Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04709822
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2021-01-12
Brief Title:
Remote Delivery of a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories of Trauma
Sponsor:
University of Iceland
Organization:
University of Iceland
Study Overview
Official Title:
Remote Delivery of a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single case series feasibility study is designed to investigate the feasibility of remote recruitment and delivery of a brief visuospatial interference intervention for decreasing the number of intrusive memories of trauma among trauma-exposed women in Iceland The current study is an extension on two studies already preregistered NCT04209283 and NCT04342416 that included some aspects of in-person recruitment andor intervention delivery rather than fully remote as we aim for here The intervention is a simple cognitive task a memory cue followed by playing the computer game Tetris with accompanying information A within-subjects multiple baseline AB design is used in that the length of baseline A no intervention and intervention B phases vary within-subjects across individual intrusive trauma memories Participants will aim to complete at least one week of the baseline A phase followed by at least two intervention sessions with a researcher remotely via telephone or secure video platform Intervention sessions comprise the simple cognitive task alongside accompanying information presented in the form of brief animated videos eg explaining the target symptom Participants are instructed that they may continue using the technique self-guided in subsequent weeks and they may opt for additional intervention sessions with remote researcher support maximum 6 intervention sessions Participants will be asked to monitor the occurrence of intrusive memories of trauma in a daily diary It is predicted that participants will report fewer total intrusive memories in the fifth week after the second intervention session primary outcome compared to in the first baseline week The investigators will also explore whether the frequency of targeted intrusive memories is going to decrease relative to non-targeted intrusive memories Furthermore the investigators will explore whether having fewer intrusive memories is related to functioning andor PTSD depressive or anxiety symptoms
Detailed Description:
Participants complete a total of 3-9 sessions with researchers and sessions will be conducted remotely via telephone or secure video platform Kara Connect In the baseline session questionnaires are administered and the individual intrusive trauma memories will be logged for monitoring their frequency in a daily diary Participants will record their intrusive memories in the daily diary for at least one week Week -1 before commencing the intervention In the first intervention session a memory will be selected and targeted with the intervention memory reminder followed by 25 min gameplay with mental rotation We aim to deliver a second intervention session soon after the first within approx one week targeting the same or a different intrusive memory Participants are instructed that they may continue using the technique self-guided after the first intervention session and they may opt for additional intervention sessions with remote researcher support maximum 6 intervention sessions Participants continue to monitor the frequency of both targeted and non-targeted intrusive memories in the daily diary throughout Weeks 0-5 Follow-up questionnaires are completed at Week 1 1-month and 3-months after the second intervention session The primary outcome is change in total number of intrusive memories from the baseline week Week -1 to the fifth week after the second intervention session Week 5 Participants will also monitor the frequency of their intrusive memories for one week at the 3-month follow-up The investigators note that the intended time-frames may differ slightly across participants depending on availability and the practicalities of remote delivery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None