Stress Disorders, Post-TraumaticNCT04394832
Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD: A Pilot Study
A study testing Brief cognitive intervention in people with Stress Disorders, Post-Traumatic and Stress Disorders, Traumatic, run by University of Surrey at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Mental Disorder
- What is being tested?
- Brief cognitive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Feb 2020to 5 May 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Mental Disorder, Trauma and Stressor Related Disorders
- Being tested
- Brief cognitive intervention
- Keywords
- Intrusive Memories, Post-Traumatic Stress Disorder, Cognitive Task Interference
- Medical subject headings
- Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Mental Disorders, Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief cognitive interventionBehavioural
See the information provided in the experimental arm description.
| Study group | Role | What they receive |
|---|---|---|
| Baseline phase, followed by intervention phase | Experimental | 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. Receives: Behavioral: Brief cognitive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of intrusive memories
Number of intrusive memories of traumatic events recorded by participants in a pen and and paper diary.
Measured: Daily through study completion, an average of 3 months. Change is assessed from baseline to post-intervention.
Secondary outcomes (6)
Concentration
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.
Measured: Baseline and 2-weeks post-intervention
Social and Occupational Activity Tally (SOAT)
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.
Measured: Baseline and 2-weeks post-intervention
Dissociation
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.
Measured: Baseline and 2-weeks post-intervention
Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)
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.
Measured: Baseline and 2-weeks post-intervention
Patient Health Questionnaire (PHQ-9)
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.
Measured: Baseline and 2-weeks post-intervention
World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version
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.
Measured: Baseline and 2-weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start25 Feb 2020
- Primary completion5 May 2020
- Study completion5 May 2020
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple baseline case-series design (AB), with a randomised duration of baseline length.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- Central and North West London NHS Foundation Trust, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Emily Greenfield, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394832
- Sponsor's protocol ID
- SPON 2019 032 FHMS (A)
- Status last verified
- Jun 2020
- First submitted
- 21 Apr 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Pilot Study
- ClinicalTrials.gov ID
- NCT04394832
- Acronym / sponsor ID
- SPON 2019 032 FHMS (A)
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Central and North West London NHS Foundation Trust, Uppsala University
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple baseline case-series design (AB), with a randomised duration of baseline length.
| Arm | Type | Receives |
|---|---|---|
| Baseline phase, followed by intervention phase | Experimental | Behavioral: Brief cognitive interventionWithin 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief cognitive interventionSee the information provided in the experimental arm description. | Behavioural | Baseline phase, followed by intervention phase |
Primary outcome
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.
6 secondary outcomes
Concentration
Time frame: Baseline and 2-weeks post-intervention
Social and Occupational Activity Tally (SOAT)
Time frame: Baseline and 2-weeks post-intervention
Dissociation
Time frame: Baseline and 2-weeks post-intervention
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
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline and 2-weeks post-intervention
World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version
Time frame: Baseline and 2-weeks post-intervention
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Greenfield principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief cognitive intervention in people with Stress Disorders, Post-Traumatic and Stress Disorders, Traumatic, run by University of Surrey at 1 site 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of intrusive memories (time frame: Daily through study completion, an average of 3 months. Change is assessed from baseline to post-intervention.). 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 11 Jun 2020.