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

NCT04394832 | Terminated

• 1 other identifier: SPON 2019 032 FHMS (A)
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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 pen and and paper diary.

  Daily through study completion, an average of 3 months. Change is assessed from baseline to post-intervention.

Secondary Outcomes (6)

• Concentration

  Baseline and 2-weeks post-intervention

• Social and Occupational Activity Tally (SOAT)

  Baseline and 2-weeks post-intervention

• Dissociation

  Baseline and 2-weeks 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

  Intervention weeks 2-5, 1 week post-intervention and 2 weeks 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) 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.

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.

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; Mental Disorders; Trauma and Stressor Related 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: April 21, 2020
• First Posted: May 19, 2020
• Study Start: February 25, 2020
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)