TraumaNCT04709822
Remote Delivery of a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories of Trauma
A study testing Visuospatial Interference in people with Trauma, run by University of Iceland at 1 site in Iceland.
Trial summary
This single case series feasibility study is designed to investigate the feasibility of remote recruitment and delivery of a brief visuospatial interference intervention 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
- 12 participants
- Where
- 1 siteIceland
- Study dates
- 15 Jan 2021to 1 Sep 2021
- 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 two intrusive memories over the previous week
- Reporting being bothered by intrusive memories over the past month (scoring at least a moderate or higher score on PCL-5 item 1)
- Being able and willing to complete 3-9 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
Official title: Remote Delivery of a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women: A Feasibility Study
This single case series feasibility study is designed to investigate the feasibility of remote recruitment and delivery of a brief visuospatial interference intervention for decreasing the number of intrusive memories of trauma among trauma-exposed women in Iceland. The current study is an extension on two studies already preregistered (NCT04209283 and NCT04342416) that included some aspects of in-person recruitment and/or intervention delivery (rather than fully remote as we aim for here). The intervention is a simple cognitive task (a memory cue followed by playing the computer game "Tetris") with accompanying information. A within-subjects multiple baseline AB design is used, in that the length of baseline ('A'; no intervention) and intervention ('B') phases vary within-subjects across individual intrusive trauma memories. Participants will aim to complete at least one week of the baseline ('A') phase followed by at least two intervention sessions with a researcher remotely (via telephone or secure video platform). Intervention sessions comprise the simple cognitive task alongside accompanying information presented in the form of brief animated videos (e.g., explaining the target symptom). Participants are instructed that they may continue using the technique self-guided in subsequent weeks, and they may opt for additional intervention sessions with remote researcher support (maximum 6 intervention sessions). 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 total intrusive memories in the fifth week after the second intervention session (primary outcome) compared to in the first baseline week. The investigators will also explore whether 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 is related to functioning and/or PTSD, depressive or anxiety symptoms.
Read the detailed description
Participants complete a total of 3-9 sessions with researchers and sessions will be conducted remotely via telephone or secure video platform (Kara Connect). In the baseline session, questionnaires are administered and the individual intrusive trauma memories will be logged for monitoring their frequency in a daily diary. Participants will record their intrusive memories in the daily diary for at least one week (Week -1) before commencing the intervention. In the first intervention session, a memory will be selected and targeted with the intervention (memory reminder followed by 25 min gameplay with mental rotation). We aim to deliver a second intervention session soon after the first (within approx. one week), targeting the same or a different intrusive memory. Participants are instructed that they may continue using the technique self-guided after the first intervention session, and they may opt for additional intervention sessions with remote researcher support (maximum 6 intervention sessions). Participants continue to monitor the frequency of both targeted and non-targeted intrusive memories in the daily diary throughout Weeks 0-5. Follow-up questionnaires are completed at Week 1, 1-month, and 3-months after the second intervention session. The primary outcome is change in total number of intrusive memories from the baseline week (Week -1) to the fifth week after the second intervention session (Week 5). Participants will also monitor the frequency of their intrusive memories for one week at the 3-month follow-up. The investigators note that the intended time-frames may differ slightly across participants depending on availability and the practicalities of remote delivery.
- 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
Also called Brief cognitive intervention
Two remote intervention sessions with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) alongside accompanying information.
Participants are instructed that they may continue using the technique self-guided after the first intervention session, and they may opt for additional intervention sessions with remote researcher support (maximum 6 intervention sessions).
| 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 (number of intrusive memories of trauma). Individual baseline phases will be used as control periods for the primary outcome.
Experimental: Intervention phase ('B'):
Measurements collected in a daily diary four times a day during the fifth week after the second intervention session for the primary outcome (number of intrusive memories of trauma). Receives: Behavioral: Visuospatial Interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total number of intrusive memories of trauma
Total number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) during the fifth week after the second intervention session (Week 5), compared to in the baseline week (Week -1).
Measured: Week 5 compared to Baseline (Week -1)
Secondary outcomes (11)
Change in the total number of intrusive memories of trauma
Total number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) during the week of receiving the first two intervention sessions (Week 0), the subsequent four weeks (Weeks 1-4) and a 3-month follow-up, compared to in the baseline week (Week -1).
Measured: Weeks 0-4 and 3-month follow-up compared to Baseline (Week -1)
Unwanted Memories of Trauma (UMT)
6 self-rated items measuring the frequency of unwanted memories of the trauma in the previous week on a 7-point scale (from never to many times a day) and the level of distress, nowness, reliving, disconnectedness and whether different triggers are associated with the unwanted memories of the trauma on a 11-point scale (from 0 to 100). High scores indicate more unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and more different triggers.
Measured: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
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), Week 1, 1-month and 3-month follow-ups
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 is scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
Measured: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
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 is scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
Measured: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
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), Week 1, 1-month and 3-month follow-ups
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
The WHODAS 2.0 is a 12-item self-rated questionnaire measuring difficulties due to health conditions, including mental or emotional problems (with reference to study event). Scores range from 1 ("none") to 5 ("extremely/cannot do"). The maximum score of the WHODAS is 60; lower scores indicate better functioning.
Measured: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
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), Week 1, 1-month and 3-month follow-ups
Rating of how long intrusive memories disrupted concentration on average
One item assessing for how long intrusive memories disrupted concentration on average on a 6-point scale (0 = <1 minute - 6 = > 60 minutes)
Measured: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
Impact of intrusive memories on functioning
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.)
Measured: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
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). Administered as part of the intrusive memory diary.
Measured: Baseline (Week -1), Weeks 0-5, 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 posted14 Jan 2021
- Study start15 Jan 2021
- Primary completion7 Jul 2021
- Study completion1 Sep 2021
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Andri Steinþór Björnsson, University of Iceland
- Investigators
- Andri Björnsson, PhD, Principal investigator, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709822
- Sponsor's protocol ID
- RDVIRMT
- Status last verified
- Dec 2021
- First submitted
- 12 Jan 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data is to be made openly available via the Open Science Framework for secondary research.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Delivery of a Brief Visuospatial Interference Intervention to Reduce Intrusive Memories Among Trauma Exposed Women: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04709822
- Acronym / sponsor ID
- RDVIRMT
- Conditions
- Trauma
- Keywords
- Intrusive memories
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 14 Jan 2021 (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 single case series feasibility study is designed to investigate the feasibility of remote recruitment and delivery of a brief visuospatial interference intervention for decreasing the number of intrusive memories of trauma among trauma-exposed women in Iceland. The current study is an extension on two studies already preregistered (NCT04209283 and NCT04342416) that included some aspects of in-person recruitment and/or intervention delivery (rather than fully remote as we aim for here). The intervention is a simple cognitive task (a memory cue followed by playing the computer game "Tetris") with accompanying information. A within-subjects multiple baseline AB design is used, in that the length of baseline ('A'; no intervention) and intervention ('B') phases vary within-subjects across individual intrusive trauma memories. Participants will aim to complete at least one week of the baseline ('A') phase followed by at least two intervention sessions with a researcher remotely (via telephone or secure video platform). Intervention sessions comprise the simple cognitive task alongside accompanying information presented in the form of brief animated videos (e.g., explaining the target symptom). Participants are instructed that they may continue using the technique self-guided in subsequent weeks, and they may opt for additional intervention sessions with remote researcher support (maximum 6 intervention sessions). 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 total intrusive memories in the fifth week after the second intervention session (primary outcome) compared to in the first baseline week. The investigators will also explore whether 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 is related to functioning and/or PTSD, depressive or anxiety symptoms.
Detailed description
Participants complete a total of 3-9 sessions with researchers and sessions will be conducted remotely via telephone or secure video platform (Kara Connect). In the baseline session, questionnaires are administered and the individual intrusive trauma memories will be logged for monitoring their frequency in a daily diary. Participants will record their intrusive memories in the daily diary for at least one week (Week -1) before commencing the intervention. In the first intervention session, a memory will be selected and targeted with the intervention (memory reminder followed by 25 min gameplay with mental rotation). We aim to deliver a second intervention session soon after the first (within approx. one week), targeting the same or a different intrusive memory. Participants are instructed that they may continue using the technique self-guided after the first intervention session, and they may opt for additional intervention sessions with remote researcher support (maximum 6 intervention sessions). Participants continue to monitor the frequency of both targeted and non-targeted intrusive memories in the daily diary throughout Weeks 0-5. Follow-up questionnaires are completed at Week 1, 1-month, and 3-months after the second intervention session. The primary outcome is change in total number of intrusive memories from the baseline week (Week -1) to the fifth week after the second intervention session (Week 5). Participants will also monitor the frequency of their intrusive memories for one week at the 3-month follow-up. The investigators note that the intended time-frames may differ slightly across participants depending on availability and the practicalities of remote delivery.
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 (number of intrusive memories of trauma). Individual baseline phases will be used as control periods for the primary outcome. Experimental: Intervention phase ('B'): Measurements collected in a daily diary four times a day during the fifth week after the second intervention session for the primary outcome (number of intrusive memories of trauma). |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having experienced at least one criterion A trauma according to the DSM-5
- Having at least two intrusive memories over the previous week
- Reporting being bothered by intrusive memories over the past month (scoring at least a moderate or higher score on PCL-5 item 1)
- Being able and willing to complete 3-9 sessions with researcher
- Being willing to monitor intrusive memories in daily life
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 InterferenceAlso: Brief cognitive interventionTwo remote intervention sessions with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) alongside accompanying information. Participants are instructed that they may continue using the technique self-guided after the first intervention session, and they may opt for additional intervention sessions with remote researcher support (maximum 6 intervention sessions). | Behavioural | Trauma exposed women |
Primary outcome
Change in the total number of intrusive memories of trauma
Time frame: Week 5 compared to Baseline (Week -1)
Total number of intrusive memories of traumatic event recorded by participants in a diary daily (morning, afternoon, evening and night) during the fifth week after the second intervention session (Week 5), compared to in the baseline week (Week -1).
11 secondary outcomes
Change in the total number of intrusive memories of trauma
Time frame: Weeks 0-4 and 3-month follow-up compared to Baseline (Week -1)
Unwanted Memories of Trauma (UMT)
Time frame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Time frame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
The Generalized Anxiety Disorder-7 scale (GAD-7)
Time frame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
The Sheehan Disability Scale (SDS)
Time frame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
Impact of intrusive memories on concentration, sleep and stress - ratings
Time frame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
Rating of how long intrusive memories disrupted concentration on average
Time frame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
Impact of intrusive memories on functioning
Time frame: Baseline (Week -1), Week 1, 1-month and 3-month follow-ups
General impact of intrusive memories - ratings
Time frame: Baseline (Week -1), Weeks 0-5, 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 10 Dec 2021.
- Individual participant dataSharing planned: Yes. Anonymised data is to be made openly available via the Open Science Framework for secondary research.
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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
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 7 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 10 Dec 2021. 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 total number of intrusive memories of trauma (time frame: Week 5 compared to Baseline (Week -1)). 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 10 Dec 2021; AzTrials last refreshed its copy on 31 Oct 2026.