Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women

NCT04209283 | Completed DMC

• 1 other identifier: UI-2019-VIRM
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is designed to investigate the use of a simple cognitive task (a memory cue followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among trauma-exposed women in Iceland. This is a single case series using a within subject multiple baseline AB design. 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 using the technique self-guided in subsequent weeks. 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 intrusive memories during the intervention phase than during the preceding baseline phase and that the frequency of targeted intrusive memories is going to decrease relative to non-targeted intrusive memories. Furthermore, we will explore whether having fewer intrusive memories has an impact on function and/or PTSD, depressive or anxiety symptoms.

Conditions

Trauma

Keywords

Intrusive memories

Outcome Measures

Primary Outcomes (2)

• Change in the number of intrusive memories of trauma

  Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) for one week during the baseline phase and each week during the intervention phase (week 1-6) and during one week at one month follow-up.

  Baseline week 1; Intervention week 1-6 and 1 month follow-up

• Change in the number of intrusive memories of trauma from baseline to 3 month follow up

  Number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) per week during the baseline phase and during one week at three month follow-up. Note that the way this outcome was measured had been specified incorrectly in the previous versions of this CTR (as using questions about frequency) and was therefore updated retrospectively after the end of data collection to the same diary as the previous time points.

  Baseline week 1; 3 month follow-up

Secondary Outcomes (12)

• Self-guided intervention adherence - usage of the gameplay intervention in daily life

  Intervention week 2-6

• Feasibility and acceptability ratings for using a smartphone game-play intervention

  Post intervention up to week 7

• Feasibility and acceptability - open ended questions

  Post intervention up to week 7

• Impact of intrusive memories on concentration, sleep and stress - ratings

  Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up

• Rating of how long intrusive memories disrupted concentration on average

  Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up

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 for the primary outcome (occurrence of intrusive memories of trauma). Individual baseline phases will be used as control periods. Experimental: Intervention phase ('B'): A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game-play with mental rotation) followed by instructions to engage in the task self-guided over the subsequent week. Measurements collected in a daily diary four times a day following the intervention for the primary outcome (occurrence of intrusive memories of trauma). Intervention: Behavioral: Brief cognitive intervention

Behavioral: Visuospatial interference

Interventions

Visuospatial interference BEHAVIORAL

Behavioral: Brief cognitive intervention. A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) with instructions to engage in the task self-guided in the subsequent weeks.

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 one intrusive memory that occurs at least three times per week in the past four weeks
• Being able to attend 3-8 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

Study Sites (1)

University of Iceland

Reykjavik, 101, Iceland

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Andri Björnsson, PhD

  University of Iceland Sæmundargata 12 101 Reykjavík, 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: December 6, 2019
• First Posted: December 24, 2019
• Study Start: January 23, 2020
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)