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

NCT ID: NCT04342416

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2021-09-01

Brief Summary

This research study is an extension on a study already preregistered NCT04209283 and 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, the investigators will explore whether having fewer intrusive memories has an impact on function and/or PTSD, depressive or anxiety symptoms.

Detailed Description

Participants will attend 3-8 sessions with researchers and sessions will be conducted remotely via telephone or secure video platform (Kara Connect). In session one, the intrusive memories will be logged for monitoring their frequency in a daily diary for the following weeks. Baseline assessment questionnaires will also administered. In the second session, a memory will be selected and targeted with the intervention (memory reminder followed by 25 min gameplay with mental rotation) followed by monitoring the frequency of both the targeted and non-targeted intrusive memories. Participants will also complete self-rated questions concerning the impact of their intrusive memories. The intervention session will be repeated for other intrusive memories (maximum 6 intervention sessions). In the last intervention session, participants will be asked to complete questionnaires and self-rated questions assessing the impact of their intrusive memories. Participants will be asked to complete measures at 1 month follow-up and at 3 month follow-up. In the 1 month follow-up and the 3 month follow-up, participants complete questionnaires and monitor the frequency of intrusive memories for one week. The investigators note that the intended timeframes (e.g. one-week for baseline and one-week for intervention phase) may differ slightly across participants depending on availability and the practicalities of remote delivery.

Conditions

Trauma

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 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

Group Type: EXPERIMENTAL

Visiospatial Interference

Intervention Type: 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.

Interventions

Visiospatial Interference

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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

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

VIRMT

Identifier Type: -

Identifier Source: org_study_id