Post Traumatic Stress DisorderNCT04394156
Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD
A study testing Brief cognitive intervention in people with Post Traumatic Stress Disorder and Stress Disorders, Post-Traumatic, run by University of Surrey at 1 site in United Kingdom.
Trial summary
This research study is 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
- Post Traumatic Stress Disorder, Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic
- 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
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jul 2020to 6 Apr 2021
- 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.
- if recruited remotely, have access to the internet and a device such as a mobile phone, I-pad or laptop, to engage in video calls and to play Tetris on.
- if recruited remotely, are able to find a quiet space for 1 hour a week to have an appointment e.g. without distraction from other family members.
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 Test of Replication to a New Population
This research study is 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 includes 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 will have a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants will complete 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 are conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.
Read the detailed description
The study is being 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). We aim to recruit up to 13 participants from this service to take part in the study, which is an extension of a pilot study previously conducted. Due to the Covid-19 pandemic, guidance from the trust R\&D and NHS service manager states that face-to-face appointments should not currently take place at the NHS clinical recruitment site. Therefore, until this guidance changes, the research will take place remotely via video calls.
The study will have 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 will create, with the help of the researcher, a list of their most frequent and distressing intrusive memories of trauma. Each intrusive memory will be given a label (for example; a letter, colour or symbol) so that the frequency of each intrusive memory can be monitored in a pen and paper diary. The frequency of specific intrusive memories the person experiences after they have received the intervention will be compared with 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 will be the baseline phase (A); therefore, the baseline phase will include 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) will be the time after the specific intrusion was targeted. Some intrusive memories on the list may not be targeted by the intervention but will be monitored (through the intrusion diary) throughout the duration of the study for comparison.
This study is a follow-up to a study conducted in Sweden with refugees. ClinicalTrials.gov Identifier: NCT03760601
Our study is extending 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
- Post Traumatic Stress Disorder, Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Trauma, Psychological, Trauma and Stressor Related Disorders, Mental Disorder
- 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, Psychological Trauma, Trauma and Stressor Related Disorders, Mental 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) will be 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 will be offered around five intervention sessions with a researcher. Each session the participant will choose which intrusive memory they would like to focus on and the cognitive task will be completed. The intervention includes 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 will be 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) will be 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 daily pen and and paper diary.
Measured: Baseline weeks 1-3, throughout the duration of the intervention phase (approximately 5 weeks), post-intervention weeks 1-2 and for 1 week 2 months post-intervention. 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, 2-weeks post-intervention and 2-months 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, 2-weeks post-intervention and 2-months 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, 2-weeks post-intervention and 2-months 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 start7 Jul 2020
- Primary completion6 Apr 2021
- Study completion6 Apr 2021
Why it stopped: Due to recruitment delays in the Covid-19 pandemic, alongside the need to submit the doctoral thesis this study was conducted for in a limited time frame, recruitment was halted prematurely (note that our recruitment aim was up to 13 participants).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies 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
- 6 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
- NCT04394156
- Sponsor's protocol ID
- SPON 2019 032 FHMS (B)
- Status last verified
- Oct 2022
- First submitted
- 14 May 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. 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 Test of Replication to a New Population
- ClinicalTrials.gov ID
- NCT04394156
- Acronym / sponsor ID
- SPON 2019 032 FHMS (B)
- Conditions
- Post Traumatic Stress Disorder, Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Trauma, Psychological, Trauma and Stressor Related Disorders, Mental Disorder
- Keywords
- Intrusive Memories, Post-Traumatic Stress Disorder, Cognitive Task Interference
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruitment delays in the Covid-19 pandemic, alongside the need to submit the doctoral thesis this study was conducted for in a limited time frame, recruitment was halted prematurely (note that our recruitment aim was up to 13 participants).
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- Central and North West London NHS Foundation Trust, Uppsala University
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (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 is 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 includes 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 will have a multiple baseline case-series design (AB), with a randomised duration of baseline length up to three weeks. Thus, participants will complete 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 are conducted after each week to monitor the frequency of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories after receiving the intervention than in the preceding baseline phase.
Detailed description
The study is being 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). We aim to recruit up to 13 participants from this service to take part in the study, which is an extension of a pilot study previously conducted. Due to the Covid-19 pandemic, guidance from the trust R\&D and NHS service manager states that face-to-face appointments should not currently take place at the NHS clinical recruitment site. Therefore, until this guidance changes, the research will take place remotely via video calls.
The study will have 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 will create, with the help of the researcher, a list of their most frequent and distressing intrusive memories of trauma. Each intrusive memory will be given a label (for example; a letter, colour or symbol) so that the frequency of each intrusive memory can be monitored in a pen and paper diary. The frequency of specific intrusive memories the person experiences after they have received the intervention will be compared with 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 will be the baseline phase (A); therefore, the baseline phase will include 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) will be the time after the specific intrusion was targeted. Some intrusive memories on the list may not be targeted by the intervention but will be monitored (through the intrusion diary) throughout the duration of the study for comparison.
This study is a follow-up to a study conducted in Sweden with refugees. ClinicalTrials.gov Identifier: NCT03760601
Our study is extending 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) will be 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 will be offered around five intervention sessions with a researcher. Each session the participant will choose which intrusive memory they would like to focus on and the cognitive task will be completed. The intervention includes 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 will be 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) will be 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 (8 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: Baseline weeks 1-3, throughout the duration of the intervention phase (approximately 5 weeks), post-intervention weeks 1-2 and for 1 week 2 months post-intervention. Change is assessed from baseline to post-intervention.
Number of intrusive memories of traumatic events recorded by participants in a daily pen and and paper diary.
6 secondary outcomes
Concentration
Time frame: Baseline, 2-weeks post-intervention and 2-months post-intervention
Social and Occupational Activity Tally (SOAT)
Time frame: Baseline, 2-weeks post-intervention and 2-months post-intervention
Dissociation
Time frame: Baseline, 2-weeks post-intervention and 2-months 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: Due to recruitment delays in the Covid-19 pandemic, alongside the need to submit the doctoral thesis this study was conducted for in a limited time frame, recruitment was halted prematurely (note that our recruitment aim was up to 13 participants).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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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 Post Traumatic Stress Disorder and Stress Disorders, Post-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 8 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 4 Nov 2022. 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: Due to recruitment delays in the Covid-19 pandemic, alongside the need to submit the doctoral thesis this study was conducted for in a limited time frame, recruitment was halted prematurely (note that our recruitment aim was up to 13 participants).). 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: Baseline weeks 1-3, throughout the duration of the intervention phase (approximately 5 weeks), post-intervention weeks 1-2 and for 1 week 2 months post-intervention. 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 4 Nov 2022.