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Clinical Trials/NCT04342416
NCT04342416
Completed
Not Applicable

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

University of Iceland1 site in 1 country10 target enrollmentSeptember 8, 2020
ConditionsTrauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma
Sponsor
University of Iceland
Enrollment
10
Locations
1
Primary Endpoint
Change in the number of intrusive memories of trauma
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 8, 2020
End Date
September 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andri Steinþór Björnsson

Professor

University of Iceland

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)).

Outcomes

Primary Outcomes

Change in the number of intrusive memories of trauma

Time Frame: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up

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 and three month follow-up.

Secondary Outcomes

  • Self-guided intervention adherence - usage of the gameplay intervention in daily life(Intervention week 2-6)
  • The Patient Health Questionnaire-9 (PHQ-9)(Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up)
  • The Generalized Anxiety Disorder-7 scale (GAD-7)(Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up)
  • Feasibility and acceptability ratings for using a smartphone game-play intervention(Post intervention up to week 7)
  • Intrusion diary adherence(Baseline phase week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up)
  • 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)
  • General impact of intrusive memories - ratings(Baseline week 1; Intervention week 1-6; 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)
  • The Posttraumatic Stress Disorder Checklist 5 (PCL-5)(Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up)
  • The Sheehan Disability Scale (SDS)(Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up)
  • Impact of intrusive memories on functioning(Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up)

Study Sites (1)

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