TraumaNCT04209283
Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
A study testing Visuospatial interference in people with Trauma, run by University of Iceland at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Trauma
- What is being tested?
- Visuospatial interference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIceland
- Study dates
- 23 Jan 2020to 20 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Trauma
- Being tested
- Visuospatial interference
- Keywords
- Intrusive memories
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visuospatial interferenceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Visuospatial interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline week 1; 3 month follow-up
Secondary outcomes (12)
Self-guided intervention adherence - usage of the gameplay intervention in daily life
How often did you manage to play Tetris after you experienced an intrusive memory? (11-point scale; 0 = not at all; 10 = every time).
Measured: Intervention week 2-6
Feasibility and acceptability ratings for using a smartphone game-play intervention
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.
Measured: Post intervention up to week 7
Feasibility and acceptability - open ended questions
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?"
Measured: Post intervention up to week 7
Impact of intrusive memories on concentration, sleep and stress - ratings
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).
Measured: 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
1 item assessing for how long intrusive memories disrupted concentration on average (<1 minute - > 60 minutes)
Measured: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
General impact of intrusive memories - ratings
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)
Measured: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
Intrusion diary adherence
Adherence to the intrusion diary assessed with 1 item: "How accurately did you fill out the diary?" (0= not at all; 10 = very accurately)
Measured: Baseline phase week 1; Intervention week 1-6 and 1 month follow-up
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
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.
Measured: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
The Patient Health Questionnaire-9 (PHQ-9)
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).
Measured: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
The Generalized Anxiety Disorder-7 scale (GAD-7)
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).
Measured: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
The Sheehan Disability Scale (SDS)
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.
Measured: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
Impact of intrusive memories on functioning
Two questions assessing the impact intrusive memories have on functioning in daily life. One question is open-ended: "How have the intrusive memories affected your ability to function in your daily life in the past week?" 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.)
Measured: Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start23 Jan 2020
- Primary completion20 Aug 2020
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andri Steinþór Björnsson, University of Iceland
- Investigators
- Andri Björnsson, PhD, Principal investigator, University of Iceland Sæmundargata 12 101 Reykjavík, Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209283
- Sponsor's protocol ID
- UI-2019-VIRM
- Status last verified
- Feb 2022
- First submitted
- 6 Dec 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women
- ClinicalTrials.gov ID
- NCT04209283
- Acronym / sponsor ID
- UI-2019-VIRM
- Conditions
- Trauma
- Keywords
- Intrusive memories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma exposed women | Experimental | Behavioral: Visuospatial interferenceNo 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 |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visuospatial interferenceBehavioral: 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. | Behavioural | Trauma exposed women |
Primary outcome
Change in the number of intrusive memories of trauma
Time frame: Baseline week 1; Intervention week 1-6 and 1 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.
Change in the number of intrusive memories of trauma from baseline to 3 month follow up
Time frame: Baseline week 1; 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.
12 secondary outcomes
Self-guided intervention adherence - usage of the gameplay intervention in daily life
Time frame: Intervention week 2-6
Feasibility and acceptability ratings for using a smartphone game-play intervention
Time frame: Post intervention up to week 7
Feasibility and acceptability - open ended questions
Time frame: Post intervention up to week 7
Impact of intrusive memories on concentration, sleep and stress - ratings
Time frame: 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
Time frame: Baseline week 1; Post intervention up to week 7; 1 month follow-up and 3 month follow-up
General impact of intrusive memories - ratings
Time frame: Baseline week 1; Intervention week 1-6; 1 month follow-up and 3 month follow-up
Intrusion diary adherence
Time frame: Baseline phase week 1; Intervention week 1-6 and 1 month follow-up
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Time frame: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
The Generalized Anxiety Disorder-7 scale (GAD-7)
Time frame: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
The Sheehan Disability Scale (SDS)
Time frame: Baseline week 1; Post intervention up to week 7 and 1 month follow-up
Impact of intrusive memories on functioning
Time frame: Baseline week 1; Post intervention up to week 7, 1 month follow-up and 3 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andri Björnsson, PhD principal investigator
University of Iceland Sæmundargata 12 101 Reykjavík, Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visuospatial interference in people with Trauma, run by University of Iceland at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of intrusive memories of trauma (time frame: Baseline week 1; Intervention week 1-6 and 1 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.