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Feasibility of an Intervention for Somatic Flashbacks in PTSD

Primary Purpose

Post-traumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Imagery rescripting
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-traumatic Stress Disorder

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Aged 18 and above DSM-5 diagnosis of PTSD or Complex PTSD Participants who are currently experiencing somatic flashbacks Willing and able to provide written informed consent to treatment Exclusion criteria: Currently receiving another trauma-focussed intervention Active suicidal intent or recent (past 8 weeks) suicide attempt Currently abusing substances Participants whose participation in the study is not considered in their best interest by the clinical team at Traumatic Stress Clinic and Woodfield Trauma Service Participants who do not consent to the intervention sessions being recorded Participants who do not consent to their assessment information being made available to the trainee clinical psychologist carrying out the intervention

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Imagery rescripting intervention for somatic flashback

    Outcomes

    Primary Outcome Measures

    Treatment Acceptability/Adherence Scale score
    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).
    What percentage of participants using the service are eligible agreed to take part?
    The percentage of participants who access the service who meet the eligibility criteria for the intervention
    What percentage of participants who are eligible to take part, accept the intervention offer?
    The percentage of participants who meet the eligibility criteria for the intervention and agree to take part in the trial.
    What percentage of participants completed treatment?
    The percentage of participants who agree to take part in the trial who go on to complete the intervention.

    Secondary Outcome Measures

    Changes in the frequency of somatic flashbacks
    A visual analogue scale from 0 (not frequent at all) to 100 (extremely frequent)
    Changes in the intensity of somatic flashbacks
    A visual analogue scale from 0 (not intense at all) to 100 (extremely intense)
    Changes in the distress associated with somatic flashbacks
    A visual analogue scale from 0 (not distressing at all) to 100 (extremely distressing)
    Changes in participants sense of ability to cope with the somatic flashbacks
    A visual analogue scale from 0 (not coping at all) to 100 (coping very well)
    Changes in global symptoms of PTSD
    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).

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 10, 2023
    Sponsor
    University College, London
    Collaborators
    Camden and Islington NHS Trust, Central and North West London NHS Foundation Trust
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05996913
    Brief Title
    Feasibility of an Intervention for Somatic Flashbacks in PTSD
    Official Title
    An Intervention for Somatic Flashbacks in Post-Traumatic Stress Disorder: a Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University College, London
    Collaborators
    Camden and Islington NHS Trust, Central and North West London NHS Foundation Trust

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-traumatic Stress Disorder

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Imagery rescripting intervention for somatic flashback
    Intervention Type
    Other
    Intervention Name(s)
    Imagery rescripting
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    Treatment Acceptability/Adherence Scale score
    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).
    Time Frame
    Through study completion, an average of 8 weeks
    Title
    What percentage of participants using the service are eligible agreed to take part?
    Description
    The percentage of participants who access the service who meet the eligibility criteria for the intervention
    Time Frame
    1 year
    Title
    What percentage of participants who are eligible to take part, accept the intervention offer?
    Description
    The percentage of participants who meet the eligibility criteria for the intervention and agree to take part in the trial.
    Time Frame
    1 year
    Title
    What percentage of participants completed treatment?
    Description
    The percentage of participants who agree to take part in the trial who go on to complete the intervention.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Changes in the frequency of somatic flashbacks
    Description
    A visual analogue scale from 0 (not frequent at all) to 100 (extremely frequent)
    Time Frame
    Through study completion, an average of 8 weeks
    Title
    Changes in the intensity of somatic flashbacks
    Description
    A visual analogue scale from 0 (not intense at all) to 100 (extremely intense)
    Time Frame
    Through study completion, an average of 8 weeks
    Title
    Changes in the distress associated with somatic flashbacks
    Description
    A visual analogue scale from 0 (not distressing at all) to 100 (extremely distressing)
    Time Frame
    Through study completion, an average of 8 weeks
    Title
    Changes in participants sense of ability to cope with the somatic flashbacks
    Description
    A visual analogue scale from 0 (not coping at all) to 100 (coping very well)
    Time Frame
    Through study completion, an average of 8 weeks
    Title
    Changes in global symptoms of PTSD
    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).
    Time Frame
    Through study completion, an average of 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria Aged 18 and above DSM-5 diagnosis of PTSD or Complex PTSD Participants who are currently experiencing somatic flashbacks Willing and able to provide written informed consent to treatment Exclusion criteria: Currently receiving another trauma-focussed intervention Active suicidal intent or recent (past 8 weeks) suicide attempt Currently abusing substances Participants whose participation in the study is not considered in their best interest by the clinical team at Traumatic Stress Clinic and Woodfield Trauma Service Participants who do not consent to the intervention sessions being recorded Participants who do not consent to their assessment information being made available to the trainee clinical psychologist carrying out the intervention
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    JOE CAMPBELL
    Phone
    07772253838
    Email
    joe.campbell.21@ucl.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Livia Ottisova, Doctorate
    Organizational Affiliation
    Camden and Islington NHS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Feasibility of an Intervention for Somatic Flashbacks in PTSD

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