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Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD: A Pilot Study

Primary Purpose

Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Mental Disorder

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Brief cognitive intervention
Sponsored by
University of Surrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Intrusive Memories, Post-Traumatic Stress Disorder, Cognitive Task Interference

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

Sites / Locations

  • Woodfield Trauma Service

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Baseline phase, followed by intervention phase

Arm Description

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.

Outcomes

Primary Outcome Measures

Frequency of intrusive memories
Number of intrusive memories of traumatic events recorded by participants in a pen and and paper diary.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 21, 2020
Last Updated
June 8, 2020
Sponsor
University of Surrey
Collaborators
Central and North West London NHS Foundation Trust, Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT04394832
Brief Title
Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD: A Pilot Study
Official Title
Reducing Intrusive Memories of Trauma Using a Visuospatial Interference Intervention With Refugees With Posttraumatic Stress Disorder (PTSD): A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Covid-19
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
May 5, 2020 (Actual)
Study Completion Date
May 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey
Collaborators
Central and North West London NHS Foundation Trust, Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Mental Disorder, Trauma and Stressor Related Disorders
Keywords
Intrusive Memories, Post-Traumatic Stress Disorder, Cognitive Task Interference

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multiple baseline case-series design (AB), with a randomised duration of baseline length.
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baseline phase, followed by intervention phase
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief cognitive intervention
Intervention Description
See the information provided in the experimental arm description.
Primary Outcome Measure Information:
Title
Frequency of intrusive memories
Description
Number of intrusive memories of traumatic events recorded by participants in a pen and and paper diary.
Time Frame
Daily through study completion, an average of 3 months. Change is assessed from baseline to post-intervention.
Secondary Outcome Measure Information:
Title
Concentration
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.
Time Frame
Baseline and 2-weeks post-intervention
Title
Social and Occupational Activity Tally (SOAT)
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.
Time Frame
Baseline and 2-weeks post-intervention
Title
Dissociation
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.
Time Frame
Baseline and 2-weeks post-intervention
Title
Post-Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)
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.
Time Frame
Baseline and 2-weeks post-intervention
Title
Patient Health Questionnaire (PHQ-9)
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.
Time Frame
Baseline and 2-weeks post-intervention
Title
World Health Organisation Disability Assessment Schedule 2.0 (WHO DAS 2.0) 12 item version
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.
Time Frame
Baseline and 2-weeks post-intervention
Other Pre-specified Outcome Measures:
Title
Self-Guided Intervention Adherence Questionnaire
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.
Time Frame
Intervention weeks 2-5, 1 week post-intervention and 2 weeks post-intervention
Title
Feedback Questionnaire
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.
Time Frame
1-week post-intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Greenfield
Organizational Affiliation
University of Surrey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woodfield Trauma Service
City
London
ZIP/Postal Code
W9 2NW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD: A Pilot Study

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