University of Iceland
Reykjavik, 101, Iceland
NCT Number: NCT04342416
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.
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Notify Me18 year–69 year
Female
Interventional
Not applicable
Reykjavik, 101, Iceland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Intervention week 2-6
How often did you manage to play Tetris after you experienced an intrusive memory? (11-point scale; 0 = not at all; 10 = every time).
Time frame: Post intervention up to week 7
Feasibility and Acceptability of the intervention assessed with two self-rated items, "Would you recommend playing Tetris to a friend?" and "Do you consider gameplay to be an acceptable way to reduce the daily frequency of intrusive memories?". Scores could range from 0 - 10 with higher scores indicating greater acceptability/feasibility.
Time frame: Post intervention up to week 7
Two open-ended questions: 1. "How did you feel about playing Tetris after you had an intrusive memory?" 2. "Did you find the intervention helpful? If yes, how?"
Time frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
Six self-rated items to assess the impact of intrusive memories on concentration, sleep, and stress in the past week. 2 items assessing concentration difficulties in general and due to intrusive memories (11-point scale; high scores indicating more difficulties). 2 items assessing sleep disturbances due to intrusive memories (11-point scale; higher scores indicating more sleep disturbance); and 1 item assessing to what degree intrusive memories affected stress levels (0 = not at all; 10 = affected very much).
Time frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
1 item assessing for how long intrusive memories disrupted concentration on average on a 6-point scale (0 = <1 minute - 6 = > 60 minutes)
Time frame: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
Two items both rated on an 11-point scale: 1. "During the last week, how distressing were your intrusive memories (0 = not at all; 10 = very distressing). 2. During the last week, how vivid were your intrusive memories (0 = not at all; 10= very vivid)
Time frame: Baseline phase week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
Adherence to the intrusion diary assessed with 1 item: "How accurately did you fill out the diary?" (0= not at all; 10 = very accurately)
Time frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
The PCL-5 is a short 20-item self-report scale used to assess the severity of PTSD symptoms corresponding to the DSM-5 criteria for PTSD. Symptoms are rated from 0-4. Higher scores indicate greater severity.
Time frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
The PHQ-9 is a 9-item self-report measure of depression symptoms and the severity of those symptoms. Each item can be scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
Time frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
The GAD-7 is a brief self-report questionnaire designed as a screening tool for symptoms of general anxiety disorder and their severity. Each item can be scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
Time frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
The SDS is a self-report questionnaire which is designed to assess functional impairment across three domains: (1) Work/school, (2) social, and (3) family life. These domains are measured on an 11-point scale which ranges from 0 (i.e., not at all) to 10 (i.e., extremely). The scale will be adjusted to assess impairment associated with intrusive memories.
Time frame: Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up
Two questions assessing the impact intrusive memories have on functioning in daily life. One question is open-ended: "Have the intrusive memories affected your ability to function in your daily life in the past week? If yes, how?" and one question is self-rated: "Have the intrusive memories affected your ability to function in your daily life?" (11-point scale, higher score indicate greater impact on functioning.)
University of Iceland
Other
Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
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