Post Traumatic Stress Disorder Clinical Trial
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
Verified date | October 2022 |
Source | University of Surrey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | April 6, 2021 |
Est. primary completion date | April 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. - 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. 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Woodfield Trauma Service | London |
Lead Sponsor | Collaborator |
---|---|
University of Surrey | Central and North West London NHS Foundation Trust, Uppsala University |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Self-Guided Intervention Adherence Questionnaire | 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. | Time Frame: Intervention sessions 2-5, 1 week post-intervention, 2 weeks post-intervention and 2 months post-intervention. | |
Other | Feedback Questionnaire | 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. | 1-week post-intervention. | |
Primary | Frequency of intrusive memories | Number of intrusive memories of traumatic events recorded by participants in a daily pen and and paper diary. | 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 | 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. | Baseline, 2-weeks post-intervention and 2-months post-intervention | |
Secondary | 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. | Baseline, 2-weeks post-intervention and 2-months post-intervention | |
Secondary | 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. | Baseline, 2-weeks post-intervention and 2-months post-intervention | |
Secondary | 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. | Baseline and 2-weeks post-intervention | |
Secondary | 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. | Baseline and 2-weeks post-intervention | |
Secondary | 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. | Baseline and 2-weeks post-intervention |
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