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Post-traumatic Stress DisorderNCT05996913

Feasibility of an Intervention for Somatic Flashbacks in PTSD

A study testing Imagery rescripting in people with Post-traumatic Stress Disorder, run by University College, London at 2 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Post-traumatic Stress Disorder
What is being tested?
Imagery rescripting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited Kingdom
Study dates
1 Nov 2023to Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites, 2 recruiting
  • Traumatic Stress clinic

    London

    Livia Ottisova

    Recruiting
  • Woodfield Trauma service

    London

    Francesca Brady

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Imagery rescripting
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imagery rescriptingOther

    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).

Study groups in NCT05996913
Study groupRoleWhat they receive
InterventionExperimentalImagery rescripting intervention for somatic flashback
Receives: Other: Imagery rescripting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Through study completion, an average of 8 weeks

  2. 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

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. 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.

    Measured: 1 year

Secondary outcomes (5)
  1. Changes in the frequency of somatic flashbacks

    A visual analogue scale from 0 (not frequent at all) to 100 (extremely frequent)

    Measured: Through study completion, an average of 8 weeks

  2. Changes in the intensity of somatic flashbacks

    A visual analogue scale from 0 (not intense at all) to 100 (extremely intense)

    Measured: Through study completion, an average of 8 weeks

  3. Changes in the distress associated with somatic flashbacks

    A visual analogue scale from 0 (not distressing at all) to 100 (extremely distressing)

    Measured: Through study completion, an average of 8 weeks

  4. 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)

    Measured: Through study completion, an average of 8 weeks

  5. 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).

    Measured: Through study completion, an average of 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start1 Nov 2023
  3. Primary completionJun 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996913
Sponsor's protocol ID
157653
Status last verified
Jan 2024
First submitted
25 Jul 2023
Last updated
12 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Imagery rescripting in people with Post-traumatic Stress Disorder, run by University College, London at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact JOE CAMPBELL (07772253838, joe.campbell.21@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Acceptability/Adherence Scale score (time frame: Through study completion, an average of 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.

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