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

NCT04709822 | Completed DMC

• 1 other identifier: RDVIRMT
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma

Keywords

Intrusive memories

Outcome Measures

Primary Outcomes (1)

• Change in the total number of intrusive memories of trauma

  Total number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) during the fifth week after the second intervention session (Week 5), compared to in the baseline week (Week -1).

  Week 5 compared to Baseline (Week -1)

Secondary Outcomes (11)

• Change in the total number of intrusive memories of trauma

  Weeks 0-4 and 3-month follow-up compared to Baseline (Week -1)

• Unwanted Memories of Trauma (UMT)

  Baseline (Week -1), Week 1, 1-month and 3-month follow-ups

• The Posttraumatic Stress Disorder Checklist 5 (PCL-5)

  Baseline (Week -1), Week 1, 1-month and 3-month follow-ups

• The Patient Health Questionnaire-9 (PHQ-9)

  Baseline (Week -1), Week 1, 1-month and 3-month follow-ups

• The Generalized Anxiety Disorder-7 scale (GAD-7)

  Baseline (Week -1), Week 1, 1-month and 3-month follow-ups

Other Outcomes (11)

• The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)

  Baseline (Week -1), Week 1, 1-month and 3-month follow-ups

• Self-rated health rating (SRHR)

  Baseline (Week -1), Week 1, 1-month and 3-month follow-ups

• Sleep Condition Indicator (SCI-02)

  Baseline (Week -1), Week 1, 1-month and 3-month follow-ups

Study Arms (1)

Trauma exposed women

EXPERIMENTAL

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).

Behavioral: Visuospatial Interference

Interventions

Visuospatial Interference 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).

Also known as: Brief cognitive intervention

Trauma exposed women

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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))

Sponsors & Collaborators

• University of Iceland: lead
• Uppsala University: collaborator

Study Sites (1)

University of Iceland

Reykjavik, 101, Iceland

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Andri Björnsson, PhD

  University of Iceland

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: January 15, 2021
• Primary Completion: July 7, 2021
• Study Completion: September 1, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: We aim to make anonymised data openly available after the publication of results in a scientific journal, and for such data to remain available indefinitely.

Locations

IC (1)