Clinical trial NCT04394832: Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD: A Pilot Study
Official title: Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorder
Trauma and Stressor Related Disorders
Keywords: Intrusive Memories
Post-Traumatic Stress Disorder
Cognitive Task Interference
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: Central and North West London NHS Foundation Trust
name: Uppsala University
First posted: 2020-05-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multiple baseline case-series design (AB), with a randomised duration of baseline length.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* are on the wait list for treatment (trauma focused therapy) at Woodfield Trauma Service
* aged 18-65
* have experienced intrusive memories in the past two weeks, as assessed by scoring 1 or above on question 1 of the PCL-5
* are able to communicate with the researcher, with or without an interpreter
* have a fixed abode. This is operationalised as having a current address (including B\&B or open access hostel) and evidence indicating that the person is likely to have a reliable address throughout the study. This is necessary to avoid sample attrition.
* can commit to attending regular appointments and keeping an intrusion diary throughout the duration of the study.

Exclusion Criteria:

* a current diagnosis of schizophrenia or bipolar disorder type 1
* Intelligence Quotient (IQ) \< 80
* acute suicide risk
* substance dependence
* have been unable to complete the routine questionnaires given to new patients in the service at assessment

Primary outcomes:
measure: Frequency of intrusive memories
timeFrame: Daily through study completion, an average of 3 months. Change is assessed from baseline to post-intervention.
Secondary outcomes:
measure: Concentration
timeFrame: Baseline and 2-weeks post-intervention
measure: Social and Occupational Activity Tally (SOAT)
timeFrame: Baseline and 2-weeks post-intervention
measure: Dissociation
timeFrame: Baseline and 2-weeks post-intervention
measure: Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)
timeFrame: Baseline and 2-weeks post-intervention
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline and 2-weeks post-intervention
measure: World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version
timeFrame: Baseline and 2-weeks post-intervention
Other outcomes:
measure: Self-Guided Intervention Adherence Questionnaire
timeFrame: Intervention weeks 2-5, 1 week post-intervention and 2 weeks post-intervention
measure: Feedback Questionnaire
timeFrame: 1-week post-intervention.
Locations:
city: London
country: United Kingdom
facility: Woodfield Trauma Service
Study officials:
affiliation: University of Surrey
name: Emily Greenfield
role: PRINCIPAL_INVESTIGATOR
References: