Remote Delivery of a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories of Trauma

NCT ID: NCT04709822

Last Updated: 2021-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-09-01

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 and/or 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 (e.g., 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 and/or 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.

Conditions

Trauma

Keywords

Intrusive memories

Study Design

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

Study Groups

Trauma exposed women

No Intervention: Baseline phase ('A'):

Measurements collected in a daily diary four times a day (morning, afternoon, evening and night) over one week (number of intrusive memories of trauma). Individual baseline phases will be used as control periods for the primary outcome.

Experimental: Intervention phase ('B'):

Measurements collected in a daily diary four times a day during the fifth week after the second intervention session for the primary outcome (number of intrusive memories of trauma).

Group Type: EXPERIMENTAL

Visuospatial Interference

Intervention Type: BEHAVIORAL

Two remote intervention sessions with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) alongside accompanying information.

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).

Interventions

Visuospatial Interference

Two remote intervention sessions with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) alongside accompanying information.

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Brief cognitive intervention

Eligibility Criteria

Inclusion Criteria

• Having experienced at least one criterion A trauma according to the DSM-5
• Having at least two intrusive memories over the previous week
• Reporting being bothered by intrusive memories over the past month (scoring at least a moderate or higher score on PCL-5 item 1)
• Being able and willing to complete 3-9 sessions with researcher
• Being willing to monitor intrusive memories in daily life
• Having access to a smartphone
• Being able to speak Icelandic and read study materials in Icelandic

Exclusion Criteria

• Current psychotic disorder (determined by the psychotic module on the Mini International Neuropsychiatric Interview (MINI))
• Current manic episode (determined by the bipolar module on the Mini International Neuropsychiatric Interview (MINI))
• Being acutely suicidal (according to the module assessing suicidality on the Mini International Neuropsychiatric Interview (MINI))

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

University of Iceland

OTHER

Sponsor Role: lead

Responsible Party

Andri Steinþór Björnsson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andri Björnsson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iceland

Locations

University of Iceland

Reykjavik, , Iceland

Countries

Iceland

Other Identifiers

RDVIRMT

Identifier Type: -

Identifier Source: org_study_id