Intrusive Memories of Traumatic Event(s)NCT05089058
Lóa Project: An Exploratory Pilot Randomised Controlled Trial of a Remotely-delivered Brief Cognitive Intervention to Reduce Intrusive Memories of Trauma for Women in Iceland
A study testing Brief, digitally delivered imagery-competing task intervention package, comprised of: and Brief, digitally delivered relaxation task intervention, comprised of: in people with Intrusive Memories of Traumatic Event(s), run by University of Iceland at 1 site in Iceland.
Trial summary
Intrusive memories are sensory memories of a traumatic event(s) that spring to mind involuntarily, evoke strong emotions, and disrupt functioning in daily life. Previous research has demonstrated that a brief cognitive intervention can prevent the development of intrusive memories as well as reduce the number of… Read more about this study
- Who is it for?
- Ages 18 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrusive Memories of Traumatic Event(s)
- What is being tested?
- Brief, digitally delivered imagery-competing task intervention package, comprised of: and Brief, digitally delivered relaxation task intervention, comprised of:
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteIceland
- Study dates
- 1 Nov 2021to 4 Nov 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged: 18-69 (at time of enrollment to cohort study)
- Able to speak and read study materials in Icelandic or English
- Willing to be contacted remotely and having access to a smartphone or computer
- Experienced intrusive memories in past month (PCL-5 item 1 score is ≥ 2)
- Experienced 2 or more intrusive memories of a traumatic event in the past week
- Willing to monitor intrusive memories in everyday life
- Willing and able to complete remote study sessions
Who cannot join
- Suicide risk indicated in the initial assessment (response of 'nearly every day' to item 9 on PHQ-9) and by responses on MINI during follow-up telephone risk assessment
Trial locations and contacts
1 site in 1 country.
About this study
Intrusive memories are sensory memories of a traumatic event(s) that spring to mind involuntarily, evoke strong emotions, and disrupt functioning in daily life. Previous research has demonstrated that a brief cognitive intervention can prevent the development of intrusive memories as well as reduce the number of intrusive memories of long-standing trauma. Initial pilot work (using case studies) with women in Iceland indicates that the intervention is acceptable and feasible.
This exploratory pilot trial will compare remote delivery of the intervention (i.e. brief, digitally delivered imagery-competing task intervention, n = 12) to an attention-placebo control condition (i.e., brief, digitally delivered relaxation exercise task; n = 12). We will explore whether (relative to the control condition) the intervention: (i) reduces the number of intrusive memories (primary outcome), and (ii) improves other symptoms and functioning.
This study is funded by the OAK foundation (OCAY-18-442) and the Strategic Research and Development Program: Societal Challenges in Iceland (200095-5601).
Read the detailed description
The proposed study will involve a brief intervention (c. 2 guided sessions with the researcher; options for up to 6 additional booster sessions) delivered digitally and remotely (i.e., not physically in-person), and with initial guided support (remotely delivered) from a researcher. Participants will be asked to fill out a diary indicating the number of intrusive memories they experienced, along with self-report questionnaires, at baseline (i.e., one week prior to commencement of the intervention), week 1 (week after the second intervention/control session), week 5 (primary outcome; 5 weeks from the second intervention/control session), and at 1-, 3- and 6-months follow-up.
Monitoring will be performed by a clinical trial unit to verify that the study is conducted and data are generated and documented in compliance with GCP and the applicable regulatory requirements.
Potentially eligible participants for this pilot study will be identified using data collected in the SAGA cohort study (an epidemiological study of trauma among Icelandic women).
- Conditions
- Intrusive Memories of Traumatic Event(s)
- Being tested
- Brief, digitally delivered imagery-competing task intervention package, comprised of:, Brief, digitally delivered relaxation task intervention, comprised of:
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief, digitally delivered imagery-competing task intervention package, comprised of:Behavioural
Two sessions guided (remotely) by a researcher. Sessions comprised of:
(i) task procedure: a memory cue followed by playing imagery-competing computer game task with mental rotation instructions. Monitoring of intrusive memories to select hotspot cue, and which intrusion to target.
(ii) accompanying information, including rationale for the brief cognitive task.
(iii) option to use the brief cognitive task after the session (self-administered); option to engage in up to 6 guided booster sessions supported by a researcher.
Brief, digitally delivered relaxation task intervention, comprised of:Behavioural
Brief, digitally delivered relaxation task intervention, comprised of:
Two sessions guided (remotely) by a researcher. Sessions comprised of:
(i) relaxation exercise task using instruction components from progressive muscle relaxation
(ii) accompanying information, including rationale for the brief relaxation exercise task.
(iii) option to use the brief relaxation exercise task after the session (self-administered); option to engage in up to 6 guided booster sessions supported by a researcher.
| Study group | Role | What they receive |
|---|---|---|
| Brief cognitive task (delivered digitally) | Experimental | Not described Receives: Behavioral: Brief, digitally delivered imagery-competing task intervention package, comprised of: |
| Brief relaxation exercise task (delivered digitally) | Placebo comparator | Not described Receives: Behavioral: Brief, digitally delivered relaxation task intervention, comprised of: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intrusive memories of traumatic event(s)
Number of intrusive memories of traumatic event(s) recorded in a brief daily diary for 7 days
Measured: Week 5
Secondary outcomes (15)
Number of intrusive memories of traumatic event(s)
Number of intrusive memories of traumatic event(s) recorded in a brief daily diary for 7 days
Measured: Baseline, Week 1, Week 12 and Week 24
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
A 20-item questionnaire assessing the severity of PTSD symptoms corresponding to the DSM-5 criteria for PTSD. Symptoms are rated on a 5-point Likert-scale.
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Patient Health Questionnaire-9 (PHQ-9)
A 9-item questionnaire assessing depression symptoms and their severity. Items are scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Generalized Anxiety Disorder-7 scale (GAD-7)
A 7-item questionnaire designed as a screening tool for symptoms of GAD and their severity. Items are scored from 0 (i.e., not at all) to 3 (i.e., nearly every day).
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Characteristics of intrusive memories
6 self-rated items assessing 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 unwanted trauma memories (on an 11-point scale, from 0 to 100). Higher scores indicate more unwanted memories, higher levels of distress/nowness/reliving/disconnectedness and more different triggers.
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Impact of intrusive memories on concentration, sleep and stress
Assessed with six self-rated items anchored to the past week: two items assessing concentration difficulties in general and due to intrusive memories (11-point scale; high scores indicating more difficulties), one item assessing duration of disruption after experiencing intrusive memory (<1 minute to > 60 minutes), two items assessing sleep disturbance due to intrusive memories (11-point scale; higher scores indicating more sleep disturbance) and one item assessing the degree to which intrusive memories affected stress levels (0 = not at all; 10 = very much).
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
General impact of intrusive memories
Assessed with two self-rated items, one assessing the degree of distress associated with intrusive memories and the other assessing how vivid they were in the past week (both rated on an 11-point scale, 0 = not at all; 10 = very distressing; 0 = not at all; 10 = very vivid).
Measured: Baseline, Week 1, Week, 5, Week 12 and Week 24
Impact of intrusive memories on daily functioning
Assessed with four items. One question is self-rated: "Have the intrusive memories affected your ability to function in your daily life?" on an 11-point scale; higher score indicating greater impact on functioning. The other question is open-ended: "How have the intrusive memories affected your ability to function in your daily life in the past week?"). We will also explore whether there is a link between the content of participants' intrusive memories and specific domains of functioning - in open-ended discussion and using questions (asked at baseline) such as: "Are there any specific activities that you would like to do, but avoid because they are linked to your intrusive memories?" and "What change in your intrusive memories would make a meaningful difference in your life?" along with (asked at follow-ups, after the intervention/control task) "Since starting the study, are there any specific activities that you used to avoid (due to your intrusive memories), but now do more often?"
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Sheehan Disability Scale (SDS)
A self-report questionnaire assessing functional impairment across three domains: (1) Work/school, (2) social, and (3) family life. Domains are measured on an 11-point Likert scale, ranging from 0 (i.e., not at all) to 10 (i.e., extremely). The scale will be adapted to assess functional impairment associated with intrusive memories.
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
A 12-item questionnaire assessing 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"). Lower scores indicate better functioning.
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Psychological Outcome Profiles; PSYCHLOPS
A 4-item a patient-generated outcome measure of symptom-change after therapy/interventions, consisting of four items measuring three domains: problems (two items), function (one item), and well-being (one item). The patient chooses which symptoms or problems are most important to measure over the course of an intervention.
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Self-rated Health rating (SRHR)
A single item assessing perceived health status on a 4-point scale (very good to very bad). The scale is reverse-scored; higher scores indicate better health.
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
A 7-item self-report questionnaire assessing the frequency of disruptive nocturnal behaviours (e.g., acting out dreams, episodes of terror or screaming) common in PTSD. Respondents report symptoms over the past month on a 4-point Likert scale, ranging from 0 (never in the past month) to 3 (three or more times each week). Total score ranges from 0 to 21. A clinical score ≥ 4 will be used, which discriminates between participants with and without PTSD.
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Sleep Condition Indicator (SCI-2)
2 self-rated items; one assesses the extent to which the respondent is experiencing poor sleep (with reference to study event) on a 5-point scale (from not at all to very much), one assesses the number of nights in the week the respondent experiences sleep problems on 5-point scale (from 0-1 to 5-7 nights). Both 5-point scales are reverse scored (0 - 4) then summed. Possible total scores range from 0-8; higher values indicate better sleep.
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Time Perspective Questionnaire (TPQ)
8-items drawn or modified from both the Temporal Orientation Scale and the Zimbardo Time Perspective Inventory. Respondents rate how true statements are for them on a 5-point scale, from not at all true (1) to very true (5) (e.g., "My plans about the future are pretty well laid out", "It is best to live day-to-day").
Measured: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Nov 2021
- Primary completion23 Jun 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrusive Memories of Traumatic Event(s)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 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, Principal investigator, University of IcelandEmily Holmes, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089058
- Sponsor's protocol ID
- 20-214
- Status last verified
- Nov 2022
- First submitted
- 5 Oct 2021
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lóa Project: An Exploratory Pilot Randomised Controlled Trial of a Remotely-delivered Brief Cognitive Intervention to Reduce Intrusive Memories of Trauma for Women in Iceland
- ClinicalTrials.gov ID
- NCT05089058
- Acronym / sponsor ID
- 20-214
- Conditions
- Intrusive Memories of Traumatic Event(s)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 22 Oct 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.
Intrusive memories are sensory memories of a traumatic event(s) that spring to mind involuntarily, evoke strong emotions, and disrupt functioning in daily life. Previous research has demonstrated that a brief cognitive intervention can prevent the development of intrusive memories as well as reduce the number of intrusive memories of long-standing trauma. Initial pilot work (using case studies) with women in Iceland indicates that the intervention is acceptable and feasible.
This exploratory pilot trial will compare remote delivery of the intervention (i.e. brief, digitally delivered imagery-competing task intervention, n = 12) to an attention-placebo control condition (i.e., brief, digitally delivered relaxation exercise task; n = 12). We will explore whether (relative to the control condition) the intervention: (i) reduces the number of intrusive memories (primary outcome), and (ii) improves other symptoms and functioning.
This study is funded by the OAK foundation (OCAY-18-442) and the Strategic Research and Development Program: Societal Challenges in Iceland (200095-5601).
Detailed description
The proposed study will involve a brief intervention (c. 2 guided sessions with the researcher; options for up to 6 additional booster sessions) delivered digitally and remotely (i.e., not physically in-person), and with initial guided support (remotely delivered) from a researcher. Participants will be asked to fill out a diary indicating the number of intrusive memories they experienced, along with self-report questionnaires, at baseline (i.e., one week prior to commencement of the intervention), week 1 (week after the second intervention/control session), week 5 (primary outcome; 5 weeks from the second intervention/control session), and at 1-, 3- and 6-months follow-up.
Monitoring will be performed by a clinical trial unit to verify that the study is conducted and data are generated and documented in compliance with GCP and the applicable regulatory requirements.
Potentially eligible participants for this pilot study will be identified using data collected in the SAGA cohort study (an epidemiological study of trauma among Icelandic women).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief cognitive task (delivered digitally) | Experimental | Behavioral: Brief, digitally delivered imagery-competing task intervention package, comprised of: |
| Brief relaxation exercise task (delivered digitally) | Placebo comparator | Behavioral: Brief, digitally delivered relaxation task intervention, comprised of: |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged: 18-69 (at time of enrollment to cohort study)
- Able to speak and read study materials in Icelandic or English
- Willing to be contacted remotely and having access to a smartphone or computer
- Experienced intrusive memories in past month (PCL-5 item 1 score is ≥ 2)
- Experienced 2 or more intrusive memories of a traumatic event in the past week
Key exclusion criteria (1 listed)
- Suicide risk indicated in the initial assessment (response of 'nearly every day' to item 9 on PHQ-9) and by responses on MINI during follow-up telephone risk assessment
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 |
|---|---|---|
| Brief, digitally delivered imagery-competing task intervention package, comprised of:Two sessions guided (remotely) by a researcher. Sessions comprised of: (i) task procedure: a memory cue followed by playing imagery-competing computer game task with mental rotation instructions. Monitoring of intrusive memories to select hotspot cue, and which intrusion to target. (ii) accompanying information, including rationale for the brief cognitive task. (iii) option to use the brief cognitive task after the session (self-administered); option to engage in up to 6 guided booster sessions supported by a researcher. | Behavioural | Brief cognitive task (delivered digitally) |
| Brief, digitally delivered relaxation task intervention, comprised of:Brief, digitally delivered relaxation task intervention, comprised of: Two sessions guided (remotely) by a researcher. Sessions comprised of: (i) relaxation exercise task using instruction components from progressive muscle relaxation (ii) accompanying information, including rationale for the brief relaxation exercise task. (iii) option to use the brief relaxation exercise task after the session (self-administered); option to engage in up to 6 guided booster sessions supported by a researcher. | Behavioural | Brief relaxation exercise task (delivered digitally) |
Primary outcome
Number of intrusive memories of traumatic event(s)
Time frame: Week 5
Number of intrusive memories of traumatic event(s) recorded in a brief daily diary for 7 days
15 secondary outcomes
Number of intrusive memories of traumatic event(s)
Time frame: Baseline, Week 1, Week 12 and Week 24
The Posttraumatic Stress Disorder Checklist 5 (PCL-5)
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Generalized Anxiety Disorder-7 scale (GAD-7)
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Characteristics of intrusive memories
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Impact of intrusive memories on concentration, sleep and stress
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
General impact of intrusive memories
Time frame: Baseline, Week 1, Week, 5, Week 12 and Week 24
Impact of intrusive memories on daily functioning
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Sheehan Disability Scale (SDS)
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Psychological Outcome Profiles; PSYCHLOPS
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Self-rated Health rating (SRHR)
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Sleep Condition Indicator (SCI-2)
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
Time Perspective Questionnaire (TPQ)
Time frame: Baseline, Week 1, and 1-month, 3-month and 6-month follow-ups
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 17 Nov 2022.
- Individual participant dataSharing planned: Yes
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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 principal investigator
University of Iceland
Emily Holmes principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief, digitally delivered imagery-competing task intervention package, comprised of: and Brief, digitally delivered relaxation task intervention, comprised of: in people with Intrusive Memories of Traumatic Event(s), 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 1 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 17 Nov 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. Some participants in this study may receive a placebo. 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?
Number of intrusive memories of traumatic event(s) (time frame: Week 5). 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 17 Nov 2022.