Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT04394156
Status:
TERMINATED
Last Update Posted:
2022-11-04
First Post:
2020-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000067073', 'term': 'Psychological Trauma'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Multiple baseline case-series design (AB), with a randomised duration of baseline length.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': '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).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2020-05-14', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-Guided Intervention Adherence Questionnaire', 'timeFrame': 'Time Frame: Intervention sessions 2-5, 1 week post-intervention, 2 weeks post-intervention and 2 months post-intervention.', 'description': 'A bespoke measure to assess adherence to self-guided practice of the intervention. It includes four questions to assess how often, and for how long, the person played Tetris after experiencing intrusive memories during the previous week.'}, {'measure': 'Feedback Questionnaire', 'timeFrame': '1-week post-intervention.', 'description': 'A bespoke questionnaire to gain feedback on the intervention. It includes 16 questions to assess acceptability and usefulness of the intervention with a variety of response options including yes/no, visual analogue scales and open responses.'}], 'primaryOutcomes': [{'measure': 'Frequency of intrusive memories', 'timeFrame': '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.', 'description': 'Number of intrusive memories of traumatic events recorded by participants in a daily pen and and paper diary.'}], 'secondaryOutcomes': [{'measure': 'Concentration', 'timeFrame': 'Baseline, 2-weeks post-intervention and 2-months post-intervention', 'description': '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.'}, {'measure': 'Social and Occupational Activity Tally (SOAT)', 'timeFrame': 'Baseline, 2-weeks post-intervention and 2-months post-intervention', 'description': '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.'}, {'measure': 'Dissociation', 'timeFrame': 'Baseline, 2-weeks post-intervention and 2-months post-intervention', 'description': '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.'}, {'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', 'description': '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.'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Baseline and 2-weeks post-intervention', 'description': '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.'}, {'measure': 'World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version', 'timeFrame': 'Baseline and 2-weeks post-intervention', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intrusive Memories', 'Post-Traumatic Stress Disorder', 'Cognitive Task Interference'], 'conditions': ['Post Traumatic Stress Disorder', 'Stress Disorders, Post-Traumatic', 'Stress Disorders, Traumatic', 'Trauma, Psychological', 'Trauma and Stressor Related Disorders', 'Mental Disorder']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThis study is a follow-up to a study conducted in Sweden with refugees. ClinicalTrials.gov Identifier: NCT03760601\n\nOur 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* are on the wait list for treatment (trauma focused therapy) at Woodfield Trauma Service\n* aged 18-65\n* have experienced intrusive memories in the past two weeks, as assessed by scoring 1 or above on question 1 of the PCL-5\n* are able to communicate with the researcher, with or without an interpreter\n* 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.\n* can commit to attending regular appointments and keeping an intrusion diary throughout the duration of the study.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* a current diagnosis of schizophrenia or bipolar disorder type 1\n* Intelligence Quotient (IQ) \\< 80\n* acute suicide risk\n* substance dependence\n* have been unable to complete the routine questionnaires given to new patients in the service at assessment'}, 'identificationModule': {'nctId': 'NCT04394156', 'briefTitle': 'Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD', 'organization': {'class': 'OTHER', 'fullName': 'University of Surrey'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SPON 2019 032 FHMS (B)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baseline phase, followed by intervention phase', 'description': '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.\n\nIn 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.', 'interventionNames': ['Behavioral: Brief cognitive intervention']}], 'interventions': [{'name': 'Brief cognitive intervention', 'type': 'BEHAVIORAL', 'description': 'See the information provided in the experimental arm description.', 'armGroupLabels': ['Baseline phase, followed by intervention phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W9 2NW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Woodfield Trauma Service', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Emily Greenfield', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Surrey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Surrey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central and North West London NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}