Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT04394832|
Recruitment Status : Terminated (Covid-19)
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Mental Disorder Trauma and Stressor Related Disorders||Behavioral: Brief cognitive intervention||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multiple baseline case-series design (AB), with a randomised duration of baseline length.|
|Masking:||None (Open Label)|
|Official Title:||Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Pilot Study|
|Actual Study Start Date :||February 25, 2020|
|Actual Primary Completion Date :||May 5, 2020|
|Actual Study Completion Date :||May 5, 2020|
Experimental: Baseline phase, followed by intervention phase
Within the baseline phase, measurements of the primary outcome measure (frequency of intrusive memories of trauma) were collected in a pen-and-paper diary for up to three weeks (dependent on baseline length). Individual baseline phases will be used as control periods.
In the intervention phase the participant was offered around five intervention sessions with a researcher. Each session the participant chose which intrusive memory they would like to focus on and the cognitive task was completed. 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. Participants were given instructions to continue to use the technique self-guided in the subsequent week. Measurements of the primary outcome measure (frequency of intrusive memories of trauma) were collected in a pen-and-paper diary.
Behavioral: Brief cognitive intervention
See the information provided in the experimental arm description.
- Frequency of intrusive memories [ Time Frame: Daily through study completion, an average of 3 months. Change is assessed from baseline to post-intervention. ]Number of intrusive memories of traumatic events recorded by participants in a pen and and paper diary.
- Concentration [ Time Frame: Baseline and 2-weeks post-intervention ]A brief bespoke measure of concentration adapted from that used previously with refugees (Holmes et al., 2017). It has three questions about disruption to concentration from intrusive memories. A higher score on each question means a worse outcome.
- Social and Occupational Activity Tally (SOAT) [ Time Frame: Baseline and 2-weeks post-intervention ]Developed by Woodfield Trauma Service. The measure asks how many hours the person has spent doing various activities in the past two weeks (for example, domestic chores, exercise, cultural activities). A higher score means a better outcome.
- Dissociation [ Time Frame: Baseline and 2-weeks post-intervention ]Four items from the Dissociative Experiences Scale II - items two, three, 14 and 20 (DES II; Carlson, & Putnam, 1993). Each item asks how often (from 0% to 100% of the time) the dissociative experience described happens to the individual. A higher score on each question means a worse outcome.
- Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) [ Time Frame: Baseline and 2-weeks post-intervention ]The PCL-5 (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Total scores can range from 0 to 80, with higher scores meaning a worse outcome.
- Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline and 2-weeks post-intervention ]The PHQ-9 (Kroenke, Spitzer & Williams, 2001) is a nine-item self-report measure that assesses the nine DSM-IV symptoms of depression. Total scores can range from 0 to 27, with higher scores meaning a worse outcome.
- World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version [ Time Frame: Baseline and 2-weeks post-intervention ]The WHO DAS 2.0 (World Health Organisation, 2010) is a measure of health and disability. Total scores can range from 0 to 48, with higher scores meaning a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394832
|Woodfield Trauma Service|
|London, United Kingdom, W9 2NW|
|Principal Investigator:||Emily Greenfield||University of Surrey|