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

NCT ID: NCT04394832

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-25
• Study Completion Date: 2020-05-05

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Baseline phase, followed by intervention phase

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.

Group Type: EXPERIMENTAL

Brief cognitive intervention

Intervention Type: BEHAVIORAL

See the information provided in the experimental arm description.

Interventions

Brief cognitive intervention

See the information provided in the experimental arm description.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central and North West London NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: collaborator

University of Surrey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emily Greenfield

Role: PRINCIPAL_INVESTIGATOR

University of Surrey

Locations

Woodfield Trauma Service

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

SPON 2019 032 FHMS (A)

Identifier Type: -

Identifier Source: org_study_id