Clinical trial NCT04209283: Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
Official title: Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Keywords: Intrusive memories
Lead sponsor: University of Iceland
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Participants will attend 3-8 sessions with the researcher. 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, participants complete questionnaires and monitor the frequency of intrusive memories for one week in the daily diary.

The previous version of the CTR incorrectly stated that at the 3 month time point the measure of intrusions will be: 'Questions about the frequency of intrusive memories for the past day/week (for each intrusive memory, to be tallied to arrive at a mean frequency for the memories for the previous day and for the week)'. We changed this measure at the study start to using the same diary as we used for the earlier time points (i.e., daily diary with the same level of detail as the ones used at e.g. at 1 month), but failed to update this in the CTR. The measure has been updated retrospectively in the CTR for this timepoint, and should be interpreted with caution accordingly.

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)).

Primary outcomes:
measure: Change in the number of intrusive memories of trauma
timeFrame: Baseline week 1; Intervention week 1-6 and 1 month follow-up
measure: Change in the number of intrusive memories of trauma from baseline to 3 month follow up
timeFrame: Baseline week 1; 3 month follow-up
Secondary outcomes:
measure: Self-guided intervention adherence - usage of the gameplay intervention in daily life
timeFrame: Intervention week 2-6
measure: Feasibility and acceptability ratings for using a smartphone game-play intervention
timeFrame: Post intervention up to week 7
measure: Feasibility and acceptability - open ended questions
timeFrame: Post intervention up to week 7
measure: Impact of intrusive memories on concentration, sleep and stress - ratings
timeFrame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
measure: Rating of how long intrusive memories disrupted concentration on average
timeFrame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
measure: General impact of intrusive memories - ratings
timeFrame: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
measure: Intrusion diary adherence
timeFrame: Baseline phase week 1; Intervention week 1-6 and 1 month follow-up
measure: The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
timeFrame: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
measure: The Generalized Anxiety Disorder-7 scale (GAD-7)
timeFrame: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
measure: The Sheehan Disability Scale (SDS)
timeFrame: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
measure: Impact of intrusive memories on functioning
timeFrame: Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up
Other outcomes:
Locations:
city: Reykjavík
country: Iceland
facility: University of Iceland
Study officials:
affiliation: University of Iceland Sæmundargata 12 101 Reykjavík, Iceland
name: Andri Björnsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: