Stress Disorders, Post-Traumatic Clinical Trial
Official title:
Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Pilot Study
This research study was designed to investigate the use of a simple cognitive task for decreasing the number of intrusive memories of traumatic events experienced by refugees and asylum seekers with a diagnosis of Post-traumatic Stress Disorder (PTSD) currently living in the UK. The intervention included a memory reminder cue, a 10-minute time gap and then around 20 minutes playing the mobile phone game Tetris, using mental rotation instructions. The study had a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants completed a no-intervention phase of up to three weeks, followed by an intervention phase. Please see the intervention section for more details about the intervention sessions. Follow ups were conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It was predicted that participants would report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.
The study was conducted at a specialist National Health Service (NHS) mental health service
for refugees, asylum seekers and forced migrants suffering from Post-Traumatic Stress
Disorder (PTSD). Four participants were enrolled in the study. This was initially intended to
be a larger study (n=15) but recruitment stopped due to the COVID-19 pandemic and advice from
the trust R&D and NHS service manager that face-to-face appointments should no longer go
ahead at the NHS clinical recruitment site. The trust R&D advised that only participants who
had started the intervention should continue and only if done remotely. An amendment was
approved for remote delivery of the intervention. Two of the four participants who gave
informed consent continued to participate in the study. They met with a researcher remotely
via video technology. The other two participants instead continued to receive standard care
by the NHS service but did not continue with the research study. This study was a pilot.
The study had a multiple baseline case-series design (AB), with a randomised duration of
baseline length up to three weeks. At the start of the baseline phase, participants created,
with the help of the researcher, a list of their most frequent and distressing intrusive
memories of trauma. Each intrusive memory was given a label (for example; a letter, colour or
symbol) so that the frequency of each intrusive memory could be monitored in a pen and paper
diary. The frequency of specific intrusive memories the person experienced after they had
received the intervention will be compared to the frequency of specific intrusive memories
they had during the baseline phase. For each specific intrusion, the period prior to that
intrusion being targeted in an intervention session was the baseline phase (A); therefore,
the baseline phase included the minimum baseline duration (lasting up to three weeks) plus
the additional weeks in which the specific intrusion remained untargeted by the intervention.
The post intervention phase (B) was the time after the specific intrusion was targeted. Some
intrusive memories on the list were not targeted by the intervention but were monitored
(through the intrusion diary) throughout the duration of the study for comparison.
This study was a follow-up to a study conducted in Sweden with refugees. ClinicalTrials.gov
Identifier: NCT03760601. The research is extending the previous research to refugees and
asylum seekers with a diagnosis of PTSD, accessing a secondary care mental health service and
living in the United Kingdom (UK).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05620381 -
Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018
|
||
Completed |
NCT02856412 -
Improving Mind/Body Health and Functioning With Integrative Exercise
|
N/A | |
Recruiting |
NCT05400200 -
PTSD and Self-regulation: Coping, Emotional Regulation and Cognitive Control and Their Relationships to Symptom Management
|
N/A | |
Not yet recruiting |
NCT06088303 -
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
|
N/A | |
Not yet recruiting |
NCT03652922 -
Propranolol Reactivation Mismatch (PRM) Treatment for PTSD
|
Phase 4 | |
Completed |
NCT02875912 -
Prospective Evaluation of Family Care Rituals in the ICU
|
N/A | |
Completed |
NCT01589575 -
Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives
|
N/A | |
Completed |
NCT00990106 -
Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT01291368 -
Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care
|
N/A | |
Active, not recruiting |
NCT00657787 -
Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans
|
||
Completed |
NCT00835627 -
Treatment Trial for Psychogenic Nonepileptic Seizures
|
Phase 4 | |
Completed |
NCT00880152 -
Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
|
N/A | |
Completed |
NCT01365247 -
Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT00514956 -
Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)
|
Phase 1 | |
Completed |
NCT00419029 -
Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
|
N/A | |
Completed |
NCT00333710 -
Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD
|
N/A | |
Completed |
NCT01120847 -
Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
|
||
Completed |
NCT00069225 -
Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder
|
N/A | |
Completed |
NCT00055354 -
Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT00186212 -
Alternative Support for Rural and Isolated Women in an HMO
|
Phase 3 |