Reducing Intrusive Memories in Refugees and Asylum Seekers With PTSD

NCT04394156 | Terminated

• 1 other identifier: SPON 2019 032 FHMS (B)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Concentration

  Baseline, 2-weeks post-intervention and 2-months post-intervention

• Social and Occupational Activity Tally (SOAT)

  Baseline, 2-weeks post-intervention and 2-months post-intervention

• Dissociation

  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)

  Baseline and 2-weeks post-intervention

• Patient Health Questionnaire (PHQ-9)

  Baseline and 2-weeks post-intervention

Other Outcomes (2)

• Self-Guided Intervention Adherence Questionnaire

  Time Frame: Intervention sessions 2-5, 1 week post-intervention, 2 weeks post-intervention and 2 months post-intervention.

• Feedback Questionnaire

  1-week post-intervention.

Study Arms (1)

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.

Behavioral: Brief cognitive intervention

Interventions

Brief cognitive intervention BEHAVIORAL

See the information provided in the experimental arm description.

Baseline phase, followed by intervention phase

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Surrey: lead
• Central and North West London NHS Foundation Trust: collaborator
• Uppsala University: collaborator

Study Sites (1)

Woodfield Trauma Service

London, W9 2NW, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Psychological Trauma; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Emily Greenfield

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple baseline case-series design (AB), with a randomised duration of baseline length.

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: July 7, 2020
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: November 4, 2022

Record last verified: 2022-10

Locations

GB (1)