Feasibility of an Intervention for Somatic Flashbacks in PTSD

January 11, 2024 updated by: University College, London

An Intervention for Somatic Flashbacks in Post-Traumatic Stress Disorder: a Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Traumatic Stress clinic
        • Contact:
          • Livia Ottisova
      • London, United Kingdom
        • Recruiting
        • Woodfield Trauma service
        • Contact:
          • Francesca Brady

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Imagery rescripting intervention for somatic flashback
Other: Imagery rescripting
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Acceptability/Adherence Scale score
Time Frame: Through study completion, an average of 8 weeks
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).
Through study completion, an average of 8 weeks
What percentage of participants using the service are eligible agreed to take part?
Time Frame: 1 year
The percentage of participants who access the service who meet the eligibility criteria for the intervention
1 year
What percentage of participants who are eligible to take part, accept the intervention offer?
Time Frame: 1 year
The percentage of participants who meet the eligibility criteria for the intervention and agree to take part in the trial.
1 year
What percentage of participants completed treatment?
Time Frame: 1 year
The percentage of participants who agree to take part in the trial who go on to complete the intervention.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the frequency of somatic flashbacks
Time Frame: Through study completion, an average of 8 weeks
A visual analogue scale from 0 (not frequent at all) to 100 (extremely frequent)
Through study completion, an average of 8 weeks
Changes in the intensity of somatic flashbacks
Time Frame: Through study completion, an average of 8 weeks
A visual analogue scale from 0 (not intense at all) to 100 (extremely intense)
Through study completion, an average of 8 weeks
Changes in the distress associated with somatic flashbacks
Time Frame: Through study completion, an average of 8 weeks
A visual analogue scale from 0 (not distressing at all) to 100 (extremely distressing)
Through study completion, an average of 8 weeks
Changes in participants sense of ability to cope with the somatic flashbacks
Time Frame: Through study completion, an average of 8 weeks
A visual analogue scale from 0 (not coping at all) to 100 (coping very well)
Through study completion, an average of 8 weeks
Changes in global symptoms of PTSD
Time Frame: Through study completion, an average of 8 weeks
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).
Through study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Camden and Islington NHS Trust
Central and North West London NHS Foundation Trust

Investigators

  • Principal Investigator: Livia Ottisova, Doctorate, Camden and Islington NHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 157653

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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