<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/NCT03251235</url>
  </required_header>
  <id_info>
    <org_study_id>09/H0604/55</org_study_id>
    <nct_id>NCT03251235</nct_id>
  </id_info>
  <brief_title>Neural Effects of Cognitive-behaviour Therapy in Panic Disorder</brief_title>
  <official_title>Neural Effects of Cognitive-behaviour Therapy in Panic Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oxford</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>
      Exposure-based cognitive-behaviour therapy (CBT) for anxiety disorders is an effective&#xD;
      intervention, but the brain mechanisms driving recovery are largely unknown. In this&#xD;
      experimental medicine study, it will be investigated to what degree CBT affects neural&#xD;
      markers of anxiety at an early stage of treatment, to identify dynamic mechanistic changes&#xD;
      which might be crucial in the process of recovery as opposed to those seen following full&#xD;
      treatment completion. Patients with panic disorder will be recruited and randomly allocated&#xD;
      to a group receiving 4 weekly sessions of cognitive-behaviour therapy versus a waiting group&#xD;
      not receiving any interventions until after the experimental procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PURPOSE The primary purpose is to enhance our understanding of the mechanisms essential in&#xD;
      effective treatment of panic disorder.&#xD;
&#xD;
      METHODS Design: The present study has a between-subjects design, including a waiting group of&#xD;
      participants with panic symptoms and a treatment group of participants with panic symptoms&#xD;
      who will receive cognitive-behavioural treatment before being tested.&#xD;
&#xD;
      Participants: Twenty-eight volunteers with panic symptoms will be recruited. For participants&#xD;
      who do meet the basic study criteria a phone screening appointment (10 - 30 mins) will be&#xD;
      arranged to further screen for relevant inclusion and exclusion criteria. They will then be&#xD;
      invited to the Department of Psychiatry for the pre-assessment session.&#xD;
&#xD;
      Treatment: Within the study, the investigators will offer participants a brief CBT course of&#xD;
      4 sessions, offered by the Lupina service. The Lupina Service forms part of the OBMH primary&#xD;
      care Counselling &amp; Psychology Service, based at the Warneford Hospital. It provides intensive&#xD;
      individual CBT for panic disorder and agoraphobia and is staffed by trained graduate&#xD;
      volunteer therapists. Potential therapists are psychology graduates with prior mental health&#xD;
      experience, who are given 2 days' intensive training in CBT for panic disorder and&#xD;
      agoraphobia by Alison Croft, Consultant Clinical Psychologist. They then receive group&#xD;
      supervision of their clinical cases. Service evaluation indicates equivalent clinical&#xD;
      outcomes for volunteer therapists relative to qualified clinical psychologists.&#xD;
&#xD;
      Procedure: Participants will be randomly allocated to either the treatment group or the&#xD;
      waiting group. On arrival to the pre-assessment session, participants will be given a copy of&#xD;
      the information sheet (previously seen during the online screening and e-mailed/ posted to&#xD;
      them). They will be invited to fill out the consent form. Screening for past or previous&#xD;
      psychiatric illness will be achieved using a structured clinical interview (SCID). In&#xD;
      addition, participants will be asked to complete a battery of questionnaires. They will also&#xD;
      be familiarised with the procedure occurring on the scanning day. Any outstanding questions&#xD;
      the participant has will be addressed. The visit lasts about 1 to 1 ½ hrs. After the&#xD;
      pre-assessment, a 4 weeks follow-up appointment (post-assessment) will be arranged with all&#xD;
      participants. Half of the participants will be referred for treatment in the LUPINA group&#xD;
      during that time. At the post-assessment 4 weeks later, the participants will be asked to&#xD;
      come to the OCMR (Oxford Clinical Resonance Imaging) Department at the John Radcliffe&#xD;
      Hospital. The visit will last a total of 2½ to 3 hrs and include a scanning session lasting 1&#xD;
      to 1 ½ hrs. Subjective mood will be assessed on the day of the scan using the State form of&#xD;
      the State-Trait Anxiety Inventory, a Mood Visual Analogue Scale and the Positive and Negative&#xD;
      Affect Schedule. In addition, subjects will again complete the questionnaires from the&#xD;
      pre-assessment. After the scan, participants will work on two behavioural computer tasks&#xD;
      using emotional faces and word stimuli to assess facial recognition and attention outside the&#xD;
      scanner. At the end of the session, patients from the waiting group will be offered the&#xD;
      taster-CBT treatment within the LUPINA service.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">February 1, 2016</completion_date>
  <primary_completion_date type="Actual">September 4, 2013</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>Basic Science</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>The care provider is not aware of whether a patient is allocated to the treatment group or the waiting group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Emotional processing</measure>
    <time_frame>Treatment Group: post 4-week CBT treatment, waiting Group: post 4-week waiting</time_frame>
    <description>Activation levels in the fear circuit of the brain in response to emotional stimuli (fMRI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical symptom severity - Global anxiety and depression (self-report)</measure>
    <time_frame>Baseline, after 4 weeks treatment/ waiting</time_frame>
    <description>Hamilton Anxiety and Depression Scale HADS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical symptom severity - Fear of physical sensations (self-report)</measure>
    <time_frame>Baseline, after 4 weeks treatment/ waiting</time_frame>
    <description>Body Sensations Questionnaire BSQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical symptom severity - Agoraphobic fear (self-report)</measure>
    <time_frame>Baseline, after 4 weeks treatment/ waiting</time_frame>
    <description>Agoraphobic Cognitions Questionnaire ACQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical symptom severity - Clinical severity and improvement (clinician-report)</measure>
    <time_frame>Baseline, after 4 weeks treatment/ waiting</time_frame>
    <description>Clinical Global Impression Scale CGI</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Panic Disorder</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group receives four weekly sessions of CBT prior to experimental testing/ fMRI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group receives four weekly sessions of CBT after experimental testing/ fMRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behaviour Therapy</intervention_name>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>CBT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18-70&#xD;
&#xD;
          -  Sufficiently fluent in English to understand the task and instructions&#xD;
&#xD;
          -  PDSS score of at least 6&#xD;
&#xD;
          -  At least two full panic attacks or limited symptoms attacks last 4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  CNS-acting medication (antidepressants within last 6 months, benzodiazepine last 3&#xD;
             days)&#xD;
&#xD;
          -  Current or past history of alcohol/ drug abuse&#xD;
&#xD;
          -  Serious medical conditions (e.g., epilepsy, heart or respiratory problems)&#xD;
&#xD;
          -  Done the task before&#xD;
&#xD;
          -  Waiting group: under current psychotherapeutic treatment&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contraindications to MRI e.g. pacemaker, mechanical heart valve, hip replacement,&#xD;
             metal implants&#xD;
&#xD;
          -  Severe claustrophobia that limits ability to participate in fMRI scanning&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cognitive behaviour therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Panic Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03251235
org study id: 09/H0604/55
nct id: NCT03251235
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Exposure-based cognitive-behaviour therapy (CBT) for anxiety disorders is an effective
      intervention, but the brain mechanisms driving recovery are largely unknown. In this
      experimental medicine study, it will be investigated to what degree CBT affects neural
      markers of anxiety at an early stage of treatment, to identify dynamic mechanistic changes
      which might be crucial in the process of recovery as opposed to those seen following full
      treatment completion. Patients with panic disorder will be recruited and randomly allocated
      to a group receiving 4 weekly sessions of cognitive-behaviour therapy versus a waiting group
      not receiving any interventions until after the experimental procedure.
PURPOSE The primary purpose is to enhance our understanding of the mechanisms essential in
      effective treatment of panic disorder.

      METHODS Design: The present study has a between-subjects design, including a waiting group of
      participants with panic symptoms and a treatment group of participants with panic symptoms
      who will receive cognitive-behavioural treatment before being tested.

      Participants: Twenty-eight volunteers with panic symptoms will be recruited. For participants
      who do meet the basic study criteria a phone screening appointment (10 - 30 mins) will be
      arranged to further screen for relevant inclusion and exclusion criteria. They will then be
      invited to the Department of Psychiatry for the pre-assessment session.

      Treatment: Within the study, the investigators will offer participants a brief CBT course of
      4 sessions, offered by the Lupina service. The Lupina Service forms part of the OBMH primary
      care Counselling & Psychology Service, based at the Warneford Hospital. It provides intensive
      individual CBT for panic disorder and agoraphobia and is staffed by trained graduate
      volunteer therapists. Potential therapists are psychology graduates with prior mental health
      experience, who are given 2 days' intensive training in CBT for panic disorder and
      agoraphobia by Alison Croft, Consultant Clinical Psychologist. They then receive group
      supervision of their clinical cases. Service evaluation indicates equivalent clinical
      outcomes for volunteer therapists relative to qualified clinical psychologists.

      Procedure: Participants will be randomly allocated to either the treatment group or the
      waiting group. On arrival to the pre-assessment session, participants will be given a copy of
      the information sheet (previously seen during the online screening and e-mailed/ posted to
      them). They will be invited to fill out the consent form. Screening for past or previous
      psychiatric illness will be achieved using a structured clinical interview (SCID). In
      addition, participants will be asked to complete a battery of questionnaires. They will also
      be familiarised with the procedure occurring on the scanning day. Any outstanding questions
      the participant has will be addressed. The visit lasts about 1 to 1 ½ hrs. After the
      pre-assessment, a 4 weeks follow-up appointment (post-assessment) will be arranged with all
      participants. Half of the participants will be referred for treatment in the LUPINA group
      during that time. At the post-assessment 4 weeks later, the participants will be asked to
      come to the OCMR (Oxford Clinical Resonance Imaging) Department at the John Radcliffe
      Hospital. The visit will last a total of 2½ to 3 hrs and include a scanning session lasting 1
      to 1 ½ hrs. Subjective mood will be assessed on the day of the scan using the State form of
      the State-Trait Anxiety Inventory, a Mood Visual Analogue Scale and the Positive and Negative
      Affect Schedule. In addition, subjects will again complete the questionnaires from the
      pre-assessment. After the scan, participants will work on two behavioural computer tasks
      using emotional faces and word stimuli to assess facial recognition and attention outside the
      scanner. At the end of the session, patients from the waiting group will be offered the
      taster-CBT treatment within the LUPINA service.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Care Provider)
masking description: The care provider is not aware of whether a patient is allocated to the treatment group or the waiting group.
measure: Emotional processing
time frame: Treatment Group: post 4-week CBT treatment, waiting Group: post 4-week waiting
description: Activation levels in the fear circuit of the brain in response to emotional stimuli (fMRI)
measure: Clinical symptom severity - Global anxiety and depression (self-report)
time frame: Baseline, after 4 weeks treatment/ waiting
description: Hamilton Anxiety and Depression Scale HADS
measure: Clinical symptom severity - Fear of physical sensations (self-report)
time frame: Baseline, after 4 weeks treatment/ waiting
description: Body Sensations Questionnaire BSQ
measure: Clinical symptom severity - Agoraphobic fear (self-report)
time frame: Baseline, after 4 weeks treatment/ waiting
description: Agoraphobic Cognitions Questionnaire ACQ
measure: Clinical symptom severity - Clinical severity and improvement (clinician-report)
time frame: Baseline, after 4 weeks treatment/ waiting
description: Clinical Global Impression Scale CGI
arm group label: Treatment Group
arm group type: Experimental
description: Group receives four weekly sessions of CBT prior to experimental testing/ fMRI
arm group label: Waiting Group
arm group type: No Intervention
description: Group receives four weekly sessions of CBT after experimental testing/ fMRI
intervention type: Behavioral
intervention name: Cognitive Behaviour Therapy
arm group label: Treatment Group
other name: CBT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Panic Disorder
sharing ipd: Undecided