Clinical trial NCT03760601: A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees: An Extension
Official title: Intrusive Memories of Trauma Experienced by Young Refugees: Using Single Case Experimental Design to Investigate a Brief Cognitive Intervention Involving Computer Gameplay: An Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single case experimental AB design with optional replication (ABAB)
Primary purpose: OTHER

Brief summary: This research study is designed to investigate the use of a simple cognitive task (a memory cue and 10 minute time gap, followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among young refugees and asylum seekers. The design is a single case experimental AB design with optional replication (ABAB). Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue to use the technique self-guided in the subsequent week. Follow ups are conducted after each week to monitor the occurrence of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase.

Detailed description: This research study follows from ClinicalTrials.gov ID: NCT03525158, with a focus on the ABAB design and adding additional questions e.g. on concentration, emotion and functioning, and with the possibility of focusing on 1 intrusive memory at a time with associated distress ratings as part of the procedure.

Eligibility criteria: Inclusion Criteria:

* Refugee or asylum seeker
* Experiencing intrusive memories of trauma
* Have access to a smartphone
* Able to speak or read the study material in Swedish, English, Arabic or Farsi
* Able to attend five to six meetings with a researcher

Exclusion Criteria:

* Exhibit psychotic symptoms or other symptoms of severe mental illness

Primary outcomes:
measure: Change in number of intrusive memories of trauma
timeFrame: Change between baseline week 1 and Intervention week 1
Secondary outcomes:
measure: Feasibility and acceptability ratings for using a smartphone game-play intervention
timeFrame: Intervention week 1
measure: Feasibility and acceptability - open ended questions
timeFrame: Intervention week 1
measure: Self-guided intervention adherence - usage of the gameplay intervention in daily life
timeFrame: Intervention week 1
measure: Impact of intrusive memories on concentration, control, sleep and stress - ratings
timeFrame: Baseline week 1 and Intervention week 1
measure: Rating of how long intrusive memories disrupted concentration on average
timeFrame: Baseline week 1 and Intervention week 1
measure: Impact of intrusive memories - open ended questions
timeFrame: Baseline week 1 and Intervention week 1
measure: Impact of the intervention on concentration, emotion and functioning - ratings
timeFrame: Intervention week 1
measure: Subjective impact of the intervention - open ended questions
timeFrame: Intervention week 1
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
timeFrame: Baseline week 1 and intervention week 1
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Swedish Language Classes for Refugees, Clinics
Study officials:
affiliation: Karolinska Institutet
name: Emily Holmes, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanstrup M, Kontio E, Geranmayeh A, Olofsdotter Lauri K, Moulds ML, Holmes EA. A single case series using visuospatial task interference to reduce the number of visual intrusive memories of trauma with refugees. Clin Psychol Psychother. 2021 Jan;28(1):109-123. doi: 10.1002/cpp.2489. Epub 2020 Jul 6.