants will complete several questionnaires to assess their
      mood before being randomly assigned to either cCBT (Stressbusters) or equivalent access to
      selected websites providing self help for LMD. Participants will complete further mood
      questionnaires 4 and 12 months after treatment completion/withdrawal. We have already
      recruited 97 individuals to this trial but aim to recruit a further 48 participants to
      collect further information.

      We are also keen to find out whether sending participants text messages before sessions and
      around follow up periods will increase attendance/completion. Therefore all trial
      participants will receive text messages from the research team during their participation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes on the Short Beck Depression Inventory from baseline to 4 and 12 months follow up
time frame: baseline, 4 months follow up, 12 months follow up
measure: Changes on the Mood and Feelings Questionnaire from baseline to 4 and 12 months follow up
time frame: Baseline, 4 months follow up, 12 months follow up
measure: The Short Mood and Feelings Questionnaire
time frame: up to 8 weeks
measure: Changes on the Spence Children's Anxiety Scale from baseline to 4 and 12 months follow up
time frame: Baseline, 4 months follow up and 12 months follow up
measure: Changes in health status measured by the EQ-5D-Y from baseline to 4 and 12 months follow up
time frame: Baseline, 4 months follow up, 12 months follow up
measure: Changes in health status measured by the HUI2 from baseline to 4 and 12 months follow up
time frame: Baseline, 4 months follow up and 12 months follow up
measure: The number of health services used by participants between baseline, 4 months and 12 months follow up
time frame: Baseline, 4 months follow up, 12 months follow up
measure: Further mental health support received during trial participation
time frame: 12 months
measure: Number of self-harm episodes during trial participation
time frame: 12 months
measure: Number of inpatient admissions during trial participation
time frame: 12 months
arm group label: Stressbsuters
arm group type: Experimental
description: Computerised Cognitive Behaviour package consisting of eight 30-45 minute sessions of CBT designed for 12-18 year olds. Each Stressbusters session is an interactive presentation featuring narration synchronised with videos, animations, graphics and printouts.
The programme has a narrator guiding individuals through each of the eight sessions in a linear progression. Each session builds on the knowledge gained in previous sessions and on tasks carried out at home. Sessions contain flexible "add-ons" such as written fact sheets (for example about bullying, sleep problems) which can be printed out and taken away together with home practice related handouts from the programme (for example mood diary sheets). Session topics include getting activated, relapse prevention, challenging negative thoughts and problem solving
arm group label: Websites
arm group type: Active Comparator
description: Any individuals randomised to arm 2 of the trial will spend the equivalent time accessing currently available self help websites that provide information about low mood/depression. These four websites will be the same as those used in our initial feasibility study of which, based on our preliminary data, there is evidence for their usefulness.
intervention type: Behavioral
intervention name: Stressbusters
description: cCBT
arm group label: Stressbsuters
intervention type: Behavioral
intervention name: Websites
description: Self help websites
arm group label: Websites
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Barry Wright
role: Principal Investigator
affiliation: LYPFT
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder