Intrusive Memories of Traumatic Event(s)NCT05849337
The Lóa Study: A Brief Digital Intervention for Women With Intrusive Memories in the SAGA Cohort
A study testing Brief imagery-competing task, Brief psychoeducation and signposting task and Treatment as usual (TAU) 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, and can evoke strong emotions and disrupt functioning in daily life. Previous research has indicated 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 73 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrusive Memories of Traumatic Event(s)
- What is being tested?
- Brief imagery-competing task, Brief psychoeducation and signposting task and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteIceland
- Study dates
- 30 Oct 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 73 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part of the SAGA cohort
- Aged 18 or above.
- Able to read, write and speak in Icelandic.
- Have internet access.
- Willing to be contacted remotely and having access to a smartphone or computer
- Experience 3 or more intrusive memories in the past week
Show all 10Show fewer
- Willing to monitor intrusive memories in everyday life
- Willing and able to provide informed consent and complete study procedures
- Willing and able to be contacted by the research team during the study period.
- Have not taken part in a previous study of this intervention from this research team (e.g., the Loa case series, feasibility trial or pilot RCT).
Who cannot join
- Have fewer than three intrusive memories during the baseline week.
- Suicide risk in the initial assessment (response of 'nearly every day' to item 9 on PHQ-9).
- Those undergoing other treatments for post-traumatic stress disorder (PTSD) or its symptoms will not be excluded, so the study will be as inclusive as possible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Lóa Study: A Randomised Control Trial of a Brief Digital Intervention to Support Women Experiencing Intrusive Memories of Traumatic Events During Their Lifespan From the SAGA Cohort
Intrusive memories are sensory memories of a traumatic event(s) that spring to mind involuntarily, and can evoke strong emotions and disrupt functioning in daily life. Previous research has indicated 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 and a pilot study, ClinicalTrials.gov identifier: NCT05089058) with women in Iceland indicates that the intervention is acceptable and feasible.
This randomised controlled trial will compare 3 arms to investigate if access to a cognitive task - either a brief self-guided imagery-competing task or a brief self-guided psychoeducation and signposting task - versus treatment as usual, can reduce the number of intrusive memories in week 5 (i.e., between-groups comparison), controlling for the number of intrusive memories in the baseline week.
Read more
The effect on the number of intrusive memories in week 5 (primary outcome), and other symptoms of post-traumatic stress, sleep and cognitive functioning will be tested.
This study is funded by the Icelandic Research Fund (11709-0270) and (200095-5601) and The Oak Foundation (OCAY-18-442).
Read the detailed description
Participants will be recruited from the Stress and Gene Analysis (SAGA) Cohort, a population-based, longitudinal study of Icelandic women (www.afallasaga.is, see selected publications in the reference box below).
A statistical analysis plan will be prepared prior to the first interim analysis using both frequentist and Bayesian analyses for statistical inference.
Regular monitoring will be performed by Vistor to verify that the study is conducted, and data are generated, documented and reported in compliance with the protocol, good clinical practice (GCP) and the applicable regulatory guidelines.
- Conditions
- Intrusive Memories of Traumatic Event(s)
- Being tested
- Brief imagery-competing task, Brief psychoeducation and signposting task, Treatment as usual (TAU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief imagery-competing taskBehavioural
Two digital self-guided sessions of a brief digital imagery-competing task. A memory cue followed by playing a computer game with mental rotation instructions.
Brief psychoeducation and signposting taskBehavioural
Two digital self-guided sessions and access to psychoeducation and signposting regarding resources for psychological trauma in Iceland.
Routine care that participants would otherwise receive if having intrusive memories of traumatic events
| Study group | Role | What they receive |
|---|---|---|
| Brief imagery-competing task | Experimental | Access to a brief imagery-competing task for 24 weeks (with optional researcher support during the study) Receives: Behavioral: Brief imagery-competing task |
| Brief psychoeducation and signposting task | Experimental | Access to psychoeducation and signposting regarding resources for psychological trauma in Iceland for 24 weeks (with optional researcher support during the study) Receives: Behavioral: Brief psychoeducation and signposting task |
| Treatment as usual (TAU) | Other | Routine care that participants would otherwise receive if having intrusive memories of traumatic events. Receives: Other: Treatment as usual (TAU) |
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)
The number of intrusive memories of traumatic events recorded by participants in a brief daily online intrusive memory diary for 7 days.
Measured: Week 5 (all arms) controlling for run-in/baseline week
Secondary outcomes (4)
Number of intrusive memories of the traumatic event(s)
The number of intrusive memories of traumatic events recorded by participants in a brief daily online intrusive memory diary for 7 days.
Measured: Week 12 and week 24 follow-ups (all arms) controlling for run-in/baseline week
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
A 20-item questionnaire assessing the severity of PTSD symptoms corresponding to the DSM-5 criteria for PTSD. Items are rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("extremely"). Scores are summed to give a total severity score (ranging 0 to 80).
Measured: Baseline, week 5, week 12 and week 24 follow-ups
The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
A 7-item questionnaire assessing the frequency of disruptive nocturnal behaviours (e.g., acting out dreams, episodes of terror or screaming). 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 with higher scores indicating worse symptoms.
Measured: Baseline, week 5, week 12 and week 24 follow-ups
Cognitive Functions Scale
An 11 item questionnaire about cognitive functions in particular memory and concentration. Items are rated on a 5-point scale, from 1 ("every day") to 5 ("never"). Total scores range from 11 to 55; higher scores indicate less concentration and memory difficulties.
Measured: Baseline, week 5, week 12 and week 24 follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start30 Oct 2023
- Primary completion15 Apr 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Arna Hauksdottir, University of Iceland
- Investigators
- Arna Hauksdóttir, PhD, Principal investigator, University of IcelandEmily Holmes, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849337
- Sponsor's protocol ID
- 22-186
- Status last verified
- May 2026
- First submitted
- 27 Apr 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised research data will be made available on Open Science Framework (OSF) indefinitely
Publications
Jonsdottir SD, Hauksdottir A, Aspelund T, Jakobsdottir J, Runarsdottir H, Gudmundsdottir B, Tomasson G, Valdimarsdottir UA, Halldorsdottir T, Thordardottir EB. Risk factors for workplace sexual harassment and violence among a national cohort of women in Iceland: a cross-sectional study. Lancet Public Health. 2022 Sep;7(9):e763-e774. doi: 10.1016/S2468-2667(22)00201-8.
PubMed 36057275Yang Q, Thornorethardottir EB, Hauksdottir A, Aspelund T, Jakobsdottir J, Halldorsdottir T, Tomasson G, Runarsdottir H, Danielsdottir HB, Bertone-Johnson ER, Sjolander A, Fang F, Lu D, Valdimarsdottir UA. Association between adverse childhood experiences and premenstrual disorders: a cross-sectional analysis of 11,973 women. BMC Med. 2022 Feb 21;20(1):60. doi: 10.1186/s12916-022-02275-7.
PubMed 35184745Danielsdottir HB, Aspelund T, Thordardottir EB, Fall K, Fang F, Tomasson G, Runarsdottir H, Yang Q, Choi KW, Kennedy B, Halldorsdottir T, Lu D, Song H, Jakobsdottir J, Hauksdottir A, Valdimarsdottir UA. Adverse childhood experiences and resilience among adult women: A population-based study. Elife. 2022 Feb 1;11:e71770. doi: 10.7554/eLife.71770.
PubMed 35101173
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lóa Study: A Randomised Control Trial of a Brief Digital Intervention to Support Women Experiencing Intrusive Memories of Traumatic Events During Their Lifespan From the SAGA Cohort
- ClinicalTrials.gov ID
- NCT05849337
- Acronym / sponsor ID
- 22-186
- Conditions
- Intrusive Memories of Traumatic Event(s)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 May 2023 (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, and can evoke strong emotions and disrupt functioning in daily life. Previous research has indicated 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 and a pilot study, ClinicalTrials.gov identifier: NCT05089058) with women in Iceland indicates that the intervention is acceptable and feasible.
This randomised controlled trial will compare 3 arms to investigate if access to a cognitive task - either a brief self-guided imagery-competing task or a brief self-guided psychoeducation and signposting task - versus treatment as usual, can reduce the number of intrusive memories in week 5 (i.e., between-groups comparison), controlling for the number of intrusive memories in the baseline week.
The effect on the number of intrusive memories in week 5 (primary outcome), and other symptoms of post-traumatic stress, sleep and cognitive functioning will be tested.
This study is funded by the Icelandic Research Fund (11709-0270) and (200095-5601) and The Oak Foundation (OCAY-18-442).
Detailed description
Participants will be recruited from the Stress and Gene Analysis (SAGA) Cohort, a population-based, longitudinal study of Icelandic women (www.afallasaga.is, see selected publications in the reference box below).
A statistical analysis plan will be prepared prior to the first interim analysis using both frequentist and Bayesian analyses for statistical inference.
Regular monitoring will be performed by Vistor to verify that the study is conducted, and data are generated, documented and reported in compliance with the protocol, good clinical practice (GCP) and the applicable regulatory guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief imagery-competing task | Experimental | Behavioral: Brief imagery-competing taskAccess to a brief imagery-competing task for 24 weeks (with optional researcher support during the study) |
| Brief psychoeducation and signposting task | Experimental | Behavioral: Brief psychoeducation and signposting taskAccess to psychoeducation and signposting regarding resources for psychological trauma in Iceland for 24 weeks (with optional researcher support during the study) |
| Treatment as usual (TAU) | Other | Other: Treatment as usual (TAU)Routine care that participants would otherwise receive if having intrusive memories of traumatic events. |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Part of the SAGA cohort
- Aged 18 or above.
- Able to read, write and speak in Icelandic.
- Have internet access.
- Willing to be contacted remotely and having access to a smartphone or computer
Key exclusion criteria (3 listed)
- Have fewer than three intrusive memories during the baseline week.
- Suicide risk in the initial assessment (response of 'nearly every day' to item 9 on PHQ-9).
- Those undergoing other treatments for post-traumatic stress disorder (PTSD) or its symptoms will not be excluded, so the study will be as inclusive as possible.
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 imagery-competing taskTwo digital self-guided sessions of a brief digital imagery-competing task. A memory cue followed by playing a computer game with mental rotation instructions. | Behavioural | Brief imagery-competing task |
| Brief psychoeducation and signposting taskTwo digital self-guided sessions and access to psychoeducation and signposting regarding resources for psychological trauma in Iceland. | Behavioural | Brief psychoeducation and signposting task |
| Treatment as usual (TAU)Routine care that participants would otherwise receive if having intrusive memories of traumatic events | Other | Treatment as usual (TAU) |
Primary outcome
Number of intrusive memories of traumatic event(s)
Time frame: Week 5 (all arms) controlling for run-in/baseline week
The number of intrusive memories of traumatic events recorded by participants in a brief daily online intrusive memory diary for 7 days.
4 secondary outcomes
Number of intrusive memories of the traumatic event(s)
Time frame: Week 12 and week 24 follow-ups (all arms) controlling for run-in/baseline week
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: Baseline, week 5, week 12 and week 24 follow-ups
The Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)
Time frame: Baseline, week 5, week 12 and week 24 follow-ups
Cognitive Functions Scale
Time frame: Baseline, week 5, week 12 and week 24 follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 36057275Jonsdottir SD, Hauksdottir A, Aspelund T, Jakobsdottir J, Runarsdottir H, Gudmundsdottir B, Tomasson G, Valdimarsdottir UA, Halldorsdottir T, Thordardottir EB. Risk factors for workplace sexual harassment and violence among a national cohort of women in Iceland: a cross-sectional study. Lancet Public Health. 2022 Sep;7(9):e763-e774. doi: 10.1016/S2468-2667(22)00201-8.
- Background: PubMed 35184745Yang Q, Thornorethardottir EB, Hauksdottir A, Aspelund T, Jakobsdottir J, Halldorsdottir T, Tomasson G, Runarsdottir H, Danielsdottir HB, Bertone-Johnson ER, Sjolander A, Fang F, Lu D, Valdimarsdottir UA. Association between adverse childhood experiences and premenstrual disorders: a cross-sectional analysis of 11,973 women. BMC Med. 2022 Feb 21;20(1):60. doi: 10.1186/s12916-022-02275-7.
- Background: PubMed 35101173Danielsdottir HB, Aspelund T, Thordardottir EB, Fall K, Fang F, Tomasson G, Runarsdottir H, Yang Q, Choi KW, Kennedy B, Halldorsdottir T, Lu D, Song H, Jakobsdottir J, Hauksdottir A, Valdimarsdottir UA. Adverse childhood experiences and resilience among adult women: A population-based study. Elife. 2022 Feb 1;11:e71770. doi: 10.7554/eLife.71770.
- Individual participant dataSharing planned: Yes. Anonymised research data will be made available on Open Science Framework (OSF) indefinitely
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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.
Arna Hauksdóttir, PhD principal investigator
University of Iceland
Emily Holmes, PhD 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 imagery-competing task, Brief psychoeducation and signposting task and Treatment as usual (TAU) 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 10 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 (all arms) controlling for run-in/baseline week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05849337, which also lists 3 linked publications.
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 7 May 2026.