xml: <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/NCT05996913</url>
    </required_header>
    <id_info>
      <org_study_id>157653</org_study_id>
      <nct_id>NCT05996913</nct_id>
    </id_info>
    <brief_title>Feasibility of an Intervention for Somatic Flashbacks in PTSD</brief_title>
    <official_title>An Intervention for Somatic Flashbacks in Post-Traumatic Stress Disorder: a Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University College, London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Camden and Islington NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Central and North West London NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University College, London</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This trial will explore the feasibility and acceptability of an intervention for Somatic&#xD;
        flashbacks in Post-Traumatic Stress Disorder (PTSD). Imagery Rescripting (ImRs) will form a&#xD;
        central part of the intervention.&#xD;
  &#xD;
        The primary objective of this trial is to explore the acceptability and feasibility of&#xD;
        delivering an intervention for the management of somatic flashbacks to a population of adults&#xD;
        experiencing post-traumatic stress disorder.&#xD;
  &#xD;
        The secondary objectives of this trial will be to examine if the intervention leads to any&#xD;
        differences in participants experience of somatic flashbacks and their global symptoms of&#xD;
        PTSD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Posttraumatic stress disorder (PTSD) is a reaction to a traumatic event where a person&#xD;
        perceived a high risk of danger to themselves or others (e.g. sexual assault, car crash).&#xD;
        Re-experiencing symptoms are a core component to diagnosis and can be understood as intrusive&#xD;
        memories of a past traumatic event which are re-experienced involuntarily, as if they are&#xD;
        happening in the present and contain more sensory details than nontraumatic memories. These&#xD;
        'intrusive memories' can be experienced as visual, auditory, olfactory, gustatory, and&#xD;
        tactile. Other symptoms of PTSD include hyperarousal, emotional numbing and avoidance of&#xD;
        stimuli which remind a person of the trauma. Trauma-focussed therapies have an established&#xD;
        evidence-base and are widely used to treat PTSD. Their broad aim is to process the memories&#xD;
        of a trauma and the meanings attached to it.&#xD;
  &#xD;
        The current project seeks to explore the phenomenon of somatic re-experiencing, which we will&#xD;
        refer to as somatic flashbacks. Within the field of trauma-focused therapy and research, the&#xD;
        experience of somatic flashbacks is acknowledged anecdotally but lacks specific research. The&#xD;
        limited research that does exist in this area is descriptive and focuses on somatic&#xD;
        flashbacks of pain (see below). There is no existing empirical research exploring the&#xD;
        management of somatic flashbacks more generally (e.g. re-experiencing of specific, bodily&#xD;
        sensations that were present at the time of the trauma, including internal or external&#xD;
        sensations, experience of warmth or coldness, and other physical sensations).&#xD;
  &#xD;
        Four existing case reports describe participants who report experiencing somatic flashbacks&#xD;
        (of pain) that resemble, in quality and location, the sensations experienced during the&#xD;
        traumatic event. This includes: two participants who report waking during surgery; a veteran&#xD;
        who re-experienced &quot;pain like a shrapnel wound&quot;; a veteran who re-experienced headaches after&#xD;
        losing an eye; and a survivor of the 2005 London bombings who re-experienced pain flashbacks&#xD;
        &quot;similar in quality to the original electrocution pain&quot; experienced during the explosion.&#xD;
  &#xD;
        An additional study completed over a two-year period to assess the prevalence of pain&#xD;
        flashbacks in a sample of participants with PTSD accessing an NHS trauma service reported&#xD;
        that 49% of the sample reported experiencing somatic flashbacks of pain.&#xD;
  &#xD;
        The current project aims to explore the feasibility of intervention featuring imagery&#xD;
        rescripting (ImRs) and grounding in the management of somatic flashbacks amongst this&#xD;
        population. ImRs was developed as a method to help activate a traumatic memory, bring&#xD;
        corrective information into the memory, create a more favourable outcome to the memory and to&#xD;
        support the participant to discover and express inhibited trauma-related emotional responses.&#xD;
  &#xD;
        In early studies, various versions of ImRs were used to target symptoms of PTSD. Over the&#xD;
        last 30 years, subsequent studies have demonstrated the efficacy of ImRs amongst participants&#xD;
        with PTSD who have been injured at work; refugee populations; participants who feel&#xD;
        contaminated following childhood sexual abuse; veterans; participants who have experienced&#xD;
        childhood trauma; and participants who feel guilt after surviving a traumatic event.&#xD;
  &#xD;
        The current project aims to contribute to the existing evidence-base for ImRs in PTSD. It&#xD;
        will address the gap in knowledge around the feasibility of ImRs in the treatment and&#xD;
        management of somatic flashbacks in PTSD. It will employ a similar intervention used in a&#xD;
        pilot study for feelings of shame. The intervention will be developed with the support of&#xD;
        experts in the field. They will provide input on the treatment protocol and review&#xD;
        intervention recordings to ensure fidelity to the approach.&#xD;
  &#xD;
        At the time of writing, no existing studies have explored the use of an intervention&#xD;
        featuring ImRs to manage somatic flashbacks in PTSD. Given the lack of existing research, an&#xD;
        acceptability and feasibility research design will be employed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Treatment Acceptability/Adherence Scale score</measure>
      <time_frame>Through study completion, an average of 8 weeks</time_frame>
      <description>The Treatment Acceptability/Adherence Scale measures a participants experience of an intervention. The questionnaire is made of up 10 items and each item is measured on a scale from 1 (disagree strongly) to 7 (Agree strongly).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>What percentage of participants using the service are eligible agreed to take part?</measure>
      <time_frame>1 year</time_frame>
      <description>The percentage of participants who access the service who meet the eligibility criteria for the intervention</description>
    </primary_outcome>
    <primary_outcome>
      <measure>What percentage of participants who are eligible to take part, accept the intervention offer?</measure>
      <time_frame>1 year</time_frame>
      <description>The percentage of participants who meet the eligibility criteria for the intervention and agree to take part in the trial.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>What percentage of participants completed treatment?</measure>
      <time_frame>1 year</time_frame>
      <description>The percentage of participants who agree to take part in the trial who go on to complete the intervention.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in the frequency of somatic flashbacks</measure>
      <time_frame>Through study completion, an average of 8 weeks</time_frame>
      <description>A visual analogue scale from 0 (not frequent at all) to 100 (extremely frequent)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the intensity of somatic flashbacks</measure>
      <time_frame>Through study completion, an average of 8 weeks</time_frame>
      <description>A visual analogue scale from 0 (not intense at all) to 100 (extremely intense)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in the distress associated with somatic flashbacks</measure>
      <time_frame>Through study completion, an average of 8 weeks</time_frame>
      <description>A visual analogue scale from 0 (not distressing at all) to 100 (extremely distressing)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in participants sense of ability to cope with the somatic flashbacks</measure>
      <time_frame>Through study completion, an average of 8 weeks</time_frame>
      <description>A visual analogue scale from 0 (not coping at all) to 100 (coping very well)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in global symptoms of PTSD</measure>
      <time_frame>Through study completion, an average of 8 weeks</time_frame>
      <description>Measured using the PCL-5 questionnaire, which is a 20-item measure. Each item measured on a scale from 0 (not at all) to 4 (extremely).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Post-traumatic Stress Disorder</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Imagery rescripting intervention for somatic flashback</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Imagery rescripting</intervention_name>
      <description>The current project aims to explore the feasibility of intervention featuring imagery rescripting (ImRs) and grounding in the management of somatic flashbacks amongst this population. ImRs was developed as a method to help activate a traumatic memory, bring corrective information into the memory, create a more favourable outcome to the memory and to support the participant to discover and express inhibited trauma-related emotional responses (Arntz &amp; Weertman, 1999).</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            -  Aged 18 and above&#xD;
  &#xD;
            -  DSM-5 diagnosis of PTSD or Complex PTSD&#xD;
  &#xD;
            -  Participants who are currently experiencing somatic flashbacks&#xD;
  &#xD;
            -  Willing and able to provide written informed consent to treatment&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Currently receiving another trauma-focussed intervention&#xD;
  &#xD;
            -  Active suicidal intent or recent (past 8 weeks) suicide attempt&#xD;
  &#xD;
            -  Currently abusing substances&#xD;
  &#xD;
            -  Participants whose participation in the study is not considered in their best interest&#xD;
               by the clinical team at Traumatic Stress Clinic and Woodfield Trauma Service&#xD;
  &#xD;
            -  Participants who do not consent to the intervention sessions being recorded&#xD;
  &#xD;
            -  Participants who do not consent to their assessment information being made available&#xD;
               to the trainee clinical psychologist carrying out the intervention&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Livia Ottisova, Doctorate</last_name>
      <role>Principal Investigator</role>
      <affiliation>Camden and Islington NHS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>JOE CAMPBELL</last_name>
      <phone>07772253838</phone>
      <email>joe.campbell.21@ucl.ac.uk</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</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>Stress Disorders, Traumatic</mesh_term>
      <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996913
  org study id: 157653
  nct id: NCT05996913
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This trial will explore the feasibility and acceptability of an intervention for Somatic
        flashbacks in Post-Traumatic Stress Disorder (PTSD). Imagery Rescripting (ImRs) will form a
        central part of the intervention.
  
        The primary objective of this trial is to explore the acceptability and feasibility of
        delivering an intervention for the management of somatic flashbacks to a population of adults
        experiencing post-traumatic stress disorder.
  
        The secondary objectives of this trial will be to examine if the intervention leads to any
        differences in participants experience of somatic flashbacks and their global symptoms of
        PTSD.
  Posttraumatic stress disorder (PTSD) is a reaction to a traumatic event where a person
        perceived a high risk of danger to themselves or others (e.g. sexual assault, car crash).
        Re-experiencing symptoms are a core component to diagnosis and can be understood as intrusive
        memories of a past traumatic event which are re-experienced involuntarily, as if they are
        happening in the present and contain more sensory details than nontraumatic memories. These
        'intrusive memories' can be experienced as visual, auditory, olfactory, gustatory, and
        tactile. Other symptoms of PTSD include hyperarousal, emotional numbing and avoidance of
        stimuli which remind a person of the trauma. Trauma-focussed therapies have an established
        evidence-base and are widely used to treat PTSD. Their broad aim is to process the memories
        of a trauma and the meanings attached to it.
  
        The current project seeks to explore the phenomenon of somatic re-experiencing, which we will
        refer to as somatic flashbacks. Within the field of trauma-focused therapy and research, the
        experience of somatic flashbacks is acknowledged anecdotally but lacks specific research. The
        limited research that does exist in this area is descriptive and focuses on somatic
        flashbacks of pain (see below). There is no existing empirical research exploring the
        management of somatic flashbacks more generally (e.g. re-experiencing of specific, bodily
        sensations that were present at the time of the trauma, including internal or external
        sensations, experience of warmth or coldness, and other physical sensations).
  
        Four existing case reports describe participants who report experiencing somatic flashbacks
        (of pain) that resemble, in quality and location, the sensations experienced during the
        traumatic event. This includes: two participants who report waking during surgery; a veteran
        who re-experienced "pain like a shrapnel wound"; a veteran who re-experienced headaches after
        losing an eye; and a survivor of the 2005 London bombings who re-experienced pain flashbacks
        "similar in quality to the original electrocution pain" experienced during the explosion.
  
        An additional study completed over a two-year period to assess the prevalence of pain
        flashbacks in a sample of participants with PTSD accessing an NHS trauma service reported
        that 49% of the sample reported experiencing somatic flashbacks of pain.
  
        The current project aims to explore the feasibility of intervention featuring imagery
        rescripting (ImRs) and grounding in the management of somatic flashbacks amongst this
        population. ImRs was developed as a method to help activate a traumatic memory, bring
        corrective information into the memory, create a more favourable outcome to the memory and to
        support the participant to discover and express inhibited trauma-related emotional responses.
  
        In early studies, various versions of ImRs were used to target symptoms of PTSD. Over the
        last 30 years, subsequent studies have demonstrated the efficacy of ImRs amongst participants
        with PTSD who have been injured at work; refugee populations; participants who feel
        contaminated following childhood sexual abuse; veterans; participants who have experienced
        childhood trauma; and participants who feel guilt after surviving a traumatic event.
  
        The current project aims to contribute to the existing evidence-base for ImRs in PTSD. It
        will address the gap in knowledge around the feasibility of ImRs in the treatment and
        management of somatic flashbacks in PTSD. It will employ a similar intervention used in a
        pilot study for feelings of shame. The intervention will be developed with the support of
        experts in the field. They will provide input on the treatment protocol and review
        intervention recordings to ensure fidelity to the approach.
  
        At the time of writing, no existing studies have explored the use of an intervention
        featuring ImRs to manage somatic flashbacks in PTSD. Given the lack of existing research, an
        acceptability and feasibility research design will be employed.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Treatment Acceptability/Adherence Scale score
  time frame: Through study completion, an average of 8 weeks
  description: The Treatment Acceptability/Adherence Scale measures a participants experience of an intervention. The questionnaire is made of up 10 items and each item is measured on a scale from 1 (disagree strongly) to 7 (Agree strongly).
  measure: What percentage of participants using the service are eligible agreed to take part?
  time frame: 1 year
  description: The percentage of participants who access the service who meet the eligibility criteria for the intervention
  measure: What percentage of participants who are eligible to take part, accept the intervention offer?
  time frame: 1 year
  description: The percentage of participants who meet the eligibility criteria for the intervention and agree to take part in the trial.
  measure: What percentage of participants completed treatment?
  time frame: 1 year
  description: The percentage of participants who agree to take part in the trial who go on to complete the intervention.
  measure: Changes in the frequency of somatic flashbacks
  time frame: Through study completion, an average of 8 weeks
  description: A visual analogue scale from 0 (not frequent at all) to 100 (extremely frequent)
  measure: Changes in the intensity of somatic flashbacks
  time frame: Through study completion, an average of 8 weeks
  description: A visual analogue scale from 0 (not intense at all) to 100 (extremely intense)
  measure: Changes in the distress associated with somatic flashbacks
  time frame: Through study completion, an average of 8 weeks
  description: A visual analogue scale from 0 (not distressing at all) to 100 (extremely distressing)
  measure: Changes in participants sense of ability to cope with the somatic flashbacks
  time frame: Through study completion, an average of 8 weeks
  description: A visual analogue scale from 0 (not coping at all) to 100 (coping very well)
  measure: Changes in global symptoms of PTSD
  time frame: Through study completion, an average of 8 weeks
  description: Measured using the PCL-5 questionnaire, which is a 20-item measure. Each item measured on a scale from 0 (not at all) to 4 (extremely).
  arm group label: Intervention
  arm group type: Experimental
  description: Imagery rescripting intervention for somatic flashback
  intervention type: Other
  intervention name: Imagery rescripting
  description: The current project aims to explore the feasibility of intervention featuring imagery rescripting (ImRs) and grounding in the management of somatic flashbacks amongst this population. ImRs was developed as a method to help activate a traumatic memory, bring corrective information into the memory, create a more favourable outcome to the memory and to support the participant to discover and express inhibited trauma-related emotional responses (Arntz & Weertman, 1999).
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Livia Ottisova, Doctorate
  role: Principal Investigator
  affiliation: Camden and Islington NHS
  last name: JOE CAMPBELL
  phone: 07772253838
  email: joe.campbell.21@ucl.ac.uk
  responsible party type: Sponsor
  mesh term: Stress Disorders, Traumatic
  mesh term: Stress Disorders, Post-Traumatic
  sharing ipd: No