Feasibility of an Intervention for Somatic Flashbacks in PTSD

NCT05996913 | Unknown

• 1 other identifier: 157653
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (4)

• 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).

  Through study completion, an average of 8 weeks

• 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

  1 year

• 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.

  1 year

• 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.

  1 year

Secondary Outcomes (5)

• Changes in the frequency of somatic flashbacks

  Through study completion, an average of 8 weeks

• Changes in the intensity of somatic flashbacks

  Through study completion, an average of 8 weeks

• Changes in the distress associated with somatic flashbacks

  Through study completion, an average of 8 weeks

• Changes in participants sense of ability to cope with the somatic flashbacks

  Through study completion, an average of 8 weeks

• Changes in global symptoms of PTSD

  Through study completion, an average of 8 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Imagery rescripting intervention for somatic flashback

Other: Imagery rescripting

Interventions

Imagery rescripting OTHER

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).

Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Camden and Islington NHS Trust: collaborator
• Central and North West London NHS Foundation Trust: collaborator

Study Sites (2)

Traumatic Stress clinic

London, United Kingdom

RECRUITING

Woodfield Trauma service

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Livia Ottisova, Doctorate

  Camden and Islington NHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JOE CAMPBELL

CONTACT

07772253838; joe.campbell.21@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 18, 2023
• Study Start: November 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)